JONS June 2014 by The Oncology Nurse

June 2014 • Vol 5, NO 3

QUALITY, OUTCOMES, AND PERFORMANCE IMPROVEMENT (QOPI) COMMITTEE Danelle Johnston, RN, MSN, OCN, CBCN

NURSE NAVIGATION PATHWAY Using a Nurse Navigation Pathway in the Timely Care of Oncology Patients

TREATMENT AMONG AFRICAN AMERICAN WOMEN Agreement Between Patient Self-Report and an Objective Measure of Treatment Among African American Women with Breast Cancer

FOURTH ANNUAL AONN+ CONFERENCE The Future of AONN Community Needs and Navigation

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LETTERS FROM LILLIE

Editor-in-Chief

Lillie D. Shockney, RN, BS, MAS

Hello everyone! Summer has finally arrived and we hope you are enjoying vacation time with family and friends. We are busy putting the final touches on our Fifth Annual AONN+ Conference at the Walt Disney World Dolphin Resort in Orlando, Florida, September 18-24, 2014. This issue of the Journal of Oncology Navigation & Survivorship (JONS) is filled with information to further your knowledge about navigation and survivorship. Danelle Johnston, RN, MSN, OCN, CBCN, shares her personal profile, which I know many of you will be able to relate to and feel inspire by. Intermountain Southwest Cancer Center wrote about how to improve timeliness of care through the application of a navigation pathway. The Cancer Prevention & Control Program at the University of South Carolina provides information about their experiences with the treatment of African American women with breast cancer. We are continuing to give you feedback regarding the content that was presented at our Fourth Annual AONN+ Conference with this issue focusing on our organization’s accomplishments in 2013. Dr Jennifer Klemp, University of Kansas, provided conference attendees with a wealth of information regarding the new standards of the Commission on Cancer (CoC), presenting specifically on how to conduct and report a community needs assessment. The final article gives us insight into the value of breast cancer survivorship support groups. I realize some folks are anxious that the CoC required standards on navigation and survivorship will be implemented on January 1, 2015. I love seeing that what we do as navigators across the continuum of care is being recognized and valued. We will be helping you and your leadership get ready to demonstrate your worth by attending some specific sessions built into the agenda with this focus in mind—bring your administrators and managers with you! We have several hundred members already registered, so register soon to get your flights and other travel arrangements set up soon. In recognition of your feedback on our website and information from last year’s conference evaluation forms, we have an amazing conference planned this year. We also have fun activities for the evenings we are together in Disney World! Last, but not least, as you read this issue of JONS, give thought to what you and your colleagues may want to submit for consideration in future issues. I look forward to your work being sent in for peer review!

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 Gentry, RN, MSN, AOCN, CBCN Breast Health Navigator Novant Health Derrick L. Davis Cancer Center

Cancer Rehabilitation & Survivorship Julie 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

Prostate Cancer Frank delaRama, 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

AONN+ Research Committee Marcy Poletti, RN, MSN

Nursing Operations Supervisor Wake Forest University Baptist Medical Center

Elaine Sein, RN, BSN, OCN, CBCN Senior Project Manager Fox Chase Cancer Center Partners

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

Mission Statement With kind regards,

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

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

PUBLISHING STAFF 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 Publishers Russell Hennessy rhennessy@the-lynx-group.com Cristopher Pires cpires@the-lynx-group.com Director, Client Services Lou Lesperance llesperance@the-lynx-group.com Editorial Director Frederique H. Evans, MBS fevans@the-lynx-group.com Copy Editor Rosemary Hansen Editorial Assistant Jennifer Brandt Senior Production Manager Lynn Hamilton

THE LYNX GROUP President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Human Resources Jennine Leale Associate Director, Content Strategy & Development John Welz Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean

Table of ConTents

June 2014 • Vol 5, NO 3

QUALITY, OUTCOMES, AND PERFORMANCE IMPROVEMENT (QOPI) COMMITTEE

6 Danelle Johnston, RN, MSN, OCN, CBCN

NURSE NAVIGATION PATHWAY

13 Using a Nurse Navigation Pathway in the Timely Care of Oncology Patients

Deborah Christensen, RN, BSN, HNB-BC; Cheryl Bellomo, RN, OCN, CBPN-IC

TREATMENT AMONG AFRICAN AMERICAN WOMEN

21 Agreement Between Patient Self-Report and an Objective Measure of Treatment Among African American Women with Breast Cancer

Sue P. Heiney, PhD, RN, FAAN; Swann Arp Adams, PhD; Leepao Khang, PhD

The Patient’s Voice

30 I Get By with a Little Help from My Friends: The Role of the Support Group in Breast Cancer Survivorship

Carolyn Comeau

FOURTH ANNUAL AONN+ CONFERENCE

34 The Future of AONN

Lisa A. Raedler, PhD, RPh

Community Needs and Navigation Lisa A. Raedler, PhD, RPh

Clinical Trial Tracker

New Clinical Trials Underway

Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Manager Jini Gopalaswamy Project Coordinators Jackie Luma 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

June 2014 • Volume 5, number 3

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.

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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.

Reference: ClinicalTrials.gov, as of 5/2014. A2396579

Quality, outcomes, and performance improvement (QOPI) committee

Danelle Johnston, RN, MSN, OCN, CBCN Manager, Breast Services, Memorial Hospital, University of Colorado Health Co-Chair: Quality, Outcomes, and Performance Improvement (QOPI) Committee Member: Academy of Oncology Nurse & Patient Navigators (AONN+)

rom the time I was a young girl I knew I wanted to pursue a career in the “helping profession” and mix that with my love for the sciences. What that career would be was uncertain to me, but nursing found me in my senior year of high school. My high school required that seniors take a semester focused on career development. As part of the education, we were required to research professions, make a mock resumé, and participate in interviews with professionals in various career fields. I was fortunate enough to have the opportunity to interview with a physical therapist and a pediatric nurse. Upon completion of my interviews, I was selected to shadow the pediatric Intensive Care Unit nurse at Children’s Hospital Los Angeles. I will never forget the moment I walked through the doors—I felt like I was home. As the day continued, I was taken on a tour of the hospital and exposed to the various opportunities nursing had to offer. I entered the Bone Marrow Transplant Unit and looked into the eyes of a child who was currently undergoing treatment. Words cannot fully capture what I experienced that day, but it was lifechanging. I vividly remember the conversation I had with my parents after that incredible day and told them that I wanted to pursue my nursing degree after graduation and become a pediatric oncology nurse. The journey to completing my nursing degree was full of life lessons and I was humbled by patient and family experiences in times of illness and crisis. I was very fortunate my junior year of nursing school to be hired as a patient care assistant at the same Bone Marrow Transplant Unit that called out to me 3 years prior. Following graduation, I was hired on that unit as a clinical nurse. While at Children’s Hospital Los Angeles, I transitioned into the role of Chemotherapy Systems Nurse Coordinator. This position was created to facilitate a large-scale performance improvement initiative after a sentinel event. I led the charge to redesign chemotherapy processes and developed standardized chemotherapy order set templates to improve efficiency, clarity, safety, and patient outcomes. This work fulfilled me and became my passion for the next 10 years. I met the love of my life, got married, and had 2 beautiful children. I recently decided to stop working for a period of time so that I could have the opportunity to be a stay-at-home mother. It was during this time I received a phone call that changed my experience with cancer for-

June 2014 • Volume 5, number 3

ever. The call was from my father who reported that he had undergone a CT scan for abdominal pain. The scan revealed a mass on the head of his pancreas and several masses in his liver. My father was diagnosed with stage IV pancreatic cancer and given less than 6 months to live. Nothing prepares you for the sucker punch a cancer diagnosis brings. My experience as an oncology nurse working with numerous patients who were diagnosed, and subsequently treated, seemed to have no bearing as the scenario became very personal. I wanted to walk the journey caring for my father as his daughter. The next 3 months were filled with multiple appointments and treatments and countless frustrations. On numerous occasions I needed to function in my role as nurse to mitigate issues and navigate the healthcare system. I often wondered what patients and families do who do not have the same knowledge about cancer and healthcare that I had. That thought was disheartening to me.

Words cannot fully capture what I experienced that day, but it was life-changing. In the beginning, my father wanted to give treatment a try to attempt to control the disease and offer him some time, but the cancer was already so far advanced and so aggressive that the treatments failed. No one on my father’s cancer team asked him what he wanted. What were his goals and how did he define quality of life for himself? Toward the end of his courageous battle, I was the one who had the very delicate conversation with both my father and my mother. Three months after his initial diagnosis, my father passed away in his home on hospice care surrounded by those who loved him. It troubled me to know that if I did not have the end-of-life conversations with my father he would have died in the hospital and his wishes would not have been honored. I knew I could not sit silent, but rather had to step back into my profession and help change the culture of care. I did not want another cancer patient and family to have the same frustrating and isolating experiences. It was not long after my father’s death that I returned to oncology nursing with the desire to have a direct impact on patient outcomes.

