JONS August 2014

August 2014 • Vol 5, NO 4

Special Abstract Issue

Fifth Annual Navigation and Survivorship Conference Orlando, Florida • Walt Disney World Dolphin Hotel

Categories Include: Category I: Patient Education Category II: Psychological Support Category III: Quality, Outcomes, and Performance Improvement Category IV: Original Research on Navigation Programs Category V: Original Research on Survivorship Programs Category VI: Community Outreach and Screening Programs

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YEA R ANN IVER SARY

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YE A R A NNI V E R S A RY

Navigating Patients Across the Continuum of Cancer Caretm

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LETTERS FROM LILLIE

Editor-in-Chief

Lillie D. Shockney, RN, BS, MAS

Lillie D. Shockney, RN, BS, MAS University Distinguished Service Assoc Prof of Breast Cancer, Depts of Surgery & Oncology; Admin Director, The Johns Hopkins Breast Center; Admin Director, Johns Hopkins Cancer Survivorship Programs; Assoc Prof, JHU School of Medicine, Depts of Surgery, Oncology & Gynecology and Obstetrics; Assoc Prof, JHU School of Nursing shockli@jhmi.edu

Section Editors

Breast Cancer Sharon S. Gentry, RN, MSN, AOCN, CBCN

Breast Health Navigator Novant Health Derrick L. Davis Cancer Center

We are into the final countdown with just a few weeks before our Fifth Annual Academy of Oncology Nurse & Patient Navigators (AONN+) Conference!

This issue of the Journal of Oncology Navigation & Survivorship (JONS) provides a preview of the posters that will be on display and presented at the conference. This year we have a total of 56 abstracts, each with a specific focus on the navigation or survivorship care process. The categories for abstracts are: Category I: Patient Education Category II: Psychological Support Category III: Quality, Outcomes, and Performance Improvement Category IV: Original Research on Navigation Programs Category V: Original Research on Survivorship Programs Category VI: Community Outreach and Screening Programs Each abstract is also a candidate for expanding its content and being considered for a future issue of JONS. We will have the poster presentation winners by category in an upcoming issue of JONS. I hope you are present at the conference to personally congratulate the winners with me.

As you read through these abstracts, give thought to how you might use this new information and knowledge so that, perhaps, it could be applied in your navigation and survivorship program. There is no benefit in reinventing the wheel! I also hope that it triggers you to consider submitting an abstract of your own at next year’s AONN+ Conference.

Mark your calendars now! The Sixth Annual AONN+ Conference will take place October 1-4, 2015, in Atlanta, GA. I hope to see you in September in Orlando. We have a great lineup of speakers, very innovative and thought-provoking presentations, networking opportunities for everyone, and there is a good chance that you will spot a Disney character or 2. I will have my Mickey Mouse ears on! Please make a point of coming over to me and introducing yourself!

With kind regards,

Lillie D. Shockney, RN, BS, MAS Editor-in-Chief

Cancer Rehabilitation & Survivorship Julie K. Silver, MD Assistant Professor Harvard Medical School

Genetic Counseling

Cristi Radford, MS, CGC Gene Mavens, LLC

Healthcare Disparities Linda Fleisher, PhD, MPH

Asst VP, Office of Health Communications and Health Disparities Asst Prof, Cancer Prevention and Control Fox Chase Cancer Center

Health Promotion and Outreach Iyaad Majed Hasan, DNP, CNP

Director and Nurse Practitioner Survivorship Clinic and Program Cleveland Clinic, Taussig Cancer Center

Patient-Centered Care Mandi Pratt-Chapman, MA Director GW Cancer Institute

Marcy Poletti, RN, MSN

Nursing Operations Supervisor Wake Forest University Baptist Medical Center

Penny Widmaier, RN, MSN Oncology Nurse Navigator Botsford Cancer Center

Prostate Cancer Frank dela Rama, RN, MS, AOCNS

Clinical Nurse Specialist Oncology/Genomics, Cancer Care Clinic Palo Alto Medical Foundation

Thoracic Oncology Pamela Matten, RN, BSN, OCN St. Joseph Hospital

Quality, Outcomes, and Performance Improvement Committee Co-Chairs

Elaine Sein, RN, BSN, OCN, CBCN Danelle Johnston, RN, MSN, OCN, CBCN

Mission Statement

The Journal of Oncology Navi­ gation & Survivorship (JONS ) promotes reliance on evidence-based prac­ tices in navigating patients with cancer and their caregivers through diagnosis, treatment, and survivorship. JONS also seeks to strengthen the role of nurse and patient navigators in cancer care by serving as a platform for these professionals to disseminate original research findings, exchange best practices, and find support for their growing community.

JONS-online.com journal of Oncology Navigation & Survivorship

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PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com Senior Vice President, Sales & Marketing Philip Pawelko ppawelko@the-lynx-group.com Vice President/Director of Sales & Marketing Joe Chanley jchanley@the-lynx-group.com Group Director, Sales & Marketing John W. Hennessy jhennessy2@the-lynx-group.com

Table of ConTents

Publishers Russell Hennessy rhennessy@the-lynx-group.com

august 2014 • Vol 5, NO 4

Special Abstract Issue

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Fifth Annual Navigation and Survivorship Conference

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Category I: Patient Education

16 Category II: Psychological Support 22 Category III: Quality, Outcomes, and Performance Improvement

50 Category IV: Original Research on Navigation Programs 55 Category V: Original Research on Survivorship Programs

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Category VI: Community Outreach and Screening Programs

Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Manager Jini Gopalaswamy Project Coordinators Mike Kodada Deanna Martinez IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski Administrative Coordinator Stephanie Ramadan Office Coordinator Robert Sorensen Green Hill Healthcare Communications, LLC 1249 South River Road - Ste 202A • Cranbury, NJ 08512 Phone: 732.656.7935 • Fax: 732.656.7938

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august 2014 • Volume 5, number 4

Journal of Oncology Navigation & Survivorship, ISSN 2166-0999 (print); ISSN 2166-0980 (online), is published 6 times a year by Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Telephone: 732.656.7935. Fax: 732.656.7938. Copy­right © 2014 by Green Hill Health­care Com­muni­cations, LLC. All rights reserved. Journal of Oncology Navigation & Survivorship logo is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America.

EDITORIAL CORRESPONDENCE should be ad­­dressed to EDITORIAL DEPARTMENT, Journal of Oncology Navigation & Survivorship (JONS), 1249 South River Road, Suite 202A, Cranbury, NJ 08512. E-mail: jbrandt@the-lynx-group.com. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $50.00; institutions, $90.00; single issues, $5.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPART­MENT, Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. The ideas and opinions expressed in JONS do not necessarily reflect those of the editorial board, the editorial director, or the publisher. Publication of an advertisement or other product mentioned in JONS should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the editorial board nor the publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications. It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician. Please convey any errors to the editorial director.

AONNonline.org

Now enrolling: MURANO study Investigating the Selective BCL-2 Inhibitor GDC-0199/ABT-199 in Chronic Lymphocytic Leukemia GDC-0199/ABT-199 is an investigational agent that has not been approved by regulatory agencies.

A Phase III Study of GDC-0199/ABT-199 Plus Rituximab Compared With Bendamustine Plus Rituximab in Patients With Relapsed or Resistant Chronic Lymphocytic Leukemia (CLL)

GDC-0199/ABT-199 + rituximab

Phase III Relapsed or resistant CLL (N=370)

GDC-0199/ABT-199 continued for 2 years or until disease progression

Bendamustine + rituximab Randomize Primary Endpoint

Secondary Endpoints

• Investigator-assessed progression-free survival, defined as time from randomization until disease progression or death from any cause

• Overall response rate • Incidence of adverse events

Key Inclusion Criteria

Key Exclusion Criteria

• Adult patients ≥18 years of age • Diagnosis of CLL per diagnostic criteria and relapsed or refractory CLL per the iwCLL guidelines • Previously treated with 1-3 lines of therapy (eg, completed ≥2 treatment cycles per therapy), including ≥1 standard chemotherapy-containing regimen • Previously treated with bendamustine, only if duration of response was ≥24 months • ECOG performance status of 0-1 • Adequate bone marrow function • Adequate renal and hepatic function

• Transformation of CLL to aggressive non-Hodgkin lymphoma or CNS involvement by CLL • Undergone an allogenic stem-cell transplant • A history of significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease • Hepatitis B, hepatitis C, or known HIV-positive • Receiving warfarin treatment • Received an anti-CLL monoclonal antibody within 8 weeks prior to the first dose of study drug • Received any anticancer or investigational therapy within 14 days prior to the first dose of study drug or has not recovered from previous therapy • Received CYP3A4 inhibitors (such as fluconazole, ketoconazole and clarithromycin) or inducers (such as rifampin, carbamezapine, phenytoin, St John’s Wort) within 7 days prior to the first dose of GDC-0199/ABT-199 • Prior GDC-0199/ABT-199 treatment

To learn more about this study, please visit www.ClinicalTrials.gov (NCT02005471, GO28667) or call the Trial Information Support Line at 1-888-662-6728.

GDC-0199/ABT-199 is being codeveloped by AbbVie and Genentech, a member of the Roche Group.

© 2014 Genentech USA, Inc. All rights reserved. BIO0002506000 Printed in USA.

Reference: ClinicalTrials.gov, as of 5/2014.

A2396579

Fifth annual aonn+ conference abstracts

CATEGORY I: Patient Education Using a Financial Assistance Program as a Gateway to Support and Education for Underserved Breast Cancer Survivors Catherine Creme Henry, MA; Arin Ahlum Hanson, MPH, CHES Living Beyond Breast Cancer

Objectives: (1) To learn about Living Beyond Breast Cancer, (LBBC) regional grant program and its national education and support programs; (2) To understand the demographics served by LBBC’s grant program and identify their unique needs as breast cancer survivors; (3) To share innovative interventions to engage and support underserved breast cancer survivors that can be used by oncology nurse navigators Background: LBBC’s Cis B. Golder Quality of Life Grant assists with the financial burden of breast cancer treatment. Since 2006, the grant has funded more than 1100 women and helped pay bills such as rent/mortgage (53% of funds disbursed), utilities (34%), and childcare percentage. More than $1 million has been distributed in the Philadelphia area—90% of recipients earn less than 300% of the federal poverty line; 41% are African American; and 60% live in urban counties. A 2010 needs assessment indicated that recipients were not familiar with LBBC’s programs and had limited interactions with the organization. For many recipients, personal and financial crises made seeking information and support a low priority. Methods: Interventions were developed to increase contact time with recipients and provide personalized invitations to other LBBC education and support programs. All applicants receive a peer support phone call from an LBBC Breast Cancer Helpline volunteer to share information about upcoming programs and refer them to resources to meet their needs. Special invitations are sent to recipients offering registration fee waivers to LBBC conferences and inviting them to tailored programs for low-income families. Results: More than half (65%) of the applicants were previously unaware of LBBC and its support and education programs. All applicants receive 10 to 20 minutes of phone peer support and invitations to 2 local programs. Applicants receive several breast cancer publications on topics related to their concerns or experience. A nutrition-on-a-budget education series was piloted in 2013 to address recipients’ other wellness needs and provide meals. Fourteen women participated and reported that the program increased their knowledge of other nutrition resources available to them (70%), improved their confidence in cooking healthy meals (85%), and increased their likelihood of using other LBBC services (85%). Conclusions: A financial assistance program provides a unique opportunity to engage underserved breast cancer survivors who may not otherwise seek support and education from an organization. The addition of peer support interventions helps assess and alleviate other concerns and connects recipients to a support system that they can access throughout their experience. Although LBBC’s financial assistance is regionally restricted, its interventions can act as a model for other grant programs.

Changes in Physical Activity Among Breast Cancer Patients Enrolled in a YMCA Program Joan Giblin, NP; Carla J. Berg, PhD; Erin Stratton, MPH; Deborah W. Bruner, PhD; Andrew H. Miller, MD; Rebecca Gary, PhD Living Beyond Breast Cancer

Little research has examined the promotion of community-based approaches to increase physical activity (PA) among cancer survivors, psychosocial factors predicating changes in PA, and the potential impact of increased PA on quality of life. Thus, the current study aimed to: (1) test the feasibility and acceptability of a coach-assisted, community-based exercise intervention at the Atlanta YMCA in Georgia targeting breast cancer survivors as well as its impact on PA; (2) examine psychosocial correlates of change in PA from baseline to week 24; and (3) determine the association between change in PA and quality of life among breast cancer survivors. We recruited 50 individuals diagnosed with breast cancer within 2 years of enrollment who were seen at the Winship Cancer Institute Cancer Survivorship Clinic. They were provided a 24-week membership to the YMCA and “The Coach Approach” program involving 3 prescribed exercise sessions each week. At baseline and week 24, we administered the Godin Leisure-Time Exercise Questionnaire, Patient Health Questionnaire-9 item, Multidimensional Fatigue Inventory, Multidimensional Scale of Perceived Social Support, and Functional Assessment of Cancer Therapy-General. Participants’ average age was 54.36 years (standard deviation [SD] =

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CATEGORY I: Patient Education 10.65), 50% were white, 50% were black, and 58% had a bachelorâ&#x20AC;&#x2122;s degree or higher. Average time since treatment completion was 23.80 weeks (SD = 32.04). We achieved 80% retention at week 24. Overall, 58% had a record of meeting with a coach, with an average of 3.14 (SD = 1.56) meetings among those who never met with a coach. Additionally, 82% had a record of attending the YMCA for an exercise session with an average of 27.59 (SD = 25.77) exercise sessions among these participants. Those who attended the YMCA reported favorable process outcomes (eg, 97.2% reported they would recommend the program to other survivors). While there were no differences in change in PA from baseline to week 24 between those who had any record of attendance at the YMCA or who met with a coach versus those who did not (M = 3.75 [SD = 4.73] vs M = 5.50 [SD = 1.78], respectively; P = .472), there were significant increases in PA from baseline to week 24 among all participants (M = 3.66 [SD = 3.35] vs M = 7.59 [SD = 4.46]; P <.001). No baseline psychosocial measures predicted change in PA. Notably, change in PA was not correlated with changes in total quality of life or any subscale measure (physical, social, emotional, functional). In conclusion, breast cancer patients report increases in PA over time, potentially due to feeling better over time or due to messages given to them by their healthcare providers regarding the importance of PA for cancer survivors. This pilot study has limitations that should be addressed in future research to examine these associations in larger samples over longer periods of time.

Preadmission Stem Cell Transplant Teaching: A Team Approach Tina Scherer, RN, MSN, OCN

Helen F. Graham Cancer Center, Christiana Care Health System

The Hematology Stem Cell Transplant Education Team addresses the educational and psychosocial needs of transplant patients in a multidisciplinary fashion. Central to this formal education plan is the unique partnership of the Oncology Certified RN Hematology Navigator and Health Psychologist who assess these needs throughout the continuum of care.

The process centers around a customized patient/caregiver educational meeting at which time comprehensive participative needs assessment and psychosocial evaluation are completed, goals are developed, and interventions are initiated and brought to discussion with the entire Stem Cell Transplant Team.

Because of the complexity of the transplant process, adequate tailored patient and caregiver education is crucial. Our purpose is to perform a coordinated assessment process to identify immediate and future educational and psychosocial needs and to develop an educational plan to foster patient/caregiver empowerment. This educational program results in a better understanding and compliance with treatment plan recommendations.

The need for earlier referrals to the Nurse Navigator and Psychologist team was recognized, and the weekly multidisciplinary bone marrow transplant meeting serves as this initial referral. Now the treatment plan is completed collaboratively by the entire transplant team. This plan provides initial insight into the educational and psychosocial needs of the patient/caregiver.

Prior to the patient/caregiver meeting, an educational binder is individualized based on transplant type. This binder guide provides the written materials necessary to satisfy alternative learning styles. A needs assessment to investigate knowledge, financial, and psychosocial issues of the patient/caregiver is performed, and an exclusive teaching plan is immediately initiated.

After the meeting, referrals are made to ancillary support services and community agencies for continued assistance, assessment, and education.

We have found our up-front assessment and screening followed by individual instruction has attained a more successful learning experience. Our patients have verbalized a marked decrease in anxiety and increase in knowledge, which has facilitated better compliance with the treatment plan. Based on assessment of knowledge and understanding, the physicians concur upon signing the informed consent.

This project stresses the importance of the nurseâ&#x20AC;&#x2122;s role in patient education, which can be duplicated in various practice settings.

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CATEGORY I: Patient Education Adjuvant Treatment with Toremifene in Hormone Receptor–Positive Breast Cancer: A Systematic Review of the Literature Carolyn Lavender, MSN, AOCNP, ARNP1; Deborah Braccia, PhD, MPA, RN1; Marcelle Kaplan, RN, MS, AOCN, CBCN2; Fiona M Herr, PhD3 1

ProStrakan, Inc; 2Adelphi University; 3Aranmore Medical Communications

Objective: To review all published data on the efficacy and safety of toremifene use in the adjuvant treatment of hormone receptor–positive breast cancer. Significance: Endocrine therapy is an integral part of the backbone for hormone receptor– positive breast cancer treatment. Toremifene and tamoxifen are approved for hormone receptor–positive metastatic breast cancer. Tamoxifen is also approved for use in adjuvant breast cancer; however, tamoxifen may not be appropriate for all patients. Therefore, alternatives to tamoxifen in the adjuvant setting should be explored.

Purpose: To review and assess all available data on the efficacy and safety of toremifene in the adjuvant treatment setting.

Methods: Systematic review of PubMed using the search terms “toremifene and adjuvant,” “Fareston and adjuvant,” “tor­ emifene and early breast,” or “Fareston and early breast.” Results: Five published prospective trials, 2 retrospective trials, and 2 meta-analyses examining the use of toremifene versus tamoxifen in the adjuvant setting were identified. Combined, the 5 prospective trials gave toremifene (40 or 60 mg) to 1557 women compared with tamoxifen (20 mg) to 1533 women for 2 to 5 years. A combined analysis of 1035 women enrolled in 2 different trials showed similar disease-free survival (DFS), overall survival (OS), and recurrence rates after a mean 5.5 years of follow-up. A separate study showed similar time to recurrence, risk of recurrence, and OS rates with 3 years of therapy with tamoxifen or toremifene. Another study in patients with 5 years of toremifene therapy demonstrated equivalent OS with a median follow-up of 59 months. A recent phase 3 prospective study in postmenopausal women reported noninferiority of adjuvant treatment with toremifene compared with tamoxifen. Both treatments were safe and well tolerated, with no significant differences in the frequency or severity of adverse events in each of these adjuvant trials. A retrospective study in premenopausal women examined records from 452 patients and showed similar OS with improved DFS with adjuvant toremifene compared with tamoxifen.

A second retrospective study with 1847 patients found similar efficacy results. Finally, 2 recent meta-analyses involving more than 3700 patients both reported similar OS, DFS, and safety in patients given adjuvant tamoxifen or toremifene.

Discussion: A series of published studies indicate toremifene is as effective and safe as tamoxifen in the adjuvant setting.

Differences in Metabolite Activity of the Selective Estrogen Receptor Modulators Tamoxifen and Toremifene: Clinical Implications for Patients with Hormone Receptor– Positive Breast Cancer Marcelle Kaplan, RN, MS, AOCN, CBCN1; Carolyn Lavender, MSN, AOCNP, ARNP2; Deborah Braccia, PhD, MPA, RN2 Adelphi University; 2ProStrakan, Inc

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Objective: To review published data on the metabolism of toremifene and assess any implications for treatment decisions.

Significance: The use of selective estrogen receptor modulators (SERMs) forms part of the treatment backbone of hormone receptor–positive breast cancer. Studies have shown that tamoxifen and toremifene, the 2 SERMs approved for the treatment of hormone receptor–positive breast cancer, have similar efficacy and safety profiles. Although tamoxifen metabolism has been extensively studied, there has been limited information regarding toremifene metabolism and any potential implications for practice. Purpose: To review recent data on the metabolism of toremifene as well as significant drug–drug interactions that may impact treatment decisions. Methods: A literature review of PubMed was conducted using the search terms “toremifene,” “metabolism,” “Fareston,” “cytochrome P450,” and “CYP2D6.” Results: Toremifene is thought to be active in its parent form, and is mainly metabolized in the liver by cytochrome (CY) P3A4. In contrast, tamoxifen requires metabolism by CYP2D6 to be converted to its biologically active 4-hydroxyl metabolites. Data suggest that potent CYP2D6 inhibitors, such as certain selective serotonin reuptake inhibitors (SSRIs), can result in alterations in plasma concentrations of the 4-hydroxyl metabolites of tamoxifen. Although published studies on the use of SSRIs and

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Fifth annual aonn+ conference abstracts

CATEGORY I: Patient Education outcome of adjuvant therapy with tamoxifen remain discordant, National Comprehensive Cancer Network guidelines currently recommend against coadministration of strong inhibitors of CYP2D6 and tamoxifen. A series of recent studies directly compared the metabolic activity of toremifene and tamoxifen in human liver microsomes and showed that metabolism of toremifene was unaffected by the presence of potent CYP2D6 inhibitors or by CYP2D6 genetic status. However, metabolism of tamoxifen was significantly altered by CYP2D6 inhibitors and CYP2D6 genetic status. Concentrations of the active form of toremifene were unaffected by SSRIs or the potential variation in CYP2D6 genetic status. Discussion: Although variations in CYP2D6 metabolic activity cause differences in plasma concentrations of active tamoxifen metabolites, the debate regarding the clinical sequelae of the CYP2D6 alterations and outcomes in patients taking tamoxifen is ongoing. Potential drug窶電rug interactions with SSRIs may alter the efficacy of tamoxifen and thereby inform treatment choices. Toremifene is unaffected by coadministration with SSRIs and represents a well-studied SERM option for treating patients with estrogen-positive breast cancer where CYP2D6 inhibition may be of concern.

Risk of Chemotherapy-Induced Anemia Among Patients Diagnosed with Lung Cancer Hairong Xu, MD, PhD1; Lanfang Xu, MSc2; John H. Page, MD, MSc, ScD1; Olivia Sattayapiwat, MSc2; Roberto Rodriguez, MD3; Chun Chao, PhD2 1

Amgen Inc; 2Kaiser Permanente Southern California; 3Los Angeles Medical Center, Kaiser Permanente Southern California

Introduction: Anemia is a common complication of chemotherapy that can cause clinically important symptoms and reduced quality of life. Yet, little data exist on the burden of chemotherapy-induced anemia (CIA) in current oncology practice. Objective: To estimate the incidence and severity of CIA in patients with lung cancer receiving chemotherapy.

Methods: Patients diagnosed with incident lung cancer who received chemotherapy were identified from the Kaiser Permanente Southern California Health Plan (2010-2012). Patients who had anemia before chemotherapy (ie, diagnosis of inherited anemia or hemoglobin [Hb] measurement <10 g/dL within 3 months prior to chemotherapy initiation) were excluded. All clinical data were collected from electronic medical records. Anemia was classified by severity (grade I: 10 g/dL to lower limit of normal; grade II: 8.0-9.9 g/dL; grade III: 6.5-7.9 g/dL; grade IV: <6.5 g/dL). Incidence proportions of patients developing CIA were calculated overall and by CIA severity and morphologic type, as well as by stage at cancer diagnosis, chemotherapy regimen, and cycle. Results: A total of 888 patients with lung cancer who received chemotherapy were included. The mean age was 67 years. The stage distribution was 4.5% stage I, 9.2% stage II, 27.8% stage III, and 58.5% stage IV. The most frequent regimens were carboplatin plus paclitaxel (34.1%), carboplatin plus etoposide (23.5%), and pemetrexed plus cisplatin/carboplatin (18.2%). A total of 827 patients (incidence proportion 93%; 95% confidence interval, 91%-95%) developed anemia during the first course of chemotherapy (51% grade I, 35% grade II, 12% grade III, and <2% grade IV; normocytic 84%, macrocytic 11%, microcytic 4%, normochromic 43%, hyperchromic 50%, hypochromic 7%). The risk of moderate-to-severe anemia (grades II-IV, Hb <10 g/dL) is 48% in stage IV disease compared with 35% in stage I. The incidence of severe anemia (grades III-IV, Hb <8 g/dL) is approximately 14% in patients with stage IV disease. Conclusions: The risk of moderate-to-severe CIA (Hb <10 g/dL) is approximately 45% overall in patients with lung cancer receiving chemotherapy, and this risk is greater in patients with distant metastasis. The risk of severe anemia (Hb <8 g/dL) is more than 10% in patients with lung cancer receiving chemotherapy.

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CATEGORY I: Patient Education Efficacy of a Transdermal Granisetron Patch in Controlling Chemotherapy-Induced Nausea and Vomiting in Patients with Head and Neck Cancer Doru Paul, MD

Monter Cancer Center–NorthShore-LIJ Health Systems

Objective: To examine the efficacy of a transdermal granisetron patch for controlling chemotherapy-induced nausea and vomiting (CINV) in patients with head and neck cancer. Significance: Patients with head and neck cancer can experience mechanical obstruction or dysphagia, making adherence to oral medications, including common oral antiemetics, very difficult. A granisetron transdermal system (GTS) has been shown to be as effective as oral granisetron in controlling CINV across multiple tumor types. This post hoc analysis specifically examined the efficacy and safety of GTS in difficult-to-treat patients with head and neck cancer. Purpose: To compare the rates of complete control (CC; no vomiting, mild nausea, no rescue medication), complete response (CR; no vomiting, no rescue medication), need for rescue medication, and patient-reported assessment in patients with head and neck cancer using either GTS or oral granisetron.

Methods: A randomized, phase 3 study has been published comparing GTS (7-day application) to oral granisetron (2 mg/ day) in patients receiving either moderately or highly emetogenic chemotherapy for 3 to 5 days. Data for this analysis were limited to patients with head and neck primary tumors. Results: Seventy-one patients (38 GTS, 33 oral granisetron) were included. The CC rate of 66% and CR rate of 68% in the GTS group were similar to rates in the overall population. There was no difference in CC, CR, and use of rescue medication between GTS and oral granisetron (P = .94, P = .91, and P = .57, respectively). Patient assessment of overall response to therapy was not different between arms (P = .26). GTS was well tolerated and treatment-related adverse events were mild. Discussion: This retrospective analysis suggests GTS may be an appropriate option for prevention of CINV in patients with head and neck cancer at high risk of dysphagia treated with chemotherapy.

Nursing Roles in Coordinating an Efficient Workflow for Radium-223 Dichloride (Ra-223) Administration Gabrielle Arauz, RN, BSN, OCN1; Tara Kilkenny, RN, BSN, OCN1; Anne-Kirsti Aksnes, MSc, PhD2; Mona Wahba, MD, MSM3; Tracy Curley, RN, OCN1 Memorial Sloan Kettering Cancer Center; 2Algeta ASA (Bayer); 3Bayer HealthCare

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Background: Radium-223 dichloride (Ra-223), a first-in-class alpha-emitting radiopharmaceutical that selectively targets bone metastases (mets) with high-energy, short-range (2-10 cell diameters) alpha particles, is approved for the treatment of patients with castration-resistant prostate cancer (CRPC) with symptomatic bone mets and no visceral metastatic disease. Administering Ra-223 involves a multidisciplinary team, including nurses who are vital in coordinating patient care and facilitating efficient workflow throughout Ra-223 treatment. Objectives: Essential to the success of an interdisciplinary therapy, such as Ra-223, is a clearly defined workflow to help patients navigate the cancer care continuum. Nurses play critical roles in educating patients and coordinating care across clinical disciplines. Here we present phase 3 ALSYMPCA trial efficacy and safety data that support using Ra-223 in patients with CRPC, along with key information on the multidisciplinary teams involved in Ra-223 administration, to help guide nurses in facilitating effective workflow. Methods: In ALSYMPCA, eligible patients had progressive, symptomatic CRPC with ≥2 bone mets and no known visceral mets; were receiving best standard of care; and had either previously received, were unfit to receive, or declined docetaxel. Patients were randomized 2:1 to 6 intravenous injections of Ra-223 (50 kBq/kg every 4 weeks; n = 614) or placebo (n = 307). The primary end point was overall survival (OS); secondary end points included symptomatic skeletal events (SSEs) and safety. Results: Ra-223 significantly improved OS (median, 14.9 vs 11.3 months; hazard ratio [HR] = 0.70; 95% confidence interval [CI], 0.58-0.83) and delayed time to first SSE (median, 15.6 vs 9.8 months; HR = 0.66; 95% CI, 0.52-0.83) versus placebo in patients with CRPC with symptomatic bone mets. Ra-223 also had a favorable safety profile with mild gastrointestinal events and a low incidence of myelosuppression. Successful Ra-223 administration depends on patient education Continued on page 15

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THE EVOLVING MBC LANDSCAPE...

Indication

Halaven is indicated for the treatment of patients with metastatic breast cancer (MBC) who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.

Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

Please see Important Safety Information on the following spread and accompanying brief summary of Halaven full Prescribing Information.

HALAVEN Ž is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. Š 2013 Eisai Inc. All rights reserved.

Printed in USA/November 2013 HALA0479

IN MBC, ONCOLOGISTS ARE CONSISTENTLY

EXTENDING THE CONTINUUM OF MEANINGFUL CARE1-3 With MBC treatment potentially extending to 6 lines and beyond, third-line chemotherapy can still be early in the fight for some patients2

LINES OF THERAPY GIVEN

1L 2L

3L 4L

2001 and earlier4

5L 6L 7L+

2005-20093,5

2010-20112,6

Indication Halaven is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

Important Safety Information Neutropenia

Monitor complete blood counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days Severe neutropenia (ANC <500/mm3) lasting more than 1 week occurred in 12% (62/503) of patients. Patients with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels Grade 3 and Grade 4 neutropenia occurred in 28% and 29%, respectively, of patients who received Halaven. Febrile neutropenia occurred in 5% of patients and two patients (0.4%) died from complications

Peripheral Neuropathy Patients should be monitored closely for signs of peripheral motor and sensory neuropathy

Grade 3 peripheral neuropathy occurred in 8% of patients, and Grade 4 in 0.4% of patients who received Halaven. Delay administration of Halaven until resolution to Grade 2 or less Neuropathy lasting more than 1 year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days) Peripheral neuropathy (5%) was the most common adverse reaction resulting in discontinuation

Pregnancy Category D Halaven is expected to cause fetal harm when administered to a pregnant woman and patients should be advised of these risks

QT Prolongation In an uncontrolled ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no prolongation on Day 1. ECG monitoring is recommended for patients with congestive heart failure; bradyarrhythmias;

HALAVEN ® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. © 2013 Eisai Inc. All rights reserved.