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Quality, outcomes, and performance improvement (QOPI) committee

I returned to work and was hired as a clinical oncology nurse for Riverside Community Hospital’s oncology program where I was instrumental in program development and quality improvement initiatives for the cancer program. I helped design and implement an inpatient Palliative Care Program. It was at this facility that I was first exposed to patient navigation. Our program developed a business plan to implement a comprehensive breast program with oncology nurse navigation. As Coordinator of Oncology Services at St. Jude Medical Center (SJMC), I was instrumental in the development of SJMC’s successful Nurse Navigator Program. I directed the hospital’s Breast Work Group, evaluating clinical outcomes and directing improvements in program content and quality. I oversaw St. Jude Breast Center’s efforts to become one of the first in California to earn recognition from the American College of Surgeons National Accreditation Program for Breast Centers (NAPBC). I implemented a variety of effective community outreach events, reaching hundreds of women, and created a peer-to-peer cancer support program that has significantly increased emotional support for women living with cancer. Whereas the concept of survivorship became integral to my practice as a nurse navigator, I was empowered to realize my dream of offering a women’s retreat where women who were being treated for breast cancer at SJMC were invited to a singleday event where they would have an opportunity to hear inspirational speakers and peer testimonials and participate in reflective and health-related activities. This event has become recognized as one of St. Jude’s cancer program best practices. At SJMC, I helped create a coalition of Oncology Nurse Navigators within Southern California to facilitate collaboration and knowledge-sharing. During my time at SJMC, I participated in a number of clinical research studies: • Primary Investigator: Breast Health Education and Cancer Awareness—October 2011 • Co-Investigator: Review Outcomes During 20062011 of Accelerated Partial Breast Irradiation for Early Stage Breast Cancer Patients Treated at SJMC —Fall 2012 • Co-Investigator: Interdisciplinary Team Education to Improve the Care of the Cancer Survivor—September 2012-September 2013 • Co-Investigator: Community Cancer Center Launches Oncology Rehab Program Demonstrating Improved Quality-of-Life Measures—2013 • Primary Investigator: Breast Cancer Nurse Navigator Facilitating Care Transitions in Cancer Survivorship —2013 In the spring of 2013, I had the privilege of being accepted to a pilot program with Western University on Transi-

tions in Care. This course was funded by a grant from The California Wellness Foundation in partnership with the California Institute for Nursing & Health Care and Western University of Health Sciences College of Graduate Nursing. This course broadened my understanding of care transitions and the role of the care coordinator within the community. We discussed the need for additional research around transitions in care and the role of nursing. As navigators we hold the ability to facilitate change through quality studies and publishing our outcomes to further build on current evidenced-based practices.

I often wondered what patients and families do who do not have the same knowledge about cancer and healthcare that I had. I have recently taken a new role at Memorial Hospital, University of Colorado (UC) Health as the Manager of Breast Services. I have oversight of our NAPBC, which encompasses the American College of Radiology, Breast Imaging Center of Excellence, oncology navigation, quality, and all aspects to ensure the standards are met and maintained. The Oncology Service Line is working closely with UC Health to elevate the program to offer patient-centered superior outcome-based care. The mission of UC Health is to “Improve lives in big ways through learning, healing, and discovery. In small personal ways through human connection. But in all ways, we improve lives.” My journey has offered me many opportunities to become better acquainted with individual patient needs and to change and improve lives, one at a time. By understanding that everyone’s journey will be different, I have become aware of the importance of understanding that everyone’s walk will bring new and different circumstances to their lives. Not only is it my role to assist the patient in understanding his or her overall treatment and the potential scenarios attached, but it is to proceed with mentoring, compassion, and a sense of humanity in recognizing his or her needs to provide the best possible outcomes. I have been an oncology nurse for the past 21 years in various roles across the spectrum as a bone marrow transplant nurse, inpatient and outpatient oncology nurse, nurse manager, oncology nurse educator, and nurse navigator. Each role has expanded my knowledge and understanding of the patient and family experience. I am humbled every day that I have an opportunity to walk beside patients during their cancer journey and at times some of their most vulnerable moments. I view my role as a nurse as a privilege and a ministry.

JONS-online.com journal of Oncology Navigation & Survivorship

Quality, outcomes, and performance improvement (QOPI) committee

I am proud to say that I was one of the early members of the Academy of Oncology Nurse & Patient Navigators (AONN+) and found this national organization beneficial to collegiate collaboration and knowledge-sharing. I have been blessed in my career to have had opportunities to work alongside as well as be mentored by leaders in the oncology field by women who have been so instrumental in my developmentâ&#x20AC;&#x201D;Kathy Pearson, RN, MS, CNS, AOCN; Mary Wickman, RN, PhD; Lillie D. Shockney, RN, BS, MAS; and Elaine Sein, RN, BSN, OCN, CBCN. I have been co-chairing the Quality, Outcomes, and Performance Improvement (QOPI) Committee for the past

year and strongly believe in the importance of collaboration and knowledge-sharing to further advance navigation and build evidence to demonstrate the value of navigation and the direct link it has to improved patient outcomes. Can I encourage you to take the time to reach out to the QOPI Committee by either participating in the work that is being accomplished or taking advantage of the tools and resources this committee has put together for AONN+ members? For additional information on the QOPI committee, visit the AONN+ website (www.aonnonline.org) or contact me at Danelle.Johnston@uchealth.org. g

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ABOUT THE COVER

The Twilight Zone of Cancer Photography by a Person Diagnosed with Cancer Artwork from the Lilly Oncology On Canvas: Expressions of a Cancer Journey Art Competition www.LillyOncologyOnCanvas.com Cancer is tricky. Cancer is sneaky. Cancer is outright mean and holds the highest regard for no one. I hate cancer. Cancer caught me by surprise. One moment I was okay, the next moment I had cancer. My world quickly went from normal to bizarre. I was in the Twilight Zone. Was this really happening to me or was this a dream? I had just buried both parents due to cancer. Why was it coming after me now? Cancer distorted my mind and world for a while, but not for long. I chose to fight back. The distorted, warped, bizarre world of cancer chose the wrong victim. I cleared my mind and head, and sent cancer packing back into its own twisted world. I beat cancer twice. I survived.

June 2014 â&#x20AC;˘ Volume 5, number 3

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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 ÂŽ is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. ÂŠ 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;

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

54 26

11 5

0 Halaven 0 TPC

TIME (MONTHS)

Number of patients at risk

508 254

406 178

274 106

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.

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) Control Group (n=247) All Grades ≥ Grade 3 All Grades ≥ Grade 3 Infections and Infestations Urinary Tract Infection 10% 1% 5% 0 a 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. ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– 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

Nurse Navigation Pathway

Using a Nurse Navigation Pathway in the Timely Care of Oncology Patients Deborah Christensen, RN, BSN, HNB-BC; Cheryl Bellomo, RN, OCN, CBPN-IC Intermountain Southwest Cancer Center, St. George, UT Patients and their families facing the diagnosis of cancer can feel lost, uncertain, overwhelmed, and fearful of the healthcare system. The goal at the Intermountain Southwest Cancer Center is to provide patients and their families with a hand to hold throughout their cancer journey and to improve the delivery of oncology care. This goal has been realized by using a nurse navigation pathway that defines steps for early involvement of an oncology nurse navigator (ONN). The role of the ONN is pivotal in assessing and providing interventions that address the patient’s immediate concerns and barriers to care, addressing the knowledge deficit of diagnosis/treatment/prognosis, hastening staging workup, and enhancing the initial consultation with the oncology physicians. The preparation enhances the initial consultation between the patient and the oncologist by allowing them to focus on the treatment plan, make informed decisions, and receive treatment services in an equitable and timely manner to improve outcomes. Early oncology nurse navigation and physician collaboration demonstrate significant improvements in the timeliness of care. Notably, with patients who are seen by an ONN prior (3-day minimum) to their initial medical oncology consult, the time interval between referral to medical oncology and the initiation of treatment was reduced by 10 days. An unexpected finding was that the time spent between patients and their medical oncologist in the initial consult was reduced by 24 minutes compared with patients who had not met with the ONN prior to the consult. Establishing pathways of oncology care that involve the intervention of early oncology nurse navigation can greatly enhance care delivery. Institutions that establish oncology nurse navigation interventions at the earliest opportunity may also see similar or additional benefits.

ne word changes lives: cancer. The uncertainty surrounding a cancer diagnosis can be paralyzing, and not only to the individual receiving the diagnosis; questions and concerns also ripple through immediate and extended families. Through the assistance and emotional support of an oncology nurse navigator (ONN), uncertainty and anxiety can be alleviated. The ONN coordinates care and resources for patients with cancer throughout their oncology experience from diagnosis into survivorship. The role of the ONN is pivotal in providing patients with information and resources to empower them to make informed decisions regarding their care, identify and remove barriers to care, and assist patients in receiving treatment services in an equitable and timely manner. Through early ONN interventions, such as basic oncology education on diagnosis and treatment, coupled with explanation and scheduling of staging studies and molecular assays, patient anxiety can be diminished, and the experience of the medical oncology consult can be enhanced.1,2 Importantly, improved patient outcomes, including time to diagnosis and treatment, mobilization of financial and psychosocial support, and continuity of care, have all been associated with the involvement of an ONN at the earliest opportunity.1,3

Background

Intermountain Healthcare With 22 hospitals and more than 185 clinics, Intermountain Healthcare is a major healthcare provider throughout Utah and parts of Idaho.4 Intermountain is ranked among the nation’s finest integrated systems and is a leader in defining methods to reduce costs while providing clinical, operational, and service excellence.5 Intermountain’s answer to meeting healthcare reform is shared accountability, which is defined as “...an overarching strategy or approach, based on quality improvement, to deliver the highest quality patient care, optimize the health of those we serve, and manage costs.”6 Key components of this strategy include patient education, shared decisionmaking between providers and patients, and insurance plan benefits that reward consumers for making optimal choices based on healthcare savings.5 Intermountain Southwest Region The mission of the Intermountain Southwest Cancer Center (ICC) is aligned with Intermountain’s quest for excellence and shared accountability. Specifically, ICC provides a supportive environment for patients with cancer through the collaboration and coordination of a skilled

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Nurse Navigation Pathway

ONN. At ICC, our goal is to provide patients and their families with a hand to hold throughout their cancer journey and to improve delivery of oncology care. Modeling the patient education focus of shared accountability, new patients referred to ICC receive optimal navigation interventions, education, and resources. The ICC has 2 facilities: Dixie Regional Medical Center (DRMC) in St. George, Utah, and Valley View Medical Center (VVMC) in Cedar City, Utah. Unique to the ICC is the hospital employment of 5 medical oncologists and 2 radiation oncologists. To date, there are no oncology surgeons employed by either facility. Oncologists from DRMC travel to VVMC to provide oncology care. Statistically, average monthly new oncology patient referrals to the cancer centers are 33 and 18 at DRMC and VVMC, respectively. An ONN meets with oncology patients and families early in the illness trajectory either postoperatively or on referral from the medical or radiation oncologist.

Being diagnosed with cancer is a lifechanging event. Patients and families are plunged into uncertainty. Beginning at diagnosis, further diagnostic testing, surgery, and subsequent treatments must be accomplished. Recipients of Early Navigation

Oncology Patients and Families Being diagnosed with cancer is a life-changing event. Patients and families are plunged into uncertainty. Beginning at diagnosis, further diagnostic testing, surgery, and subsequent treatments must be accomplished. It has been shown that oncology patients benefit from early navigation and care coordination.1,2 Realized benefits include: reduced anxiety, timely care, a reduction in overusage of hospital services, and, importantly, one point of contact to assist with each patientâ&#x20AC;&#x2122;s individual needs.1,2,7 Ideally, an ONN meets with patients and families as close to diagnosis as possible. During a time when many medical decisions must be made, providing education and supportive care is vital. Informed decision-making and shared accountability does not happen without this key component. Early patient education on diagnosis, treatment options, and symptom management empowers patients with the information needed to make informed deÂ cisions regarding their care, alleviating anxiety and uncertainty surrounding their diagnosis. It also prepares patients for their initial consultation with the oncology physician and allows them to focus on the treatment plan,

June 2014 â&#x20AC;˘ Volume 5, number 3

make informed decisions, and receive treatment services in an equitable and timely manner to improve outcomes.

Oncologists and Healthcare Providers

Each ONN at ICC routinely communicates with physicians and other healthcare providers to assist in the care of patients. Formal communication by members of the navigation team occurs weekly. One-on-one communication between oncologists and the ONN happens on a daily basis. Accordingly, both healthcare providers and patients benefit through the personalized communication the ONN provides. General oncology education provided by the ONN can answer many of the initial questions that patients and families have and allows the oncologist to focus on treatment planning. Staging studies and other preliminary tests may be scheduled prior to the initial consult if there is time.

Methods

Clinic Transitions/Gap Analysis Throughout 2011, the ICC experienced major transitions in medical oncologists. Changes in staffing and a subsequent influx of referrals led to perceived gaps in care by patients and providers alike. As would be expected, a gap analysis demonstrated that timeliness from referral to an appointment with the medical oncologist had increased from 7 days to 14 days. Temporary oncologists were brought in to help address the situation as permanent oncologists were recruited and interviewed. It was a difficult time for patients and staff and required diligence on the part of the ONN staff to assist patients during this transition. The navigation team revised the care coordination pathway and developed the navigation pathway depicted in Table 1. Group consensus foresaw the navigation pathway as a fitting answer to timely interventions with patients and families. Newly diagnosed patients with breast cancer referred to ICC were selected as the first group to pilot the use of the navigation pathway. Breast Patient Pilot Program Starting in November 2011, the navigation pathway was followed for newly diagnosed patients with breast cancer referred to ICC. Schedulers contacted referred patients with breast cancer and scheduled both the medical oncology consult and an appointment with the ONN. It was explained to the patient that the ONN appointment, termed new patient education (NPE), was to assist them in preparing for their physician visit, identify and address barriers to care, and ultimately, provide education intended to reduce anxiety and uncertainty. Family members were also encouraged to attend. Basic oncology education was provided and patients were

AONNonline.org

Nurse Navigation Pathway

Table 1 Oncology Nurse Navigation Pathway Referral to medical oncology Oncology scheduler makes appointments for new patient education and medical oncology consult.

Care coordination

New patient education

Navigator and medical oncologists meet weekly and one-onone as needed to discuss patient cases and order staging studies, molecular profiling, and other tests as needed.

Navigator meets with patient and family to discuss oncology basics, staging studies, and resources. Barriers to care are identified and addressed.

Medical oncology consult

Active treatment begins

Active treatment complete

Survivorship and surveillance

Oncology scheduler makes appointment for chemotherapy education with the patient, family, and navigator prior to first day of treatment.

Navigator meets with patient and family members as needed during treatment and provides brief visits through rounds in the chemotherapy room.

Oncology scheduler makes an appointment for end-oftreatment visits with the navigator. Treatment summary and care plan are reviewed. Referrals to cancer rehab and other services as needed.

Navigator encourages and facilitates support group. Also contacts patient at 3and 6-month intervals and yearly thereafter.

assessed for their understanding of treatment options and feelings about these treatments. Any tests ordered by the physician were also explained and scheduled. Molecular testing and education were initiated for eligible patients so that the results would be available at the initial medical oncology consult. Patients with breast cancer were also given the new patient paperwork to complete at home and a brief tour of the cancer center. Referral to a financial counselor and/or licensed clinical social worker (LCSW) was also provided when needed. Patients were referred to the LCSW if they met 2 of the following criteria: advanced-stage cancer, age 50 years or younger, history of depression or anxiety disorder, weak social support, or if there were children under age 18 years in the home. The conditions were based on items from the National Comprehensive Cancer Network (NCCN) Distress Thermometer and an abbreviated version of the Brief Systems Inventory (BSI-18). Both of these tools have been validated for use in the inpatient and outpatient oncology setting.2,8,9 During November 2011 through May 2012, a total of 29 patients with breast cancer were navigated using the navigation pathway. All of the patients and their caregivers were given the opportunity to ask questions and receive information on staging and treatments for their cancer type. Molecular studies were requested for 7 patients, 12 patients needed additional lab tests, and 7 patients were set up with a financial counselor (Figure 1, on page 16). Previsit paperwork was given to 28 of the patients, and 20 patients took advantage of a short tour of the infusion area and an explanation of where to present for their appointment. The ONN also used this visit to identify barriers to

Transition care Navigator assists with palliative care, hospice, and end-of-life education, resources, and support.

care such as transportation, lodging, emotional concerns, and financial hardship. Survivorship and support groups were also introduced and encouraged. Although a formal survey was not done with this pilot group, patients and families expressed feeling more prepared for their visits. They also expressed that wait times to initial contact with the ONN were reduced and timely care was initiated. Notably, the pathway did not establish a process for the ONN to meet with patients prior to being referred to medical oncology. Therefore, patients with breast cancer who were navigated prior to the medical oncology referral were not included in the data set. Navigation Pathway Extended By November 2012, the shortage of medical oncologists at ICC was resolved. The cancer center now employed 4 fulltime medical oncologists. Consequently, the time lapse from referral to medical oncologist returned to a baseline of 7 business days. Irrespective of these resolutions, the use of the navigation pathway was extended to new patients with all solid tumor types at the initiation of referral to ICC. Patients, families, and the navigation team expressed their perception of improved care delivery and support through the use of the navigation pathway. This alone influenced the decision to extend the use of the pathway. A database was set up to capture the metrics associated with the use of the pathway when navigating solid tumor oncology patients within the ICC. Barriers to Early Navigation It is important to note that despite earnest effort, not all

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Nurse Navigation Pathway

patients will receive or are open to the NPE meeting with the ONN. This is a critical component of the navigation pathway because it is from this visit that the time reductions have been appreciated. Barriers to early nurse navigation include the immediate need of a patient to be seen by medical oncology, lack of appointment availability, and patient reluctance to attend an additional appointment. Efforts made to alleviate appointment-related barriers include having the ONN meet with the patient on the same day as the initial consult and hiring an additional ONN.