Printed in USA/November 2013 HALA0479

GIVE YOUR PATIENTS

AN OPPORTUNITY FOR MORE LIFE The FIRST and ONLY single agent that significantly extended OVERALL SURVIVAL in third-line MBC7-14

UPDATED OVERALL SURVIVAL (OS) ANALYSIS (UNPLANNED): MEDIAN OS, MONTHS (95% CI)1,15,a

P R O P O R T I O N O F PAT I E N T S A L I V E

1.0 0.9 0.8

Halaven

0.77

25% (2.6 month)

(n=508)

13.2

INCREASE

(12.1, 14.4)

0.6

IN MEDIAN OS

Deaths=386

0.5

Treatment of Physician’s Choice

0.4

(n=254)

0.3

10.6

0.2

(9.2, 12.0)

0.1

Deaths=203

0.0 0

6

12

508 254

406 178

274 106

18

24

30

36

54 26

11 5

0 Halaven 0 TPC

TIME (MONTHS)

Number of patients at risk

142 61

Results from an updated, unplanned survival analysis of the Phase III, randomized, openlabel, multicenter, multinational Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice versus E7389 (Eribulin) (EMBRACE) trial of Halaven versus Treatment of Physician’s Choice (TPC) in patients with MBC (N=762), conducted when 77% of events (deaths) had been observed. The primary endpoint was OS. Patients were randomized (2:1) to receive either Halaven 1.4 mg/m2 intravenously for 2 to 5 minutes on Days 1 and 8 of a 21-day cycle, or any singleagent therapy, selected prior to randomization.

At baseline, all patients had received ≥2 prior chemotherapeutic regimens for metastatic disease and demonstrated disease progression within 6 months of their last chemotherapeutic regimen. All patients received prior anthracyclineand taxane-based chemotherapy, unless contraindicated. Therapies in the TPC arm consisted of 97% chemotherapy (26% vinorelbine, 18% gemcitabine, 18% capecitabine, 16% taxanes [included paclitaxel, docetaxel, nab-paclitaxel, and ixabepilone], 9% anthracyclines, 10% other chemotherapy), and 3% hormonal therapy.

CI=confidence interval.

Conducted in the intent-to-treat population.

a

The updated OS analysis was consistent with the primary analysis7 The primary analysis, conducted when ~50% of events (deaths) had been observed, demonstrated a median OS for Halaven vs TPC of 13.1 months (95% CI: 11.8, 14.3) vs 10.6 months (95% CI: 9.3, 12.5), hazard ratio=0.81 (95% CI: 0.66, 0.99) (P=0.041)7,15

concomitant use of drugs that prolong QT interval, including Class Ia and III antiarrhythmics; and electrolyte abnormalities Correct hypokalemia or hypomagnesemia prior to initiating Halaven and monitor electrolytes periodically during therapy.

Avoid in patients with congenital long QT syndrome

Hepatic and Renal Impairment For patients with mild (Child-Pugh A) or moderate (ChildPugh B) hepatic and/or moderate (CrCl 30-50 mL/min) renal impairment, a reduction in starting dose is recommended

Most Common Adverse Reactions Most common adverse reactions (≥25%) reported in patients receiving Halaven were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%) The most common serious adverse reactions reported in patients receiving Halaven were febrile neutropenia (4%) and neutropenia (2%)

References: 1. Dufresne A, et al. Breast Cancer Res Treat. 2008;107(2):275-279.

2. Planchat E, et al. Breast. 2011;20(6):574-578. 3. Ray S, et al. In: J Clin Oncol.

San Francisco, CA: ASCO Breast Cancer Symposium; 2012. Abstract 116.

4. Cardoso F, et al. Ann Oncol. 2002;13(2):197-207. 5. Seah DS, et al. Poster presented at: 2012 ASCO Annual Meeting; June 1–5, 2012; Chicago, IL. Abstract 6089. 6. Lin NU, et al. Lancet. 2011;377(9769):878-880. 7. Halaven [package insert]. Woodcliff Lake, NJ: Eisai Inc; 2013. 8. Saad ED, et al. J Clin Oncol. 2010;28(11):1958-1962. 9. Slamon DJ, et al.

N Engl J Med. 2001;344(11):783-792. 10. Geyer CE, et al. N Engl J Med. 2006;355(26): 2733-2743. 11. von Minckwitz G, et al. J Clin Oncol. 2009;27(12):1999-2006.

12. Miller K, et al. N Engl J Med. 2007;357(26):2666-2676. 13. Robert NJ, et al.

J Clin Oncol. 2011;29(10):1252-1260. 14. Sparano JA, et al. J Clin Oncol. 2010;28(20): 3256-3263. 15. Cortes J, et al. Lancet. 2011;377(9769):914-923.

Please see accompanying brief summary of Halaven full Prescribing Information.

Visit www.halaven.com/hcp.aspx

S:7"

Table 2 (cont'd) MedDRA ver 10.0

HALAVEN (n=503) All Grades ≥ Grade 3

Control Group (n=247) All Grades ≥ Grade 3

Infections and Infestations Urinary Tract Infection 10% 1% 5% 0 Based upon laboratory data. b Includes neuropathy peripheral, neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, and paraesthesia. c Not applicable; (grading system does not specify > Grade 2 for alopecia).

Cytopenias: Grade 3 neutropenia occurred in 28% (143/503) of patients who received HALAVEN in Study 1, and 29% (144/503) of patients experienced Grade 4 neutropenia. Febrile neutropenia occurred in 5% (23/503) of patients; two patients (0.4%) died from complications of febrile neutropenia. Dose reduction due to neutropenia was required in 12% (62/503) of patients and discontinuation was required in <1% of patients. The mean time to nadir was 13 days and the mean time to recovery from severe neutropenia (<500/mm3) was 8 days. Grade 3 or greater thrombocytopenia occurred in 1% (7/503) of patients. G-CSF (granulocyte colony-stimulating factor) or GM-CSF (granulocyte–macrophage colony-stimulating factor) was used in 19% of patients who received HALAVEN. Peripheral Neuropathy: In Study 1, 17% of enrolled patients had Grade 1 peripheral neuropathy and 3% of patients had Grade 2 peripheral neuropathy at baseline. Dose reduction due to peripheral neuropathy was required by 3% (14/503) of patients who received HALAVEN. Four percent (20/503) of patients experienced peripheral motor neuropathy of any grade and 2% (8/503) of patients developed Grade 3 peripheral motor neuropathy.

Liver Function Test Abnormalities: Among patients with Grade 0 or 1 ALT levels at baseline, 18% of HALAVEN-treated patients experienced Grade 2 or greater ALT elevation. One HALAVEN-treated patient without documented liver metastases had concomitant Grade 2 elevations in bilirubin and ALT; these abnormalities resolved and did not recur with re-exposure to HALAVEN. Less Common Adverse Reactions: The following additional adverse reactions were reported in ≥5% to <10% of the HALAVEN-treated group: Eye Disorders: increased lacrimation; Gastrointestinal Disorders: dyspepsia, abdominal pain, stomatitis, dry mouth; General Disorders and Administration Site Conditions: peripheral edema; Infections and Infestations: upper respiratory tract infection; Metabolism and Nutrition Disorders: hypokalemia; Musculoskeletal and Connective Tissue Disorders: muscle spasms, muscular weakness; Nervous System Disorders: dysgeusia, dizziness; Psychiatric Disorders: insomnia, depression; Skin and Subcutaneous Tissue Disorders: rash.

6.2 Postmarketing Experience The following adverse drug reactions have been identified during post-approval of HALAVEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders: lymphopenia; Gastrointestinal Disorders: pancreatitis; Hepatobiliary Disorders: hepatitis; Immune System Disorders: drug hypersensitivity; Infections and Infestations: pneumonia, sepsis/neutropenic sepsis; Metabolism and Nutrition Disorders: hypomagnesemia, dehydration; Respiratory, thoracic, and mediastinal disorders: interstitial lung disease; Psychiatric Disorders: anxiety; Skin and Subcutaneous Tissue Disorders: pruritus.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Category D There are no adequate and well-controlled studies with HALAVEN in pregnant women. HALAVEN is a microtubule inhibitor; therefore, it is expected to cause fetal harm when administered to a pregnant woman. Embryo-fetal toxicity and teratogenicity occurred in rats that received eribulin mesylate at approximately half of the recommended human dose based on body surface area. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

In a developmental toxicity study, pregnant rats received intravenous infusion of eribulin mesylate during organogenesis (Gestation Days 8, 10, and 12) at doses approximately 0.04, 0.13, 0.43 and 0.64 times the recommended human dose, based on body surface area (mg/m2). Increased abortion and severe external or soft tissue malformations were observed in offspring at doses 0.64 times the recommended human dose based on body surface area (mg/m2), including the absence of a lower jaw, tongue, stomach and spleen.

Increased embryo-fetal death/resorption, reduced fetal weights, and minor skeletal anomalies consistent with developmental delay were also reported at or above doses of 0.43 times the recommended human dose.

Maternal toxicity of eribulin mesylate was reported in rats at or above doses of 0.43 times the recommended human dose (mg/m²), and included enlarged spleen, reduced maternal weight gain and decreased food consumption.

8.3 Nursing Mothers It is not known whether HALAVEN is excreted into human milk. No studies in humans or animals were conducted to determine if HALAVEN is excreted into milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in human milk fed infants from HALAVEN, a decision should be made whether to discontinue nursing or to discontinue HALAVEN taking into account the importance of the drug to the mother.

8.4 Pediatric Use The safety and effectiveness of HALAVEN in pediatric patients below the age of 18 years have not been established.

8.6 Hepatic Impairment Administration of HALAVEN at a dose of 1.1 mg/m2 to patients with mild hepatic impairment and 0.7 mg/m2 to patients with moderate hepatic impairment resulted in similar exposure to eribulin as a dose of 1.4 mg/m2 to patients with normal hepatic function. Therefore, a lower starting dose of 1.1 mg/m2 is recommended for patients with mild hepatic impairment (Child-Pugh A) and of 0.7 mg/m2 is recommended for patients with moderate hepatic impairment (Child-Pugh B). HALAVEN was not studied in patients with severe hepatic impairment (Child-Pugh C).

8.7 Renal Impairment For patients with moderate renal impairment (CrCl 30-50 mL/min), the geometric mean dose-normalized systemic exposure increased 2-fold compared to patients with normal renal function. A lower starting dose of 1.1 mg/m2 is recommended for patients with moderate renal impairment. The safety of HALAVEN was not studied in patients with severe renal impairment (CrCl <30 mL/min).

10 OVERDOSAGE Overdosage of HALAVEN has been reported at approximately 4 times the recommended dose, which resulted in Grade 3 neutropenia lasting seven days and a Grade 3 hypersensitivity reaction lasting one day.

There is no known antidote for HALAVEN overdose.

12 CLINICAL PHARMACOLOGY 12.3 Pharmacokinetics Specific Populations Hepatic Impairment A study evaluated the PK of eribulin in patients with mild (Child-Pugh A; n=7) and moderate (Child-Pugh B; n=5) hepatic impairment.

Compared to patients with normal hepatic function (n=6), eribulin exposure increased 1.8-fold and 2.5-fold in patients with mild and moderate hepatic impairment, respectively. Administration of HALAVEN at a dose of 1.1 mg/m2 to patients with mild hepatic impairment and 0.7 mg/m2 to patients with moderate hepatic impairment resulted in similar exposure to eribulin as a dose of 1.4 mg/m2 to patients with normal hepatic function.

Renal Impairment No formal PK trials were conducted with HALAVEN in patients with renal impairment. Available data suggests that geometric mean dose-normalized systemic exposure is similar for patients with mild renal impairment (CrCl 50-80 mL/min) relative to patients with normal renal function. However, for patients with moderate renal impairment (CrCl 30-50 mL/min), the geometric mean dose-normalized systemic exposure increased 2-fold compared to patients with normal renal function.

12.6 Cardiac Electrophysiology The effect of HALAVEN on the QTc interval was assessed in an open-label, uncontrolled, multicenter, single-arm dedicated QT trial. A total of 26 patients with solid tumors received 1.4 mg/m2 of HALAVEN on Days 1 and 8 of a 21-day cycle. A delayed QTc prolongation was observed on Day 8, with no prolongation observed on Day 1. The maximum mean QTcF change from baseline (95% upper confidence interval) was 11.4 (19.5) ms.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, mutagenesis, impairment of fertility Carcinogenicity studies have not been conducted with eribulin mesylate.

Eribulin mesylate was not mutagenic in in vitro bacterial reverse mutation assays (Ames test). Eribulin mesylate was positive in mouse lymphoma mutagenesis assays, and was clastogenic in an in vivo rat bone marrow micronucleus assay.

The effects of HALAVEN on human fertility are unknown. Fertility studies have not been conducted with eribulin mesylate in humans or animals. However, nonclinical findings in repeated-dose dog and rat toxicology studies suggest that male fertility may be compromised by treatment with eribulin mesylate. Rats exhibited testicular toxicity (hypocellularity of seminiferous epithelium with hypospermia/aspermia) following dosing with eribulin mesylate at or above 0.43 times the recommended human dose (mg/m2) given once weekly for 3 weeks, or at or above 0.21 times the recommended human dose (mg/m2) given once weekly for 3 out of 5 weeks, repeated for 6 cycles. Testicular toxicity was also observed in dogs given 0.64 times the recommended human dose (mg/m2) weekly for 3 out of 5 weeks, repeated for 6 cycles.

17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling • Advise patients to contact their health care provider for a fever of 100.5°F or greater or other signs or symptoms of infection such as chills, cough, or burning or pain on urination.

• Advise women of childbearing potential to avoid pregnancy and to use effective contraception during treatment with HALAVEN. a

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– HALAVEN® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. © 2013 Eisai Inc. All rights reserved. Printed in USA / November 2013 HALA0475

S:10"

HALAVEN® (eribulin mesylate) Injection BRIEF SUMMARY – See package insert for full prescribing information.

2.2 Dose Modification Assess for peripheral neuropathy and obtain complete blood cell counts prior to each dose.

Recommended dose delays • Do not administer HALAVEN on Day 1 or Day 8 for any of the following: – ANC <1,000/mm3 – Platelets <75,000/mm3 – Grade 3 or 4 non-hematological toxicities.

• The Day 8 dose may be delayed for a maximum of 1 week.

– If toxicities do not resolve or improve to ≤ Grade 2 severity by Day 15, omit the dose.

– If toxicities resolve or improve to ≤ Grade 2 severity by Day 15, administer HALAVEN at a reduced dose and initiate the next cycle no sooner than 2 weeks later.

Recommended dose reductions • If a dose has been delayed for toxicity and toxicities have recovered to Grade 2 severity or less, resume HALAVEN at a reduced dose as set out in Table 1.

• Do not re-escalate HALAVEN dose after it has been reduced.

Table 1 Recommended Dose Reductions Recommended Event Description HALAVEN Dose 2 Permanently reduce the 1.4 mg/m HALAVEN dose for any of the following: ANC <500/mm3 for >7 days ANC <1,000 /mm3 with fever or infection 1.1 mg/m2 Platelets <25,000/mm3 Platelets <50,000/mm3 requiring transfusion Non-hematologic Grade 3 or 4 toxicities Omission or delay of Day 8 HALAVEN dose in previous cycle for toxicity Occurrence of any event requiring permanent dose reduction while receiving 1.1 mg/m2 0.7 mg/m2 Occurrence of any event requiring permanent dose reduction while receiving 0.7 mg/m2 Discontinue HALAVEN ANC = absolute neutrophil count.

Toxicities graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

5 WARNINGS AND PRECAUTIONS 5.1 Neutropenia Severe neutropenia (ANC <500/mm3) lasting more than one week occurred in 12% (62/503) of patients in Study 1, leading to discontinuation in <1% of patients. Patients with alanine aminotransferase or aspartate aminotransferase >3 × ULN (upper limit of normal) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal aminotransferase levels. Patients with bilirubin >1.5 × ULN also had a higher incidence of Grade 4 neutropenia and febrile neutropenia.

Monitor complete blood counts prior to each dose; increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias.

Delay administration of HALAVEN and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days. Clinical studies of HALAVEN did not include patients with baseline neutrophil counts below 1,500/mm3.

5.2 Peripheral Neuropathy Grade 3 peripheral neuropathy occurred in 8% (40/503) of patients, and Grade 4 in 0.4% (2/503) of patients in Study 1. Peripheral neuropathy was the most common toxicity leading to discontinuation of HALAVEN (5% of patients; 24/503). Neuropathy lasting more than one year occurred in 5% (26/503) of patients. Twenty-two percent (109/503) of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Monitor patients closely for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.

5.3 Embryo-Fetal Toxicity There are no adequate and well-controlled studies of HALAVEN in pregnant women. HALAVEN is a microtubule inhibitor; therefore, it is expected to cause fetal harm when administered to a pregnant woman. Embryo-fetal toxicity and teratogenicity occurred in rats that received eribulin mesylate at approximately half of the recommended human dose based on body surface area. If this drug is used during pregnancy, or if a patient becomes pregnant while taking this drug, she should be apprised of the potential hazard to the fetus.

5.4 QT Prolongation In an uncontrolled open-label ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no QT prolongation observed on Day 1. ECG monitoring is recommended if therapy is initiated in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid HALAVEN in patients with congenital long QT syndrome.

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience The following adverse reactions are discussed in detail in other sections of the labeling: • Neutropenia • Peripheral neuropathy • QT interval prolongation The most common adverse reactions (≥25%) reported in patients receiving HALAVEN were neutropenia, anemia, asthenia/ fatigue, alopecia, peripheral neuropathy, nausea, and constipation. The most common serious adverse reactions reported in patients receiving HALAVEN were febrile neutropenia (4%) and neutropenia (2%). The most common adverse reaction resulting in discontinuation of HALAVEN was peripheral neuropathy (5%).

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.

In clinical trials, HALAVEN has been administered to 1,222 patients with multiple tumor types, including 240 patients exposed to HALAVEN for 6 months or longer. The majority of the 1,222 patients were women (82%) with a median age of 58 years (range: 26 to 91 years). The racial and ethnic distribution was Caucasian (83%), Black (5%), Asian (2%), and other (5%).

The adverse reactions described in Table 2 were identified in 750 patients treated in Study 1. In Study 1, patients were randomized (2:1) to receive either HALAVEN (1.4 mg/m2 on Days 1 and 8 of a 21-day cycle) or single agent treatment chosen by their physician (control group). A total of 503 patients received HALAVEN, and 247 patients in the control group received therapy consisting of chemotherapy [total 97% (anthracyclines 10%, capecitabine 18%, gemcitabine 19%, taxanes 15%, vinorelbine 25%, other chemotherapies 10%)] or hormonal therapy (3%). The median duration of exposure was 118 days for patients receiving HALAVEN and 63 days for patients receiving control therapy. Table 2 reports the most common adverse reactions occurring in at least 10% of patients in either group.

Table 2 Adverse Reactions with a Per-Patient Incidence of at Least 10% in Study 1 MedDRA ver 10.0 HALAVEN (n=503) Control Group (n=247) All Grades ≥ Grade 3 All Grades ≥ Grade 3 a Blood and Lymphatic System Disorders Neutropenia 82% 57% 53% 23% Anemia 58% 2% 55% 4% Nervous system disorders Peripheral neuropathyb 35% 8% 16% 2% Headache 19% <1% 12% <1% General disorders and administrative site conditions Asthenia/Fatigue 54% 10% 40% 11% Mucosal inflammation 9% 1% 10% 2% Pyrexia 21% <1% 13% <1% Gastrointestinal disorders Constipation 25% 1% 21% 1% Diarrhea 18% 0 18% 0 Nausea 35% 1% 28% 3% Vomiting 18% 1% 18% 1% Musculoskeletal and connective tissue disorders Arthralgia/Myalgia 22% <1% 12% 1% Back pain 16% 1% 7% 2% Bone pain 12% 2% 9% 2% Pain in extremity 11% 1% 10% 1% Investigations Weight decreased 21% 1% 14% <1% Metabolism and nutrition disorders Anorexia 20% 1% 13% 1% Respiratory, thoracic, and mediastinal disorders Cough 14% 0 9% 0 Dyspnea 16% 4% 13% 4% Skin and subcutaneous tissue disorders Alopecia 45% NAc 10% NAc

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Continued from page 10

CATEGORY I: Patient Education

(eg, importance of completing all 6 cycles, side effects, managing expectations of symptom improvement) and efficient workflow across departments. Responsibility for insurance verification, administration, and symptom management can vary greatly, depending on the institution. Nurses play a significant role in coordination between disciplines and are fundamental in maintaining a well-defined process for managing these patients to ensure optimal care. Conclusions: Ra-223 is a well-tolerated, effective, easily administered treatment for patients with CRPC and symptomatic bone mets. Nurses are essential members of the oncology team, providing patients with education and guidance about Ra-223; they are integral in coordinating patient care throughout treatment and ensuring efficiency across multidisciplinary teams.

Nurses as Scribes: A New Role for the Oncology Nurse Navigator Lisa Bruno, RN BSN, OCN; Peggy Malone, RN, BS, OCN OSF Saint Anthony Center for Cancer Care

Background: Being adequately prepared for an experience such as cancer empowers the patient as well as improves self-management and quality of life.1 The first visit with the oncologist can be extremely overwhelming and anxiety-producing. Oncology nurse navigators need an effective way to communicate the information that is discussed during the initial oncology physician consultation to newly diagnosed cancer patients and their families. A documentation template was developed so the oncology nurse navigators could take notes while accompanying patients and families during the initial visit with the oncologist. Objective: To help patients and families better understand all the information that is presented in the initial consult with the medical oncologist. Methods: A 1-page form was developed that included headings for the following: type of cancer, stage of cancer, details of cancer, test results, medications prescribed, chemotherapy planned, name of chemotherapy and how often it will be given, radiation therapy planned, and an area on the form labeled “What’s next?” to aid the patient in understanding the next steps to take in the cancer care process. Two separate documentation templates were developed for both medical oncology and radiation oncology consults. This form can also be utilized as a teaching tool to summarize the important information covered in the visit before the patient leaves utilizing the “teach-back” method. Results: The oncology nurse navigators now consistently use this “Summary of Visit” form to provide a written summary of everything discussed with patients during their initial oncology consultation, and a copy is provided to the patient before leaving the clinic. The nurse acts as a scribe for the patient and families, ensuring that all the pertinent information discussed at the visit is recorded. Conclusions: Patients and families verbalized that having access to the information provided by the oncologist from the initial consult enhanced comprehension and supported communication regarding disease stage, treatment plan, and referral information. They also commented that they were better able to focus on details of the oncologist’s interactions knowing they did not need to take notes themselves. The use of this “Summary of Visit” form has enhanced the readiness of patients for treatment and improved communication between the patient and the oncology team members. The next steps include: (1) creating an electronic version of the templates that can be entered directly into the electronic medical record at the time of the visit, which would allow other practitioners access to the information; and (2) incorporating the “Summary of Visit” note into OSF myHealth functionality, which allows the patient online access to some of his or her medical record information.

Reference

1. Knobf MT. Being prepared: essential to self-care and quality of life for the person with cancer. Clin J Oncol Nurs. 2013;17(3):255-261.

JONS-online.com journal of Oncology Navigation & Survivorship

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CATEGORY I: Patient Education Using a National Needs Assessment to Direct Programs for Young Women Affected

by Breast Cancer Arin Ahlum Hanson, MPH, CHES; Janine Guglielmino, MA; Catherine Creme Henry, MA; Kimlin Ashing, PhD Living Beyond Breast Cancer

Introduction: Ten percent of breast cancer cases occur in women under age 45 years. Although younger women are less likely than older women to be diagnosed, their survivorship needs can differ, making breast cancer a significant public health concern for this age group. To address this need, Living Beyond Breast Cancer (LBBC) developed new national programming for young women, after conducting a comprehensive needs assessment and selecting program priorities based on assessment findings. This project was funded through a cooperative agreement with the Centers for Disease Control and Prevention. Methods: LBBC identified the needs of women diagnosed with breast cancer before age 45 years and determined how young women prefer to receive emotional support and breast cancer information. Needs assessment phases were (1) an environmental scan to identify existing resources; (2) key informant interviews with 12 healthcare providers; (3) 4 focus groups with 32 women; and (4) an 85-question national online survey completed by 1474 women diagnosed with breast cancer before age 45 years. LBBC analyzed findings by stage, ethnicity, age, and time since diagnosis, setting program priorities based on these findings. Results: The needs assessment findings led LBBC to create online resources for young women, expand the Breast Cancer Helpline, develop a Young Advocate Program, and educate healthcare providers about the needs of young women. In addition, LBBC expanded resources for women diagnosed before age 30 years, young women living with metastatic breast cancer, and young African American women who reported different needs for and interests in health information. Conclusion/Implications: LBBC successfully expanded its program offerings to better serve young women. Preliminary evaluation data show LBBC’s new programs are increasing knowledge and support. This process demonstrates the benefits of using needs assessments to drive program development. This model can be used for other cancer survivor populations, where knowledge of their needs and program offerings are lacking.

Category II: Psychological Support Camp Oasis: Implementing a Day of Support for Children Who Have a Parent Diagnosed with Cancer Jackie Miller, RN, BSN, OCN Virtua Fox Chase Cancer Program

Significance and Background: A diagnosis of cancer can set off a cascade of emotional turmoil for patients and their families. During a busy time of a parent’s multiple appointments and treatment schedules, children often do not receive the support they need to cope. Offering a local 1-day camp is a welcomed spirit-lifting day. It provides a supportive environment, an educational opportunity, and allows children to recognize they are not alone.

Purpose: The goals of the camp are to (1) provide a supportive environment to children (8-18 years) who have a parent diagnosed with cancer at any stage; (2) carry out a supportive session by an oncology licensed clinical social worker to teach coping mechanisms and skills that can be adapted and applied as needed during difficult times; (3) provide a folder for each camper to take home containing community resources; (4) promote positive bonding between campers that continues after camp has ended; (5) initiate open dialogue between parents and children about their diagnosis/feelings/ fears and educate on how to continue discussions at home with their parents/family/teachers/counselors; and (6) have fun.

This presentation will discuss the importance of providing a supportive camp. Although these outcomes are anecdotal and subjective, positive participant/parent satisfaction and feedback have indicated that children are able to communicate more easily, cry less, have improved dialogue with others, as well as continue to build relationships with team members after camp has ended. It will also provide the building blocks to starting a 1-day support camp, discuss the pitfalls to

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Fifth annual aonn+ conference abstracts

Category II: Psychological Support avoid, and the lessons learned. Intervention: Camp begins with the children arriving in limousines. Participation in archery, canoeing, relay races, and art therapy is encouraged. A coping session with an oncology social worker is offered.

Lunch and a demonstration from our local police canine team follows. A DJ pool party and water ice wrap up the day.

All campers leave with a folder of resources to share with parents, educational material, and a variety of donated gifts.

Camp Oasis is funded by a $2000 grant made available from the Virtua Foundation in addition to donated items and services from local vendors. Evaluation: Each team is led by nurses who monitor campers to assure camp goals are met.

In addition, the children receive an evaluation form after camp. They have the opportunity to express why they came to camp, if we met our goals, as well as any additional comments. Parents can add their feedback on the evaluation. Discussion: Each year Camp Oasis forms a community of struggling children and teenagers, volunteers, certified camp staff, and professional counselors. Many parents provide ongoing feedback on their child’s progress and are very appreciative for the opportunity their child and family had by attending Camp Oasis.

Patients’ Trust for Involvement in Shared Decision-Making: A Longitudinal Study Chi-Chang Chang; Ting Teng; Che-Hsin Hsu; Pei-Shan Su School of Medical Informatics, Chung Shan Medical University

Introduction: Trust is a key feature of the patient–physician relationship. That is, patients’ trust may influence health status through continuity of care, adherence to treatment regimens, and the willingness to seek care. Objectives: To investigate the reliability and validity of patients’ trust for participants in medical decision-making and to explore the linkage of patients’ trust to shared medical decision-making (SMDM) among women with cervical cancer. Methods: The patients’ trust questionnaire (PTQ) of Hall et al (2002) was independently translated into Chinese by 2 native speakers, and verified by a schoolteacher of Chinese. Furthermore, an expert panel discussed several language differences and agreed on the final version of the questionnaire. In addition, the valid PTQ and the SMDM questionnaire were then assessed at 6 months (T1) and 12 months (T2), respectively. Cross-sectional regression analyses were used to examine the linear and quadratic components of the relation between patients’ trust and SMDM. Longitudinal regression analyses were used to examine the linear and quadratic relations between T1 patients’ trust and T2 SMDM. Quadratic components of the longitudinal relations between T1 patients’ trust and T2 SMDM were examined by adding the quadratic component of the predictor to the equation. Results: Seventy consecutive women were recruited from Chung Shan Medical University Hospital. Taiwanese Patients’ Trust Questionnaire (TPTQ) is a 10-item normative instrument. The intraclass correlation coefficient for the PTQ index was 0.86, and Cohen’s kappa values for the PTQ dimensions ranged from 0.52 to 0.84. In addition, we found the curvilinear relations linking patients’ trust to SMDM. That is, individuals with high or low levels of patient trust at study start had lower levels of trust in physicians than those with moderate levels of patient trust, and individuals with high or low levels of patient trust 3 months later had better trust in the medical profession than those with moderate levels of patient trust. Conclusions: Patients viewed trust as an iterative process and commonly tested their physicians against their knowledge and expectations. Based on the results of this study, TPTQ is reliable and valid for the assessment of trust in patients with cervical cancer in Taiwan. Overall, it is important for clinicians to consider the notion that more trust may sometimes, but not always, be better.

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Category II: Psychological Support Journey Toward Empowerment: A 7-Part Empowerment Series for Breast Cancer Patients Peggy Wheeler, RN, OCN, CBCN Central Baptist Hospital

Objectives: (1) Provide tools for breast cancer patients to use during their journey with breast cancer; (2) address particular issues that may not be addressed by their healthcare providers; (3) provide fellowship with other breast cancer patients in a healthy environment; (4) provide resources for the patients; and (5) improve the patient’s satisfaction with his or her cancer care. Methods: Through a grant from the Susan G. Komen Foundation, Journey Toward Empowerment is a 7-part series of programs chosen to address issues faced by breast cancer patients that may not have been addressed by their healthcare providers. A partnership was obtained with a local health psychology group. Resources from our cancer center were also utilized (genetic counselor, oncology dietitian, and fitness director from our health program). The series addressed the following 7 topics: nutrition, movement, insomnia, and pain; intimacy; balancing life’s responsibilities; genetics; fear of recurrence; depression; and caring for the spirit. Each session began with a light dinner, time for fellowship, and was then followed by a speaker. Additional resources were also provided. The patients were given an evaluation form at the end of each session to assess what particular part of each topic was most helpful to them. We also asked for suggestions for future topics. Results: The comments on the evaluation forms revealed the following: enjoyment of the fellowship time—knowing that they were not alone; learned breathing and relaxation techniques; learned about genetics in terms of breast cancer; learned self-care tools; and addressing of spiritual issues during the holidays.

Conclusion: Journey Toward Empowerment provided tools for women diagnosed with breast cancer to cope with life issues they face during their journey with breast cancer.