Figure 1 Breast Cancer Patient Early Interventions 30

Patients, N

20 15

12 9

1 0

Education

Labs

Genetic MUGA counseling scan

Molecular studies

PET scan

Paperwork

Tour

Financial assistance

Navigation interventions (N = 29)

Figure 2 T ime Reductions Realized from Using the Navigation Pathway

40 35

Prenavigation pathway Postnavigation pathway

Time in days

25 20 15

5 0

35 30

Referral to navigation

Prenavigation pathway Postnavigation pathway

Time in days

Stages l-lV (N = 129)

Referral to treatment

Stages lll-lV (N = 62) 30 23

15 10 5

0 Referral to navigation

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Referral to treatment

Results

Data analysis demonstrated that when patients were navigated via the navigation pathway and attended the NPE, overall care delivery was expedited (Figures 2 and 3). The time span between oncology referral to the start of treatment was reduced by 7 days in advanced-stage patients with cancer (stages III-IV) and 10 days in patients with stages I-IV solid tumor types compared with patients who were not navigated using the steps of the navigation pathway. Scheduling patients for the NPE at the earliest possible appointment reduced the time between oncology referral and face-to-face navigation contact by 7 days and 11 days, respectively. Medical oncologists perceived a time reduction in the amount of time needed to complete a new patient consult if the patient had met with the ONN prior to the initial consult. Billing charges and new consult time values were collected for analysis on 149 patients that were seen by 1 of 4 medical oncologists between September 2012 and June 2013 (Figure 3). Variation in the consult times between oncologists was expected due to each oncologistâ&#x20AC;&#x2122;s years of experience in oncology and communication styles. Despite these variations, a combined group analysis demonstrated that, on average, the time needed to complete a new patient consult was reduced by 24 minutes when patients attended the NPE prior to the initial consult. This reduction in time may be a result of patients having immediate barriers to care addressed and resolution initiated prior to meeting with the oncologist, which may have led to improved patient and physician preparation, enhanced shared decision-making, and the ability to expedite treatment. As a result, the oncologists at ICC have requested that qualifying patients meet with the ONN a minimum of 3 days prior to the medical oncology consult. Interventions deemed critical to the success of timely treatment and seamless transitions for the patient were also tracked. The ONN referenced the NCCN guidelines and facilitated a total of 33 staging studies on the appropriate patients. The studies were ordered by the medical oncologist or the referring physician and completed prior to the

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Nurse Navigation Pathway

Theoretically, a medical oncologist could see an additional patient each day due to the time reduction associated with the navigation visit. In addition to a hand to hold, the goal of the ONN is to empower the patient with a voice in his or her healthcare decisions. One of Intermountain Healthcareâ&#x20AC;&#x2122;s board goals for 2011 was for 25% of patients to have advance directives completed and scanned into their electronic medical records (EMRs); this initiative was extended through 2013 with the new goal being 75% completion.10 Addressing the call for advance directives was also part of the NPE. To illustrate, less than 10% of the 60 patients included in this data set had advance directives in their EMRs, but as a result of having the conversation with patients regarding their desires for immediate treatment throughout their lifetime, 52 of the 60 patients were given advance directive packets. Cost-Benefit Analysis Prior to the navigation pathway, new patient consults were scheduled for 80 minutes. As shown in a cost-benefit analysis (Table 2), new patient consults were scheduled for 60 minutes if the patient was scheduled for the NPE with the ONN. Theoretically, a medical oncologist could see an additional patient each day due to the time reduction associated with the navigation visit. More important, however, is the early establishment of the ONN/patient relationship because when the ONN is involved early in the patientâ&#x20AC;&#x2122;s care, a patient reports greater satisfaction and less anxiety overall.2,3 The cost-benefit analysis was also used to demonstrate the

Figure 3 Initial ConsultaTime Reduction in Patients That Attended NPE Consult time with NPE Consult time without NPE Time reduction in minutes

All

Medical oncologist

initial medical oncology consult. Financial hardships were identified in 15 patients and financial counselors or the ONN assisted these patients with the forms and instruction necessary to begin the financial assistance process. Addressing the financial concerns of patients and families at the earliest opportunity enabled patients to make decisions concerning their care with less financial barriers influencing their choices. In addition, molecular tests were facilitated for 7 patients and 36 referrals were made for other members of the multidisciplinary team, including lymphedema management, nutritionist, LCSW, and physical therapy. All 60 patients received basic oncology education that answered questions such as: What is cancer? How is it treated? What can I expect regarding testing and appointments? Moreover, the ONN addressed cancer treatment goals, tips on how to communicate with physicians, and specific patient needs and concerns.

96 18

88 19 89 37 106 42

#1 0

120 80

100 110 120

Time in minutes NPE indicates new patient education scheduled with ONN prior to medical oncology consult.

Table 2 Cost-Benefit Analysis New patient consult (NPC) metrics

Prenavigation pathway

Postnavigation pathway

Time in minutes

Per clinic day

Cost per consult

$408

$270

Total cost per day

$4896

$3240

Number of clinic days per year Total NPC cost per year Total cost-savings per year

192

$940,032

$662,080 $277,952

Additional revenue potential

$207,360

Total cost-savings + revenue potential

$485,312

Additional revenue by seeing 1 new patient per day per 4 oncologists.

cost-savings to the clinic that may be realized when patients have received education through the NPE meeting. Coupled with the metrics in Figure 2, these data were used to promote the need for an additional ONN, which, subsequently, was successful. Consequently, the program was extended again to include hematologic patients with cancer. Data on patients who have been navigated by using the navigation pathway continue to be collected. These are examples of how data can justify the expansion of ONN positions as well as define the role of the ONN nationwide.

JONS-online.com journal of Oncology Navigation & Survivorship

Nurse Navigation Pathway

Limitations and Future Direction The initial results of the benefits of using the navigation pathway to establish early ONN contact for education and addressing barriers to care appears promising. However, several limitations of the study have been identified. The sample size was not optimal and the study was limited to 1 institution. Furthermore, patient demographic information was not collected and analyzed. Therefore, it is not known if the study population is a true representation of the ICC oncology patients benefiting from early navigation. Stratifying results by using patient demographics, including age, diagnosis, socioeconomic status, and culture, may have identified consequential variances in statistical results. To improve further study results, patient demographics, including, age, gender, and diagnosis, are now being collected in a dedicated database designed specifically to capture ONN interventions and outcomes. The results of patients’ perceptions of distress pre- and postnavigation would have been useful in verifying study results. To that end, a patient satisfaction survey and results from using the NCCN Distress Thermometer will be used in the coming year to help qualify patient’s perception of distress and the benefits of the NPE and early intervention and support by the ONN.

Conclusion

With a diagnosis of cancer, patients and their families need assistance, resources, emotional support, and a hand to hold during a time filled with uncertainty, fear, and anxiety. The interventions of an ONN in identifying and addressing barriers, providing education and resources, and giving emotional support can assist in alleviating patients’ fear and anxiety, as well as helping to empower them to make informed decisions regarding their care. Statistical outcomes have demonstrated that at ICC, early ONN interventions led to reductions in time from referral to medical oncology and the initiation of treatment. In addition, patients that were educated on the basics of oncology treatments, staging studies, molecular profiling, and patient- specific resources were better prepared for their initial

medical oncology consult and were able to focus on treatment plans, resulting in less time needed to thoroughly complete the initial consult. Further research into pathway and process design is needed within each institution to continue to gather best practice evidence and to extend the ONN role and benefits of early oncology nurse navigation in the care of oncology patients. g Author Disclosure Statement: Ms Christensen reports receiving honorarium from Millennium Pharmaceutical and Celgene Pharmaceutical. Ms Bellomo has nothing to disclose. Corresponding Author: Deborah Christensen, RN, BSN, HNB-BC, Intermountain Southwest Cancer Center, 1155 W. Bloomington Drive South, St. George, UT 84790. E-mail: deborah.christensen@imail.org.

References

1. Case M. Oncology nurse navigator: ensuring safe passage. Clin J Oncol Nurs. 2011;15(1):33-40. 2. Swanson J, Koch L. The role of the oncology nurse navigator in distress management of adult inpatients with cancer. Oncol Nurs Forum. 2010;37(1): 69-76. 3. Campbell C, Craig J, Eggert J, Bailey-Dorton C. Implementing and measuring the impact of patient navigation at a comprehensive community cancer center. Oncol Nurs Forum. 2010;37(1):61-68. 4. Intermountain Healthcare. Awards and recognition website. http://inter mountainhealthcare.org/about/overview/awards/Pages/home.aspx. Updated 2013. Accessed October 28, 2013. 5. Intermountain Healthcare. Shared accountability strategy website. http:// intermountainhealthcare.org/about/overview/trustees/fortrustees/shared accountability/Pages/strategy.aspx. Updated 2013. Accessed October. 28, 2013. 6. American Nurses Association. The value of nursing care coordination (white paper). American Nurses Association; 2012:1-24. www.nursingworld. org/carecoordinationwhitepaper. Accessed August 18, 2013. 7. Fulcher C, Gosselin-Acomb TK. Distress assessment: practice change through guideline implementation. Clin J Oncol Nurs. 2007;11(6):817-821. 8. Jacobson P, Donovan K, Trask P, et al. Screening for psychological distress in ambulatory cancer patients. Cancer. 2005;103(7):1492-1502. 9. Merport A, Bober S, Grose A, Recklitis C. Can the distress thermometer (DT) identify significant psychological distress in long term cancer survivors? Support Care Cancer. 2012;20(1):195-198. 10. Intermountain Healthcare. Cancer services at Intermountain facilities website. http://intermountainhealthcare.org/services/cancer/centers/Pages/ home.aspx#Intermountain. Updated 2013. Accessed October 23, 2013.

2014 SAVE WORLD THE CUTANEOUS DATE MALIGNANCIES CONGRESS THIRD ANNUAL

™

June 2014 • Volume 5, number 3

October 29-31, 2014

Marriott Marquis San Francisco, California CONFERENCE CHAIR SANJIV S. AGARWALA, MD Professor of Medicine Temple University School of Medicine Chief, Medical Oncology & Hematology St. Luke’s Cancer Center Bethlehem, Pennsylvania

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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.

S:7”

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.

treatment among african american women

Agreement Between Patient Self-Report and an Objective Measure of Treatment Among African American Women with Breast Cancer Sue P. Heiney, PhD, RN, FAAN1; Swann Arp Adams, PhD1-3; Leepao Khang, PhD 2,3 1 College of Nursing, University of South Carolina; 2Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina; 3Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina Background: Only a limited amount of research is focused on African American women with breast cancer and treatment adherence (TA). One potential barrier to TA may be a lack of knowledge and understanding of benefits for the therapies that they receive. To further explore this hypothesis, we examined participants’ recall of their receipt of chemotherapy, radiation, or hormone therapy in comparison to cancer registry data among African American women with breast cancer. Methods: We compared patient self-report in a sample of 108 African American women with breast cancer with cancer registry data. Univariate conditional logistic regression was used to calculate the odds ratio of discordance for chemotherapy, radiation, and hormone therapy. Results: There was a high degree of agreement for chemotherapy (95.4%). For radiation, agreement was slightly lower at 83%. For hormone therapy, 72% of the patients were concordant and 28% were discordant. For all covariates, only intervention assignment predicted discordance for radiation therapy at an alpha level of 0.05. The most intriguing finding was the level of discordance between treatment reported in the medical record and treatment reported by the patient. Conclusion: An important area for future investigations is the relationship between patient education, patient understanding, group support, and TA in African American women with breast cancer. Our findings and future work will provide a foundation for the development of interventions to improve TA.

reatment nonadherence is associated with increased mortality in women with breast cancer.1-11 It may also partially explain significantly higher mortality in African American women with breast cancer than in white women.12-14 Little data are available that describe treatment adherence (TA) in African American women with breast cancer.12,15 A few studies have focused on TA to radiation therapy or parenteral chemotherapy in African American women with breast cancer,16 although most have examined TA to adjunctive hormonal therapy or oral antineoplastic chemotherapy.15,17-23 Results from these studies have estimated that the proportion of nonadherence ranged between 9% and 46% with only 5.6% to 41% representation of African American women with breast cancer.15,17-23 Only 2 studies were identified that examined oncologic patient factors and adherence.22,23 Kahn and colleagues found that involvement in decision-making and support from healthcare providers positively influenced TA.22 One factor that may negatively impact TA of patients is the lack of understanding of their treatment as measured by accurate treatment recall. In a very small French

sample, participants reported a lack of accurate knowledge about the side effects associated with tamoxifen, and the importance of support from healthcare providers in managing side effects.23 Patients’ awareness of and understanding about treatment is an important factor in TA. Neither of these studies examined African American women specifically. The purpose of this investigation was to examine the participants’ recall of receiving chemotherapy, radiation, or hormone therapy compared with data from a cancer registry abstracted from medical records in a large sample of African American women in breast cancer. We were also interested in determining the agreement between patient self-report and tumor registry data to provide beginning evidence of patient knowledge about their treatment in an understudied population.

Methods

Design We conducted a retrospective cohort study, with a secondary data analysis of self-reported treatment data compared with data obtained from the tumor registry. The parent

JONS-online.com journal of Oncology Navigation & Survivorship

treatment among african american women

study, Sisters Tell Others and Revive Yourself (STORY), was a randomized trial comparing the effectiveness of a therapeutic group via teleconference of African American women with breast cancer with usual psychosocial care.24 The STORY study was approved by the Institutional Review Board. Patients signed informed consents and research authorizations giving the study team permission to access their medical information. Data were collected from all participants at baseline, 8 weeks, and 16 weeks. Medical and psychosocial data were collected.

The study evaluated the effects of the teleconference group intervention on social connection and identified mediators and moderators of the intervention. Inclusion/exclusion criteria and recruitment have been described elsewhere and included African American women who had been diagnosed with invasive breast cancer in the previous 6 months and opted for lumpectomy treatment.24,25 The study evaluated the effects of the teleconference group intervention on social connection and identified mediators and moderators of the intervention. Eight weekly 90-minute teleconference sessions were conducted with women randomized to the intervention arm. Knowledge, fear, isolation, and fatalism were also evaluated. Population The population for this analysis only included a subset of participants in the original STORY study. Although the STORY study recruited patients across the state of South Carolina, we included only those patients whose data were abstracted by the tumor registry of a local hospital system. This was largely due to this hospital having an established in-house registry and the largest proportion of study participants were from this hospital system. Data Collection Data for this investigation were obtained from 3 items on the patient treatment information form. At baseline, patients were asked, “Are you taking any cancer treatment now, yes or no?”, and “If yes, what kind of treatment - radiation and/or chemotherapy?” The third item assessed hormone therapy asking, “Please mark any drug you are taking - goserelin acetate, letrozole, toremifene citrate, anastrozole, fulvertrant” (generic name and trade name were both listed). At time points 2 and 3, patients were asked, “Mark any treatment that you are currently taking - radiation,

June 2014 • Volume 5, number 3

chemotherapy.” Hormone treatment was assessed using the same question as baseline. Registry treatment data were obtained by linking the participants of the STORY study with breast cancer cases diagnosed at the local hospital system. This was performed using several patient identifiers, including address, birth date, and social security number when available. There were 185 patients with demographics and time-point assessments; however, only 113 cases were abstracted from the hospital system cancer registry that matched our data set. Four patients were excluded because of missing treatment data and 1 patient was not treated for cancer, which left 108 patients for our analysis. Treatment data captured within the local hospital cancer registry represent a quality-controlled data element for the central cancer registry. All data were obtained from primary sources such as the hospital’s electronic or paper medical record. As the central cancer registry has extensive quality-control measures and protocols to ensure accurate and timely data, we considered this source an objective (“gold-standard”) measure of their treatment. Outcome Variables We had 3 outcome variables: agreements between patient report and medical record data for chemotherapy, radiation, and hormone therapy. The agreements were coded as “concordant” or “discordant” for each of the 3 types of treatments. We calculated whether patients’ self-reported treatment agreed with the hospital system tumor registry data by creating a series of algorithms in SAS version 9.3 software (SAS Institute; Cary, NC). Patients were classified as concordant to chemotherapy if they had a record in the hospital system tumor registry and they indicated “yes” that they were taking chemotherapy in any of the time-point assessments. They were also classified as concordant to chemotherapy if they had no record in the hospital system tumor registry and they indicated “no” that they were taking chemotherapy in all of the time-point assessments. Radiation treatment agreements were calculated using the same methods as chemotherapy agreements. Patients were classified as concordant to hormone therapy if they had a record in the hospital system tumor registry and they indicated that they were taking any of the previously reported drugs at any of the time-point assessments. Patients were classified as discordant to chemotherapy if they had a record in the hospital system tumor registry and they indicated “no” that they were taking chemotherapy in all of the time-point assessments or they indicated “yes” on any time-point assessments and had no record in the tumor registry. Disagreement for radiation and hormone therapy treat-

AONNonline.org

treatment among african american women

Table 1 Characteristics of Study Population by Treatment Type,a N = 108 Chemotherapy Variable Age, yrs n (mean ± SD)

N (%)

Radiation

Hormone therapy

Concordant, Discordant, Concordant, Discordant, Concordant, Discordant, n (%) n (%) P valueb n (%) n (%) P valuec n (%) n (%) P valued

108 103 5 (56.2±11.1) (56.6±11.1) (48.2±8.5)

.89

90 18 (57.1±11.3) (51.8±8.9)

.06

78 30 (57.0±11.0) (54.3±11.3)

.26

Education Less than high school

17 (15.7)

17 (16.5)

–

High school

34 (31.5)

34 (33.0)

Some college

35 (32.4)

4 yrs or above

22 (20.4)

Partnered or married Neither partnered nor married

.17

14 (15.6)

3 (16.7)

–

29 (32.2)

32 (31.1)

3 (60)

20 (19.4)

2 (40)

85 (78.7)

81 (78.6)

4 (80)

23 (21.3)

22 (21.4)

1 (20)

15 (16.5)

15 (17.4)

–

.84

13 (16.7)

4 (13.3)

5 (27.8)

25 (32.1)

9 (30)

30 (33.3)

5 (27.8)

23 (29.5)

12 (40)

17 (18.9)

5 (27.8)

17 (21.8)

5 (22.7)

70 (77.8)

15 (83.3)

62 (79.5)

23 (76.7)

20 (22.2)

3 (16.7)

16 (20.5)

7 (23.3)

13 (17.1)

2 (13.3)

11 (16.7)

4 (16)

.79

Marital status .71

.76

.75

Income <$10,000

.02

.74

$10K - $19,999

20 (22.0)

20 (23.3)

–

17 (22.4)

3 (20)

14 (21.2)

6 (24)

$20K - $29,999

15 (16.5)

15 (17.4)

–

14 (18.4)

1 (6.7)

10 (15.2)

5 (20)

$30K - $39,999

11 (12.1)

8 (9.3)

3 (60)

9 (11.8)

2 (13.3)

9 (13.6)

2 (8)

$40K - $49,999

14 (15.4)

13 (15.1)

1 (20)

10 (13.2)

4 (26.7)

9 (13.6)

5 (20)

$50K+

16 (17.6)

15 (17.4)

1 (20)

13 (17.1)

3 (20)

13 (19.7)

3 (12)

.88

Comorbidity 0

17 (15.7)

15 (14.6)

2 (40)

14 (15.6)

3 (16.7)

14 (18)

3 (10)

19 (17.6)

18 (17.5)

1 (20)

.08

12 (13.3)

7 (38.9)

.09

14 (18)

5 (16.7)

26 (24.1)

24 (23.3)

2 (40)

23 (25.6)

3 (16.7)

21 (26.9)

5 (16.7)

46 (42.6)

46 (44.7)

0 (0)

41 (45.6)

5 (27.8)

29 (37.2)

17 (56.7)

Usual

58 (53.7)

55 (53.4)

3 (60)

44 (48.9)

14 (77.8)

41 (52.6)

17 (56.7)

Therapeutic

50 (46.3)

48 (46.6)

2 (40)

.29

Intervention status .77

.03

.70

46 (51.1)

4 (22.2)

37 (47.4)

13 (43.3)

Resource use n (mean ± SD)

108 103 (11.2±4.4) (11.2±4.4)