Surveying Young Women with Metastatic Breast Cancer to Create Interventions with Impact Tracy Leduc, JD; Michelle Esser, JD, MBA; Jean Rowe, LCSW, OSW-C, CJT; Megan McCann, MPH; Stacy Lewis, CHES Young Survival Coalition

Background: The Young Survival Coalition (YSC) Research Think Tank began in 2012 with the goal of identifying the most pressing research questions that would improve the quality and quantity of life for young women diagnosed with breast cancer. YSC assembled teams of doctors, researchers, and advocates to focus on 6 areas of importance to its young constituents, including metastasis. One of the top research priorities announced by the metastasis workgroup was “How can we better meet the psychosocial needs of young women with metastatic breast cancer (MBC) and their families?” YSC decided this priority warranted immediate action. Objectives: (1) To understand the needs of young women with MBC and their families; and (2) to provide the breast cancer community with an informed landscape to identify and create impactful interventions that meet the needs of young women living with MBC. Methods: We reviewed previous surveys of women living with MBC. Only a couple focused on young women. While these surveys examined the problems of women living with MBC, few, if any, examined what interventions could be utilized to address their psychosocial needs.

YSC crafted a comprehensive survey that incorporated the topics and issues identified in previous surveys to probe further and learn the root of the problems and how to address them. Inclusion criteria were women diagnosed with any stage of breast cancer before 41 years of age, who had MBC at initial diagnosis or developed it thereafter. The survey launched in September 2013. Results: Four hundred seventy participants met the inclusion criteria with 360 completing the survey in full by the end of February 2014. The survey results provided in-depth information about the needs, concerns, and struggles of this patient population as well as interventions they believed would be helpful. Three common themes emerged from the data. First, online tools, with information that is easy to find, clear, and current, is of paramount importance. Second, the value of finding other young women with MBC cannot be overstated. Although complaints about difficulty in finding in-person support and women under 30 years of age were mentioned, 91% said it was important to connect with other young MBC women. Third, respondents noted the importance of the medical oncologist in treating the whole patient, as they rely on this doctor for a broad range of information and support. Conclusions: Young women living with MBC are Continued on page 21

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IN PLANNING DURATION OF THERAPY WITH VELCADE® (bortezomib)

WHAT MORE CAN YOU DO FOR YOUR PATIENTS WITH MULTIPLE MYELOMA?

An online resource—created just for nurses—is available to help you do more to manage your patients’ treatment.

The VELCADE (bortezomib) Nurse Portal features: ▼

Patient education tools to help support your patients throughout their journey with multiple myeloma

▼

A learning center to help you and your patients get the most out of their treatment

▼

Case studies to support you in managing different clinical scenarios

Start learning more today at www.VELCADE-RN.com

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR VELCADE® (bortezomib) INDICATIONS VELCADE (bortezomib) is indicated for the treatment of patients with multiple myeloma. VELCADE is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.

CONTRAINDICATIONS VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of VELCADE. WARNINGS, PRECAUTIONS, AND DRUG INTERACTIONS ▼ Peripheral neuropathy: Manage with dose modification or discontinuation. Patients with preexisting severe neuropathy should be treated with VELCADE only after careful riskbenefit assessment. ▼ Hypotension: Use caution when treating patients taking antihypertensives, with a history of syncope, or with dehydration. ▼ Cardiac toxicity: Worsening of and development of cardiac failure have occurred.

Closely monitor patients with existing heart disease or risk factors for heart disease. ▼ Pulmonary toxicity: Acute respiratory syndromes have occurred. Monitor closely for new or worsening symptoms. ▼ Posterior reversible encephalopathy syndrome: Consider MRI imaging for onset of visual or neurological symptoms; discontinue VELCADE if suspected.

Gastrointestinal toxicity: Nausea, diarrhea, constipation, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement. ▼ Thrombocytopenia or Neutropenia: Monitor complete blood counts regularly throughout treatment. ▼ Tumor lysis syndrome: Closely monitor patients with high tumor burden. ▼ Hepatic toxicity: Monitor hepatic enzymes during treatment. ▼ Embryo-fetal risk: Women should avoid becoming pregnant while being treated with VELCADE. Advise pregnant women of potential embryo-fetal harm. ▼ Closely monitor patients receiving VELCADE in combination with strong CYP3A4 inhibitors.

Avoid concomitant use of strong CYP3A4 inducers.

ADVERSE REACTIONS Most commonly reported adverse reactions (incidence ≥20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia. ▼

Please see Brief Summary for VELCADE on the next page of this advertisement.

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Brief Summary

VELC3X0043_A_Velcade_BS_7x10_r3.indd 1

Embryo-fetal: Pregnancy Category D. Women of reproductive potential should avoid becoming pregnant while being treated with VELCADE. Bortezomib administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post-implantation loss and a decreased number of live fetuses.

ADVERSE EVENT DATA: Safety data from phase 2 and 3 studies of single-agent VELCADE 1.3 mg/m2/dose administered intravenously twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously-treated multiple myeloma (N=1008) and previously-treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma.

In the integrated analysis, the most commonly reported (≥10%) adverse reactions were nausea (49%), diarrhea NOS (46%), fatigue (41%), peripheral neuropathies NEC (38%), thrombocytopenia (32%), vomiting NOS (28%), constipation (25%), pyrexia (21%), anorexia (20%), anemia NOS (18%), headache NOS (15%), neutropenia (15%), rash NOS (13%), paresthesia (13%), dizziness (excl vertigo 11%), and weakness (11%). Eleven percent (11%) of patients experienced at least 1 episode of ≥Grade 4 toxicity, most commonly thrombocytopenia (4%) and neutropenia (2%). A total of 26% of patients experienced a serious adverse reaction during the studies. The most commonly reported serious adverse reactions included diarrhea, vomiting, and pyrexia (3% each), nausea, dehydration, and thrombocytopenia (2% each), and pneumonia, dyspnea, peripheral neuropathies NEC, and herpes zoster (1% each).

In the phase 3 VELCADE+melphalan and prednisone study in previously untreated multiple myeloma, the safety profile of VELCADE administered intravenously in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/prednisone. The most commonly reported adverse reactions in this study (VELCADE+melphalan/prednisone vs melphalan/prednisone) were thrombocytopenia (48% vs 42%), neutropenia (47% vs 42%), peripheral neuropathy (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia (34% vs <1%), anemia (32% vs 46%), leukopenia (32% vs 28%), vomiting (26% vs 12%), fatigue (25% vs 14%), lymphopenia (23% vs 15%), constipation (23% vs 4%), anorexia (19% vs 6%), asthenia (16% vs 7%), pyrexia (16% vs 6%), paresthesia (12% vs 1%), herpes zoster (11% vs 3%), rash (11% vs 2%), abdominal pain upper (10% vs 6%), and insomnia (10% vs 6%).

In the phase 3 VELCADE subcutaneous vs intravenous study in relapsed multiple myeloma, safety data were similar between the two treatment groups. The most commonly reported adverse reactions in this study were peripheral neuropathy NEC (37% vs 50%), thrombocytopenia (30% vs 34%), neutropenia (23% vs 27%), neuralgia (23% vs 23%), anemia (19% vs 23%), diarrhea (19% vs 28%), leukopenia (18% vs 20%), nausea (16% vs 14%), pyrexia (12% vs 8%), vomiting (9% vs 11%), asthenia (7% vs 16%), and fatigue (7% vs 15%). The incidence of serious adverse reactions was similar for the subcutaneous treatment group (20%) and the intravenous treatment group (19%). The most commonly reported SARs were pneumonia and pyrexia (2% each) in the subcutaneous treatment group and pneumonia, diarrhea, and peripheral sensory neuropathy (3% each) in the intravenous treatment group.

DRUG INTERACTIONS: Bortezomib is a substrate of cytochrome P450 enzyme 3A4, 2C19 and 1A2. Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the exposure of bortezomib by 35% in 12 patients. Monitor patients for signs of bortezomib toxicity and consider a bortezomib dose reduction if bortezomib must be given in combination with strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir). Co-administration of omeprazole, a strong inhibitor of CYP2C19, had no effect on the exposure of bortezomib in 17 patients. Co-administration of rifampin, a strong CYP3A4 inducer, is expected to decrease the exposure of bortezomib by at least 45%. Because the drug interaction study (n=6) was not designed to exert the maximum effect of rifampin on bortezomib PK, decreases greater than 45% may occur. Efficacy may be reduced when VELCADE is used in combination with strong CYP3A4 inducers; therefore, concomitant use of strong CYP3A4 inducers is not recommended in patients receiving VELCADE. St. John’s wort (Hypericum perforatum) may decrease bortezomib exposure unpredictably and should be avoided. Co-administration of dexamethasone, a weak CYP3A4 inducer, had no effect on the exposure of bortezomib in 7 patients. Co-administration of melphalan-prednisone increased the exposure of bortezomib by 17% in 21 patients. However, this increase is unlikely to be clinically relevant.

USE IN SPECIFIC POPULATIONS: Nursing Mothers: It is not known whether bortezomib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from VELCADE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: The safety and effectiveness of VELCADE in children has not been established.

Geriatric Use: No overall differences in safety or effectiveness were observed between patients ≥age 65 and younger patients receiving VELCADE; but greater sensitivity of some older individuals cannot be ruled out.

Patients with Renal Impairment: The pharmacokinetics of VELCADE are not influenced by the degree of renal impairment. Therefore, dosing adjustments of VELCADE are not necessary for patients with renal insufficiency. Since dialysis may reduce VELCADE concentrations, VELCADE should be administered after the dialysis procedure. For information concerning dosing of melphalan in patients with renal impairment, see manufacturer’s prescribing information.

Patients with Hepatic Impairment: The exposure of bortezomib is increased in patients with moderate and severe hepatic impairment. Starting dose should be reduced in those patients.

Patients with Diabetes: During clinical trials, hypoglycemia and hyperglycemia were reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetic medication.

Please see full Prescribing Information for VELCADE at VELCADEHCP.com.

VELCADE, MILLENNIUM and are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners.

Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright © 2013, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA V-14-0087a Printed in USA 4/14

8/27/13 4:54 PM

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INDICATIONS: VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma. VELCADE for Injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.

CONTRAINDICATIONS: VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of VELCADE. WARNINGS AND PRECAUTIONS: Peripheral Neuropathy: VELCADE treatment causes a peripheral neuropathy that is predominantly sensory; however, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with pre-existing symptoms (numbness, pain, or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy (including ≥Grade 3) during treatment with VELCADE. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. In the Phase 3 relapsed multiple myeloma trial comparing VELCADE subcutaneous vs intravenous, the incidence of Grade ≥2 peripheral neuropathy events was 24% for subcutaneous and 39% for intravenous. Grade ≥3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 15% in the intravenous treatment group.

Starting VELCADE subcutaneously may be considered for patients with pre-existing or at high risk of peripheral neuropathy.

Patients experiencing new or worsening peripheral neuropathy during VELCADE therapy may require a decrease in the dose and/or a less dose-intense schedule. In the VELCADE vs dexamethasone phase 3 relapsed multiple myeloma study, improvement in or resolution of peripheral neuropathy was reported in 48% of patients with ≥Grade 2 peripheral neuropathy following dose adjustment or interruption. Improvement in or resolution of peripheral neuropathy was reported in 73% of patients who discontinued due to Grade 2 neuropathy or who had ≥Grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma.

Hypotension: The incidence of hypotension (postural, orthostatic, and hypotension NOS) was 8%. These events are observed throughout therapy. Caution should be used when treating patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated. Management of orthostatic/postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics.

Cardiac Toxicity: Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have occurred during VELCADE therapy, including reports in patients with no risk factors for decreased left ventricular ejection fraction. Patients with risk factors for, or existing, heart disease should be closely monitored. In the relapsed multiple myeloma study of VELCADE vs dexamethasone, the incidence of any treatment-related cardiac disorder was 8% and 5% in the VELCADE and dexamethasone groups, respectively.

The incidence of adverse reactions suggestive of heart failure (acute pulmonary edema, pulmonary edema, cardiac failure, congestive cardiac failure, cardiogenic shock) was ≤1% for each individual reaction in the VELCADE group. In the dexamethasone group, the incidence was ≤1% for cardiac failure and congestive cardiac failure; there were no reported reactions of acute pulmonary edema, pulmonary edema, or cardiogenic shock. There have been isolated cases of QT-interval prolongation in clinical studies; causality has not been established.

Pulmonary Toxicity: Acute Respiratory Distress Syndrome (ARDS) and acute diffuse infiltrative pulmonary disease of unknown etiology, such as pneumonitis, interstitial pneumonia, and lung infiltration have occurred in patients receiving VELCADE. Some of these events have been fatal.

In a clinical trial, the first two patients given high-dose cytarabine (2 g/m2 per day) by continuous infusion with daunorubicin and VELCADE for relapsed acute myelogenous leukemia died of ARDS early in the course of therapy. There have been reports of pulmonary hypertension associated with VELCADE administration in the absence of left heart failure or significant pulmonary disease.

In the event of new or worsening cardiopulmonary symptoms, consider interrupting VELCADE until a prompt, comprehensive, diagnostic evaluation is conducted.

Posterior Reversible Encephalopathy Syndrome (PRES): Posterior Reversible Encephalopathy Syndrome (PRES; formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS)) has occurred in patients receiving VELCADE. PRES is a rare, reversible, neurological disorder, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. Brain imaging, preferably MRI (Magnetic Resonance Imaging), is used to confirm the diagnosis. In patients developing PRES, discontinue VELCADE. The safety of reinitiating VELCADE therapy in patients previously experiencing PRES is not known.

Gastrointestinal Toxicity: VELCADE treatment can cause nausea, diarrhea, constipation, and vomiting, sometimes requiring use of antiemetic and antidiarrheal medications. Ileus can occur.

Fluid and electrolyte replacement should be administered to prevent dehydration. Interrupt VELCADE for severe symptoms.

Thrombocytopenia/Neutropenia: VELCADE is associated with thrombocytopenia and neutropenia that follow a cyclical pattern, with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle. The cyclical pattern of platelet and neutrophil decreases and recovery remained consistent over the 8 cycles of twice-weekly dosing, and there was no evidence of cumulative thrombocytopenia or neutropenia. The mean platelet count nadir measured was approximately 40% of baseline.

The severity of thrombocytopenia was related to pretreatment platelet count. In the relapsed multiple myeloma study of VELCADE vs dexamethasone, the incidence of bleeding (≥Grade 3) was 2% on the VELCADE arm and <1% on the dexamethasone arm. Complete blood counts (CBC) should be monitored frequently during treatment with VELCADE. Platelet counts should be monitored prior to each dose of VELCADE. Patients experiencing thrombocytopenia may require change in the dose and schedule of VELCADE. Gastrointestinal and intracerebral hemorrhage has been reported in association with VELCADE. Transfusions may be considered.

Tumor Lysis Syndrome: Tumor lysis syndrome has been reported with VELCADE therapy.

Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment.

Monitor patients closely and take appropriate precautions.

Hepatic Toxicity: Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic reactions include hepatitis, increases in liver enzymes, and hyperbilirubinemia. Interrupt VELCADE therapy to assess reversibility. There is limited re-challenge information in these patients.

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Category II: Psychological Support

an understudied population with limited to no existing research focusing on what interventions could improve their quality of life. Information from the YSC survey provides data on the next layer, adding insight to their needs and possible interventions as well as program delivery. The responses highlight the variety of experiences in this patient population, such that a “one-size-fits-all” approach is not appropriate.

Live Forward: Healing Through Emotional Connections Melissa Andres, BSN, RN, OCN, CBPN-C St. Vincent Health

Objective: In 2010, St. Vincent Health had a vision to transcend cancer care to support the mind, body, and spirit of each person they serve throughout the continuum of their cancer journey by implementing a formal navigation program. Since 2010, St. Vincent has developed and expanded both navigation and survivorship services to address barriers to care and to support the clinical, psychosocial, and spiritual needs of our patients. The care is individualized and sensitive to each person’s culture and beliefs. This poster will showcase our services through one of our breast cancer patient’s experience and also include statistics showing the growth of our navigation and survivorship programs over the years. There are also 2 videos that, from patients’ perspectives, show what navigation and survivorship services have meant to them. Background: In 2011, TW was diagnosed with stage III triple-negative breast cancer. As an Anishinaabe Kwe (First Nations Woman), her journey with breast cancer was very frightening. TW had an aggressive cancer diagnosis, complex family and social dynamics, cultural and spiritual needs, and psychosocial concerns. Her navigation needs were complex, and some were unique. Collaboration with multiple disciplines was needed to ensure coordinated, culturally sensitive care to meet her complex needs. Methods: TW was connected with navigation services. The navigator assessed TW’s available resources and needs, and developed a rapport with her. She connected TW with other support services to assist with her medical, psychosocial, and cultural needs. One connection was with a woman who lived in Colorado who was also Native American and walked a similar journey. This helped alleviate much of TW’s distress. TW became involved in our support group and art program, which also provided her with a sense of belonging, acceptance, and friendship. It strengthened her will to survive and fight her cancer. TW transformed from being quiet, scared, and untrusting to now being a spokesperson, an advocate, and a mentor for others. Results: TW is one of many who have benefited from our services. In 2011, we navigated 277 patients; in 2012, we navigated 804 patients. In 2013, we increased to 1039 patients—a 375% increase in 2 years. In 2012, we started our survivorship programs. In 2012, we had 435 visits, and in 2013, we had 1561 visits. This is a 359% increase.

Visits include attendance at our support groups, art program, Yoga classes, and other educational and support programs. This poster will also include a summary of comments from patients on the benefits these services have given them.

The Count Us, Know Us, Join Us Global Survey: Comparing Emotional Needs Among Patients with Metastatic Breast Cancer in the United States, Latin America, Europe, and Asia Deana Percassi1; Kyle Hornyak2

Nielsen Consumer Insights (formerly Harris Interactive Inc); 2 CancerCare

1

Background: Approximately 232,670 cases of breast cancer will be diagnosed in the United States in 2014, of which 86,088 (37%) cases will involve cancer that has spread regionally or metastasized. Distant metastasis of breast cancer to sites such as the brain, bone, or liver, carries important health implications, requires lifelong treatment, and is usually fatal.

Support needs of patients with metastatic breast cancer (MBC; breast cancer that has spread to a distant site) are unique and should be met to improve patient experience. To identify new approaches to meet the needs of this patient group, a global survey was conducted. Methods: In partnership with global advocacy organizations, an online survey was conducted by the Harris Poll between October 2012 and March 2013 among women ≥21 years of age with MBC from 12 countries

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Category II: Psychological Support (Argentina, Brazil, Canada, Germany, Hong Kong, India, Lebanon, Mexico, Russia, Taiwan, United Kingdom, and United States). Total sample data were not weighted and were representative only of the individuals surveyed. A global postweight was applied to ensure equal weight of each country in global and regional data. Results: A total of 1273 women responded to the survey. Patients in the United States were more likely than patients in most other countries to: (1) feel isolated from the nonmetastatic community (70% vs 40%); (2) often feel that no one understands what they are experiencing (73% vs 63%); (3) say that support from friends and family has diminished since their initial advanced diagnosis (53% vs 41%); and (4) believe their coworkers view them differently as a result of their MBC (34% vs 17%; among employed women). Patients in the United States were more likely than patients in other countries to actively seek information (97% vs 77%), yet also less likely to feel there is enough information available (31% vs 51%). Conclusions: Despite the considerable attention paid to breast cancer and the resources available in the United States, our survey found that many women in the United States with MBC feel more alone and isolated than their counterparts do in most other countries, and more often feel that no one understands what they are experiencing. Our findings identified unmet emotional needs of US women with MBC, indicating that more must be done to support all women with MBC. Given the central role of nurses on the multidisciplinary team, awareness of the emotional needs of women with MBC is critical to supporting women throughout their patient journey.

Category III: Quality, Outcomes, and Performance Improvement Utilizing Metrics to Advance Navigation Services Deborah Christensen, RN, BSN, HNB-BC; Katie Wahler, RN, BSN, OCN Intermountain Southwest Cancer

Background: Oncology navigation services continue to be seen as a valuable and needed component of person-centered care. Despite the differences in navigation programs from one institution to another, collecting clearly defined metrics and presenting the resulting data to program administrators can be useful in acquiring additional personnel. Human capital is not easily rationalized within the uncertainty of healthcare reform, especially if the position is not revenue-producing.

Several tracking metrics were utilized within 1 institution to quantify the need for additional personnel and show how the additional hours would be utilized to expand and extend navigation services. Objectives: (1) Identify current services being provided by 1 nurse navigator; (2) identify additional services that could be provided with additional personnel; (3) define current usage and additional hours needed to offer essential navigation services; and (4) demonstrate revenue-00generating potential and cost-reduction strategies through the expansion of navigation services. Methods: Metrics, aligned with the above objectives, were developed and tracked for 9 months by the nurse navigator. A navigation flow chart, defining how navigation would be carried out utilizing additional personnel, was also developed and presented with the data to the director of the oncology program. The presentation was refined, and the nurse navigator and a medical oncologist presented the data to the hospital administrator. Results: Discussion and presentation of navigation data resulted in the approval to hire 1 nurse navigator and 1 patient navigator to the oncology program. Conclusion: Research verifies that oncology navigation programs improve patient care and elevate patient and provider satisfaction. Despite the evidence, oftentimes well-defined metrics, data, and program planning will be needed for continued development and success of oncology navigation programs.

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Category III: Quality, Outcomes, and Performance Improvement Integrate Knowledge Gained from an Educational Event into Practice Using a Motivation Action Plan (MAP) Deborah Christensen, RN, BSN, HNB-BC; Katie Wahler, RN, BSN, OCN Intermountain Southwest Cancer

Background: Attending an educational event, such as a national conference, workshop, or in-service, can renew enthusiasm and produce ideas for personal and professional growth. Some type of strategy is needed to ensure that the motivation and knowledge gained from attending these types of events are brought home and integrated into practice. A Motivation Action Plan (MAP) is a simple planning tool that can be used during and at the conclusion of an educational event to map out strategic steps for transforming knowledge into attainable actions. The process is simple; the results can be profound. Objectives: (1) Document and organize key points, questions, and ideas from an educational event; (2) formulate 1 to 4 action plan items; (3) assess motivation and self-efficacy using a 1 to 10 Likert scale; (4) prioritize intentions based on Likert scale scores; (5) detail MAP intention, action, and success; and (6) complete action plan items and report success. Methods: Creating a MAP prior to returning home after an educational event must be easily accomplished yet structured in such a way that objectives can be reached and enthusiasm maintained. Therefore, MAP has a minimum of 1, but no more than 3, focused objectives/intentions per conference or educational event. There are 2 pages to a MAP; page 1 is designed to structure and document notes taken during the presentation, whereas page 2 is a more formalized planning document that details specific measurable actions and time frames. The MAP process is based on Albert Ban­ dura’s self-efficacy theory. Simply stated, self-efficacy is a person’s belief in his or her ability to accomplish a task, goal, or life pursuit. This concept is integral when filtering the abundance of information and excitement generated from attending motivating educational events. High levels of self-efficacy and motivation lead to improved performance outcomes. Results: A group of nurses from across the country volunteered to beta test a MAP during the Oncology Nursing Society 2014 Congress. One week following the conference, a survey was sent to each of the volunteers. Revisions made from suggestions by MAP beta testers included offering MAP in both printable and editable formats and providing preconference access. All respondents acknowledged that they were likely to use MAP in future educational events. Conclusion: Participation in educational events is a fundamental part of continuing education. Attendees who use MAP can easily transform gained knowledge and personal enthusiasm into doable actions. The MAP project will continue to gather data on motivation, action planning, and outcomes through continued use of the tool by education event participants and planners.

Enhancing Survivorship Care Through a New Integrative Model of Navigation Christine Stone, RN, MSN, OCN; Barbara McDonnell, RN, MSN, CBCN; Carrie Friedman, RN, BS Inova Health System/Inova Life with Cancer

Background: Inova Health System (IHS) is a large multihospital, not-for-profit community health system. Each year, Inova diagnoses approximately 6000 new cancer cases. Within IHS is the Life with Cancer (LWC) program of nurses and social workers whose mission is to enhance the quality of life for those affected by cancer by providing information, education, support, and therapeutic services. LWC is a unique program, recently named “Best Practices” by the American College of Surgeons, that services not only Inova patients, but the larger community as well at no cost to patients and family members. Because a new diagnosis of cancer encompasses multiple physician visits and procedures, it produces overwhelming stress and emotion for all involved. Because of the complexity and growing number of cancer patients, LWC restructured their Nursing Team. They also created a centralized telephone number and e-mail address for entry into LWC. Through this access, callers are connected with the appropriate Oncology Nurse Navigator (ONN) or social worker as early as possible to gain diagnosis-specific support and education. Objectives: To meet the psychosocial and educational needs of all cancer patients and their family members within the Inova community and beyond. (1) Restructure LWC nursing staff by merging nursing roles and functions into 1 job description; (2) create easy entry into LWC services through 1 phone number and e-mail supported by a triage team; and (3) establish ONNs as primary contacts once callers are triaged. Methods: (1) Over a 6-month period, a team of LWC Nurse Educators and Inova Breast Care Institute Navigators

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Category III: Quality, Outcomes, and Performance Improvement reviewed, discussed, and developed a new role that encompassed ONN functions; (2) accessed the expertise of the process improvement department and collected the number of disease-specific cancer cases at all 5 facilities; (3) researched other oncology centers similar to our health system to see what job descriptions had been developed; (4) reviewed Oncology Nursing Society 2013 Nurse Navigator Core Competencies and assimilated those into the new ONN role. Results: Changes resulted in a new framework and job description for navigation across IHS. The Oncology Nurse Educator and Breast Nurse Navigator roles were merged into 1 titled ONN. This led to a centralized phone number and e-mail for all cancer patients, families, and healthcare providers. The LWC staff triages the call and disseminates the information to the appropriate navigator across IHS. The next steps involve developing a New Cancer Diagnosis Orientation led by LWC social workers and ONNs. This will include healthcare team expectations, preparation for treatment, LWC programs and services, distress screening, and a survivorship care plan in addition to creating a postdiagnosis survivorship class to address such topics as side effects, late effects, fears of recurrence, coping skills, who to call, returning to work, sexuality and fertility, nutrition, survivors offering support, children support, etc. This will eventually become a formal survivorship clinic.

Conclusion: Through this change, there will be increased patient satisfaction and quality of life, decreased distress associated with a cancer diagnosis, physician satisfaction, and seamless care for patients and families.

Utilizing a Screening Tool to Measure Distress on the Initial Consultation of a Cancer Diagnosis and Implementing a Distress Protocol Barbara R. McHale, RN, BS, OCN, CBCN; Sabrina Mosseau, RN, BS, OCN Samaritan Hospital Cancer Treatment Center, St. Peter’s Health Partners

Background: Oncology nurses have observed patients struggling with both the physical and psychosocial effects of being diagnosed with cancer. With the knowledge that each individual develops different coping mechanisms during his or her lifetime, we realized each patient may react and deal differently with his or her diagnosis. Some of the patients may exhibit confusion, teariness, denial, anger, or become depressed and withdrawn. We struggled with the best way to address these issues and concerns. The decision was made to utilize an evidence-based tool to assess our patients’ distress level and to have a referral system established to remove barriers to care. Screening for distress is the first step in identifying factors that contribute to a poorer quality of life. By addressing these issues in the beginning of the cancer journey, we would be able to improve the patients’ quality of life and outcomes. The nurse navigator was involved with many of the patients, but we needed to have a protocol to initiate referrals to other services—counseling; pastoral care; nutrition; American Cancer Society navigator; physical, occupational, and speech therapy; and lymphedema rehabilitation. Objectives: Initiate a distress protocol utilizing the National Comprehensive Cancer Network (NCCN) distress tool as our screening tool. (The tool was used with permission of NCCN. No content was altered.) Evaluate the impact of the distress tool screening on the initial consultation of a cancer diagnosis and referral to interventions established with the distress protocol. Methods: (1) The distress tool was given to patients on their first consult at the cancer treatment center at Samaritan Hospital.

Patients were able to rate their distress on a scale of 0 to 10 and identify any problems within the areas of practical, family, emotional, spiritual/religious, and physical they had experienced in the past week. Based on these results, referrals were to be initiated. If the score on the Distress Thermometer was <4 (lower level of distress), a physician and RN team intervention would occur. If the score was >4 (severe level of distress), the distress protocol would be implemented. The distress protocol consists of referrals for intervention to nurse navigator; counseling services; pastoral care; nutrition; American Cancer Society navigator; physical, occupational, and speech therapy; and lymphedema rehabilitation services. (2) Staff education was conducted prior to implementing the NCCN distress tool and the distress protocol. In the initial pilot, the distress tool was given to all new patients coming to the cancer treatment center and then readministered after completion of treatment, change in treatment, progression of disease, or a recurrence. Distress can occur at multiple points from a cancer diagnosis onward and may go unrecognized if screening is done only one time. Results: The distress tool was implemented in December 2013. A chart audit was conducted on 81 new patients that started with the center in the first quarter of 2014. Chart audit revealed 71 charts had documented distress tools, 9 had no tools (they were inpatients at the hospital and were not given the distress tool), 1 had a blank tool, and 1 noted that the patient had refused to answer the Continued on page 26

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Y EA R ANNIVERSARY

FiFth annual

Navigation and Survivorship Conference septembeR 18-21, 2014 Walt disney WoRld dolphin hotel oRlando, FloRida

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Continued from page 24

Category III: Quality, Outcomes, and Performance Improvement questions. Utilizing the Distress Thermometer, 58% of patient scores were <4 and 42% of patient scores were >4. Patients who scored <4 on the thermometer were able to be assisted with direct education interventions by primary care physicians and the oncology nursing staff. Expandable folders with resources available by county were placed in the Medical Oncology and Radiation Oncology Clinic areas as a reference source. Distress Thermometer scores >4 had major areas of concern identified: (1) 80% of individuals indicated emotional problems: depression, nervousness, worry, and loss of interest in usual activity; (2) 73% of individuals indicated physical problems: fatigue, appearance, pain, sleep, eating, and getting around; (3) 33% of individuals indicated practical problems: insurance/financial, transportation, and work; (4) 13% experienced family problems: dealing with their partner; and (5) 3% indicated spiritual/religious concerns. Utilization of the distress protocol for referrals to interventions resulted in 100% referred to a nurse navigator; 27% referred to physical, occupational, speech, and lymphedema therapy; 10% referred to nutrition; 7% referred to counseling; 7% referred to American Cancer Society Navigation; and no referrals to pastoral care. Conclusions: Review of data from the audit revealed that several areas need to be addressed for reeducation on the utilization of the distress tool and the distress protocol. Although the highest level of distress in patients who scored >4 on the Distress Thermometer was noted to be emotional problems (80% of the patients), only 7% of these patients were referred to counseling services. Physical problems were noted in 73% of the patients, but only 10% were referred to nutrition and 27% were referred to physical, occupational, speech, and lymphedema therapy. Practical problems were noted in 33% of the patients, and 100% were referred to the nurse navigator. Family problems were rated at 13%, with only 7% referred to counseling. The data showed that the oncology staff would benefit from further education and empowerment to initiate referrals to the various interventions. The nurse navigator was referred to 100% of the time, but to prove the effectiveness of the distress protocol, the other referrals needed to be initiated the day the distress tool was utilized. A second area of concern that was noted with the chart audit was there were no documented follow-up distress tool assessments after the initial one. To measure change in distress scores after referrals to various interventions, a second assessment needs to be done. NCCN included a standard that “all patients should be screened for distress at their initial visit, at appropriate intervals, and as clinically indicated, especially with changes in disease status.”1 “The role of the oncology nurse as a care provider is vital in distress management and includes a responsibility to understand the construct of distress and how to screen for it, educate patients and navigate patients to supportive care interventions as their assessments indicate.”2 References

1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): distress management. Version 1.2008. 2007: Dis-3. Accessed June 27, 2014.

2. Hammelef K, Friese C, Breslin TM, et al. Implementing distress management guidelines in ambulatory oncology: a quality improvement project. Clin J Oncol Nurs.

2014;18(suppl):31-36.

Advanced Cancer Patient Toolkit: Assisting Nurse Navigation in Assessing and Meeting Needs of the Advanced Cancer Patient Lindsey Bowman, RN, BSN

Virtua Fox Chase Cancer Program

Background: There are numerous barriers that prevent patients from receiving quality end-of-life care, including lack of end-of-life education, patient/caregiver avoidance, and poor communication. These barriers can prevent patients from receiving many important resources and interventions at the end of life. Research shows that adequate end-of-life care both decreases costs and improves patient outcomes; therefore, it is imperative that healthcare workers use the many resources that are available to these patients. Nurse navigators are in an important position to ensure that this happens.

Objectives: Nurse navigators are tasked with helping cancer patients get to and through treatment, but there are times that treatment fails or no longer is an option for our patients. It is important for navigators to have the tools necessary to continue to support our patients through to the end of life. The objective of this project is the implementation of a developed toolkit to assist nurse navigators in starting conversations about end-of-life wishes and plans. The toolkit also contains all of the resources needed to ensure patients and families are as comfortable as possible. Methods: An educational needs assessment was obtained through a short survey of the nurse navigators to determine their comfort level with end-

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Category III: Quality, Outcomes, and Performance Improvement of-life conversations and assessments. After the need was determined, a review of end-of-life care literature was performed to determine key points in end-of-life care. Based on the literature review, a toolkit was developed to assist nurse navigators in assessing the needs of the patient with advanced cancer. The toolkit also includes information on referrals that are often necessary and the contact information to streamline the referral process. Evaluation: The toolkit was developed in March 2014. There is ongoing feedback regarding the use of the toolkit. The plan is to resurvey the navigators to determine the use of the toolkit and their satisfaction with the resource. Outcomes will be measured by the survey results and frequency of which the toolkit is being utilized. Goals moving forward would be to incorporate the checklist into our electronic databases for easier use, provide continued end-of-life education opportunities for navigators, and develop an end-of-life toolkit for patients and caregivers. Conclusion: Part of our role as nurse navigators is to assist in removing barriers to ensure that patients with advanced cancer have their end-of-life wishes addressed and carried out. Increasing our own knowledge regarding end of life and staying current on the latest research surrounding the topic will ensure that we are providing the best care to the dying patient.

Improved Outcomes with Successful Intramuscular Injections of Octreotide LongActing Repeatable in Patients with Neuroendocrine Tumors: Training and Techniques April Boyd, RN, BSN, OCN MD Anderson Cancer Center

Background: Octreotide long-acting repeatable (OCT) is currently the only US Food and Drug Administration–approved therapy for symptoms associated with carcinoid syndrome (ie, diarrhea and flushing) and has been the mainstay of therapy for these symptoms in patients with neuroendocrine tumors (NET). OCT is administered monthly by gluteal intramuscular (IM) injections. However, IM injections can be inadvertently delivered subcutaneously (SC), with unknown effects on pharmacokinetics and efficacy. Objectives: We investigated possible causes for unsuccessful injections and describe practical methods used by nurses at our institution to improve successful gluteal IM injections of OCT. Methods: The project was conducted in 3 phases. In the retrospective baseline period, patient computed tomography (CT) scans underwent review to ascertain the ideal injection site, identify reasons for missed injections, and collect anthropomorphic data. In the awareness period, center nurses received informal communication about the project, including reasons for missed injections, but no specific training. Individual technique data were collected on 22 nurses. In the reassessment period, a skilled reference nurse demonstrated an ideal injection technique, and improvements in injection success and patient outcomes were assessed. Results: The overall success rate improved from 52% (baseline) to 75% (reassessment period) (P <.001) after a skilled reference nurse shared a best practice method with the center nurses. Communication alone regarding injection issues led to significant improvement in overall injection success (P = .03) in the awareness period. Identification of the ideal injection site, confirmed by absence of opaque gluteal nodule on CT review, was the primary criterion for successful injection. Locating bony landmarks, specifically the posterior-superior iliac spine (PSIS) and greater trochanter, should be done first. The ideal injection site lies within 10 to 12 cm from the patient’s midline, approximately 4 to 6 cm inferior to the level of the PSIS and 7 to 9 cm above the level of the greater trochanter. Application of pressure to the injection site with the nurse’s free hand aided in placement of a successful IM injection (P <.001). Special care should be taken in females and patients with a high body mass index, because of the low rates of successful injections in these patients. Improvement in the rate of injection success was reflected in patient outcomes. The mean number of flushing episodes per day was reduced by two-thirds in patients receiving correctly placed OCT IM injections versus inadvertent delivery SC (0.22 vs 0.69; P = .005), while a trend toward improvement in the mean number of bowel movements per day (2.9 vs 3.3; P = .67) was observed. Conclusions: Correct injection site choice and regular in-service training are pivotal for increased success of gluteal IM injections. These appear to have direct beneficial effects on symptom control in patients with NET and may have implications for other conditions in which the primary treatment is administered intramuscularly.

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Category III: Quality, Outcomes, and Performance Improvement Treatment Patterns for Anemia Among Lung Cancer Patients Treated with Chemotherapy in 2000-2013 Hairong Xu, MD, PhD1; Langfang Xu, MSc2; John H. Page, MD, MSc, ScD1; Olivia Sattayapiwat, MSc2; Roberto Rodriguez, MD3; Chun Chao, PhD2 Amgen Inc; 2Kaiser Permanente Southern California; 3Los Angeles Medical Center, Kaiser Permanente Southern California

1

Background: Anemia is a common complication of chemotherapy that can cause clinically important symptoms and reduced quality of life. It is unclear how management of chemotherapy-induced anemia (CIA) has evolved over time given the changes in US prescribing information (March 2007, July 2008), reimbursements (July 2007), and the implementation of a Risk Evaluation and Mitigation Strategy (REMS) (March 2010) for the use of erythropoiesis-stimulating agents (ESAs). Objective: Describe treatment trends and current treatment patterns for CIA in 2000-2013. Methods: Incident lung cancer patients (n = 1751) who developed CIA were identified from the Kaiser Permanente Southern California Health Plan. We estimated the proportions of anemia episodes with ESA use, prescription medication (ie, iron, folate, or B12), red blood cell (RBC) transfusion, and no anemia treatment in 3 calendar periods P1-P3: January 2000-December 2006 (P1), January 2007-March 2010 (P2), and March 2010-June 2013 (P3). We also estimated the hemoglobin (Hb) concentrations within 7 days preceding use of ESAs and transfusion. Differences between calendar periods were assessed for proportions treated and for Hb concentration prior to CIA treatment. Standard errors were estimated with generalized estimating equation models. Results: The observed grade 2+ anemia episodes (Hb <10 g/dL) were 643 in P1, 257 in P2, and 262 in P3. The use of ESAs declined over time, with the proportion of grade 2+ anemia episodes treated with ESAs decreasing from 2006 to 2013 (36% in P1, 24% in P2, and 3% in P3; P <.01). This corresponded with an observed increased trend of transfusion use over time (10% in P1, 21% in P2, and 20% in P3; P <.01). The most evident increase in transfusion use was observed in grade 3-4 (Hb <8 g/dL) anemia episodes (23% in P1, 43% in P2, and 57% in P3; P <.01).

A slight increased trend of use of prescription medication (ie, iron, folate, or B12) was observed over time in patients with any grade of anemia (2% in P1, 2% in P2, and 5% in P3; P = .01). The proportion of untreated grade 2+ anemia episodes increased significantly (58% in P1, 62% in P2, and 74% in P3; P <.01). We observed no significant difference in Hb levels (g/dL) at initiation of ESA use (mean [SD]: 9.5 [1.2] in P1; 9.3 [1.1] in P2; 9.1 [0.9] in P3; P = .26) or prior to transfusion use over time (mean [SD]: 8.4 [1.4] in P1; 8.3 [1.2] in P2; 8.2 [1.2] in P3; P = .66). Conclusion: The study indicates that along with the decreased utilization of ESAs, utilization of RBC transfusion has increased significantly over time. Approximately 74% of patients with moderate-to-severe anemia (Hb <10 g/dL) remained untreated after the implementation of a REMS program for ESAs.

Development and Evolution of an Oncology Nurse Navigation Program: From Formation to Fruition Peggy Malone, RN, BS, OCN; Lisa Bruno, RN, BSN, OCN; Beth Hayden, RN, BSN, MBA, OCN; Julie Carlson, RN, MSN, APN, AOCNS OSF Saint Anthony Medical Center, Center for Cancer Care

Background: To better meet the holistic needs of our patients and the new program standards introduced in 2012 by the American College of Surgeons Commission on Cancer (CoC), the Center for Cancer Care at OSF Saint Anthony Medical Center clearly needed to develop a more comprehensive nurse navigation program. The concept of navigation was first introduced in 2006 with the addition of a part-time nurse navigator dedicated to the care of the breast cancer patient population. While anecdotal feedback regarding the navigation program was extremely positive, no concrete metrics were in place to measure outcomes. In addition, patients were not systematically screened, and survivorship care plans were not initiated. Objectives: (1) Develop and implement an oncology nurse navigation program that achieves the following desired quality outcomes: improve referrals to ancillary support services, increase patient satisfaction, and ensure patients are seen by the oncologist within a week from the time of initial referral; and (2) meet CoC accreditation standards. Methods: Continued on page 30

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Category III: Quality, Outcomes, and Performance Improvement The existing navigation program was evaluated using the patient navigation preassessment tool and needs assessment checklist developed by the Association of Community Care Centers. A 10-step action plan was implemented to restructure the overall program, which included obtaining administrative and budgetary approval to hire 1.5 additional full-time employees (FTEs), resulting in a total of 2 FTEs for nurse navigation. The key to our success has been the use of the “care maps” based on National Comprehensive Cancer Network guidelines that were developed by a multidisciplinary team.

These care maps expedite diagnostic testing, staging, and treatment for patients, but also assure integration of education, as well as supportive, palliative, and survivorship care into the patient care planning. The maps have been created and implemented for our top 4 analytic disease sites, which are breast, prostate, colon, and lung. Results: For the first half of 2014, all new patients with a diagnosis of breast, prostate, lung, and colon cancer have been navigated–a total of 134 patients. Referrals have increased to ancillary services, including support groups, genetics, physical therapy, pulmonary rehabilitation, hospice, advanced directive services, social services, American Cancer Society, and financial services. Implementation of the oncology nurse navigation program has shown a marked increase in enrollment to the chemotherapy class offered in the department. The majority of patients are seen within 1 week of diagnosis. Conclusions: Over the past 6 months, the navigation program at OSF Saint Anthony Medical Center has experienced tremendous growth in terms of volume and services offered to patients. Oncology nurse navigation is a valuable service that positively promotes referrals to ancillary and community services. Next steps include the following: (1) developing care maps and navigating additional disease sites, including head and neck and pancreatic cancers; (2) streamlining the survivorship care planning tool and process to ensure all patients navigated receive a survivorship care plan upon treatment completion; and (3) implementing a navigation-based patient satisfaction survey.

Aligning the Hematology Oncology Patient Navigator Program at Boston Medical Center with the Commission on Cancer Standards for 2015 Katie Finn, BA; Kathryn Ankner, BA; Mikaela Murphy, BA; Ina Petreli, BS; Robyn Souza, RN, MPH Boston Medical Center

Boston Medical Center (BMC) is a private, not-for-profit academic medical center and the primary teaching affiliate for Boston University School of Medicine. The largest safety-net hospital in New England, BMC has approximately 73% of its patients coming from neighborhoods with the highest levels of mortality and health disparities. The hematology oncology (HemOnc) patient navigator (PN) program was developed in 2005 and now houses 5 full-time PNs to manage the multitude of barriers identified in our patient population. To remain an accredited medical center by the American College of Surgeons Commission on Cancer (CoC), we look to align our PN program with the 4 compliance criteria outlined in CoC Standard 3.1.

CoC Standard 3.1 for 2015, PN process, calls for a PN program to comply with 4 main criteria, including: (1) conducting a community needs assessment, (2) establishing navigation processes and resources for addressing barriers, (3) evaluating the PN program by the center’s cancer committee annually, and (4) modifying and enhancing the program yearly to address additional patient needs and barriers. The BMC PN program currently meets these standards through a variety of processes. These processes include measures such as reporting on and analyzing data from PN documentation, identifying additional resources uncovered by such reports, and presenting these data regularly to BMC’s Cancer Committee. Additionally, such reports demonstrated the increasing patient need, showing the number of unique patients served per month rising 3% from FY 2012 to FY 2013, as well as the number of PN contacts up 24%. Due to the continuous growth and successes of the PN program, a standardized training curriculum was established for developing the skills and knowledge required to become a fully competent PN. This became a “best practice” example, recognized by the BMC Patient Satisfaction Steering Committee in 2012. The annual community needs assessment also identified the city’s ever-growing need for assistance with transportation, despite Boston’s public transportation system, in order to access health facilities. BMC’s PN program responded to these findings, by establishing processes to address barriers, resulting in an average of approximately 160 rides scheduled per PN each month. By adhering to CoC standards, the BMC HemOnc PN program proves to be a successful, comprehensive, patient-focused program that is committed to excellence and quality improvement.

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Category III: Quality, Outcomes, and Performance Improvement Noninfectious Pneumonitis with Mammalian Target of Rapamycin Inhibitors in Patients with Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer; Management Measures and Clinical Experiences Nina Jinks, RN, OCN

Highlands Oncology Group

Background: Noninfectious pneumonitis (NIP) is a nonmalignant noninfectious infiltration of the lungs, a class effect of mammalian target of rapamycin (mTOR) inhibitors. Oncology nurse navigators, who are integral members of the healthcare team may find this condition among patients with breast cancer. In this analysis, NIP associated with mTOR inhibitors was evaluated from a nurse navigator perspective. Objectives: To educate nurse navigators about NIP associated with mTOR inhibitors in patients with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer. To provide information on various management techniques that can help nurse navigators in better patient management and to improve patient outcomes. Methods: In Breast Cancer Trials of Oral Everoli­mus (BOLERO)-2, a phase 3 study, patients with HR+, HER2– advanced breast cancer, who recurred or progressed on previous letrozole and anastrozole, were randomized 2:1 to receive everolimus + exemestane or placebo + exemestane. NIP was reported among these patients, and this analysis will highlight the clinical data from BOLERO-2 and the measures used in the management of patients with NIP associated with everolimus. Best practices and additional experiences from a single clinical center will also be presented. Results: In BOLERO-2, all-grade NIP was reported in 16% of patients in the everolimus arm, and most of the events were grade 1/2. Grade 3 NIP was observed in 3% of patients. No grade 4 events were observed. Among patients with grade 3 NIP and related events in the everolimus arm, 80% had improvement to grade ≤1 within a median duration of 3.8 weeks. Patients should be evaluated for pulmonary history prior to initiation of everolimus therapy, educating them about the potential risk of NIP, and guiding them to approach nurse navigators if they have sudden cough or dyspnea or worsening of baseline symptoms. It is also important to rule out infection as the cause of symptoms. Grade 1 events (asymptomatic, with only radiologic changes) do not necessitate treatment discontinuation; however, patients have to be monitored closely for development of clinical symptoms. In patients with mild-to-moderate symptoms, treatment interruption until resolution of symptoms is a management option, and for management of respiratory distress, treatment with antibiotics and corticosteroids should be considered. Dose reductions and discontinuation of therapy may be necessary. Conclusions: Evaluation of radiographic changes and clinical symptoms, early recognition, and early intervention are the important measures for proper management of NIP associated with mTOR inhibitors. Oncology nurse navigators must carefully monitor patients with NIP, as the symptoms are nonspecific in nature and can result in potentially serious consequences.

Developing a No-Cost, High-Impact Oncology Navigation Database Anna Liza Rodriguez, MHA, MSN, RN, OCN; Stella Estrella, BSN, RN, OCN; Roxana Iacob, MSW; Tammy Kalinowski, RT (R)(M) Presence Resurrection Medical Center

Background: Patient navigation is an integral component of a quality oncology program. While literature support the value of navigators in improving key metrics, such as timeliness and access to care, patient satisfaction, and coordination of care, oncology program administrators are challenged to demonstrate measurable navigation productivity and quality indicators to assess navigator full-time equivalent return on investment.

The current tracking system for Presence Resurrection Medical Center (PRMC) nurse navigation was an Excel document with multiple tabs. The spreadsheet was cumbersome to use; therefore, documentation of encounters was not entered consistently.

The oncology program director created a navigation database in Microsoft Office Access, which was further refined with input from the nurse navigator, breast navigator, and social worker. The new oncology navigation database was designed to enable the navigators to document in real time all navigation activities, including patient and family encounters.

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Category III: Quality, Outcomes, and Performance Improvement Objective: Develop a no-cost oncology navigation tool for tracking operational and quality indicators. Methods: The navigation team determined what indicators were relevant to track, and developed a password-protected Oncology Navigation Access database. The following access data forms were created that simplified the data entry during each encounter: intake, needs assessment, encounter, and outmigration/retention. Access reports were also created for ease of generating real-time productivity reports, including time spent, volume per navigator, new cancer patients navigated, number of encounters, referral sources, and tumor sites. Program indicator reports included reason for referral, barriers/concerns, and interventions, among others. The database was set up to group encounters by patient so that the navigator team could easily view all activities for each patient. The database is saved in a shared drive, allowing navigators to access the tool from various locations.

Results: The homegrown database simplified tracking of various navigation indicators. The number of encounters documented since database implementation significantly increased from a baseline of 61 documented encounters in 2012 to 1308 in calendar year 2013 and 771 year to date in 2014. The Access report functionality allowed quick generation of date- and time-stamped reports for cancer committee or department meetings. The database also has the capability to run customized patient-specific reports that can be scanned into the electronic health record. Conclusion: Oncology program administrators can develop a no-cost patient navigation tool that can effectively track navigation outcomes and productivity without significant software investment. The PRMC homegrown navigator database validates navigator productivity.

Coordinating Care and Cutting Costs: Utilizing Navigation to Provide Pegfilgrastim and Rituximab Closer to Home Chelsea Passwater, RN, BSN, OCN; Judy Koutlas, RN, MS, OCN; Evelina Kolychev, PharmD, BCOP; Andrea Faison, PharmD, BCPS; Janet Reimer, RN, BSN, OCN; Debra Mascarenhas, RN, BSN, CBCN; Teresa Parent, RN, BSN, OCN; Phyllis DeAntonio, RN, MSN, FAAMA Vidant Medical Center

Background: Vidant Medical Center (VMC), the flagship hospital for Vidant Health System, serves approximately 1.4 million patients in 29 counties of eastern North Carolina. Oncology patients often live far distances from VMC, creating barriers to care. Transportation issues and inability to commute have caused prolonged hospital stays for administration of agents such as pegfilgrastim and rituximab. In January 2014, the nurse navigation program was restructured to enhance timely cancer care across the continuum, removing barriers, and reducing costs. Objectives: (1) Describe the navigation process utilized to arrange medication administration in the home or at a facility closer to home, and (2) quantify the cost-savings of administering pegfilgrastim and rituximab in the outpatient versus inpatient setting. Methods: Nurse navigators collaborated with pharmacists and regional providers to determine an optimal location for medication administration. Safety concerns and medication costs were considered. Navigation data from January 1, 2014, to May 31, 2014, were utilized to identify patient encounters involving services closer to home collected by 3 nurse navigators. Encounters were specific to the administration of pegfilgrastim or rituximab. Drug cost-saving data from the first 5 months of 2013 and 2014 were compared utilizing medication administration records. Specifically, location of service (inpatient vs outpatient) and associated drug costs utilizing average wholesale price were examined. Data collected included length of stay defined as 1 nightâ&#x20AC;&#x2122;s stay per dose, number of doses administered, and overall estimated cost-savings. Results: Fifty encounters were identified; 48 patients received pegfilgrastim in the outpatient setting at VMC, regional facility, or at home. This corresponded to an approximate total savings of $204,370. Similarly, 2 patients received rituximab, which corresponded to an approximate total savings of $9605. In 2013, 3.46% ($46,835) of all pegfilgrastim administrations at VMC were done in the inpatient setting; in 2014, it was 2.75% ($29,803). In 2013, 12.54% ($84,389) of all rituximab administrations for hematologic malignancies at VMC were done in the inpatient setting; in 2014, it was 6.62% ($39,107). In addition, 32 overnight inpatient stays were prevented, corresponding to an estimated savings of $67,136. Conclusions: When comparing 2013 with 2014, a 0.71% decrease in inpatient administration of pegfilgrastim and a 5.92% decrease in inpatient administration of rituximab were found. There was an estimated total cost-savings of $281,111 within the 5-month study period. This confirms that utilizing navigation to coordinate care closer to home has a positive financial impact on the healthcare system. Future areas of study include examining patient satisfaction and adherence to plan of care as it relates to coordination of care by cancer care navigators.

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Category III: Quality, Outcomes, and Performance Improvement Teamwork; Implementing a Chemotherapy Checklist to Improve Efficiency, Safety, and Adherence for Patients Receiving Oral Chemotherapy Elizabeth Sunderland, RNBC, BSN, OCN; Carolyn Fansler, RN, BSN Paoli Hospital

Background: The face of chemotherapy administration has changed dramatically over the past decade. Oral chemotherapy is becoming a more popular option for patients facing cancer treatment. The number of oral chemotherapy agents and their usage has shed light on unique challenges. Many hurdles are associated with prescribing, dispensing, reimbursement, adherence, safety, and education. In our practice, we were noticing gaps in care. Physicians were not sharing who they started on oral chemotherapy agents; therefore, patients were not properly educated, resulting in an influx of poorly managed side effects. Patients were also unsure how to obtain their drug, creating disjointed interdisciplinary involvement. Objectives: Our primary objective was to improve patient care by updating standards and guidelines for our practice based on the updated 2013 American Society of Clinical Oncology/Oncology Nursing Society (ASCO/ONS) guidelines on the usage of oral chemotherapeutics. Second, we wanted to streamline the process and create a user-friendly flow for both the patient and the practice. Methods: We created an interdisciplinary task force consisting of physicians, clinical nurse coordinator, nurse navigator, pharmacist, administrative assistant, and social worker. We reviewed the 2013 ASCO/ONS guidelines on the usage of oral chemotherapeutics with our present practice, realizing success would require a team effort. Each practitioner defined their roles/responsibilities in the confusing paradigm of oral chemotherapy usage.

Results: Our end result was the creation of an oral chemotherapy checklist that is initiated when a patient is prescribed an oral chemotherapy agent. The list serves as a pathway from initial screening, informed consent, written prescription, order verification, precertification, insurance authorization, education on patient copay, dispensing, drug interaction screening, patient/family education, start date, labs, follow-up, and phone calls. Each practitioner signs off when they have completed their task/responsibilities so all team members know where the patient is in the process of initiating treatment. This checklist has improved care 2-fold: improved communication among the team serving the patient, and improved efficiency, safety, and adherence for patients taking oral chemotherapy. Conclusion: Although taking an oral chemotherapy agent may sound more appealing to patients, understanding the process of obtaining the drug, paying for it, and appropriately taking and reporting side effects is an overwhelming scenario. Initiating treatment requires the assistance of the entire multidisciplinary team.

Navigation: Patient Experience, Clinical Outcomes, and Business Performance Tricia Strusowski, MS, RN Oncology Solutions, LLC

Background: Over the years, the role of the navigator has become an essential component for cancer programs. As navigators were hired, the need for evidence-based tools and guidelines became a high priority. Navigation programs need to demonstrate strong metrics in regard to patient experience, clinical outcomes, and business performance.

Objectives: • To provide assessment tools for implementing a strong navigation program that is Commission on Cancer (CoC)-compliant and focused on patient- and family-centered care • To identify program success metrics for patient experience, clinical outcomes, and business performance A quality navigation program must be created and modified to meet the patient population needs, which are identified through completion of a thorough community needs assessment. A part of the CoC Standards for 2015, the assessment aids in understanding the patients’ specific needs and barriers to care in the community. This creates a strong foundation for the navigation program across the entire continuum of care since the role of the navigator is to assess the patients’ and families’ understanding of their diagnosis and treatment, identify and remove barriers to care, provide psychosocial screening, and coordinate support staff and resources.

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Category III: Quality, Outcomes, and Performance Improvement The navigation matrix, created by the National Comprehensive Cancer Center (NCCN) Program Navigation Networking Committee, is a tool that helps with evaluating all the components of the program. Every navigation program is unique, and the role of the matrix is not to gauge one program against another but to provide guidance to create a strong program. The matrix categorizes 16 elements with ranking levels 1 through 5, including key stakeholders, quality measures, clinical trials, etc.

As the navigation program is built, patient experience, clinical outcomes, and business performance should be a priority. This will ensure the patient is always at the forefront, and high-quality clinical standards will help ensure financial strength.

In a recent survey, an Institute of Medicine (IOM) report, “Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis”, revealed that the number one response from cancer patients was “listen to me.” Patients want to participate in the decision-planning sessions with their healthcare team. To ensure a superb patient experience, some tools and measures to utilize are: • Measurement of outcomes/interventions related to barriers to care and distress screening • Patient experience survey • Patient education packets for surgery • Survival toolkits for families Method: The poster abstract will provide sample tools and metrics to ensure CoC compliance and address concerns documented in the IOM report.

Measuring clinical outcomes elevates the standard of oncology care. Every navigation program needs to incorporate research and quality measures into its foundation. Some examples are: • Clinical care in accordance with NCCN or other national guidelines • Survivorship surveillance plan compliance/monitoring • Creation of standing order sets by cancer disease site for multidisciplinary teams Strong business performance is very important for maintaining a navigation program. Navigation programs can be very expensive and return on investment is critical. Some financial outcomes to measure include: • Decrease in emergency room visits and readmissions • Medication reconciliation program • Patient retention rates/decrease outmigration Conclusion: Successful navigation programs demand solid metrics that are patient-centered and evidence-based. Patient experience and outcomes are imperative for a state-of-the-art cancer program. This presentation will provide ideas and examples that will further enhance your navigation program. Tools and metrics will be shared at the Academy of Oncology Nurse & Patient Navigators Conference.

Prehabilitation Improves the Physical Functioning of a Newly Diagnosed Lung Cancer Patient Before and After Surgery to Allow for a Safe Surgical Resection and Decreased Hospital Length of Stay: A Case Report Elizabeth Hunt, RN, MSN, CRRN, CCM; Kristen VanderWijst, PT; Bobbi Stokes, PTA; Regina Kenner, RN; Kathryn Duval, MS, CCC-SLP; Messina Corder, RN, BSN, MBA Mary Washington Healthcare

Background: Patients diagnosed with cancer often present with decreased functional status because of age, deconditioning, and comorbidities—all factors that may influence surgical intervention as a potential treatment option. The Survivorship Training and Rehabilitation (STAR) Program team, which includes nurse navigators at Mary Washington Healthcare, piloted a prehabilitation program for patients with lung cancer to evaluate readiness for surgery through improved physical and emotional well-being. Objective: This case study reports on the impact of a cancer prehabilitation program Continued on page 36

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Fifth annual aonn+ conference abstracts Continued from page 34

Category III: Quality, Outcomes, and Performance Improvement that included physical therapy and nurse navigator interventions in an effort to improve patient readiness for lung cancer surgery. Methods: MS is a 75-year-old woman diagnosed with stage IA lung cancer with comorbidities of osteoarthritis and chronic knee and back pain. Her initial symptoms included dyspnea at rest and with exertion, limited functional mobility, and severe deconditioning. The thoracic surgeon referred her to the STAR Program for prehabilitation in an effort to decrease surgical risk. The physical therapist utilized evidence-based practices to improve the patient’s mobility, endurance, and strength. MS was also screened for distress and referred to the nurse navigator program, where an assessment identified and interventions reduced distress triggers and barriers to care. Results: Three weeks after the initial diagnosis, MS underwent bronchoscopy for staging and started prehabilitation 5 days later. Prehabilitation lasted 6 weeks, and she underwent lung resection and then had 6 weeks of physical therapy followed by transition to a community-based exercise program at the YMCA. Functional outcomes included a 6-Minute Walk Test baseline (992 feet), after prehabilitation (1120 feet; 13% improvement) and after surgery/rehabilitation (1130 feet; 14% improvement); Timed Up and Go baseline (13 seconds) and after surgery/rehabilitation (8 seconds; 38% improvement); and, the Movement Assessment Log (53% decrease in impairment). MS no longer experienced dyspnea at rest or on exertion. The navigator was instrumental in providing emotional support, education, and guidance on treatment decisions. MS had a shortened postoperative stay of 3 days versus the usual 4 to 5 days and a successful discharge to home. Conclusions: This case study demonstrated the following results regarding prehabilitation: (1) improved the patient’s health above baseline status at diagnosis; (2) decreased surgical risk; (3) decreased hospital length of stay; and (4) combined with rehabilitation after surgery, the patient’s overall health and functional status was better than it was at diagnosis. The STAR Program staff at Mary Washington Healthcare decided to implement a permanent protocol with physical therapy and nurse navigation specifically for patients with lung cancer. The team is working with the thoracic surgeon to identify appropriate patients and plans to further evaluate the impact on surgical readiness and postsurgical function.

Assessing Cancer Patient Supportive Needs Through Dual Screening for Physical and Emotional Problems Elizabeth Hunt, RN, MSN, CRRN, CCM; Regina Kenner, RN; Kathryn Duval, MS, CCC-SLP; Messina Corder, RN, BSN, MBA Mary Washington Healthcare

Background: Cancer and its accompanying treatments can cause significant physical and emotional side effects that impact quality of life for many patients. The ability to screen patients at key intervals at any stage of treatment may identify physical and/or emotional factors with an opportunity to intervene and improve outcomes. A key component to early identification is not only completing an appropriate distress screen but also a physical screening focused on impairments and function. This is called “dual screening” and is recommended by the Survivorship Training and Rehabilitation (STAR) Program. Objective: To evaluate cancer patient functional and support needs through a dual screening process.