5 (10.3±2.9)

.52

90 (10.9±4.2)

18 (12.6±5.1)

.18

78 (11.3±4.7)

30 (10.9±4.5)

.72

Religious n (mean ± SD)

108 103 (33.6±4.5) (33.5±4.5)

5 (36.6±2.4)

.14

90 (33.5±4.6)

18 (34.2±4.2)

.60

78 (33.8±4.7)

30 (33.2±4.0)

.55

Fatalism n (mean ± SD)

108 (3.6±1.9)

5 (3.2±1.9)

.61

90 (3.7±1.9)

18 (3.2±2.0)

.27

78 (3.6±1.9)

30 (3.6±1.9)

.92

103 (3.6±1.9)

Cancer knowledge 108 103 5 n (mean ± SD) (68.4±14.3) (68.1±14.4) (72.9±13.5)

.47

90 18 (67.8±13.7) (71.2±17.2)

.35

78 30 (67.7±14.1) (70.0±15.2)

.46

Missing values were excluded. Comparison of chemotherapy adherence to chemotherapy nonadherence groups. c Comparison of radiation adherence to radiation nonadherence groups. d Comparison of hormone adherence to hormone nonadherence groups. SD indicates standard deviation. a

ments were calculated using the same algorithms as chemotherapy disagreements. We also compared the date obtained from the hospital tumor registry with the time-point assessments to make sure the treatment date from the

hospital preceded the time-point assessments. If the hospital date was after the time-point assessments, then we coded the hospital record as having no treatments (at the time that the patient completed the assessment form).

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treatment among african american women

Table 2 Agreement Between Recall and Medical Record by Treatment Type, N = 108 n (%)

κ (95% CI)

P value

Concordant

103 (95.4)

0.90 (0.82-0.99)

.18

Discordant

5 (4.6)

Treatment

Description of discordant pairs

n (%)

Medical Record - Yes/Self-Report - No

1 (20)

Medical Record - No/Self-Report - Yes

4 (80)

Chemotherapy

Radiation Concordant

90 (83.3)

Discordant

18 (16.7)

0.46 (0.26-0.66)

<.01 Medical Record - Yes/Self-Report - No

2 (11.1)

Medical Record - No/Self-Report - Yes

16 (88.9)

Medical Record - Yes/Self-Report - No

12 (40)

Medical Record - No/Self-Report - Yes

18 (60)

Hormone therapy Concordant

78 (72.2)

Discordant

30 (27.8)

0.44 (0.28-0.61)

.27

CI indicates confidence interval.

Study Covariates Due to the small sample size in some of the variables, we categorized majorities of the covariates into dichotomous variables. Age at diagnosis was categorized into “<50” and “>50” years. Education was divided into 2 groups: “<high school” and “>high school.” Relational support was categorized as “partnered or married” and “neither partnered nor married.” Income was categorized into “<$30,000” and “>$30,000.” We categorized comorbidity into “0-2” and “3+.” Resource use evaluation, religiousness, fatalism, and cancer knowledge scores were computed using questionnaires. The scale and computation of the score have been reported previously. For resource use evaluation, religiousness, fatalism, and cancer knowledge, a higher summed score indicated a greater level of the relevant factor. Analysis Frequencies of patients’ characteristics were calculated for each of the treatment methods and by agreements. Two-sided Pearson chi-square, t test, and Fisher exact test were computed (where appropriate) to assess for differences between agreements for each treatment type and covariates. Kappa statistics were calculated among concordant and discordant pairs for each type of treatment. Univariate conditional logistic regression was used to calculate the odds ratio of discordance for chemotherapy, radiation, and hormone therapy. Resource use evaluation, religiousness, fatalism, and cancer knowledge were modeled as continuous variables. All analyses were conducted using SAS and an alpha level of 0.05 was used to determine the significance of all tests.

Results

A total of 108 patients were included in this analysis.

June 2014 • Volume 5, number 3

The mean age of the patients was 56 years (standard deviation, 11; range, 34-81). The majority (84%) of the patients had at least a high school education or above, approximately 79% were partnered or married, and 43% had 3 or more comorbidities. Table 1 (page 23) presents other characteristics by treatment types and agreements (concordant/discordant). We observed that those individuals who did not accurately recall their chemotherapy treatment were more likely to have a higher income than those who accurately recalled their chemotherapy treatment.

Patients who were assigned to the usual treatment group were 3.66 times more likely to disagree with their medical record report of radiation treatment compared with patients who were assigned to the intervention arm. Table 2 displays the degree of agreement between self-report and registry data for chemotherapy, radiation, and hormone therapy treatments. Similar to a correlation coefficient, kappa measures the degree of agreement on a scale of 0 to 1 (0 represents no agreement; 1 represents perfect agreement). Because we were interested not only in the degree of agreement, but also the type of recall (patient recalling treatment when there was none documented in the registry versus patient not recalling treatment when documented in the registry), we provided a description for those patients where disagreement was documented. There

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treatment among african american women

Table 3 Univariate Conditional Logistic Regression for Discordance by Treatment Type Chemotherapya D, n

C, n

<50

1.00 (Referent)

50+

High school or less

More than high school

Radiation P value

D, n

C, n

1.00 (Referent)

0.21 (0.03-1.35)

.10

0.36 (0.06-2.31)

.28

1.00 (Referent)

Partnered or married

1.00 (Referent)

Neither partnered nor married

0.92 (0.10-8.66)

<$30,000

0.56 (0.09-3.53)

$30,000+

1.00 (Referent)

0-2

1.00 (Referent)

0.31 (0.05-1.97)

.22

1.31 (0.21-8.17)

Characteristics

Odds ratio (95% CI)

Hormone therapy P value

D, n

C, n

Odds ratio (95% CI)

1.00 (Referent)

0.48 (0.17-1.39)

.18

0.95 (0.37-2.47)

.91

0.87 (0.32-2.42)

.80

0.81 (0.35-1.88)

.62

1.00 (Referent)

.94

0.70 (0.18-2.66)

.60

1.18 (0.43-3.23)

.75

.54

0.55 (0.20-1.53)

.25

1.32 (0.55-3.19)

.54

1.00 (Referent)

0.46 (0.15-1.40)

.17

2.21 (0.94-5.20)

.07

.77

44 3.66 (1.12-11.97)

.03

1.18 (0.51-2.76)

.70

P value

Age, yrs

Education

Marital status

Income

Comorbidity

Intervention status Usual Therapeutic

1.00 (Referent)

Resource useb

103

0.91 (0.73-1.13)

.38

1.10 (0.99-1.21)

.09

0.99 (0.90-1.08)

.79

Religious

103

1.28 (0.92-1.79)

.14

1.03 (0.92-1.16)

.60

0.97 (0.89-1.07)

.55

Fatalism

103

0.89 (0.58-1.39)

.61

0.87 (0.68-1.12)

.27

0.99 (0.80-1.23)

.92

Cancer knowledge

103

1.03 (0.96-1.10)

.47

1.02 (0.98-1.06)

.35

1.01 (0.98-1.04)

.46

Education was broken down into “high school or less” and “more than high school”; income was categorized into “<$30,000” and “>$30,000”; and comorbidity was categorized into “0-2” and “3+.” b Continuous scale–Resource use: range 0-28, higher score = higher support resource; Religious: range 0-40, higher score = more religious; Fatalism: range 0-11, higher score = higher the fatalism; Cancer knowledge: range 0-100%, higher percentage = higher cancer knowledge. C indicates concordant; CI, confidence interval; D, discordant. a

was a high degree of agreement for chemotherapy (95.4%, κ = 0.90). For radiation, agreement was slightly lower at 83% (κ = 0.46). For hormone therapy, 72% of the patients were concordant and 28% were discordant (κ = 0.44). To further examine the direction of the discordance, we compared the report from each source (Table 2). Predictors of discordance (between self-report and the medical record) in univariate logistic regression models appear in Table 3. The intervention assignment was the only statistically significant variable predicting discordance for radiation therapy at the 0.05 alpha level. Patients who were assigned to the usual treatment group were 3.66 times more likely to disagree with their medical record report of radiation treatment compared with patients who were as-

signed to the intervention arm. Because there were relatively small numbers available to explore our hypothesis, a more relaxed statistical significance criterion of .10 was used to evaluate potential predictors of disagreement. At the 0.10 alpha level, those who were older than 50 years were more likely to be in agreement with their medical record report of chemotherapy compared with patients younger than 50 years. In addition, a higher evaluation of resources used was a significant predictor for discordance for radiation therapy, and a greater number of comorbidities were a significant predictor for discordance for hormone therapy.

Discussion

The purpose of this study was to examine the participants’

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treatment among african american women

recall of receiving chemotherapy, radiation, or hormone therapy compared with cancer registry data among a sample of African American women with breast cancer. We sought to determine the agreement between patient report and medical record data as it would provide evidence of patient knowledge about their treatment in an understudied population. Conceptually, we would expect that patient knowledge or perception of treatment would be inherently linked with their TA. We found evidence for discordance between women’s self-report of their cancer treatment and the medical record. More importantly, there was a larger frequency than expected of women who did not self-report a treatment that was found in the medical record.