Methods: As part of the STAR Program, the outpatient cancer care team implemented the STAR Program Physical Impairment and Functional Assessment Screening Tool–Diagnostic Use: Survivor General modified to include questions from the Distress Thermometer to screen for both physical problems and emotional distress. Patients were screened over 4 months during their treatment visit at outpatient infusion or radiation therapy. The screening questionnaire was divided into sections with yes/no questions regarding nutrition, emotional and psychosocial issues, and functional issues. Any section that had trigger questions answered “yes” or had any 2 questions answered “yes,” generated a discussion with the patient regarding available services. The patient did not necessarily receive an automatic consult to the service unless an obvious immediate intervention was needed. Results: The goal was to screen 40 patients. Over the 4-month period, 77 patients were screened. A total of 59% of the patients had a diagnosis of breast, lung, or prostate cancer. The STAR Program team found that more than 60% of patients met the criteria for a physical therapy consult, 50% for occupational therapy, and close to 30% for speech language pathology. In addition, nearly 10% of patients met the criteria for a nurse navigator consult and 17% for nutrition. Actual consults to these services were not consistent with what the need

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Category III: Quality, Outcomes, and Performance Improvement showedâ&#x20AC;&#x201D;there was a demonstrable gap in care. Of the 77 screenings, 12% of patients followed through with the suggested consults for physical therapy, speech language pathology, and/or navigator services. Conclusions: The STAR Program team identified a significant need for supportive services that continued beyond the screening process, suggesting that screening alone is not sufficient for patients to receive necessary services. Realizing that a more proactive approach was needed, the team modified the STAR Program Referral/Physician Order Form to integrate with the dual screening tools. This change in the screening process is now being measured to determine whether patients will be better able to access care.

Supporting Evidence-Based Practice in Nurse Navigation Sharon Gentry, RN, MSN, AOCN, CBCN; Laurie Mathis, RN, OCN, CBCN; Jamie Calcutt-Flaherty, RN, CBEC Novant Health Derrick L. Davis Cancer Center

Background: Original research from 2011 demonstrated that a positive experience with a breast nurse navigator decreased outmigration from the healthcare system. The annual revenue attributed to this decrease covered the costs of the navigation program.1 Despite the gain of patients, an average of 30 to 45 patients with breast cancer were leaving our program annually.

Desimini and colleagues showed that placement of a nurse navigator early in the breast care continuum decreased outmigration after 1 year from 240 patients per year to 28, fully covering the additional salary cost.2 Similarly, Balderson and Safavi reported that patient navigation generated enough revenue in 3.5 months to cover 2 full-time navigators, and each navigator added $150,000 in hospital revenue.3 Objectives: The purpose of this project was to decrease breast cancer patient outmigration through a redesigned breast nurse navigation process. A secondary objective was to promote clinical trial participation.

Methods: In an effort to strategically align breast nurse navigation upstream in the patient experience, the critical element of diagnosis disclosure was moved from the primary care physician to the radiologist at the breast imaging center. An additional breast nurse navigator was placed in the imaging center who took on the responsibility of following up with all biopsied diagnostic breast patients within 72 hours. All negative biopsies were called with their results, except for those with benign pathology that would need further surgical follow-up. The benign patients needing further treatment and all positive biopsy patients remained on the schedule to be seen at the imaging center for their diagnosis. The radiologist shared the diagnosis, and the nurse navigator provided education on breast cancer type, prognostics, and next steps.

Results: In 2012, 45 patients with breast cancer left the system for various reasons despite the presence of breast navigators.

After the systemic change of placing a breast nurse navigator further upstream in the care process, only 25 patients left the system in 2013. This was a drop from an outmigration rate of 6.31% to 3.97%, which equaled a 63% decrease in patients leaving the system for care. In comparison with cost-savings from the original study in 2011, this further decrease brought in $272,500 of revenue to the healthcare system. Interestingly, the influence of this change in navigation contact was seen within 6 months since the outmigration rate fell to 3.97% at that time and remained consistent throughout the year.

The secondary objective to promote clinical trial participation was also successful. Each stage III patient (excluding inflammatory patients) was screened for consideration of neoadjuvant chemotherapy. Within 1 year of the new breast navigation process, there was a 20.4% increase of eligible patients who had a neoadjuvant consult prior to surgery. Several studies in the current literature promote this role for nurse navigators to increase clinical trial involvement.4,5 The nurse navigator is the key to a trusting relationship of care, which allows the introduction of a clinical trial at an earlier stage in the care continuum.

Conclusions: Nurse navigation can decrease patient outmigration in the breast care setting and provide revenue to support the position. Nurse navigation can have a role in patientsâ&#x20AC;&#x2122; awareness of availability of clinical trials and positively influence clinical trial participation.

Continued on page 40

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5

Y E AR A NN I V E RS A RY

FIFTH ANNUAL

Navigation and Survivorship Conference September 18-21, 2014 • Walt Disney World Dolphin Hotel • Orlando, FL AONN+ LEADERSHIP PROGRAM DIRECTOR

TARGET AUDIENCE

This educational initiative is directed toward oncology nurse navigators, patient navigators, case managers, care managers, administrators, and social workers whose focus is on cancer care and survivorship.

STATEMENT OF NEED/PROGRAM OVERVIEW

Lillie D. Shockney, RN, BS, MAS University Distinguished Service Associate Professor of Breast Cancer Departments of Surgery and Oncology Administrative Director, The Johns Hopkins Breast Center Administrative Director, Johns Hopkins Cancer Survivorship Programs Associate Professor, JHU School of Medicine Departments of Surgery, Oncology & Gynecology and Obstetrics Associate Professor, JHU School of Nursing Baltimore, MD

AONN+’s Fifth Annual Conference will continue to advance the navigation profession by expanding the scope of educational sessions, networking opportunities, and poster presentations. In addition, this year’s conference will address the evolving challenges of program improvement, the role of personalized medicine, and implementing best practices in navigation, survivorship, and psychosocial care for cancer patients.

EDUCATIONAL OBJECTIVES

After completing this activity, the participant should be better able to: • Describe the evolution of the role of navigation in healthcare • Interpret strategies for navigating diverse patient populations by cancer type and environmental factors • Define methods for providing patient support and guidance in the age of personalized cancer care • Explain how to evaluate best practices regarding survivorship and psychosocial care

NURSING CONTINUING EDUCATION

Global Education Group is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s COA. This educational activity for 15.75 contact hours is provided by Global Education Group.

Nurses should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN CASE MANAGEMENT ASSOCIATION

Application for certification of ACMA hours has been applied for and is pending decision.

Sharon Gentry, RN, MSN, AOCN, CBCN Breast Health Navigator Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, NC

This activity is co-provided by Global Education Group and Center of Excellence Media, LLC.

NATIONAL ASSOCIATION OF SOCIAL WORKERS

This program has been submitted and is pending approval by the National Association of Social Workers for continuing education contact hours.

DISCLOSURE OF CONFLICTS OF INTEREST

Global Education Group (Global) requires instructors, planners, managers, and other individuals and their spouse/life partner who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by Global for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.

AMERICANS WITH DISABILITIES ACT

Event staff will be glad to assist you with any special needs (ie, physical, dietary, etc).

Please contact Patrice Melluso prior to the live event at pmelluso@the-lynx-group.com and 516-835-6529.

REGISTER TODAY! www.regonline.com/AONN2014

AGENDA

*

Thursday, September 18 12:30 pm - 1:30 pm 3:30 pm - 4:30 pm 5:30 pm - 8:00 pm

Start a Subcommittee Meeting (non–CE-certified activity) Start an AONN Chapter Meeting (non–CE-certified activity) Welcome Reception and Keynote Session (non–CE-certified activity)

4:45 pm - 5:45 pm

Friday, September 19 Navigators Exploring Xtra Tracks (N.E.X.T.) Day

Breakfast/Session 1 sponsored by Celgene Corporation (non–CE-certified activity) 8:15 am - 9:15 am Session 2 sponsored by Lilly Oncology (non–CE-certified activity) 9:30 am - 10:30 am Session 3 sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. (non–CE-certified activity) 10:45 am - 11:45 am Session 4 (non–CE-certified activity) 12:00 pm - 1:00 pm Lunch/Session 5 sponsored by Millennium: The Takeda Oncology Company (non–CE-certified activity) 1:15 pm - 2:15 pm Session 6 (non–CE-certified activity) 2:30 pm - 3:30 pm Session 7 (non–CE-certified activity) 3:45 pm - 4:45 pm Session 8 (non–CE-certified activity) 4:45 pm - 6:15 pm Poster Question and Answer Session in the Exhibit Hall (non–CE-certified activity) 6:30 pm - 9:30 pm Heroes of Hope AONN+ Family Event at Epcot Center Extra registration fee required for this event. (non–CE-certified activity) 7:00 am - 8:00 am

TM

Saturday, September 20

Meet the Experts Breakfast in the Exhibit Hall (non–CE-certified activity) 8:00 am - 8:15 am Welcome, Introductions & Business Update (non-CE-certified activity) - Lillie D. Shockney, RN, BS, MAS; Sharon Gentry, RN, MSN, AOCN, CBCN 8:00 am - 9:00 am General Session 1: Finding Humor Where You Least Expect It: An Oncology Nurse Navigator’s Experiences with Breast Cancer Lillie D. Shockney, RN, BS, MAS 9:00 am - 10:00 am General Session 2: Sex, Chemo, and Rock & Roll - Penny Daugherty, RN, MS, OCN 10:00 am - 11:00 am General Session 3: Navigation and Survivorship Standards —Are You Ready for Your Commission on Cancer Accreditation? Virginia Vaitones, MSW, OSW-C 11:00 am - 12:00 pm General Session 4: Multiorgan Site Navigation - Libby F. Daniels, RN, OCN 12:00 pm - 1:15 pm Poster Award Winner Announcements, Presentations, and Luncheon in the Exhibit Hall (non–CE-certified activity) 1:15 pm - 2:15 pm General Session 5: Pediatric Oncology Navigation and Survivorship - Kathy Ruble, RN, CRNP, PhD 2:15 pm - 3:15 pm General Session 6: Medical Home and Quality Accreditations Update - Maureen Lowry, RN, BSN, OCN; John Sprandio, MD 3:15 pm - 5:30 pm Exhibit Hall Open 3:15 pm - 3:30 pm Break in the Exhibit Hall (non–CE-certified activity) 3:30 pm - 4:30 pm Breakout Session 1 (Choose one of the following sessions) • Basic Navigation (0-2 years) - Britta Newcomer, RN 7:00 am - 8:00 am

6:00 pm - 10:00 pm

• Intermediate Navigation (3-5 years) - Lucy Gansauer, RN, MSN, CPSO, OCN - Elaine Sein, RN, BSN, OCN, CBCN • Advanced Navigation (5+ years) - Sharon Gentry, RN, MSN, AOCN, CBCN • Administrators - Lisa Shalkowski, RN, BSN, MSHA Breakout Session 2 (Choose one of the following sessions) • Breast Cancer Navigation and Survivorship • Hematologic Malignancies Navigation and Survivorship - Peg Rummel, RN, MHA, OCN • Head, Neck, and Neurologic Cancers Navigation and Survivorship - Tamara Bowen, RN, BSN, MHA • Gynecologic Cancers Navigation and Survivorship - Carol Cherry, MSN, RN, AOCNS, APNG Heroes of Hope AONN+ 2nd Annual Gala Extra registration fee required for this event. (non–CE-certified activity) TM

Sunday, September 21

Breakfast in the Exhibit Hall (non–CE-certified activity) 7:45 am - 8:00 am Welcome - Lillie D. Shockney, RN, BS, MAS; Sharon Gentry, RN, MSN, AOCN, CBCN 8:00 am - 8:45 am General Session 6: Sharing Best Practices - Mandi Pratt-Chapman, MA 8:45 am - 9:30 am General Session 7: Lay Navigation - Jean B. Sellers, RN, MSN 9:30 am - 10:45 am General Session 8: Utilizing EPIC to Successfully Navigate Patients - Lisa DelPizzo, RN, MSN, CCM, CBPN-IC; Danielle Guillama, RN, BSN, OCN 10:45 am - 12:00 pm Exhibit Hall Open 10:45 am - 11:00 am Break in the Exhibit Hall (non–CE-certified activity) 11:00 am - 12:15 pm Breakout Session 3 (Choose one of the following sessions) • Lung Cancer Navigation and Survivorship - Caryn M. Vadseth, RN, BSN, OCN • Prostate Cancer Navigation and Survivorship - Frank dela Rama, RN, MS, AOCNS • Gastrointestinal/Colorectal Cancer Navigation and Survivorship - Allyson Foor; Gail Sullivan, RN, BS • Melanoma Navigation and Survivorship - Krista M. Rubin, MS, RN, FNP-C 12:15 pm - 1:30 pm Lunch/General Session 9: Cancer Support Community/ UF Health Cancer Center Pilot Program - Linda House, RN, BSN, MSN; Diane Robinson, PhD 1:30 pm - 2:30 pm General Session 10: Sexuality and Intimacy - Michael L. Krychman, MD, FACOG 2:30 pm - 3:30 pm General Session 11: Doctor, Doctor Lend Me Your Ear - Marisa C. Weiss, MD 3:30 pm - 3:45 pm Closing Remarks - Lillie D. Shockney, RN, BS, MAS; Sharon Gentry, RN, MSN, AOCN, CBCN 7:00 am - 7:45 am

*Agenda subject to change.

Complete agenda and faculty information available on our website at AONNonline.org

*

Blackout Times

†

Thursday, September 18 8:00 am - 8:00 pm Friday, September 19 6:30 am - 8:00 pm

Saturday, September 20 6:30 am - 8:00 pm Sunday, September 21 6:30 am - 8:00 pm

Please note that organizations may not hold functions during the defined “blackout” times unless approved by AONN+.

AONN+ will strictly enforce the blackout times. Failure to have approval to hold any event in these established time frames may result in a fine and exclusion from all AONN+ events.

†

AONN2014ConfAd Asize_60914

Fifth annual aonn+ conference abstracts Continued from page 37

Category III: Quality, Outcomes, and Performance Improvement References

1. Advisory Board Company. Document revenues for returned patients. “Realizing the Promise of Navigation.” Nursing Executive Center (2011): Pages 38-39.

2. Desimini EM, Kennedy JA, Helsley MF, et al. Making the case for nurse navigators. Oncol Issues. 2011;September/October:26-33.

3. Balderson D, Safavi K. How patient navigation can cut costs and save lives. HBR Blog Network. http://blogs.hbr.org/2013/03/how-patient-navigation-brings/.

Accessed June 18, 2014.

4. Gonzalez M, Berger M, Bryant D, et al. Using a minority matrix and patient navigation to improve accrual to clinical trials. Oncol Issues. 2011;March/April:59-60.

5. Holmes DR, Majo J, Lyonga DE, et al. Increasing minority patient participation in cancer clinical trials using oncology nurse navigation. Am J Surg.

2012;203:415-422.

Navigator Role in Clinical Trial Education and Accrual: Fox Chase Cancer Center Partner Initiative Elaine Sein, RN, BSN, OCN, CBCN; Kelly Filchner, MSN, RN, OCN, CCRC Fox Chase Cancer Center Partners

Background: The navigation process has opened a unique opportunity to enhance clinical trial recruitment practices.

Navigators, who are often the first point of contact of the patient’s entry into a health system, have the ability to introduce basic clinical trial concepts to the patient so that the patient can explore this option within his or her care trajectory.

Navigators are from various practice backgrounds and possess different levels of knowledge and attitudes regarding clinical trials. The goal of this project was to investigate reasons for variation in care and to develop strategies to implement change. Objectives: Evaluate the knowledge base and comfort level of nurse navigators in discussing clinical trials with their patients. Methods: The Fox Chase Cancer Center Partner Initiative (FCCCP) navigator and research nurse subcommittee created a knowledge-based survey of clinical research concepts and used a short attitude survey adopted from “ENACCT Oncology Staff in Cancer Clinical Trials Survey 2008” to assess knowledge base, comfort levels, and attitudes in clinical trials. This survey was distributed to FCCCP navigators and was extended to the Academy of Oncology Nurse & Patient Navigators (AONN+) membership through SurveyMonkey mechanism. Results: A total of 159 navigators participated in the survey: 40% practice in academic institutions, 60% in nonacademic institutions. A total of 100% FCCCP and 85% AONN+ institutions participated in clinical research and 57% FCCCP and 78% AONN+ navigators discussed clinical research with their patients. A total of 78% of navigators strongly believed cancer clinical trials are important in finding better ways to prevent, diagnose, or treat cancer; 67% strongly agreed if someone they loved were diagnosed with cancer, they would encourage him/her to find out more about participating in an appropriate clinical trial.

Sixty percent of navigators were comfortable or extremely comfortable with most of the knowledge questions: awareness of clinical trials, phases of clinical trials, therapeutic versus nontherapeutic trials, common research terms, eligibility criteria, informed consent, educational tools available, current collaboration with the research team, and ability to identify appropriate patients for a trial. However, responses related to when they introduce clinical trials to patients and how the navigator interacts with the research team varied greatly across the sites. Conclusion: There was strong interest from navigators to find methods to collaborate with the research team. Strategies were developed to bring navigators and research teams together to determine roles in the clinical trial process and identify strategies to educate navigators on key focus areas. Targeted educational programs and tools to support navigator information regarding clinical trials will be instituted, and metrics to track success and barriers will be established.

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Category III: Quality, Outcomes, and Performance Improvement Identifying Newly Diagnosed Cancer Patients Through a Call Center Process Improvement Patricia Hegedus, RN, OCN, MBA; Sharon Bartelt, RN, MSN, MBA, CPHQ, CSSBB, OCN; Kirsten Beeker, RN, BSN, OCN, CBCN Gibbs Cancer Center & Research Institute

Background: Spartanburg Regional Healthcare System (SRHS)’s Gibbs Cancer Center & Research Institute (GCC&RI) is a nationally recognized cancer treatment and research facility located in Spartanburg, SC. All SRHS patients diagnosed with cancer are identified by the clinical navigation staff. Early intervention by clinical navigation provides coordination and facilitation from cancer diagnosis through survivorship. Those patients who are diagnosed outside of SRHS may potentially go unidentified by a clinical navigator unless referred by the physician. A process was needed to earlier identify new cancer patients not diagnosed within SRHS. Objectives: The primary objective was to develop a process for Call Center clinical navigation of cancer patients who are new to the SRHS. Secondary objectives included early identification of patients for clinical trials and promotion of GCC&RI services. Method: The Call Center for SRHS has offered 24/7 access to a nurse for more than 15 years. The Call Center was identified as an entry portal for new SRHS patients seeking cancer care. A process improvement team developed Call Center and Navigation flowcharts to utilize clinical navigation to intervene and facilitate physician referrals, diagnostic workup, clinical trial referral, and patient education. The team secured a 1-855-DNA-GIBBS number to promote the new cancer 24/7 line. Scripting was designed to assist Call Center staff to easily identify appropriate patients for cancer clinical navigation services and clinical navigation staff with triaging the patient to GCC&RI services. A marketing campaign was developed with the 1-855-DNA-GIBBS logo on city buses, hospital vehicles, billboards, local airport signage, and parking lot flags, to name a few. Results: The Call Center process began in October 2013. Data for the 9 months following initiation of the program are: (1) total calls: 597; monthly average: 66; (2) calls resulting in appointments: 71; monthly average: 8; (3) physician referrals: medical oncology - 51, radiation oncology - 8, surgery - 8, and other physician - 2; and (4) top 5 disease site referrals (listed highest to lowest): gastrointestinal, genitourinary, breast, hematology, and lung. Conclusion: The first 9 months of data demonstrate the success of utilizing a Call Center process for initiating cancer clinical navigation services. Approximately 600 calls were processed related to cancer services, with a 12% (71 patients) capture by navigation services with referral to GCC&RI physicians’ services. The 1-855-DNA-GIBBS number is visible in our catchment area. The campaign has been successful by recognizing the depth and quality of cancer care provided by GCC&RI.

An Analysis of a Practical Application of the STAR (Survivorship Training and Rehabilitation) Dual Screening Protocol in Patients Newly Diagnosed with Breast Cancer Cynthia Frankel, RN, OCN, CBCN; Ines Rodriguez, RN, OCN, CBCN; Vanessa Rodriquez, BA, MSW; Alissa Newman, PA-C; Mayra Lima, MSN, ARNP, FNP-C; Alejandra Perez, MD; Aruna Mani, MD; Aurelio Castrellon, MD; Michel Velez, MD; Dawn Broksch, DPT, MAOM; Sameet Kumar, PhD; Carmen Calfa, MD Memorial Cancer Institute Breast Cancer Program

The trajectory of care within the Memorial Cancer Institute’s Breast Cancer Program begins with an abnormal physical finding or image followed by a biopsy that reveals a cancer diagnosis. A new diagnosis triggers immediate intervention by a designated breast cancer navigator assuring timely intervention.

New cases are presented by the physicians at our Interdisciplinary Breast Conference/Clinic (IDCC), and the treatment plans are collaboratively developed. The majority of our new patients are diagnosed with stage 0-III breast cancer. The remaining present with advanced disease and are treated with palliative intent to improve symptoms and hopefully survival.

Breast cancer survivorship is reported to be associated with significant emotional, functional, and physical impairments.

The goal of the Survivorship Training and Rehabilitation (STAR) Program is to detect early and intervene to improve

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Category III: Quality, Outcomes, and Performance Improvement outcomes. During the implementation phase of the STAR Program, we reviewed the STAR Dual Screening Protocol and have chosen the STAR Distress Thermometer, Program Physical Impairment and Functional Screening Assessment Tool (Diagnostic Use: Clinician-Breast Cancer) to be used in our pilot. Because the active cancer treatment lasts 9 to 12 months, in our dual screening we assess patients at 3 significant time points; (1) at baseline, during the IDCC (the physicians, rehabilitation representative, and navigator determine the need for prehabilitation); (2) 3 months from baseline; and (3) 6 months from baseline. We wanted to develop a standardized approach to ensure the patients were assessed at pivotal medical visits in order to identify a baseline and provide early interventions to improve outcomes. In addition, we wanted to make the timetable consistent among disciplines to ensure that the dual assessments would take place regardless of where the patients’ treatment was occurring (medical, surgical, or radiation oncology). This would ensure the patient is assessed throughout the most critical time of active therapy (surgery, chemotherapy, radiation). In our pilot dual screening, we will capture the first 25 new patients presented to our IDCC and report our findings.

The assessments will serve to develop our STAR Program Cancer Rehabilitation Service line and provide specific interventions under the treating physician’s supervision.

Our goals are to develop a standardized approach, document patients’ baseline status, provide interventions before acute cancer treatment begins (prehabilitation), refer patients with impairments or other problems for appropriate services, and improve both the individual patient experience as well as the overall health outcomes of our breast cancer survivor population.

Impact of Oncology Nurse Navigators on No-Show Rates in Supportive Care Clinic Trial for Stage 2B Through Stage IV Lung Cancer Patients Angie Flynn, RN, OCN; Cynthia Smart, RN, OCN Novant Health Derrick L. Davis Cancer Center

Background: Metastatic non–small-cell lung cancer (NSCLC) is the leading cause of cancer death worldwide (D’Addario G, et al. Ann Oncol. 2010;21[suppl 5]:116-119). Research published in August 2010 (Ichihara E, et al. N Engl J Med. 2010;363:2263) concluded that early palliative care intervention for metastatic NSCLC patients improved survival and quality of life. Our data are compared with other regional outpatient palliative care clinics that report a no-show rate between 20% and 30%. Objective: The goal of our trial in the Supportive Care Clinic at the Novant Health Derrick L. Davis Cancer Center is to decrease unnecessary inpatient services by oncology patients, improve their quality of life, provide ease in discussion of end-of-life issues, and increase overall patient satisfaction. To achieve these goals, the patients need to be active participants in the clinic and be present for their scheduled appointments. The thoracic oncology nurse navigators have an opportunity to build relationships with their patients from the time of diagnosis throughout the continuum of care.

The building of these relationships turned out to be a vital component as it relates to the attendance in the Supportive Care Clinic, and led us to have much lower no-show rates than other clinics nationally. Method: The nurse navigators would receive referrals from oncologists at the Supportive Care Clinic. Oftentimes the navigators had already met the lung cancer patients and had begun to gain their trust by providing education about their diagnosis and referring them to community resources. Patients were also contacted in follow-up phone calls and visits. If the navigators had not met the patient prior to the referral, they would make an initial phone call to introduce their services and provide information about the Supportive Care Clinic and its purpose. Seeing a familiar face and hearing the familiar voice of their navigator seemed to lend credibility to a service that was unfamiliar to most patients. The nurse navigators were present with the patient at each clinic visit and provided follow-up phone calls between clinics as deemed necessary by the palliative care physician.

Results: Our trial of the Supportive Care Clinic began on September 11, 2013, and is still ongoing. Early results indicate that of 115 scheduled clinic visits, we had 6 no-shows. This indicates a no-show rate of 5.21%, which is significantly lower than the regionally reported average. Three of the no-show patients were later rescheduled and are now followed closely by our clinic.

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Category III: Quality, Outcomes, and Performance Improvement Cancer Rehabilitation Service Line Directors Perceive Navigators as Having High Value on Multidisciplinary Rehabilitation Teams and Identify 3 Key Barriers to Improving Their Value Alexander J. Silver1; Sasha E. Knowlton, MD2; Julie K. Silver, MD2; Lori McKitrick, MA, CCC-SLP, MBA3

Williams College; 2Spaulding Rehabilitation Hospital/Harvard Department of Physical Medicine and Rehabilitation; 3Bon Secours St. Frances Health System

1

Background: Rehabilitation is an essential component of high-quality cancer care. However, many patients are not properly screened and referred for these services. Navigators are increasingly being utilized in hospitals and cancer centers throughout the United States. As such, they may provide important contributions to improving access and delivery of cancer rehabilitation services. This national survey assessed the perception by cancer rehabilitation service line coordinators on the current value of navigators. The survey also assessed perceived barriers to improving the value of navigators as members of cancer rehabilitation teams in an effort to identify strategies that may improve access and delivery of rehabilitation services to survivors. Objective: To determine the perceived value of navigators by cancer rehabilitation service line coordinators, and assess opportunities to improve the value of navigators on multidisciplinary cancer rehabilitation teams. Methods: Cancer rehabilitation service line coordinators (STAR [Survivorship Training and Rehabilitation] Program coordinators) were sent an e-mail invitation with a link to a survey designed to assess and improve the quality of cancer rehabilitation service lines in facilities throughout the United States that have received STAR Program Certification or are undergoing initial implementation. In total, 188 surveys were sent, and 94 responses were received via SurveyMonkey. The survey had 49 multiple-choice and open-response questions and was conducted from June 27, 2014, to July 17, 2014. The results of all 94 surveys were reviewed and included for this analysis. Results: Of the 94 respondents, 85 answered the question “What is your discipline?”—43.53% were physical therapists, 11.76% occupational therapists, 5.88% speech-language pathologists, 11.76% nurses, 2.35% nurse navigators, and 24.5% administrative (nonclinical).

Respondents were asked to answer how much value they thought navigators could bring to multidisciplinary cancer rehabilitation teams. Of 94 surveyed, 87 answered the question. More than 95% of those responding answered that navigators could provide either “Exceptional” (72.41%) or “Important” (22.99%) value, whereas only 2.3% answered that navigators could provide “Some” (1.15%) or “Minimal” (1.15%) value, and no respondents answered that navigators would provide “No value” (0%). In a separate question, respondents were asked to identify the key barriers to improving the value of navigators at their institution from a list of options. Of 94 surveyed, 70 answered this question. The most commonly selected response was that navigators “need to be more engaged in the screening process on the oncology side” (44.29%), one-third of the respondents indicated navigators needed “more time and support from administration” (32.86%), and one-quarter identified that a key barrier is that navigators are not adequately “involved with prehabilitation” (25.71%).

Conclusions: These results demonstrate that the study participants–cancer rehabilitation service line coordinators–perceived navigators as having high value as members of a multidisciplinary cancer rehabilitation team. The respondents perceived that the primary way that navigators could have more value is to be more engaged in the screening process on the oncology side. Of note is that STAR Programs are implementing dual screening for physical impairments and distress (rather than just distress screening). Furthermore, the second and third most commonly perceived barriers were identified as navigators’ need for more time and support from administration, and the lack of their active participation in prehabilitation, respectively. Currently, there is a documented underutilization of rehabilitation for cancer patients. This survey suggests that navigators are not only highly valued currently, but that their value may be increased by overcoming barriers, including better integration with dual screening, more dedicated time and administrative support for participation on rehabilitation teams, and active participation in the delivery of prehabilitation.

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Category III: Quality, Outcomes, and Performance Improvement Can Nurses Provide Assessments and Interventions for Prehabilitation? A Survey Study of Cancer Rehabilitation Service Line Coordinators Sasha E. Knowlton, MD1; Alexander J. Silver2; Julie K. Silver, MD3; Lori McKitrick, MA, CCC-SLP, MBA4

Spaulding Rehabilitation Hospital/Harvard Department of Physical Medicine and Rehabilitation; 2Williams College; 3Harvard Medical School/ Department of Physical Medicine and Rehabilitation; 4Bon Secours St. Frances Health System

1

Background: Rehabilitation is an essential component of high-quality cancer care. However, many patients are not properly screened and referred for these services. Navigators are increasingly being utilized in hospitals and cancer centers throughout the United States. The pivotal role of nurse navigators during diagnosis provides an ideal time to introduce and engage cancer patients in prehabilitation. Nurses, particularly navigators, often provide education prior to the start of acute cancer treatments. However, prehabilitation goes beyond traditional education efforts and involves rehabilitation assessments and interventions designed to improve physical and psychological health outcomes. Because nurses may be uniquely positioned at the time of diagnosis to deliver this care, and prehabilitation has the potential to improve outcomes and reduce healthcare costs, the aim of this study was to assess whether cancer rehabilitation service line coordinators thought that nurses could be trained and develop competency in basic prehabilitation assessments and interventions.

Objective: To determine whether cancer rehabilitation service line directors agree that nurses can provide basic assessments and interventions for prehabilitation if they receive appropriate training and demonstrate competency. Methods: Cancer rehabilitation service line coordinators (STAR [Survivorship Training and Rehabilitation] Program coordinators) were sent an e-mail invitation with a link to a survey designed to assess and improve the quality of cancer rehabilitation service lines in facilities throughout the United States that have received STAR Program Certification or are undergoing initial implementation. In total, 188 surveys were sent and 94 responses received via SurveyMonkey. The survey had 49 multiple-choice and open-response questions and was conducted from June 27, 2014, to July 17, 2014. The results of all 94 surveys were reviewed and included for this analysis. Results: Of the 94 respondents, 85 answered the question “What is your discipline?”—43.53% were physical therapists, 11.76% occupational therapists, 5.88% speech-language pathologists, 11.76% nurses, 2.35% nurse navigators, and 24.5% administrative (nonclinical). For this study, respondents were asked the following question: “As there is a need to streamline care, reduce healthcare expenses, and improve early referrals to rehabilitation professionals, do you agree that nurses (navigators, etc) can provide basic screening and interventions for prehabilitation (eg, QuickDASH and upper extremity physical examination in newly diagnosed breast cancer patients) if they receive appropriate training and demonstrate competency?” Of the 94 surveyed, 87 respondents answered the question. Of those answering the question, 74.7% (65 responses) agreed with the statement, 18.4% (16 responses) were unsure, and only 6.9% (6 responses) disagreed. Conclusions: Prehabilitation is part of the rehabilitation care continuum, and nurses have typically not been trained in this type of care. In this study, the majority of cancer rehabilitation service line coordinators agreed that nurses could deliver prehabilitation services if they were properly trained and demonstrated competency. It is important to note that approximately 62% of the respondents that identified their disciplines were rehabilitation clinicians, whereas only 14% were nurses. Given the documented gap between need for and provision of rehabilitation services for cancer patients, improving care will require better methods of screening and delivery—from diagnosis onward. One way to improve care at the time of diagnosis is to provide evidence-based or best practices prehabilitation assessments and interventions. This study suggests that the majority of cancer rehabilitation service line coordinators will support nurses delivering basic prehabilitation services if they are appropriately trained and able to demonstrate competency. Barriers to this care may still include lack of dedicated time and other resources. However, as cancer prehabilitation becomes increasingly important in oncology, considering the role that nurses may have in this care is important.

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august 2014 • Volume 5, number 4

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Think Avastin

Clinically meaningful activity in 4 distinct tumor types1

Confronting a common threat across approved indications Indications

Avastin is indicated for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.

Avastin is indicated for the treatment of glioblastoma as a single agent for adult patients with progressive disease following prior therapy. The effectiveness of Avastin in glioblastoma is based on an improvement in objective response rate. There are no data demonstrating an improvement in disease-related symptoms or increased survival with Avastin.

Avastin is indicated for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer in combination with carboplatin and paclitaxel.

Avastin is indicated for the first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil– based chemotherapy.

Avastin, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidineoxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastincontaining regimen.

Limitation of Use: Avastin is not indicated for adjuvant treatment of colon cancer.

Boxed WARNINGS

Gastrointestinal (GI) perforation — Serious and sometimes fatal GI perforation occurs at a higher incidence in Avastintreated patients compared to controls — The incidences of GI perforation ranged from 0.3% to 2.4% across clinical studies — Discontinue Avastin in patients with GI perforation Surgery and wound healing complications — The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in Avastin-treated patients — Do not initiate Avastin for at least 28 days after surgery and until the surgical wound is fully healed. The appropriate interval between termination of Avastin and subsequent elective surgery required to reduce the risks of impaired wound healing/wound dehiscence has not been determined — Discontinue Avastin at least 28 days prior to elective surgery and in patients with wound healing complications requiring medical intervention Hemorrhage — Severe or fatal hemorrhage, including hemoptysis, GI bleeding, hematemesis, central nervous system hemorrhage, epistaxis, and vaginal bleeding, occurred up to 5-fold more frequently in patients receiving Avastin. Across indications, the incidence of grade ≥3 hemorrhagic events among patients receiving Avastin ranged from 1.2% to 4.6% — Do not administer Avastin to patients with serious hemorrhage or recent hemoptysis (≥1/2 tsp of red blood) — Discontinue Avastin in patients with serious hemorrhage (ie, requiring medical intervention)

Additional serious adverse events

Additional serious and sometimes fatal adverse events with increased incidence in the Avastin-treated arm vs control included — Non-GI fistula formation (≤0.3%) — Arterial thromboembolic events (grade ≥3, 2.6%) — Proteinuria (nephrotic syndrome, <1%) Additional serious adverse events with increased incidence in the Avastin-treated arm vs control included — Hypertension (grade 3–4, 5%–18%) — Reversible posterior leukoencephalopathy syndrome (RPLS) (<0.1%) Infusion reactions with the first dose of Avastin were uncommon (<3%), and severe reactions occurred in 0.2% of patients Inform females of reproductive potential of the risk of ovarian failure prior to starting treatment with Avastin

Most common adverse events

Across indications, the most common adverse reactions observed in Avastin patients at a rate >10% and at least twice the control arm rate were — Epistaxis — Rhinitis — Dry skin — Back pain — Headache — Proteinuria — Rectal hemorrhage — Exfoliative dermatitis — Hypertension — Taste alteration — Lacrimation disorder

Across all studies, Avastin was discontinued in 8.4% to 21% of patients because of adverse reactions

Pregnancy warning

Avastin may impair fertility Based on animal data, Avastin may cause fetal harm Advise patients of the potential risk to the fetus during and following Avastin and the need to continue adequate contraception for at least 6 months following the last dose of Avastin For nursing mothers, discontinue nursing or Avastin, taking into account the importance of Avastin to the mother

Indication-specific adverse events

In mRCC, the most common grade 3–5 adverse events in AVOREN, occurring at a ≥2% higher incidence in Avastin-treated patients vs controls, were fatigue (13% vs 8%), asthenia (10% vs 7%), proteinuria (7% vs 0%), hypertension (6% vs 1%), and hemorrhage (3% vs 0.3%) In GBM Study AVF3708g, in patients receiving Avastin alone, the most frequently reported adverse events were infection (55%), fatigue (45%), headache (37%), hypertension (30%), epistaxis (19%), and diarrhea (21%). Of these, the incidence of grade ≥3 adverse events was infection (10%), fatigue (4%), headache (4%), hypertension (8%), and diarrhea (1%). Two deaths were possibly related to Avastin: 1 retroperitoneal hemorrhage and 1 neutropenic infection In GBM patients receiving Avastin alone or Avastin plus irinotecan,* the incidences of Avastin-related adverse events (grade 1–4) were bleeding/hemorrhage (40%), epistaxis (26%), CNS hemorrhage (5%), hypertension (32%), venous thromboembolic events (8%), arterial thromboembolic events (6%), wound healing complications (6%), proteinuria (4%), GI perforation (2%), and RPLS (1%). The incidences of grade 3–5 events in these 163 patients were bleeding/hemorrhage (2%), CNS hemorrhage (1%), hypertension (5%), venous thromboembolic events (7%), arterial thromboembolic events (3%), wound healing complications (3%), proteinuria (1%), and GI perforation (2%). Intracranial hemorrhage occurred in 8 of 163 patients; 2 patients had grade 3–4 hemorrhage In NSCLC, grade 3–5 (nonhematologic) and grade 4–5 (hematologic) adverse events in Study E4599 occurring at a ≥2% higher incidence in Avastin-treated patients vs controls were neutropenia (27% vs 17%), fatigue (16% vs 13%), hypertension (8% vs 0.7%), infection without neutropenia (7% vs 3%), venous thrombus/embolism (5% vs 3%), febrile neutropenia (5% vs 2%), pneumonitis/pulmonary infiltrates (5% vs 3%), infection with grade 3 or 4 neutropenia (4% vs 2%), hyponatremia (4% vs 1%), headache (3% vs 1%), and proteinuria (3% vs 0%) In first-line MCRC, the most common grade 3–4 events in Study 2107, which occurred at a ≥2% higher incidence in the Avastin plus IFL vs IFL groups, were asthenia (10% vs 7%), abdominal pain (8% vs 5%), pain (8% vs 5%), hypertension (12% vs 2%), deep vein thrombosis (9% vs 5%), intra-abdominal thrombosis (3% vs 1%), syncope (3% vs 1%), diarrhea (34% vs 25%), constipation (4% vs 2%), leukopenia (37% vs 31%), and neutropenia (21% vs 14%) In second-line MCRC, the most common grade 3–5 (nonhematologic) and 4–5 (hematologic) events in Study E3200, which occurred at a higher incidence (≥2%) in the Avastin plus FOLFOX4 vs FOLFOX4 groups, were diarrhea (18% vs 13%), nausea (12% vs 5%), vomiting (11% vs 4%), dehydration (10% vs 5%), ileus (4% vs 1%), neuropathy–sensory (17% vs 9%), neurologic–other (5% vs 3%), fatigue (19% vs 13%), abdominal pain (8% vs 5%), headache (3% vs 0%), hypertension (9% vs 2%), and hemorrhage (5% vs 1%). These data are likely to underestimate the true adverse event rates due to the reporting mechanisms used in this study When continued beyond first progression in MCRC, no new safety signals were observed in the TML study (ML18147) when Avastin was administered in second-line MCRC patients who progressed on an Avastin containing regimen in first-line MCRC. The safety data was consistent with the known safety profile established in first- and second-line MCRC *Avastin is not approved for use in combination with irinotecan or any other combination regimens.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.

Please see accompanying brief summary of Prescribing Information, including Boxed WARNINGS, for additional important safety information.

Reference: 1. Avastin Prescribing Information.

Genentech, Inc. March 2013.

©2013 Genentech USA, Inc. All rights reserved. AVA0000488304 Printed in USA. (12/13)

www.avastin-hcp.com

AVASTIN® (bevacizumab)

AVASTIN® (bevacizumab)

AVASTIN® (bevacizumab)

Solution for intravenous infusion Initial U.S. Approval: 2004 This is a brief summary of information about AVASTIN. Before prescribing, please see full Prescribing Information.

gastrointestinal bleeding, hematemesis, CNS hemorrhage, epistaxis, and vaginal bleeding occurred up to five‑fold more frequently in patients receiving Avastin compared to patients receiving only chemotherapy.

Across indications, the incidence of Grade ≥ 3 hemorrhagic events among patients receiving Avastin ranged from 1.2 to 4.6%. [See Adverse Reactions (6.1).]

Serious or fatal pulmonary hemorrhage occurred in four of 13 (31%) patients with squamous cell histology and two of 53 (4%) patients with non‑squamous non‑small cell lung cancer receiving Avastin and chemotherapy compared to none of the 32 (0%) patients receiving chemotherapy alone.

In clinical studies in non–small cell lung cancer where patients with CNS metastases who completed radiation and surgery more than 4 weeks prior to the start of Avastin were evaluated with serial CNS imaging, symptomatic Grade 2 CNS hemorrhage was documented in one of 83 Avastin‑treated patients (rate 1.2%, 95% CI 0.06%–5.93%).

Intracranial hemorrhage occurred in 8 of 163 patients with previously treated glioblastoma; two patients had Grade 3–4 hemorrhage.

Do not administer Avastin to patients with recent history of hemoptysis of ≥ 1/2 teaspoon of red blood. Discontinue Avastin in patients with hemorrhage. [See Boxed Warning, Dosage and Administration (2.4).]

use for which Avastin is not approved. Inform females of reproductive potential of the risk of ovarian failure prior to starting treatment with Avastin. [See Adverse Reactions (6.1), Use in Specific Populations (8.6).]

WARNING: GASTROINTESTINAL PERFORATIONS, SURGERY AND WOUND HEALING COMPLICATIONS, and HEMORRHAGE Gastrointestinal Perforations The incidence of gastrointestinal perforation, some fatal, in Avastin‑treated patients ranges from 0.3 to 2.4%. Discontinue Avastin in patients with gastrointestinal perforation. [See Dosage and Administration (2.4), Warnings and Precautions (5.1).]

Surgery and Wound Healing Complications The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in Avastin‑treated patients. Discontinue Avastin in patients with wound dehiscence. The appropriate interval between termination of Avastin and subsequent elective surgery required to reduce the risks of impaired wound healing/wound dehiscence has not been determined. Discontinue at least 28 days prior to elective surgery. Do not initiate Avastin for at least 28 days after surgery and until the surgical wound is fully healed. [See Dosage and Administration (2.4), Warnings and Precautions (5.2), Adverse Reactions (6.1).]

Hemorrhage Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, central nervous systems (CNS) hemorrhage, epistaxis, and vaginal bleeding occurred up to five‑fold more frequently in patients receiving Avastin. Do not administer Avastin to patients with serious hemorrhage or recent hemoptysis. [See Dosage and Administration (2.4), Warnings and Precautions (5.3), Adverse Reactions (6.1).]

1.3 Glioblastoma Avastin is indicated for the treatment of glioblastoma with progressive disease in adult patients following prior therapy as a single agent.

The effectiveness of Avastin in glioblastoma is based on an improvement in objective response rate. There are no data demonstrating an improvement in disease‑related symptoms or increased survival with Avastin. [See Clinical Studies (14.4).]

1.4 Metastatic Renal Cell Carcinoma (mRCC) Avastin is indicated for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.

4 CONTRAINDICATIONS None.

5 WARNINGS AND PRECAUTIONS 5.1 Gastrointestinal Perforations Serious and sometimes fatal gastrointestinal perforation occurs at a higher incidence in Avastin treated patients compared to controls. The incidence of gastrointestinal perforation ranged from 0.3 to 2.4% across clinical studies. [See Adverse Reactions (6.1).]

The typical presentation may include abdominal pain, nausea, emesis, constipation, and fever. Perforation can be complicated by intra‑abdominal abscess and fistula formation. The majority of cases occurred within the first 50 days of initiation of Avastin.

Discontinue Avastin in patients with gastrointestinal perforation. [See Boxed Warning, Dosage and Administration (2.4).]

5.2 Surgery and Wound Healing Complications Avastin impairs wound healing in animal models. [See Nonclinical Toxicology (13.2).] In clinical trials, administration of Avastin was not allowed until at least 28 days after surgery. In a controlled clinical trial, the incidence of wound healing complications, including serious and fatal complications, in patients with mCRC who underwent surgery during the course of Avastin treatment was 15% and in patients who did not receive Avastin, was 4%. [See Adverse Reactions (6.1).]

Avastin should not be initiated for at least 28 days following surgery and until the surgical wound is fully healed. Discontinue Avastin in patients with wound healing complications requiring medical intervention.

The appropriate interval between the last dose of Avastin and elective surgery is unknown; however, the half‑life of Avastin is estimated to be 20 days. Suspend Avastin for at least 28 days prior to elective surgery. Do not administer Avastin until the wound is fully healed. [See Boxed Warning, Dosage and Administration (2.4).]

Necrotizing fasciitis including fatal cases, has been reported in patients treated with Avastin; usually secondary to wound healing complications, gastrointestinal perforation or fistula formation. Discontinue Avastin therapy in patients who develop necrotizing fasciitis. [See Adverse Reactions (6.3).]

5.3 Hemorrhage Avastin can result in two distinct patterns of bleeding: minor hemorrhage, most commonly Grade 1 epistaxis; and serious, and in some cases fatal, hemorrhagic events. Severe or fatal hemorrhage, including hemoptysis,

5.5 Arterial Thromboembolic Events Serious, sometimes fatal, arterial thromboembolic events (ATE) including cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and a variety of other ATE occurred at a higher incidence in patients receiving Avastin compared to those in the control arm. Across indications, the incidence of Grade ≥ 3 ATE in the Avastin containing arms was 2.6% compared to 0.8% in the control arms. Among patients receiving Avastin in combination with chemotherapy, the risk of developing ATE during therapy was increased in patients with a history of arterial thromboembolism, diabetes, or age greater than 65 years. [See Use in Specific Populations (8.5).]

The safety of resumption of Avastin therapy after resolution of an ATE has not been studied. Discontinue Avastin in patients who experience a severe ATE. [See Dosage and Administration (2.4).]

5.6 Hypertension The incidence of severe hypertension is increased in patients receiving Avastin as compared to controls. Across clinical studies the incidence of Grade 3 or 4 hypertension ranged from 5‑18%.

Monitor blood pressure every two to three weeks during treatment with Avastin. Treat with appropriate anti‑hypertensive therapy and monitor blood pressure regularly. Continue to monitor blood pressure at regular intervals in patients with Avastin‑induced or ‑exacerbated hypertension after discontinuation of Avastin.

Temporarily suspend Avastin in patients with severe hypertension that is not controlled with medical management. Discontinue Avastin in patients with hypertensive crisis or hypertensive encephalopathy. [See Dosage and Administration (2.4).]

5.7 Reversible Posterior Leukoencephalopathy Syndrome (RPLS) RPLS has been reported with an incidence of < 0.1% in clinical studies. The onset of symptoms occurred from 16 hours to 1 year after initiation of Avastin. RPLS is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. Mild to severe hypertension may be present. Magnetic resonance imaging (MRI) is necessary to confirm the diagnosis of RPLS. Discontinue Avastin in patients developing RPLS. Symptoms usually resolve or improve within days, although some patients have experienced ongoing neurologic sequelae. The safety of reinitiating Avastin therapy in patients previously experiencing RPLS is not known. [See Dosage and Administration (2.4).]

5.8 Proteinuria The incidence and severity of proteinuria is increased in patients receiving Avastin as compared to controls. Nephrotic syndrome occurred in < 1% of patients receiving Avastin in clinical trials, in some instances with fatal outcome. [See Adverse Reactions (6.1).] In a published case series, kidney biopsy of six patients with proteinuria showed findings consistent with thrombotic microangiopathy.

Monitor proteinuria by dipstick urine analysis for the development or worsening of proteinuria with serial urinalyses during Avastin therapy.

Patients with a 2 + or greater urine dipstick reading should undergo further assessment with a 24‑hour urine collection.

Suspend Avastin administration for ≥ 2 grams of proteinuria/24 hours and resume when proteinuria is < 2 gm/24 hours. Discontinue Avastin in patients with nephrotic syndrome. [See Dosage and Administration (2.4).]

Data from a postmarketing safety study showed poor correlation between UPCR (Urine Protein/Creatinine Ratio) and 24 hour urine protein (Pearson Correlation 0.39 (95% CI 0.17, 0.57). [See Use in Specific Populations (8.5).]

5.9 Infusion Reactions Infusion reactions reported in the clinical trials and post‑marketing experience include hypertension, hypertensive crises associated with neurologic signs and symptoms, wheezing, oxygen desaturation, Grade 3 hypersensitivity, chest pain, headaches, rigors, and diaphoresis. In clinical studies, infusion reactions with the first dose of Avastin were uncommon (< 3%) and severe reactions occurred in 0.2% of patients.

Stop infusion if a severe infusion reaction occurs and administer appropriate medical therapy. [See Dosage and Administration (2.4).]

5.10 Ovarian Failure The incidence of ovarian failure was higher (34% vs. 2%) in premenopausal women receiving Avastin in combination with mFOLFOX chemotherapy as compared to those receiving mFOLFOX chemotherapy alone for adjuvant treatment for colorectal cancer, a

6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data below reflect exposure to Avastin in 4599 patients with CRC, non‑squamous NSCLC, glioblastoma, or mRCC trials including controlled (Studies 1, 2, 4, 5 and 8) or uncontrolled, single arm (Study 6) treated at the recommended dose and schedule for a median of 8 to 23 doses of Avastin.

[See Clinical Studies (14).] The population was aged 18‑89 years (median 60 years), 45.4% male and 85.8% (3729/4345) White. The population included 2184 first‑ and second‑line mCRC patients who received a median of 10 doses of Avastin, 480 first‑line metastatic NSCLC patients who received a median of 8 doses of Avastin, 163 glioblastoma patients who received a median of 9 doses of Avastin, and 337 mRCC patients who received a median of 16 doses of Avastin. These data also reflect exposure to Avastin in 363 patients with metastatic breast cancer (MBC) who received a median of 9.5 doses of Avastin, 669 female adjuvant CRC patients who received a median of 23 doses of Avastin and exposure to Avastin in 403 previously untreated patients with diffuse large B‑cell lymphoma (DLBCL) who received a median of 8 doses of Avastin. Avastin is not approved for use in MBC, adjuvant CRC, or DLBCL. Surgery and Wound Healing Complications The incidence of post‑operative wound healing and/or bleeding complications was increased in patients with mCRC receiving Avastin as compared to patients receiving only chemotherapy. Among patients requiring surgery on or within 60 days of receiving study treatment, wound healing and/or bleeding complications occurred in 15% (6/39) of patients receiving bolus‑IFL plus Avastin as compared to 4% (1/25) of patients who received bolus‑IFL alone.

In Study 6, events of post‑operative wound healing complications (craniotomy site wound dehiscence and cerebrospinal fluid leak) occurred in patients with previously treated glioblastoma: 3/84 patients in the Avastin alone arm and 1/79 patients in the Avastin plus irinotecan arm. [See Boxed Warning, Dosage and Administration (2.4), Warnings and Precautions (5.2).]

Hemorrhage The incidence of epistaxis was higher (35% vs. 10%) in patients with mCRC receiving bolus‑IFL plus Avastin compared with patients receiving bolus‑IFL plus placebo. All but one of these events were Grade 1 in severity and resolved without medical intervention. Grade 1 or 2 hemorrhagic events were more frequent in patients receiving bolus‑IFL plus Avastin when compared to those receiving bolus‑IFL plus placebo and included gastrointestinal hemorrhage (24% vs. 6%), minor gum bleeding (2% vs. 0), and vaginal hemorrhage (4% vs. 2%). [See Boxed Warning, Dosage and Administration (2.4), Warnings and Precautions (5.3).]

Venous Thromboembolic Events The overall incidence of Grade 3–4 venous thromboembolic events in Study 1 was 15.1% in patients receiving bolus‑IFL plus Avastin and 13.6% in patients receiving bolus‑IFL plus placebo. In Study 1, more patients in the Avastin containing arm experienced deep venous thrombosis (34 vs. 19 patients ) and intra‑abdominal venous thrombosis (10 vs. 5 patients).

The risk of developing a second thromboembolic event while on Avastin and oral anticoagulants was evaluated in two randomized studies. In Study 1, 53 patients (14%) on the bolus‑IFL plus Avastin arm and 30 patients (8%) on the bolus‑IFL plus placebo arm received full dose warfarin following a venous thromboembolic event (VTE). Among these patients, an additional thromboembolic event occurred in 21% (11/53) of patients receiving bolus‑IFL plus Avastin and 3% (1/30) of patients receiving bolus‑IFL alone.

In a second, randomized, 4‑arm study in 1401 patients with mCRC, prospectively evaluating the incidence of VTE (all grades), the overall incidence of first VTE was higher in the Avastin containing arms (13.5%) than the chemotherapy alone arms (9.6%). Among the 116 patients treated with anticoagulants following an initial VTE event (73 in the Avastin plus chemotherapy arms and 43 in the chemotherapy alone arms), the overall incidence of subsequent VTEs was also higher among the Avastin treated patients (31.5% vs. 25.6%). In this subgroup of patients treated with anticoagulants, the overall incidence of bleeding, the majority of which were Grade 1, was higher in the Avastin treated arms than the chemotherapy arms (27.4% vs. 20.9%). [See Dosage and Administration (2.4).]

Safety:10”

1 INDICATIONS AND USAGE 1.1 Metastatic Colorectal Cancer (mCRC) Avastin is indicated for the first‑ or second‑line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5‑fluorouracil–based chemotherapy.

Avastin, in combination with fluoropyrimidine‑irinotecan‑ or fluoropyrimidine‑oxaliplatin‑based chemotherapy, is indicated for the second‑line treatment of patients with metastatic colorectal cancer who have progressed on a first‑line Avastin‑containing regimen.

Limitation of Use: Avastin is not indicated for adjuvant treatment of colon cancer. [See Clinical Studies (14.2).]

1.2 Non‑Squamous Non–Small Cell Lung Cancer (NSCLC) Avastin is indicated for the first‑line treatment of unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer in combination with carboplatin and paclitaxel.

5.4 Non‑Gastrointestinal Fistula Formation Serious and sometimes fatal non‑gastrointestinal fistula formation involving tracheo‑esophageal, bronchopleural, biliary, vaginal, renal and bladder sites occurs at a higher incidence in Avastin‑treated patients compared to controls. The incidence of non‑gastrointestinal perforation was ≤ 0.3% in clinical studies. Most events occurred within the first 6 months of Avastin therapy.

Discontinue Avastin in patients with fistula formation involving an internal organ. [See Dosage and Administration (2.4).]

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: • Gastrointestinal Perforations [See Boxed Warning, Dosage and Administration (2.4), Warnings and Precautions (5.1).]

• Surgery and Wound Healing Complications [See Boxed Warning, Dosage and Administration (2.4), Warnings and Precautions (5.2).]

• Hemorrhage [See Boxed Warning, Dosage and Administration (2.4), Warnings and Precautions (5.3).]

• Non‑Gastrointestinal Fistula Formation [See Dosage and Administration (2.4), Warnings and Precautions (5.4).]

• Arterial Thromboembolic Events [See Dosage and Administration (2.4), Warnings and Precautions (5.5).]

• Hypertensive Crisis [See Dosage and Administration (2.4), Warnings and Precautions (5.6).]

• Reversible Posterior Leukoencephalopathy Syndrome [See Dosage and Administration (2.4), Warnings and Precautions (5.7).]

• Proteinuria [See Dosage and Administration (2.4), Warnings and Precautions (5.8).]

• Ovarian Failure [See Warnings and Precautions (5.10), Use in Specific Populations (8.6).]

The most common adverse reactions observed in Avastin patients at a rate > 10% and at least twice the control arm rate, are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis.

Across all studies, Avastin was discontinued in 8.4 to 21% of patients because of adverse reactions.

AVASTIN® (bevacizumab)

AVASTIN® (bevacizumab)

AVASTIN® (bevacizumab)

Neutropenia and Infection The incidences of neutropenia and febrile neutropenia are increased in patients receiving Avastin plus chemotherapy compared to chemotherapy alone. In Study 1, the incidence of Grade 3 or 4 neutropenia was increased in mCRC patients receiving IFL plus Avastin (21%) compared to patients receiving IFL alone (14%). In Study 5, the incidence of Grade 4 neutropenia was increased in NSCLC patients receiving paclitaxel/carboplatin (PC) plus Avastin (26.2%) compared with patients receiving PC alone (17.2%). Febrile neutropenia was also increased (5.4% for PC plus Avastin vs.

1.8% for PC alone). There were 19 (4.5%) infections with Grade 3 or 4 neutropenia in the PC plus Avastin arm of which 3 were fatal compared to 9 (2%) neutropenic infections in patients receiving PC alone, of which none were fatal. During the first 6 cycles of treatment, the incidence of serious infections including pneumonia, febrile neutropenia, catheter infections and wound infections was increased in the PC plus Avastin arm [58 patients (13.6%)] compared to the PC alone arm [29 patients (6.6%)].

In Study 6, one fatal event of neutropenic infection occurred in a patient with previously treated glioblastoma receiving Avastin alone. The incidence of any grade of infection in patients receiving Avastin alone was 55% and the incidence of Grade 3–5 infection was 10%.

Grade 1–4 adverse events which occurred at a higher incidence (≥ 5%) in patients receiving bolus‑IFL plus Avastin as compared to the bolus‑IFL plus placebo arm are presented in Table 2. Grade 1–4 adverse events were collected for the first approximately 100 patients in each of the three treatment arms who were enrolled until enrollment in Arm 3 (5‑FU/LV + Avastin) was discontinued.

Table 2 NCI‑CTC Grade 1‑4 Adverse Events in Study 1 (Occurring at Higher Incidence [≥ 5%] in IFL + Avastin vs. IFL)

small intestinal hemorrhage, aneurysm ruptured, gastric ulcer hemorrhage, gingival bleeding, haemoptysis, hemorrhage intracranial, large intestinal hemorrhage, respiratory tract hemorrhage, and traumatic hematoma).

Grade 1–5 adverse events occurring at a higher incidence ( ≥ 5%) in patients receiving IFN‑α plus Avastin compared to the IFN‑α plus placebo arm are presented in Table 3.

Table 3 NCI‑CTC Grades 1−5 Adverse Events in Study 8 (Occurring at Higher Incidence [≥5%] in IFN‑α + Avastin vs. IFN‑α + Placebo)

Proteinuria Grade 3–4 proteinuria ranged from 0.7 to 7.4% in Studies 1, 2, 4, 5 and 8. The overall incidence of proteinuria (all grades) was only adequately assessed in Study 8, in which the incidence was 20%. Median onset of proteinuria was 5.6 months (range 15 days to 37 months) after initiation of Avastin. Median time to resolution was 6.1 months (95% CI 2.8 months, 11.3 months). Proteinuria did not resolve in 40% of patients after median follow up of 11.2 months and required permanent discontinuation of Avastin in 30% of the patients who developed proteinuria (Study 8).

In an exploratory, pooled analysis of 8,273 patients treated in 7 randomized clinical trials, 5.4% (271 of 5037) of patients receiving Avastin in combination with chemotherapy experienced Grade ≥ 2 proteinuria. The Grade ≥ 2 proteinuria resolved in 74.2% (201 of 271) of patients. Avastin was re‑initiated in 41.7% (113 of 271) of patients. Of the 113 patients who re‑initiated Avastin, 47.8% (54 of 113) experienced a second episode of Grade ≥ 2 proteinuria. [See Warnings and Precautions (5.8).]

Ovarian Failure The incidence of new cases of ovarian failure (defined as amenorrhoea lasting 3 or more months, FSH level ≥ 30 mIU/mL and a negative serum β‑HCG pregnancy test) was prospectively evaluated in a subset of 179 women receiving mFOLFOX chemotherapy alone (n = 84) or with Avastin (n = 95). New cases of ovarian failure were identified in 34% (32/95) of women receiving Avastin in combination with chemotherapy compared with 2% (2/84) of women receiving chemotherapy alone [relative risk of 14 (95% CI 4, 53)]. After discontinuation of Avastin treatment, recovery of ovarian function at all time points during the post‑treatment period was demonstrated in 22% (7/32) of the Avastin‑treated women. Recovery of ovarian function is defined as resumption of menses, a positive serum β‑HCG pregnancy test, or a FSH level < 30 mIU/mL during the post‑treatment period. Long term effects of Avastin exposure on fertility are unknown. [See Warnings and Precautions (5.10), Use in Specific Populations (8.6).]

Metastatic Colorectal Cancer (mCRC) The data in Table 1 and Table 2 were obtained in Study 1, a randomized, double‑blind, controlled trial comparing chemotherapy plus Avastin with chemotherapy plus placebo. Avastin was administered at 5 mg/kg every 2 weeks.

All Grade 3–4 adverse events and selected Grade 1–2 adverse events (hypertension, proteinuria, thromboembolic events) were collected in the entire study population. Severe and life‑threatening (Grade 3–4) adverse events, which occurred at a higher incidence ( ≥ 2%) in patients receiving bolus‑IFL plus Avastin as compared to bolus‑IFL plus placebo, are presented in Table 1.

Table 1 NCI‑CTC Grade 3−4 Adverse Events in Study 1 (Occurring at Higher Incidence [ ≥ 2 %] Avastin vs. Control)

NCI‑CTC Grade 3‑4 Events Body as a Whole Asthenia Abdominal Pain Pain Cardiovascular Hypertension Deep Vein Thrombosis Intra‑Abdominal Thrombosis Syncope Digestive Diarrhea Constipation Hemic/Lymphatic Leukopenia Neutropeniaa a

Arm 1 IFL+ + Placebo (n = 396) 74%

Arm 2 IFL+ + Avastin (n = 392) 87%

7% 5% 5%

10% 8% 8%

2% 5% 1% 1%

12% 9% 3% 3%

25% 2%

34% 4%

31% 14%

37% 21%

Central laboratories were collected on Days 1 and 21 of each cycle.