To our knowledge, this is one of the first studies of its kind to examine self-reported cancer treatment among a rural, African American population. It is not surprising to us that women’s recall of hormonal therapy may have more discordance than other treatment modalities because oral treatment could be confused with medications for symptom management or comorbid conditions. These findings are similar to data in the literature for other populations of breast cancer survivors.5,9,15,21 We were surprised to observe that more deliberate and obvious treatments such as chemotherapy and radiation therapy also were not recalled by women for whom the hospital registry did report the treatment. Given that the literature has documented significant nonadherence in African American populations for radiation therapy,26 this may provide some indirect insights into African American breast cancer survivor perceptions of their treatment. This provides indirect evidence of the need of intervention to increase patient knowledge of their treatment modality. One of the limitations of the research was that we were unable to determine whether discordance in the direction of a reported “yes” by a patient and not captured in the hospital registry was because of the patient’s inaccurate recall or a product of the patient choosing to receive treatment at an external facility. However, because of the unique and limited nature of the local environment for cancer care (only 1 major treatment center), the hospital registry was able to capture complete treatment information on virtually all of the diagnosed patients (personal communication). Therefore, there may be a small number of patients who received treatment at another external facility, which was not captured in the hospital registry. This phenomenon would not have any impact on our findings

June 2014 • Volume 5, number 3

where patients did not report on therapies that they had been documented as receiving. In addition, we most likely did not have sufficient power to observe all possible relationships for predictors of discordance. Nevertheless, this would have no effect on the significant factors that were observed even with our limited power. Our study also has several strengths. To our knowledge, this is one of the first studies of its kind to examine self- reported cancer treatment among a rural, African American population. Further research into treatment self-report and adherence has significant implications for decreasing breast cancer mortality disparities in African American women. In addition, we were able to conduct our study within a unique environment in which cancer care was limited to a single provider or medical home that reported to the hospital cancer registry. This study also capitalizes on the linkage of 2 separate data sources: self-report and a hospital tumor registry.

Conclusion

Our findings point to further research avenues, which could prove influential in eliminating cancer disparities. Specifically, our results on the influence of age and comorbidity identify specific populations of women who may have inadequate knowledge of their treatment. We were encouraged that the psychosocial intervention from the parent study, which indicated an improvement of social connection among participants, also appeared to significantly improve patient recall/knowledge of their treatment. We hypothesize that the “story sharing” during the intervention sessions functioned to increase patient understanding of their treatment modality. More research is warranted to investigate the relationship between patient knowledge and TA using electronic medical records as a comparison source for the agreement analyses. g

Acknowledgments

Funding Source: Funding support was provided by the National Cancer Institute, award number R01CA107305, and supported by the Centers for Disease Control and Prevention, Cooperative Agreement Number U48DP001936. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health or the Centers for Disease Control and Prevention. Author Disclosure Statement: All authors have nothing to disclose. Corresponding Author: Sue P. Heiney, PhD, RN, FAAN, 1601 Greene Street, College of Nursing, University of South Carolina, Columbia, SC 29208. E-mail: heineys@ mailbox.sc.edu.

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treatment among african american women

At the time a portion of this research was conducted, Heiney was employed as Manager, Psychosocial Oncology at Palmetto Health Cancer Centers in Columbia, SC.

References

1. Hershman DL, Shao T, Kushi LH, et al. Early discontinuation and non-adherence to adjuvant hormonal therapy are associated with increased mortality in women with breast cancer. Breast Cancer Res Treat. 2011;126(2):529-537. 2. Murphy CC, Bartholomew LK, Carpentier MY, Bluethmann SM, Vernon SW. Adherence to adjuvant hormonal therapy among breast cancer survivors in clinical practice: a systematic review. Breast Cancer Res Treat. 2012;134(2): 459-478. 3. Sedjo RL, Devine S. Predictors of non-adherence to aromatase inhibitors among commercially insured women with breast cancer. Breast Cancer Res Treat. 2011;125(1):191-200. 4. Doggrell SA. Adherence to oral endocrine treatments in women with breast cancer: can it be improved? Breast Cancer Res Treat. 2011;129(2):299-308. 5. Verma S, Madarnas Y, Sehdev S, Martin G, Bajcar J. Patient adherence to aromatase inhibitor treatment in the adjuvant setting. Curr Oncol. 2011;18 (Suppl 1):S3-S9. 6. Sheppard VB, Adams IF, Lamdan R, Taylor KL. The role of patient-provider communication for black women making decisions about breast cancer treatment. Psychooncology. 2011;20(12):1309-1316. 7. Andic F, Godette K, O’Regan R, et al. Treatment adherence and outcome in women with inflammatory breast cancer: does race matter? Cancer. 2011; 117(24):5485-5492. 8. Nekhlyudov L, Li L, Ross-Degnan D, Wagner AK. Five-year patterns of adjuvant hormonal therapy use, persistence, and adherence among insured women with early-stage breast cancer. Breast Cancer Res Treat. 2011;130(2): 681-689. 9. Albert US, Zemlin C, Hadji P, et al. The impact of breast care nurses on patients’ satisfaction, understanding of the disease, and adherence to adjuvant endocrine therapy. Breast Care (Basel). 2011;6(3):221-226. 10. Sharma C, Harris L, Haffty BG, Yang Q, Moran MS. Does compliance with radiation therapy differ in African-American patients with early-stage breast cancer? Breast J. 2010;16(2):193-196. 11. Simons S, Ringsdorf S, Braun M, et al. Enhancing adherence to capeci tabine chemotherapy by means of multidisciplinary pharmaceutical care. Support Care Cancer. 2010;19(7):1009-1018. 12. Hershman DL, Unger JM, Barlow WE, et al. Treatment quality and outcomes of African American versus white breast cancer patients: retrospective analysis of Southwest Oncology studies S58814/S8897. J Clin Oncol. 2009;27

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(13):2157-2162. 13. Albain KS, Unger JM, Crowley JJ, Coltman CA, Hershman DL. Racial disparities in cancer survival among randomized clinical trials patients of the Southwest Oncology Group. J Natl Cancer Inst. 2009;101(14):984-992. 14. Berz JP, Johnston K, Backus B, et al. The influence of black race on treatment and mortality for early-stage breast cancer. Med Care. 2009;47(9):986-992. 15. Hershman DL, Kushi LH, Shao T, et al. Early discontinuation and nonadherence to adjuvant hormonal therapy in a cohort of 8,769 early-stage breast cancer patients. J Clin Oncol. 2010;28(27):4120-4128. 16. Magai C, Consedine NS, Adjei BA, Hershman D, Neugut A. Psychosocial influences on suboptimal adjuvant breast cancer treatment adherence among African American women: implications for education and intervention. Health Educ Behav. 2008;35(6):835-854. 17. Mayer EL, Partridge AH, Harris LN, Gelman RS, Schumer ST, Burstein HJ, Winer EP. Tolerability of and adherence to combination oral therapy with gefitinib and capecitabine in metastatic breast cancer. Breast Cancer Res Treat. 2009;117(3):615-623. 18. Partridge AH, Avorn J, Wang PS, Winer EP. Adherence to therapy with oral antineoplastic agents. J Natl Cancer Inst. 2002;94(9):652-661. 19. Ruddy K, Mayer E, Partridge A. Patient adherence and persistence with oral anticancer treatment. CA Cancer J Clin. 2009;59(1):56-66. 20. Partridge AH, Archer L, Kornblith AB, et al. Adherence and persistence with oral adjuvant chemotherapy in older women with early-stage breast cancer in CALGB 49907: adherence companion study 60104. J Clin Oncol. 2010;28(14):2418-2422. 21. Kimmick G, Anderson R, Camacho F, Bhosle M, Hwang W, Balkrishnan R. Adjuvant hormonal therapy use among insured, low-income women with breast cancer. J Clin Oncol. 2009;27(21):3445-3451. 22. Kahn KL, Schneider EC, Malin JL, Adams JL, Epstein AM. Patient centered experiences in breast cancer: predicting long-term adherence to tamoxifen use. Med Care. 2007;45(5):431-439. 23. Pellegrini I, Sarradon-Eck A, Soussan PB, et al. Women’s perceptions and experience of adjuvant tamoxifen therapy account for their adherence: breast cancer patients’ point of view. Psychooncology. 2010;19(5):472-479. 24. Heiney SP, Underwood SM, Tavakoli A, Adams SA, Wells LM, Bryant LH. Randomized trial of therapeutic group by teleconference: African American women with breast cancer. Cancer. 2012;118(15):3822-3832. 25. Heiney SP, Adams SA, Wells LM, Johnson H, King JM. Participant evaluation of teleconference group for African American women with breast cancer. Cancer Nurs. 2012;35(2):e24-e30. 26. Rizzo M, Lund MJ, Mosunjac M, et al. Characteristics and treatment modalities for African American women diagnosed with stage III breast cancer. Cancer. 2009;115(13):3009-3015.

AN N I VE R S A RY

FIFTH ANNUAL

Navigation and Survivorship Conference September 18-21, 2014 • Walt Disney World Dolphin Hotel • Orlando, FL

www.regonline.com/AONN2014 JONS-online.com journal of Oncology Navigation & Survivorship

Y E AR A N N 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.