Neutrophil counts are available in 303 patients in Arm 1 and 276 in Arm 2.

Body as a Whole Pain Abdominal Pain Headache Cardiovascular Hypertension Hypotension Deep Vein Thrombosis Digestive Vomiting Anorexia Constipation Stomatitis Dyspepsia GI Hemorrhage Weight Loss Dry Mouth Colitis Hemic/Lymphatic Thrombocytopenia Nervous Dizziness Respiratory Upper Respiratory Infection Epistaxis Dyspnea Voice Alteration Skin/Appendages Alopecia Skin Ulcer Special Senses Taste Disorder Urogenital Proteinuria

55% 55% 19%

61% 61% 26%

62% 50% 26%

14% 7% 3%

23% 15% 9%

34% 7% 6%

47% 30% 29% 18% 15% 6% 10% 2% 1%

52% 43% 40% 32% 24% 24% 15% 7% 6%

47% 35% 29% 30% 17% 19% 16% 4% 1%

0%

5%

5%

20%

26%

19%

39% 10% 15% 2%

47% 35% 26% 9%

40% 32% 25% 6%

26% 1%

32% 6%

6% 6%

9%

14%

21%

24%

36%

36%

Avastin in Combination with FOLFOX4 in Second‑line mCRC Only Grade 3‑5 non‑hematologic and Grade 4–5 hematologic adverse events related to treatment were collected in Study 2. The most frequent adverse events (selected Grade 3–5 non‑hematologic and Grade 4–5 hematologic adverse events) occurring at a higher incidence (≥2%) in 287 patients receiving FOLFOX4 plus Avastin compared to 285 patients receiving FOLFOX4 alone were fatigue (19% vs. 13%), diarrhea (18% vs.

13%), sensory neuropathy (17% vs. 9%), nausea (12% vs. 5%), vomiting (11% vs. 4%), dehydration (10% vs. 5%), hypertension (9% vs. 2%), abdominal pain (8% vs. 5%), hemorrhage (5% vs. 1%), other neurological (5% vs. 3%), ileus (4% vs. 1%) and headache (3% vs. 0%). These data are likely to under‑estimate the true adverse event rates due to the reporting mechanisms used in Study 2.

Avastin in Combination with Fluoropyrimidine‑Irinotecan or Fluoropyrimidine‑ Oxaliplatin Based Chemotherapy in Second‑line mCRC Patients who have Progressed on an Avastin Containing Regimen in First‑line mCRC: No new safety signals were observed in Study 4 when Avastin was administered in second line mCRC patients who progressed on an Avastin containing regimen in first line mCRC. The safety data was consistent with the known safety profile established in first and second line mCRC. Unresectable Non‑Squamous Non‑Small Cell Lung Cancer (NSCLC) Only Grade 3‑5 non‑hematologic and Grade 4‑5 hematologic adverse events were collected in Study 5. Grade 3–5 non‑hematologic and Grade 4–5 hematologic adverse events (occurring at a higher incidence (≥2%) in 427 patients receiving PC plus Avastin compared with 441 patients receiving PC alone were neutropenia (27% vs. 17%), fatigue (16% vs. 13%), hypertension (8% vs. 0.7%), infection without neutropenia (7% vs. 3%), venous thrombus/embolism (5% vs. 3%), febrile neutropenia (5% vs. 2%), pneumonitis/ pulmonary infiltrates (5% vs. 3%), infection with Grade 3 or 4 neutropenia (4% vs. 2%), hyponatremia (4% vs. 1%), headache (3% vs. 1%) and proteinuria (3% vs. 0%).

Glioblastoma All adverse events were collected in 163 patients enrolled in Study 6 who either received Avastin alone or Avastin plus irinotecan. All patients received prior radiotherapy and temozolomide. Avastin was administered at 10 mg/kg every 2 weeks alone or in combination with irinotecan. Avastin was discontinued due to adverse events in 4.8% of patients treated with Avastin alone.

In patients receiving Avastin alone (N = 84), the most frequently reported adverse events of any grade were infection (55%), fatigue (45%), headache (37%), hypertension (30%), epistaxis (19%) and diarrhea (21%). Of these, the incidence of Grade ≥ 3 adverse events was infection (10%), fatigue (4%), headache (4%), hypertension (8%) and diarrhea (1%). Two deaths on study were possibly related to Avastin: one retroperitoneal hemorrhage and one neutropenic infection.

In patients receiving Avastin alone or Avastin plus irinotecan (N = 163), the incidence of Avastin‑related adverse events (Grade 1–4) were bleeding/ hemorrhage (40%), epistaxis (26%), CNS hemorrhage (5%), hypertension (32%), venous thromboembolic event (8%), arterial thromboembolic event (6%), wound‑healing complications (6%), proteinuria (4%), gastrointestinal perforation (2%), and RPLS (1%). The incidence of Grade 3–5 events in these 163 patients were bleeding/hemorrhage (2%), CNS hemorrhage (1%), hypertension (5%), venous thromboembolic event (7%), arterial thromboembolic event (3%), wound‑healing complications (3%), proteinuria (1%), and gastrointestinal perforation (2%).

Metastatic Renal Cell Carcinoma (mRCC) All grade adverse events were collected in Study 8. Grade 3–5 adverse events occurring at a higher incidence (≥ 2%) in 337 patients receiving interferon alfa (IFN‑α) plus Avastin compared to 304 patients receiving IFN‑α plus placebo arm were fatigue (13% vs. 8%), asthenia (10% vs. 7%), proteinuria (7% vs. 0%), hypertension (6% vs. 1%; including hypertension and hypertensive crisis), and hemorrhage (3% vs. 0.3%; including epistaxis,

System Organ Class/ IFN‑α + Placebo (n = 304) Preferred terma Gastrointestinal disorders Diarrhea 16% General disorders and administration site conditions Fatigue 27% Investigations Weight decreased 15% Metabolism and nutrition disorders Anorexia 31% Musculoskeletal and connective tissue disorders Myalgia 14% Back pain 6% Nervous system disorders Headache 16% Renal and urinary disorders Proteinuria 3% Respiratory, thoracic and mediastinal disorders Epistaxis 4% Dysphonia 0% Vascular disorders Hypertension 9%

IFN‑α + Avastin (n = 337) 21% 33% 20% 36% 19% 12% 24% 20% 27% 5% 28%

Adverse events were encoded using MedDRA, Version 10.1.

a

The following adverse events were reported at a 5‑fold greater incidence in the IFN‑α plus Avastin arm compared to IFN‑α alone and not represented in Table 3: gingival bleeding (13 patients vs. 1 patient); rhinitis (9 vs. 0); blurred vision (8 vs. 0); gingivitis (8 vs. 1); gastroesophageal reflux disease (8 vs. 1); tinnitus (7 vs. 1); tooth abscess (7 vs. 0); mouth ulceration (6 vs. 0); acne (5 vs. 0); deafness (5 vs. 0); gastritis (5 vs. 0); gingival pain (5 vs. 0) and pulmonary embolism (5 vs. 1).

6.2 Immunogenicity As with all therapeutic proteins, there is a potential for an immune response to Avastin. In clinical trials of adjuvant colon carcinoma, 14 of 2233 evaluable patients (0.63%) tested positive for treatment‑emergent anti‑bevacizumab antibodies detected by an electrochemiluminescent (ECL) based assay. Among these 14 patients, three tested positive for neutralizing antibodies against bevacizumab using an enzyme‑linked immunosorbent assay (ELISA). The clinical significance of these anti‑product antibody responses to bevacizumab is unknown.

Immunogenicity assay results are highly dependent on the sensitivity and specificity of the test method and may be influenced by several factors, including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Avastin with the incidence of antibodies to other products may be misleading.

6.3 Postmarketing Experience The following adverse reactions have been identified during post‑approval use of Avastin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: Polyserositis Cardiovascular: Pulmonary hypertension, RPLS, Mesenteric venous occlusion Eye disorders (from unapproved intravitreal use for treatment of various ocular disorders): Permanent loss of vision; Endophthalmitis (infectious and sterile); Intraocular inflammation; Retinal detachment; Increased intraocular pressure; Hemorrhage including conjunctival, vitreous hemorrhage or retinal hemorrhage; Vitreous floaters; Ocular hyperemia; Ocular pain or discomfort Gastrointestinal: Gastrointestinal ulcer, Intestinal necrosis, Anastomotic ulceration Hemic and lymphatic: Pancytopenia Hepatobiliary disorders: Gallbladder perforation Infections and infestations: Necrotizing fasciitis, usually secondary to wound healing complications, gastrointestinal perforation or fistula formation Musculoskeletal: Osteonecrosis of the jaw Renal: Renal thrombotic microangiopathy (manifested as severe proteinuria) Respiratory: Nasal septum perforation, dysphonia Systemic Events (from unapproved intravitreal use for treatment of various ocular disorders): Arterial thromboembolic events, Hypertension, Gastrointestinal perforation, Hemorrhage 7 DRUG INTERACTIONS A drug interaction study was performed in which irinotecan was administered as part of the FOLFIRI regimen with or without Avastin. The results demonstrated no significant effect of bevacizumab on the pharmacokinetics of irinotecan or its active metabolite SN38.

In a randomized study in 99 patients with NSCLC, based on limited data, there did not appear to be a difference in the mean exposure of either carboplatin or paclitaxel when each was administered alone or in combination with Avastin.

However, 3 of the 8 patients receiving Avastin plus paclitaxel/carboplatin had substantially lower paclitaxel exposure after four cycles of treatment (at Day 63) than those at Day 0, while patients receiving paclitaxel/carboplatin without Avastin had a greater paclitaxel exposure at Day 63 than at Day 0.

In Study 8, there was no difference in the mean exposure of interferon alfa administered in combination with Avastin when compared to interferon alfa alone.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C There are no adequate or well controlled studies of bevacizumab in pregnant women.

While it is not known if bevacizumab crosses the placenta, human IgG is known to cross the placenta. Reproduction studies in rabbits treated with approximately

Safety:10”

T:10.75”

Congestive Heart Failure (CHF) The incidence of Grade ≥ 3 left ventricular dysfunction was 1.0% in patients receiving Avastin compared to 0.6% in the control arm across indications. In patients with metastatic breast cancer (MBC), an indication for which Avastin is not approved, the incidence of Grade 3–4 CHF was increased in patients in the Avastin plus paclitaxel arm (2.2%) as compared to the control arm (0.3%). Among patients receiving prior anthracyclines for MBC, the rate of CHF was 3.8% for patients receiving Avastin as compared to 0.6% for patients receiving paclitaxel alone.

The safety of continuation or resumption of Avastin in patients with cardiac dysfunction has not been studied.

In previously untreated patients with diffuse large B‑cell lymphoma (DLBCL), an indication for which Avastin is not approved, the incidence of CHF and decline in left‑ventricular ejection fraction (LVEF) were significantly increased in the Avastin plus R‑CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) arm (n=403) compared to the placebo plus R‑CHOP arm (n=379); both regimens were given for 6 to 8 cycles. At the completion of R‑CHOP therapy, the incidence of CHF was 10.9% in the Avastin plus R‑CHOP arm compared to 5.0% in the R‑CHOP alone arm [relative risk (95% CI) of 2.2 (1.3, 3.7)]. The incidence of a LVEF event, defined as a decline from baseline of 20% or more in LVEF or a decline from baseline of 10% or more to a LVEF value of less than 50%, was also increased in the Avastin plus R‑CHOP arm (10.4%) compared to the R‑CHOP alone arm (5.0%). Time to onset of left‑ventricular dysfunction or CHF was 1‑6 months after initiation of therapy in at least 85% of the patients and was resolved in 62% of the patients experiencing CHF in the Avastin arm compared to 82% in the control arm.

Arm 1 Arm 2 Arm 3 IFL + Placebo IFL + Avastin 5‑FU/LV + Avastin (n = 98) (n = 102) (n = 109)

Safety:2.6875" AVASTIN® (bevacizumab) 1 to 12 times the recommended human dose of bevacizumab demonstrated teratogenicity, including an increased incidence of specific gross and skeletal fetal alterations. Adverse fetal outcomes were observed at all doses tested. Other observed effects included decreases in maternal and fetal body weights and an increased number of fetal resorptions. [See Nonclinical Toxicology (13.3).]

Because of the observed teratogenic effects of bevacizumab in animals and of other inhibitors of angiogenesis in humans, bevacizumab should be used during pregnancy only if the potential benefit to the pregnant woman justifies the potential risk to the fetus.

8.3 Nursing Mothers It is not known whether Avastin is secreted in human milk. Human IgG is excreted in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from bevacizumab, a decision should be made whether to discontinue nursing or discontinue drug, taking into account the half‑life of the bevacizumab (approximately 20 days [range 11–50 days]) and the importance of the drug to the mother. [See Clinical Pharmacology (12.3).]

8.4 Pediatric Use The safety, effectiveness and pharmacokinetic profile of Avastin in pediatric patients have not been established.

Antitumor activity was not observed among eight children with relapsed glioblastoma treated with bevacizumab and irinotecan. There is insufficient information to determine the safety and efficacy of Avastin in children with glioblastoma.

Juvenile cynomolgus monkeys with open growth plates exhibited physeal dysplasia following 4 to 26 weeks exposure at 0.4 to 20 times the recommended human dose (based on mg/kg and exposure). The incidence and severity of physeal dysplasia were dose‑related and were partially reversible upon cessation of treatment.

8.5 Geriatric Use In Study 1, severe adverse events that occurred at a higher incidence (≥ 2%) in patients aged ≥65 years as compared to younger patients were asthenia, sepsis, deep thrombophlebitis, hypertension, hypotension, myocardial infarction, congestive heart failure, diarrhea, constipation, anorexia, leukopenia, anemia, dehydration, hypokalemia, and hyponatremia. The effect of Avastin on overall survival was similar in elderly patients as compared to younger patients.

In Study 2, patients aged ≥65 years receiving Avastin plus FOLFOX4 had a greater relative risk as compared to younger patients for the following adverse events: nausea, emesis, ileus, and fatigue.

In Study 5, patients aged ≥65 years receiving carboplatin, paclitaxel, and Avastin had a greater relative risk for proteinuria as compared to younger patients. [See Warnings and Precautions (5.8).]

10 OVERDOSAGE The highest dose tested in humans (20 mg/kg IV) was associated with headache in nine of 16 patients and with severe headache in three of 16 patients.

17 PATIENT COUNSELING INFORMATION Advise patients: • To undergo routine blood pressure monitoring and to contact their health care provider if blood pressure is elevated.

• To immediately contact their health care provider for unusual bleeding, high fever, rigors, sudden onset of worsening neurological function, or persistent or severe abdominal pain, severe constipation, or vomiting.

• Of increased risk of wound healing complications during and following Avastin.

• Of increased risk of an arterial thromboembolic event.

• Of the potential risk to the fetus during and following Avastin and the need to continue adequate contraception for at least 6 months following last dose of Avastin.

• Of the increased risk for ovarian failure following Avastin treatment.

Avastin® (bevacizumab) Manufactured by: Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080‑4990

03/14 AVA0000764707 Initial U.S. Approval: February 2004 Code Revision Date: March 2014 Avastin® is a registered trademark of Genentech, Inc. © 2014 Genentech, Inc.

T:10.75”

In a prospectively designed substudy of 179 premenopausal women randomized to receive chemotherapy with or without Avastin, the incidence of ovarian failure was higher in the Avastin arm (34%) compared to the control arm (2%). After discontinuation of Avastin and chemotherapy, recovery of ovarian function occurred in 22% (7/32) of these Avastin‑treated patients. [See Warnings and Precautions (5.10), Adverse Reactions (6.1).]

Safety:10”

8.6 Females of Reproductive Potential Avastin increases the risk of ovarian failure and may impair fertility. Inform females of reproductive potential of the risk of ovarian failure prior to starting treatment with Avastin. Long term effects of Avastin exposure on fertility are unknown.

Safety:9.125"

Of the 742 patients enrolled in Genentech‑sponsored clinical studies in which all adverse events were captured, 212 (29%) were age 65 or older and 43 (6%) were age 75 or older. Adverse events of any severity that occurred at a higher incidence in the elderly as compared to younger patients, in addition to those described above, were dyspepsia, gastrointestinal hemorrhage, edema, epistaxis, increased cough, and voice alteration.

In an exploratory, pooled analysis of 1745 patients treated in five randomized, controlled studies, there were 618 (35%) patients aged ≥65 years and 1127 patients <65 years of age. The overall incidence of arterial thromboembolic events was increased in all patients receiving Avastin with chemotherapy as compared to those receiving chemotherapy alone, regardless of age. However, the increase in arterial thromboembolic events incidence was greater in patients aged ≥65 years (8.5% vs. 2.9%) as compared to those <65 years (2.1% vs. 1.4%).

[See Warnings and Precautions (5.5).]

Fifth annual aonn+ conference abstracts

Category III: Quality, Outcomes, and Performance Improvement Breast Patientsâ&#x20AC;&#x2122; Perception of Pain During SLNB Injection Procedures Laura Stearns Jones, MSN, RN, CBPN-IC Infirmary Health; Mobile Infirmary

Background: Patients were accompanied in nuclear medicine for the sentinel lymph node biopsy (SLNB) injection by the breast health nurse navigator. The observation revealed patients endured pain to the point of tears, as well as distress if the patient had searched the Internet, or had previous SLNB injections. At Mobile Infirmary, as the breast health nurse navigator, my goal was to guide the patient through this process and assist in the management of this painful process. Objectives: (1) Improve patient experience during the SLNB injection procedure; (2) research and identify an accepted method of pain reduction during the SLNB injection; and (3) explain the pain management process with confidence to the patient to reduce the distress of the SLNB injection process. Methods: (1) As the nurse navigator, I began a pilot program with the periareolar application of EMLA cream (lidocaine/prilocaine) and Tegaderm 1 hour prior to SLNB injection; (2) tracking and documenting patient perception of pain for the SLNB injection experience based on the 1-10 pain scale; (3) patient perception of pain scores was consistently above an average of 3.63. Results: After 1 year of tracking SLNB patients, the pain perception had been reduced to 2.42. These results were presented to the cancer committee with a proposed radiology order, which was implemented by the committee. EMLA cream became a stocked item in the breast center for needle localization patients, as well as the preoperative areas. Education was provided to staff on the process and its effectiveness. Conclusion: Data support the EMLA cream/Tegaderm application reduced pain perception.

Clinical Navigators Improve the Number of Prospective Cases Presented Kirsten Beeker, RN, BSN, OCN, CBCN; Patricia Hegedus, RN, OCN, MBA; Sharon Bartelt, RN, MSN, MBA, CPHQ, CSSBB, OCN Gibbs Cancer Center & Research Institute, Spartanburg Medical Center

Background: The American College of Surgeons Commission on Cancer (CoC) is a consortium of professional organizations dedicated to improving survival and quality of life for patients with cancer through standard-setting, prevention, research, education, and monitoring of comprehensive quality care. Two of the key elements of an accredited CoC cancer center are: 1. Clinical services that provide pretreatment evaluation, staging, treatment, and clinical follow-up for patients with cancer.

2. Cancer conferences that provide a forum for patient consultation and contribute to physician education. (http://inspiringquality.facs.org/about/commission-on-cancer/) Gibbs Cancer Center & Research Institute (GCC&RI) has emphasized developing and fulfilling these 2 key elements for 10 disease sites with weekly and bimonthly multidisciplinary planning conferences (MPCs). The transition to providing patient-centered MPCs with prospective case presentations began in 2007. Data show that over the past 6 years, presentation of prospective cases has increased from 14% of all cases presented in 2007 to 96% of all cases presented in 2013.

Objective: The purpose of this poster is to demonstrate the increase in prospective cases presented and the role of the clinical navigators in the evolution of the MPCs. Methodology: The clinical navigators have been instrumental in increasing prospective cases presented at the MPCs. The clinical navigator obtains, coordinates, facilitates administrative paperwork, and locates all appropriate imaging and pathology studies, along with participating in each of these MPCs. There is a process for identifying new diagnoses for each disease site and expediting these new cases to the MPC for presentation at the next appropriate MPC. The clinical navigatorâ&#x20AC;&#x2122;s coordinated effort with pathology, radiology, and the diagnosing physician groups is critical to identifying the newly diagnosed cases to be presented at the designated MPC. Results: In 2007, GCC&RI held MPCs for 3 disease sites, and 14% of 1444 analytical cases presented were prospective cases for treatment planning. By 2013, GCC&RI had increased to 11 different MPCs, and 96% of the cases presented are prospective cases. This represents a 7-fold increase in the presentation of prospective cases. Conclusion: The clinical navigators have provided a conduit for increasing the number of prospective cases from 14% to 96% of the cases presented at our MPCs over the past 6 years. The increase of prospective presentations at MPCs ensures that staging and treatment planning are completed to prevent delays in treatment for these patients.

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Category III: Quality, Outcomes, and Performance Improvement Navigation Workload Tracker: A Unique Tool for Measuring and Evaluating the Work of the Nurse Navigator and Clerical Staff in Navigation Programs Amanda Hertel, BSc, MSc; Barbara-Anne Maier, RN, BScN, CON(c) Grand River Regional Cancer Center, Grand River Hospital

Background: As part of a navigation program, an experienced oncology nurse contributes to the quality, accessibility, and continuity of care for oncology patients and their families. As navigation programs become more popular, there is a need for objective evaluation of not only the impact on patient outcomes, but also the work of the nurse navigators in achieving those outcomes. Understanding the roles and responsibilities of each team member allows navigation programs to run efficiently and provide the very best care for oncology patients. Objective: The objective of the present study was to collect and evaluate detailed information on the daily activities and tasks of nurse navigators and clerical support staff in the navigation programs. Evaluation of this data would provide staff and management with an in-depth look at the work of the nurse navigators in order to optimize time management, responsibility distribution, and, ultimately, patient care. Methods: A Navigation Workload Tracker was developed in-house using Excel spreadsheets. The tracker was developed after multiple consultations with staff and management, creating process maps and task categories that reflect the work of the team. A pilot was run prior to the beginning of the experiment proper to further refine the tracker tool. Following this pilot, the nurse navigator and administrative staff recorded their daily activities using the tracker for 1 month, after which data were collected and evaluated. Results: The results of the Navigation Workload Tracker project showed a marked difference between staff and management expectations of the nurse navigator programs and the realities of the day-to-day operations. The impact of documentation on workload was unexpected, including the finding that one-half of the navigatorâ&#x20AC;&#x2122;s time was spent on tasks that did not include direct patient care. Other findings included task redundancies between nurses and clerical support staff, distinct patterns in workload, and opportunities for time-saving from task categorization.

Also, the average time spent per patient referred to the program was determined, as well as patient circumstances that required additional time. Conclusions: The Navigation Workload Tracker was developed to allow staff and management to best understand the day-to-day operations of the navigator-led programs. The choice to develop the tool in-house using an available and familiar program decreased the costs and training time of the project, making it an easily adaptable pilot.

It has also provided staff and management with information to increase efficiencies in operations such as staffing, evaluation of program changes on workload, and task distribution among staff members. Despite initial staff concerns around the burden of utilizing the tracker, postproject evaluation showed staff members were pleased with the value added to the program from the project.

Category IV: Original Research on Navigation Programs Development and Utilization of an Acuity Scale for Oncology Patient Navigation Raizalie Roman, RN, BSN, OCN, CMSRN; Laura Beaupre, RN, OCN, CBPN-IC Lehigh Valley Health Network

Background: The oncology navigation team at Lehigh Valley Health Network (LVHN) is responsible for removing barriers, coordinating care, and assisting patients with complex medical, social, and emotional needs during cancer treatment.

In 2013, the navigator team was charged with broadening their scope to navigate patients according to complexity, not just by diagnosis. The acuity tool and needs assessment help determine which patients do not need navigation, which can be referred to other internal cancer support resources, which are appropriate for navigation, and the level of navigation needed. Objective: To determine which patients are appropriate for active navigation, utilizing the acuity tool. Methods: A literature search proved unsuccessful in finding other acuity tools suitable for our purpose of navigating oncology patients; therefore, the team benchmarked with other oncology programs to share information regarding patient acuity tools.

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Category IV: Original Research on Navigation Programs A survey was sent to LVHN oncology medical staff, including providers and nurses, asking them to prioritize their needs from the navigation team. Navigators met with 3 outpatient care teams (Palliative Care, Hospice, and Medical Home) to review case studies, complexity of care, and scope of services, and to eliminate duplication of services. Navigators met monthly to discuss time requirements for individual patient needs to determine the degree of navigation needed. The navigators created a needs assessment to identify barriers to care and to determine appropriate referrals. The navigation acuity scale is based on the time and amount of coordination needed to navigate patients before, during, and after treatment. The patient is assigned a score from 0 to 4 (low to high) and is incorporated into the electronic medical record (MOSAIQ), which allows all staff to identify the navigator and level of navigation care required. The acuity tool was implemented in March 2014. Results: The poster will show the tools developed by the navigation team, including the needs assessment and acuity scale. A graph outlining the patient acuity levels for the patient caseload during the most recent quarter will be displayed, demonstrating for the period from March 2014 through May 2014 that 4% of patients assigned an acuity score had an acuity of 0, 21% of 1, 24% of 2, 27% of 3, and 23% of 4. The data show that the acuity of the navigated patients is evenly distributed. Conclusions: By utilizing the needs assessment and acuity scale, the navigators are able to determine if patients are appropriate for navigation, have stable needs, or require active navigation. The intensity of navigation is also indicated. In the future, we hope to include the acuity measurements to help determine workload.

Understanding the Needs for Cancer Care Patient Navigation at an Academic Medical Center Melissa Grossman, MPH1; Jessica Keim Malpass, PhD, RN2; Lindsay Hauser, MS1; Christi Sheffield1; Pamela DeGuzman, PhD, MBA, RN2 University of Virginia Cancer Center; 2University of Virginia School of Nursing

1

Background: Improving quality of life and minimizing suffering are priorities for clinicians across the cancer continuum from diagnosis, through treatment, and continuing into survivorship and end-of-life care. Patient navigation is a healthcare service delivery model that is patient-centered and created to reduce barriers to care through the use of patient navigators. These professionals support patients through the continuum of care as it pertains to their specific diagnosis. The purpose of this analysis was to explore the experiences of cancer care providers and staff in delivering complex cancer care in a tertiary academic medical center with a rural catchment area. Methods: Cancer center key informants (nurses, physicians, support staff) and community partners (medical providers in the community who refer to the cancer center) underwent in-depth interviews regarding an overall needs assessment for the cancer center. Interviews were transcribed verbatim and coded based on hermeneutic interpretation. Results were interpreted using content analysis. Results: There were 5 themes that emerged: (1) care of patients who are both rural and low income is highly complex; (2) patients’ care is centered around medical needs; (3) providers use “work-arounds” to address patients’ complex needs; (4) consolidation of care to minimize patients’ trips; and (5) employees want a stronger link to survivorship care. Conclusion: Providers and staff who deliver cancer care to rural and low-income patients make tremendous efforts to address the complex needs of their patients. However, to provide continuity of care for this complex population, development of a patient navigation process is necessary. A well-planned patient navigation program will help to coordinate care and support rural cancer patients and their families to overcome barriers in the healthcare system.

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Category IV: Original Research on Navigation Programs Disease Burden Among Cancer Patients Suffering from Anemia and Their Caregivers: A Multinational Study in the United States, Italy, and France November McGarvey, MPH1; Patricia Corey-Lisle, PhD, RN2; Elizabeth Donahue, BS3; Marie-Pierre Desrosiers, MSc4; G. Chet Bohac, PharmD, MD, MSc Epi2; Sharon Hunter, MS2; Stephanie Hubbard, BA3 UCLA Fielding School of Public Health; 2Amgen Inc; 3United BioSource Corporation; 4United BioSource Corporation, Canada

1

Background and Aims: Chemotherapy-induced anemia (CIA), prevalent in cancer patients, may contribute to patient fatigue, declining functional capacity, and health-related quality of life (HRQoL), potentially increasing the need for caregiver assistance and caregiver burden. The study aims to explore the burden of disease among patients with CIA and their caregivers. Methods: This cross-sectional study was conducted from March 2012 to July 2013 in 8 oncology centers in the United States (3), Italy (3), and France (2) among consecutively presenting adult breast, colorectal, lung, and gynecological cancer patients with anemia (hemoglobin [Hb] <12.0 g/dL) currently receiving myelosuppressive chemotherapy and their caregivers. Patients and their caregivers completed surveys with questions on sociodemographics, time spent caregiving, burden, productivity, fatigue, and HRQoL. Descriptive statistical analysis was conducted. Results: A total of 182 patients and their caregivers were enrolled (United States: n = 55; Italy: n = 101; France: n = 26). Patients across all countries (74.7% female; 50.5% ≥65 years; mean Hb = 10.4 g/dL) reported a Functional Assessment of Cancer Therapy-Fatigue (FACT-F) mean score of 30.1 and a Short Form 12-Item Health Survey (SF-12) physical component mean score (PCS) of 38.1 and mental component mean score (MCS) of 45.0. Italian patients reported the highest mean FACT-F score (33.15), followed by French (30.71) and US patients (24.61) (score range, 0-52; higher score = less fatigue). Patient SF-12 PCSs were highest in France (41.6), followed by Italy (38.3) and the United States (36.2), whereas MCSs were highest in the United States (47.3), followed by Italy (44.1) and France (43.8) (score range, 0-100; higher score = better health). Across all countries, caregivers (50% female; 65.4% <65 years) reported a daily mean of 4.4 hours providing assistance with instrumental activities of daily living (IADLs) and 7.9 hours with activities of daily living (ADLs). US caregivers reported the greatest daily mean hours in assistance (ADL: 9.80; IADL: 6.83), followed by Italy (ADL: 7.81; IADL: 3.55) and France (ADL: 4.14; IADL: 2.92). Caregivers reported a Zarit Burden mean score of 10.02 across all countries with highest mean scores in the United States (10.8), followed by Italy (9.8) and France (9.1) (score range, 0-48; high burden cut-off at ≥10; higher score = greater burden). Caregivers also reported weekly work impairment (WI) (among employed, mean WI = 31%) and activity impairment (AI) (mean AI = 23.43%). The greatest WI occurred in Italy (36.6%), followed by the United States (30.1%) and France (2.9%), and the United States had the highest AI (28.0%), followed by Italy (24.2%) and France (11.2%). Conclusions: Data support that patients with CIA and their caregivers in the United States, Italy, and France are experiencing disease burden. Research of this kind aids healthcare providers, patients, and caregivers in making more informed decisions related to patient and caregiver needs.

90-Day Pilot Program: A Nurse Navigator’s Assessment of Psychosocial Distress in Gynecologic Cancer Patients Antoinette Solnik, RN, BSN

Johns Hopkins Medicine, Sibley Memorial Hospital Center for Gynecologic Oncology and Advanced Pelvic Surgery

Background: In 2012, the Commission on Cancer (CoC) developed Standard 3.2, which calls for screening patients with cancer for psychological distress and is now being phased into practices nationwide by 2015. This standard requires accredited hospitals to define a process by which practitioners monitor on-site distress screening and make referrals to services as needed for patients with cancer. To prepare to meet the new CoC standard, a newly appointed nurse navigator began implementing a 90-day pilot to assess sources and levels of stress in women facing gynecologic cancers. Because issues related to depression, insurance, financial matters, social and family relationships, and spirituality are often seen as a cause of psychosocial distress in patients facing a cancer diagnosis, screening these newly diagnosed patients with cancer helped the nurse navigator identify issues that had the potential to negatively impact their treatment and outcome. Objectives: The purpose of this 90-day pilot was to fine-tune a process to address gynecologic patients who reported significant distress Continued on page 54

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SCIENTIFIC CONFERENCES 2014-2015

Marsha Rivkin Center for Ovarian Cancer Research-AACR 10th Biennial Ovarian Cancer Research Symposium Co-Chairpersons: Kathleen Cho, Sandra Orsulic, Mary L. “Nora” Disis, and Saul E. Rivkin September 8-9, 2014 Seattle, WA

EORTC-NCI-AACR International Symposium on Molecular Targets and Cancer Therapeutics Scientific Committee Co-Chairpersons: Jean-Charles Soria, Lee J. Helman, and Jeffrey A. Engelman November 18-21, 2014 Barcelona, Spain

Targeting PI3K-mTOR Networks in Cancer Co-Chairpersons: Lewis C. Cantley, Jose Baselga, Joan S. Brugge, Brendan D. Manning, and Malte Peters September 14-17, 2014 Philadelphia, PA

Tumor Immunology and Immunotherapy: A New Chapter Co-Chairpersons: Robert H. Vonderheide, Nina Bhardwaj, Stanley Riddell, and Cynthia L. Sears December 1-4, 2014 Orlando, FL

Hematologic Malignancies: Translating Discoveries to Novel Therapies Chairperson: Kenneth C. Anderson Co-Chairpersons: Scott Armstrong and Riccardo Dalla-Favera September 20-23, 2014 Philadelphia, PA Advances in Melanoma: From Biology to Therapy Co-Chairpersons: Suzanne L. Topalian, Keith T. Flaherty, and Levi A. Garraway, September 20–23, 2014 Philadelphia, PA 13th Annual International Conference on Frontiers in Cancer Prevention Research Program Committee Chairperson: Phillip A. Dennis September 28-October 1, 2014 New Orleans, LA Seventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and Medically Underserved Co-Chairpersons: Ethan Dmitrovsky, Rick A. Kittles, Electra D. Paskett, and Victoria L. Seewaldt November 9-12, 2014 San Antonio, TX

San Antonio Breast Cancer Symposium Co-Directors: Carlos L. Arteaga, Ismail Jatoi, and C. Kent Osborne December 9-13, 2014 • San Antonio, TX Myc: From Biology to Therapy Co-Chairpersons: James E. Bradner, Martin Eilers, Dean W. Felsher, and Carla Grandori January 7-10, 2015 • La Jolla, CA Translation of the Cancer Genome February 7-9, 2015 Co-Chairpersons: William Hahn, Lynda Chin, and William Sellers Computational and Systems Biology of Cancer February 9-11, 2015 Co-Chairpersons: Andrea Califano, Brenda Andrews, and Peter Jackson The Fairmont, San Francisco, CA AACR-Society of Nuclear Medicine and Molecular Imaging Joint Conference: Molecular Imaging in Cancer Biology and Therapy Co-Chairpersons: Carolyn J. Anderson, Christopher H. Contag, and David Piwnica-Worms February 11-14, 2015 • San Diego, CA

Fifth annual aonn+ conference abstracts Continued from page 52

Category IV: Original Research on Navigation Programs early in the treatment trajectory in order to treat them proactively and hopefully avoid future psychosocial problems. The other important objective was to better determine the capacity with current staffing to respond and follow up with patients who met or exceeded a threshold for significant distress. The information obtained in the screening was reviewed and triaged by the nurse navigator, who then either acted upon the expressed concern or referred the patient to the social worker. Methods: Newly diagnosed patients were identified during their first scheduled appointment. The nurse navigator provided eligible patients with a letter explaining the pilot’s objective and instructions for completing a distress screening form, “The Distress Thermometer,” prior to seeing the physician. The National Comprehensive Cancer Network (NCCN) Distress Thermometer was chosen because of its proven reliability, ease of use, and review of both practical and psychosocial issues. Two additional questions were added at the end of the distress screening tool to determine if the patient is already getting help for these problems and/or if she wanted Sibley staff to follow-up to provide additional support. If a patient indicated a 6 or greater (of a potential high of 10) on the thermometer, the nurse navigator called her within 1 week to more clearly determine which staff could appropriately address each area of concern. The nurse navigator then made referrals to the oncology social worker, a physical or lymphedema therapist, the palliative care nurse practitioner, oncology dietitian, or the hospital chaplain. For issues pertaining to medical care, the nurse navigator would address them directly. Results: One hundred women were surveyed during the 90-day pilot. Approximately 25 (25%) of these women indicated a distress score of 0 (no distress), with many of these indicating they were already working with a therapist. More than 50 (50%) of the women surveyed indicated a distress score of 4 or greater, prompting follow-up by the nurse navigator and social worker with about 50% of these patients being referred to a specialist (eg, dietitian, physical therapist, etc) for their targeted need. Physical and emotional problems ranked highest among patient problems above child care, house, insurance/financial, transportation, work/school, and family problems. Primary physical problems included fatigue, pain, and sleep. Top emotional problems included fear, nervousness, and worry. Conclusions: Distress screening is extremely useful to the nurse navigator and has become crucial in identifying patient needs at a challenging time of early diagnosis and pretreatment. Appropriate screening and triage can likely result in treatment of those patients who are most in need of care and may not have accessed it otherwise. The modified NCCN Distress Tool offers an efficient way to identify which newly diagnosed patients may require and be receptive to additional support from the oncology team. Next steps include evaluating whether current staffing has the capacity to respond to patients with a screen of 4 or more. Staff will also compare the gynecologic patients’ needs to a parallel pilot being conducted at Sibley with newly diagnosed patients with breast cancer. The data obtained will allow staff to better meet individual patient needs, as well as to develop supportive programming and education that may serve the broader population of cancer patients. Other pilot projects may include screening individual patients at various transition points in their cancer care.

The Evolution of Navigation in Virginia; If You Build it, They Will Come: Leveraging Data and Best Practices to Create a Sustainable Statewide Network Katie Benson, BS1; Donna Moore Wilson, BSN, RN, CBCN2; Christi Sheffield, BS3

Onyx Pharmaceuticals; 2Bon Secours Richmond Health System; 3University of Virginia Cancer Center

1

Background: In the past decade, patient navigation has become a core component in defining and providing quality patient-centered oncology care. In 2007, recognizing that a new position was emerging in the oncology nursing field, a Virginia-based Genentech Territory Manager created a forum, Virginia Coalition of Oncology Nurse Navigators (VCONN), to bring oncology nurses from various health systems together to share how their roles were evolving to incorporate patient navigation. As time progressed, statewide stakeholders, health systems, administrators, industry partners, and cancer advocacy groups noticed the patient navigation model expanded beyond nursing into other areas of the cancer control spectrum to include other professionals such as social workers as well as community lay navigators. Methods: In 2012, these stakeholders, in collaboration with VCONN, conducted a statewide multistep analysis to identify existing navigation services, explore gaps and barriers, and define essential elements for professional development. This multidisciplinary team used existing data sources from national organizations and other state networks to conduct focus groups and numerous internal surveys to address the needs of patient navigation in their state. As a leading partner and funder, the University of Virgin-

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Category IV: Original Research on Navigation Programs ia Cancer Center hosted a series of interactive conferences to explore opportunities, best practices, and lessons learned from other states such as Georgia and North Carolina. Results: The needs assessment identified 5 priorities: (1) a desire for a multidisciplinary network of navigators; (2) a need for continuing education and professional development opportunities; (3) systems that aid in data collection, metrics, and return on investment; (4) promoting navigation within organizations and statewide; (5) increased need in survivorship resources; and 1 nonpriority: establishing credentials/educational standards. This in-depth analysis provided focus and a clear opportunity for multidisciplinary collaboration. Within 1 year, this group established the Virginia Cancer Patient Navigator Network (VaCPNN), defined their mission and vision, elected a steering committee, and grew from 30 to 142 members. Based on survey data and programmatic evaluations, VaCPNN has hosted 5 seminars with leading experts, provided continuing education credits, and is developing an interactive website for members. Conclusion: Leveraging national data and experiences from other states, VaCPNN has created a statewide platform to empower patient navigators across the continuum of cancer care to become advocates and educate their own organizations on the evolution of navigation and, ultimately, act as leaders in this emerging career to define their role and value to the patient and the organization.

Category V: Original Research on Survivorship Programs Breast Cancer Survivors Rockinâ&#x20AC;&#x2122; for Health Jane Metsker, RN, CBPN St. Joseph Medical Center

Background: Women Embracing and Loving Life (WELL) is a healthy lifestyle program started in October 2010 based on research showing the benefits of exercise for breast cancer survivors, prevention and/or treatment of fatigue, improving functional status with upper-body limitations and lymphedema prevention or improvement. The Quality of Life Survey research study received institutional review board approval and was initiated in October 2011. Pre- and postprogram surveys were completed by participants to assess the impact of the program in regard to pain, physical and emotional health, daily activities, exercise, food choices, and coping ability.

WELL Fusion was added in October 2012 in response to participants who wanted to continue and who were physically ready to advance to more strenuous exercise. Fusion provides additional strength training, circuit training, and more advanced Zumba routines.

Research Goals: (1) Minimize or reduce the side effects of cancer treatment; (2) promote healing and recovery; (3) provide nutrition education and accountability; (4) engage in physical exercise in a group setting; and (5) improve mental health received from group support and sharing.

Research Questions: (1) Will participation in this program improve the quality of life for breast cancer survivors? (2) Do survivors feel empowered to move toward â&#x20AC;&#x153;wellnessâ&#x20AC;? through this program? and (3) Does diet and exercise reduce stress for breast cancer survivors?

Methods: WELL is an 8-week program for breast cancer survivors providing nutrition and fitness information. Participants are assisted in setting individual goals to foster commitment and encourage long-term success. A registered dietitian provides education on improving nutrition and weight management (when applicable). Participants can use food diaries to track food choices.

The fitness instructor is a Pink Ribbon certified instructor. The exercise program includes the Pink Ribbon Pilates program and Zumba, exposing women to a variety of exercise choices.

The program is being offered at no charge, and participants can join at any point during the 8-week session. This gives women the opportunity to feel supported at a critical time in their care. The coordinator of this program is a breast cancer survivor, nurse, and a certified breast patient navigator.

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Category V: Original Research on Survivorship Programs Results: Survey results demonstrated the following: (1) increased awareness in choosing nutritious foods; (2) increased participation in fitness/exercise; and (3) improved perception of life being back to normal.

Comments by Participants: • “After my surgery I didn’t know where to go or what to do next and WELL has provided encouragement and guidance.”

• “My family has been very supportive, but sharing stories with other women who have experienced many of the same things I have has given me a sense of caring and understanding.”

• “This is the first breast cancer support group that I have been involved in and in just a few weeks it has answered many of my questions. I’ve learned about the importance of nutrition and exercise.”

Conclusion: It is anticipated that the WELL program will benefit breast cancer survivors by improving their physical health through promoting healthy nutrition and rebuilding muscular strength and endurance, reducing fatigue, and regaining range of motion and flexibility. It may also benefit breast cancer survivors by improving their psychological health by allowing them to take a more active role in their recovery and the healing process and interact with other survivors.

A Not-for-Profit Model of Survivorship Care and Navigation to Facilitate Care Planning for Young Breast Cancer Survivors Rochelle Shoretz, JD; Amy Mines, MS; Sharon Stahl, LMSW; Adina Fleischmann, LMSW Sharsheret

Background: By 2015, the American College of Surgeons Commission on Cancer’s accreditation standards will call for certified cancer centers to provide a treatment summary and follow-up plan to cancer survivors. There is a pressing need for the development of collaborative and cost-effective tools to facilitate the implementation of these survivorship care plans.

Oncology nurses and patient navigators have a unique opportunity to develop and implement comprehensive, proactive survivorship care planning that will meet the Commission on Cancer’s guidelines for survivorship. Objectives: To develop a breast cancer support program that includes survivorship care plans and personalized navigation for young breast cancer survivors (diagnosed age <45 years). Methods: Clinicians engaged in a comprehensive review of the literature regarding young adult cancer survivors and relevant support programs. More than 1400 young breast cancer survivors were surveyed to better understand their unique, unmet needs and identify priority concerns. Four national focus groups of breast cancer survivors were conducted for feedback in creating a program to address these concerns. Results: With the data collected, Sharsheret developed Thriving Again, a comprehensive survivorship program that includes (1) a kit of tools mailed to young breast cancer survivors (survivorship care plan, tailored resources, fitness DVD, and cookbook); (2) personalized survivor navigation with a member of Sharsheret’s clinical staff; and (3) teleconferences addressing key survivorship issues. More than 1200 Thriving Again kits have been distributed to young breast cancer survivors, and Sharsheret has conducted more than 700 individualized survivor navigation sessions to date. Additionally, Sharsheret has presented 4 survivorship teleconferences addressing priority concerns identified by young breast cancer survivors. Conclusions: The Thriving Again model can be used to advance cost-effective survivorship care through multilevel collaboration. The methods and data used to develop Thriving Again can inform the development of other programs for survivors of breast and other cancers. Healthcare professionals can cobrand survivorship kits or survivor care plans, or create new kits and care plans based on the Thriving Again model. Working collaboratively with support organizations like Sharsheret, oncology nurse and patient navigators can also refer patients for survivorship navigation to provide comprehensive survivorship planning and support.

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Category V: Original Research on Survivorship Programs The Impact of Exercise on Cancer-Related Fatigue Staci Oertle, ANP-BC, MSN, OCN

Inspira Health Network Frank and Edith Scarpa Regional Cancer Pavilion

Background: Cancer-related fatigue (CRF) is one of the most common symptoms experienced by patients with cancer and may persist for months to years after completion of treatment. CRF is a stressor that causes a ripple effect on patients and their daily routines, and often results in poor quality of life (QOL). CRF is an internal stressor that causes an imbalance in the 5 dimensions of self: physiological, psychological, sociocultural, developmental, and spiritual, as described by nurse theorist Betty Neuman. Although there have been numerous studies published in recent years citing exercise as a safe and effective intervention for CRF, this particular stressor continues to be a challenge for both patients and healthcare providers. Objectives: This study encompasses the Neuman Systems Model and utilizes exercise as a patient-centered intervention to decrease CRF and facilitate overall improvement in patients’ QOL. Methods: This study utilized a supervised 60day physician-referred exercise program (PREP) as an intervention for CRF, and evaluated the outcome of exercise on patients’ self-reported fatigue and QOL. The Brief Fatigue Inventory (BFI) scale was used to measure fatigue, and the Quality-of-Life Questionnaire (QLQ-C30) was used to measure QOL. A convenience sample of 70 predominantly low-income and minority cancer survivors who completed their treatment at Inspira Health Network Frank and Edith Scarpa Regional Cancer Pavilion were recruited to participate in this study. Results: Forty patients who were eligible and enrolled in this study completed the PREP program. Pre- and posttest exercise comparisons using the BFI and QLQ-C30 revealed that study participants experienced a significant reduction in self-reported fatigue as well as a significant improvement in QOL (all P <.05). Conclusions: Effective nursing management is essential for assessment, interventions, and successful outcomes for patients experiencing CRF. Findings suggest that oncology nurses and navigators can be instrumental in the assessment and early recognition of CRF to initiate exercise as an effective intervention to reduce fatigue and to improve QOL in cancer survivors.

Dyadic End-of-Treatment Challenges in Head and Neck Cancer: Development of a Head and Neck Cancer Survivorship Program Ashley Laursen, BSN, RN1; Terrance Day, MD1; Jane Zapka, ScD2; Amy McEachin Buchanan, MPH2; Katherine Regan Sterba, PhD, MPH2

Department of Otolaryngology - Head & Neck Surgery, Medical University of South Carolina; 2Public Health Sciences, Hollings Cancer Center, Medical University of South Carolina

1

Introduction: Head and neck cancer (HNC) is a severely debilitating disease significantly affecting quality of life for both patients and their caregivers. Head and neck cancer survivorship research is limited and has often overlooked the dyadic challenges faced at the end of treatment. Potentially unique patient and caregiver end-of-treatment needs should be identified to improve HNC survivorship care. Objectives: To evaluate and compare challenges and unmet needs in HNC dyads 6 months following diagnosis, and explore implications for the development of a specialized survivorship care program.

Methods: Patients (n = 66; 73% male; average age, 60 years) with newly diagnosed HNC and their primary caregivers (n = 69; 51% partners; 24% male; average age, 58 years) were recruited in an HNC cancer clinic and completed separate surveys to evaluate unmet needs 6 months after diagnosis. Key elements for an HNC survivorship program were identified.

Results: Survivors and caregivers reported similar unmet needs. The most prevalent needs in both dyad members included wanting up-to-date information about the cancer and its treatment (>45%) and wanting to feel more like part of the team managing their health (>35%). Dyads also commonly reported needing reassurance about their care coordination and their multidisciplinary providers’ communication (>35%). In addition, survivors and caregivers reported needing help with ongoing symptom management (>30%). Common unmet needs unique to survivors included persistent pain (52%), financial concerns (43%), and a desire to speak with other survivors (35%). Approximately one-third of the survivors also needed help with feelings of uncertainty, weight loss, adjusting to posttreatment life, and defining a new sense of normal.

Needing more emotional support and help dealing with the impact their cancer had on relationships were also reported

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Category V: Original Research on Survivorship Programs (>30%). Caregivers uniquely reported needing help reducing stress (30%). Lastly, 24% of survivors reported continued use of tobacco products. Conclusions: This study highlighted common persistent physical, emotional, and social concerns of HNC survivors and caregivers. Findings indicate that a comprehensive survivorship program is needed to prepare dyads for the posttreatment period. In addition to addressing physical and emotional recovery concerns, programs should also help dyads manage concerns about life after treatment, identify those with high-risk behaviors, and help dyads understand their follow-up care schedule plan.

Category VI: Community Outreach and Screening Programs Womenâ&#x20AC;&#x2122;s Health Screening Event: Reducing Barriers to Provide Clinical Care Katharine Conroy, BSPH; Amanda Recchini, RN, BSN; Gean Brown, MSN, RN, OCN Middlesex Hospital Cancer Center

Background: Despite their varied etiologies, incidence rates, and mortality rates, breast and cervical cancer are both considerably more treatable when detected in their precancerous or early-stage phases. Nurse navigation, which is becoming an increasingly important subspecialty in oncology nursing, can serve to increase the efficacy of early-detection efforts, particularly for women with limited or no insurance coverage. Collaboration with trusted agencies such as the Connecticut Breast and Cervical Cancer Early Detection Program (CBCCEDP), which provides cost coverage for mammograms, Pap tests, and other examinations to those who qualify based on their insurance and income status, is also essential in reducing barriers to screening. Methods, Intervention, and Analysis: The Middlesex Hospital Cancer Center (MHCC) designed and implemented the Womenâ&#x20AC;&#x2122;s Health Screening Program, a 3-part event. In Part I, the gynecology nurse navigator and community outreach coordinator attended a local health conference with CBCCEDP representatives to educate and enroll women in CBCCEDP, as well as schedule them for a mammogram and/or Pap test 1 week later. All women were given an event-specific reminder card with their appointment information and other necessary details. During the interim week (Part II), the nurse navigator and outreach coordinator called all registrants to remind them of their appointments and ensure that they could be contacted. Transportation was arranged as needed. On the day of the screenings (Part III), women were met at the door and physically navigated through the exam process. Results: All (100%) of the women registered for screening examinations at the health conference arrived for and completed their mammogram and/or Pap test 1 week later. A total of 10 women were provided with services, and the success of the event resulted from collaboration between 6 unique departments and physicians. On program evaluations, participants identified both the opportunity and the presence of a navigator as the greatest influences on their decision to be screened. Discussion: The 100% rate of compliance with scheduled tests, combined with the navigation provided indicates that this model was effective in reducing significant barriers to care. Although none of the patients were found to have breast cancer or abnormal Pap test results through this event, 3 patients were diagnosed with dense breasts and 4 were referred for additional services, including colonoscopy, pelvic ultrasound, and genetic counseling. This reveals that the event had multifaceted benefits, as nongynecological findings were also able to be identified and addressed. Additionally, enrolling all participants in CBCCEDP ensures that a mechanism for future breast and cervical care is in place.

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Thank you again for a wonderful conference on the conference to my administration each year to help me get funding for the following year and so far...so good. I attend various national conferences throughout the year and stand amazed at your ability to continue

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– 2013 Conference Attendee

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93% of 2013 conference attendees said they intended to change their practice as a result of participating in the AONN+ Conference

50 40 30 20

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23

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2011

2012

2013

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“WOW! I am so impressed with the growth of AONN. Lillie, Sharon, and their team are awesome. The speakers were knowledgeable about their subject matter and all the presentations were relevant to my practice. I will use the pearls of wisdom shared by the speakers to my team at

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Category VI: Community Outreach and Screening Programs Towson University Cancer Wellness Program Mary Sharon Curran, MS, RN

Towson University/Ulman Cancer Fund

Objectives: The participant shall be able to identify strategies for assisting young adult cancer patients/survivors in increasing their exercise; identify how exercise can benefit young adult survivors psychologically; and name entities in effective program collaboration. Purpose: The Comprehensive Cancer Wellness Program is a joint initiative from the Towson University Wellness Center, Towson University Nursing Department, and the Ulman Cancer Fund (UCF) for Young Adults. This free, 8-week program is an outreach initiative aimed at improving the quality of life of young adult cancer patients/survivors (ages 18-40 years) in the Towson region who are undergoing active treatment for cancer, have had cancer in the recent past, or are living with significant long-term effects of cancer treatment as children or teens. Method: Individually tailored exercise training and guidance is provided by Towson University Wellness Center staff 2 to 3 times per week in a fully equipped facility with state-of-the-art cardiovascular and strength-training equipment. Emotional support is provided by the UCF patient navigator, who also serves as a Towson University Nursing Department Clinical Associate Professor specializing in psychiatric and mental health nursing. Young adult cancer patients/survivors are referred from local cancer centers where UCF social workers and UCF nurse patient navigators are stationed. All participants must be cleared by their treating oncologist to participate in the program. Results: Among cancer patients, the most commonly preferred feature was access to consultation with an exercise specialist who could take into account the patient’s previous exercise and cancer history, and their physical and emotional recovery goals. Medical oncologists were in favor of their younger patients increasing their posttreatment physical activity under appropriate supervision and noted the value of the real-world collegiate setting. Conclusions: The program offers examples of how medical centers, academic institutions, and nonprofit organizations can effectively collaborate to develop and implement a wellness program for young adults in their 20s and 30s who are surviving cancer. Exercise is not only safe after cancer, but it can also improve physical functioning and psychological adaptation. The advice of medical oncologists to “get more exercise” can best be followed by young adult survivors when they have a safe, structured option that allows for professional guidance in a real-life setting. Research Implications: Further research is needed to determine if this model can be effectively utilized in other urban academic settings. In addition, longer-term outcomes such as frequency and intensity of weekly exercise, general psychological well-being, and remediation of treatment side effects 1 year after program completion should be explored. Clinical Implications: The program model demonstrates how oncologists can easily and effectively help young adult cancer patients transition into survivorship, and how exercise can be integrated into survivorship planning.

Role of Clinical Navigation in a Colonoscopy Screening Program Patricia Hegedus, RN, OCN, MBA; Noel Kinard, LMSW; Sharon Bartelt, RN, MSN, MBA, CPHQ, CSSBB, OCN; Kirsten Beeker, RN, BSN, OCN, CBCN Gibbs Cancer Center & Research Institute, Spartanburg Regional Healthcare System

Background: Spartanburg Regional Healthcare System Gibbs Cancer Center & Research Institute (GCC&RI) is a nationally recognized cancer treatment and research facility located in Spartanburg, SC. To reduce colorectal cancer (CRC), there is a great need in South Carolina and throughout the United States to increase colonoscopy screening services.

Objectives: The Betty Ann Moore Colorectal Cancer Screening Program (BAM) has focused on increasing the number of people screened for CRC since 2007. The program began with seed funding from the children of Betty Ann Moore. Her children wanted to remove the financial barrier for residents in the upstate South Carolina community who would otherwise be unable to receive a screening colonoscopy. Clinical navigation services have played an integral role in the success of the program. Method: The Gastrointestinal (GI) Clinical Navigator screens the patient for eligibility, facilitates physician referral, provides patient education, and monitors program outcomes. The GI Clinical Navigator facilitates the referrals throughout the care continuum, screening through treatment and survivorship. Navigation services played a key role in the development of the financial and clinical requirements to qualify to receive the screening colonoscopy. This process

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Category VI: Community Outreach and Screening Programs continues to be utilized today. In fall 2010, GCC&RI’s involvement in the statewide screening effort, the South Carolina Colon Cancer Prevention Network (SCCCPN), enabled us to utilize BAM funds to provide both diagnostic and screening colonoscopies. Results: BAM has provided 174 colonoscopies: 93 were screening colonoscopies and 81 were diagnostic colonoscopies. Three patients have been diagnosed with CRC under BAM’s diagnostic colonoscopy services. These patients were able to avoid the delay in diagnosis, thereby improving their chances of a cure. A total of 114 (66%) patients had polyps removed. Of the 114 patients, 63 (55%) were adenomatous precancerous polyps. Conclusion: The challenge to increase CRC screening in the upstate community has been achieved through our collaborative efforts and support from our statewide partners, including the SCCCPN. Our continued partnership will inevitably ensure earlier CRC detection and prevention for upstate South Carolina residents. BAM continues to be supported by individual donations and fundraising events. The contribution of the Clinical Navigator in program facilitation and patient coordination is undeniable and has led to the success of the program. BAM continues to provide CRC screening to the underinsured in Spartanburg and surrounding counties in upstate South Carolina, making it a unique program in the state.

Women’s Health Cancer Screening–An Initiative Reaching Uninsured Women in the Communities North of Pittsburgh, Pennsylvania Kathleen Bryte, MSN, RN, OCN; Elizabeth Shumaker, MSN, RN, OCN UPMC CancerCenter

Background: To prevent or detect cancer at an early stage, the American Cancer Society recommends that healthy women should have yearly clinical breast examinations and mammograms starting at age 40 years and Papanicolaou (Pap) tests every 3 years starting at age 21 years. Community leaders in the North Hills of Pittsburgh completed a needs assessment that revealed a privation of cancer screening services for uninsured women living in our community; they sought programs that could address this need. Objectives: The primary intention of the Women’s Health Cancer Screening (WHCS) is to provide breast and gynecologic cancer screenings and healthy lifestyle education free of charge for women who would otherwise not have these basic medical services. Methods: WHCS is an initiative led by the University of Pittsburgh Medical Center Passavant that not only offers a one-time physical examination and testing on the day of the screening, but more importantly provides women with no-cost, long-term access to these potentially lifesaving procedures by introducing them to the Pennsylvania Healthy Woman Program (HWP). Informational flyers announcing the WHCS were given to the local food banks and other community centers for distribution. In addition to their 20- to 30-minute visit with a gynecologic specialist where they received thorough breast and pelvic examinations and personalized discussions about appropriate health issues, the women also received other health screenings, education about cancer prevention and healthy lifestyle choices, and the opportunity to learn about and complete the forms for enrollment in the HWP. Biopsies were done that day for identified lesions, and transvaginal ultrasounds (TVUS) performed when pelvic masses were detected. All of the women also met with medical financial counselors, who helped them discern appropriate avenues for health insurance coverage. A letter containing copies of all test results, any recommendations for follow-up, and a reminder about getting their mammogram through the Pennsylvania HWP was sent to each woman. Results: Two WHCSs have been held on Saturdays, with 27 and 29 participants, respectively. Between the 56 participants, abnormal findings and procedures on the day of their screening included 5 pelvic masses/TVUS, 4 breast masses, 3 cervical biopsies, 2 positive HPV results, and 1 positive Pap test. All women who met the criteria received a voucher to have a free mammogram.

Conclusions: Each woman who attended the WHCS was given the cancer screenings and healthy lifestyle education personalized according to their age, identified issues, and the recommended, evidence-based preventive guidelines. The administration of the hospital deemed the WHCSs to be a successful endeavor that fulfilled the expectations described in the community needs assessment and plans to continue the program at least annually.

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Category VI: Community Outreach and Screening Programs Support Your Girls: They’ll Thank You Later Donna Moore Wilson, BSN, RN, CBCN; Judy Heilman, MBA Bon Secours Richmond Health System

Background: Research has proven that the earlier breast cancer is found, the higher the probability of cure. According to the American Cancer Society (http://www.cancer.org/cancer/breastcancer/index) breast cancer found during screening examinations tends to be smaller and confined to the breast. Providing breast education and dispelling myths increases the likelihood that women will perform breast self-examinations and obtain yearly screening mammograms. Methods: For the past 4 years, Bon Secours Cancer Institute has hosted “Support Your Girls” seminars at local country club and hotel banquet rooms, inviting women to a ladies’ night out and providing dinner, education, photo booths, prizes, scheduling for screening mammograms, bra fittings, and the opportunity to purchase bras from local merchants, Dillard’s and Nordstrom.

Staff and community partners provided booths with education and community resources prior to the event. Nutrition education was provided by Whole Foods and Fresh Market. Women are invited via television, radio, and newspaper ads, and the Internet. Advanced registration was required, with a limit of 175 attendees. For the past 2 years, the events have filled to capacity, with women being placed on waiting lists. Upon their arrival to the event, women were given gift bags and a bingo card filled with the names of the vendors providing education and services. Women were required to visit each booth to have their bingo cards signed. The completed bingo cards were collected, and a winner was drawn at the end of the evening. The winner received a pink Coach pocketbook. During the dinner, speakers provided education on a variety of subjects, such as integrative medicine, breast reconstruction, breast radiology, navigation, breast surgery, and how to be fitted for the perfect bra. Community partners provided additional giveaways including a hotel weekend package for 2, gift certificates for facials, dinner out at restaurants, gift baskets, and massages. Results: The annual events have become increasingly popular with the community. This event provides Bon Secours Cancer Institute the opportunity to provide education and updates on breast health from experts including fellowship trained breast surgeons. Attendees were given information on complete breast diagnosis and treatment under 1 roof. For 2014 events, 23 screening mammograms were scheduled; of those, 27% had never been treated by a Bon Secours provider, 33% were over the age of 40 and never had a mammogram, and 22.4% were women under the age of 40 who came to be educated on breast health and awareness.

Conclusion: The events provided an opportunity for the women in the community to be educated on breast health in an informal relaxed setting. The relaxed atmosphere provides a trusting safe environment where women feel comfortable asking questions and learning about the importance of breast health.

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