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

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

The Patient’s voice

I Get By with a Little Help from My Friends: The Role of the Support Group in Breast Cancer Survivorship Carolyn Comeau

“

ow, those meetings must be sober events.” I’ve gotten this and other similar comments regularly over the past 6½ years since I received my diagnosis of stage III breast cancer in 2007. Fortunately for me and many other women, the assumption couldn’t be less accurate. Mind you, my support group meetings aren’t nonstop laugh riots, but neither are they gloom-and-doom fests. My sisters help me gain perspective as I navigate the road of the survivor. I think the Merriam-Webster Dictionary hit the proverbial bull’s-eye, because its definition of “support” includes, as a noun, a “thing that bears the weight of something or keeps it upright,” and as a verb, “to keep from fainting, yielding, or losing courage.” My support group has personified these qualities and much, much more. Despite the sad statistic that more than 232,000 women will be diagnosed with invasive breast cancer in 2014 in the United States (ww5.komen.org/breastcancer/statistics. html), one can feel awfully alone when one is first diagnosed. The unknowns and the fear that accompany this life-changing news are enough to drive one crazy—or at least cause serious sleep loss. But there’s a superstatistic too: the growth of breast cancer support groups points to the happy fact that there is a growing need for survivor services, because there are a growing number of survivors. Support groups help with, first and foremost, the questions that everyone from the newly diagnosed to the seasoned survivor has: What do ductal carcinoma in situ, invasive ductal carcinoma, inflammatory breast cancer, triple negative breast cancer, HER2/neu-positive status (and countless other terms reminiscent of an especially terrifying Latin class) mean? Whom do I listen to first (concerned loved ones, nurse navigator, oncologist, radiologist, or acupuncturist)? How do I internalize and comprehend this diagnosis myself, let alone explain it to family, friends, and acquaintances? How will I handle chemotherapy, radiation, and other treatments? How can I start healing, emotionally and physically, from surgery? Should I undergo reconstructive surgery? How do I begin to make the daunting ascent out of this experiential abyss and attempt to sculpt a “new normal” life? This is exactly where my support group, dubbed the “Young and the Breastless,” or Y&B for short (who says we don’t have a sense of humor?!) comes in. Aside from being a group of women to whom you don’t have to explain

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much (unfortunately, they understand), they’re allies who welcome newbies into the fold, share their feelings and experiences, and plain-old disseminate hope. When I went to my first support group meeting, I was newly diagnosed, had 2 young children, and was, to put it mildly, petrified. Breast cancer equaled death. It meant bald women, like the one I’d seen just a few months before at a holiday party, whom, I’m ashamed to say, I was afraid to talk to and avoided. In fact, when I first took my place at the local restaurant’s table these warriors graced, I could barely speak. I clearly remember sputtering, “Is this the…the…meeting?” semicoherently. I couldn’t even utter the words “breast cancer” out loud. After sitting down, I got the first 2 syllables of my first name out before I broke down sobbing.

Support groups come in all shapes and sizes, and, as with that elusive pair of comfortable and chic jeans, I advise trying on a few before you commit to the purchase. They didn’t stare at me aghast, as I would have; they put their arms around me, shared their amazing stories, and enveloped me in understanding, which was so validating and desperately needed! Cancer survivors definitely deal with a very real form of PTSD; like veterans or crime victims, breast cancer survivors benefit from the therapeutic gifts of sharing their experiences and developing coping skills unique to their realities. My support group has also been an amazing example of the “pay it forward” principle. One day it occurred to me that I was no longer the “new one.” I, along with the others, were now ushering in frightened women who sought connection with others who understood. Support groups come in all shapes and sizes, and, as with that elusive pair of comfortable and chic jeans, I advise trying on a few before you commit to the purchase. What makes a support group able to successfully serve its members? Like a succulent culinary dish, it requires essential ingredients, with no substitutions allowed.

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The Patient’s voice

The first is a skilled facilitator. My group’s is like a mother to us; she was the staff social worker from my oncologist’s practice, but then she retired. We loved her so much, and she us, that she stayed with us even after her professional career ended—a true gift. She sees to it that new members feel welcome, helps keep us focused and (loosely) organized, invites speakers to meetings who discuss everything from clinical trials to integrative healing modalities, and, possibly most importantly, ensures that the group is a safe and nonjudgmental place to share. That said, there’s no “right” way to “do” cancer. No member should feel obligated to contribute in a certain way or a required amount during a meeting. Our breast cancer journeys are as different as our individual selves, and so too are our internal lives and struggles. Another requirement that’s decidedly simple sounding is the chance for members to witness survivorship up close, to really see what it looks like. I assert that what women need most when they’re first diagnosed is simply witnessing other women who’ve been in the same place and come from relatable life circumstances. In my case, I needed, quite simply, to see women who were alive. In Asheville, North Carolina, where I live, my support group formed because more and more younger women, often with young children, were being diagnosed. The only support group that existed years ago had a membership that consisted primarily of postmenopausal women who more than likely had adult children helping them through their breast cancer experiences. Younger women with young children have very different needs in terms of support, so a younger survivors group was born. Members could then talk to each other about issues unique to them, like how to explain a cancer diagnosis and treatment to children at varying developmental levels, how one’s marriage might be affected, and, very importantly, how to ask for and receive help, from emotional support to meals and child care. As a result of our accepting philosophy, my group’s “all over the place” politically, religiously, and in many other ways. Nevertheless, we respect each other’s views and communication styles, and we honor each other’s experiences as singular and equally valuable. We offer suggestions and advice in nonpushy ways, and, not unlike a 12-step meeting, we encourage members to “take what you like and leave the rest.” Each member is acutely aware that everyone’s case is different; hence, we rarely, if ever, utter or hear the words “You should.” Our typical conversational hallmarks more often sound like this: “What helped me in that situation was…” or “Have you considered…?” Now back to the decidedly nonsober mood of the meet-

ings. I’m happy to report that there are, consistently, lots of laughs and hugs! Sure, we have times of happy and sad tears, but our group shares a special humor because we have walked the same path, albeit via different routes. And hugs are not only healing, they’re free! There’s a palpable joy that emanates from a group of people who have dealt with or are still dealing with the specter of breast cancer. My own experiences, as well as conversations with many survivors, reveal that, especially after the shock of diagnosis and the intensity of the treatment phase (for some, treatment will never end), we are often left very confused about what to do next. We frequently reassess everything about our lives, from our careers and volunteer commitments to our friendships. I’ve been the lucky recipient of an extraordinary combination of guided peer support, interaction in a nonclinical setting, and simply talking with women who “get it.” After all, even our loved ones either don’t understand our experiences fully—how can they?—or we worry about boring or alarming them with what may seem like endless “cancer talk.” I’ve got some stories, too, of valuable lessons learned from long-term survivors and women living with cancer and how this is an instance in life when it decidedly does not pay to compare myself to others. My support group serves to remind me, every time I start feeling sorry for myself (and I believe that everyone, cancer or not, deserves to indulge in the occasional “pity party”; I think it’s therapeutic!), that my worst day is someone else’s best, that every member knows the anguish of awaiting test results, and that loyalty and love are priceless. I remember that, when I was fairly new in my group, we all participated in a wonderful Relay for Life event at a local high school, whose beautiful campus is nestled in the mountains that define our region. At this point, I was healing from 2 surgeries, was smack-dab in the middle of chemotherapy, and was pretty much shell-shocked. As we walked, my support group sisters, literally and figuratively, held me up as my emotions overcame me: the throngs of perfect strangers cheering us on, the concentrated energy of so many fighting for a cure, the natural beauty surrounding us. Amazingly, at the end of the Relay laps, we looked up to see a stunning double rainbow! Was it a mere coincidence? I think not! As Margaret Meade so aptly said, “Never underestimate the power of a few committed people to change the world. Indeed, it is the only thing that ever has.” My Y&B posse, for me, has been just such a lovingly committed group of “Wonder Women.” I’ve gained healing, wisdom, and strength since my diagnosis, all made priceless by the gift of connection. g

JONS-online.com journal of Oncology Navigation & Survivorship

Call for Papers The Journal of Oncology Navigation & Survivorship (JONS) is publishing a theme issue on the American College of Surgeons Commission on Cancer (CoC) 2014 guidelines for accreditation. JONS was founded in 2010 and is the nation’s first peer-reviewed clinical journal for oncology nurse and patient navigators. As this essential specialty grows, research and sharing of the best practices are integral to improve the clinical care of patients with cancer and expand the existing literature and knowledge base. Our goal at JONS is to help facilitate that growth. We invite you to submmit a manuscript on what you and your institution have done to become compliant with the CoC accreditation guidelines. Topics of interest include: •

Best Practices

•

Tips on Getting Started

•

A Profile of Your Accredited Institution

•

Case Reports

•

Share Your Experience as a Navigator

Manuscripts submitted will be subject to an internal preliminary review to determine if the topic is appropriate for the scope and mission of the journal. All papers are subject to a blinded peer review prior to acceptance for publication. Submit your manuscript for consideration by

July 15, 2014. To submit an article for the CoC theme issue, please visit our website at www.JONS-online.com/submit-a-manuscript. If you have any questions or need additional information, please contact the Editorial Department at jbrandt@the-lynx-group.com.

June 2014 • Volume 5, number 3

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Fourth Annual AONN+ Conference

The Future of AONN Lisa A. Raedler, PhD, RPh

Memphis, TN—During the first day of the Fourth Annual Navigation and Survivorship Conference of the Academy of Oncology Nurse Navigators (AONN) in Memphis, Tennessee, the meeting co-chairs, Lillie D. Shockney, RN, BS, MAS, University Distinguished Service Associate Professor of Breast Cancer at Johns Hopkins University; Program Director of the Academy of Oncology Nurse & Patient Navigators (AONN+), and Sharon Gentry, RN, MSN, AOCN, CBCN, Breast Health Navigator, Derrick L. Davis Forsyth Regional Cancer Center, reviewed accomplishments and painted a compelling picture of the future of AONN+ as an organization.

Key Accomplishments in 2013

Lillie opened the presentation with a summary of AONN’s key accomplishments in 2013, including the following updated mission and vision statement: ission: The mission of AONN+ is to advance the role M of patient navigation in cancer care and survivorship care planning by providing a network for collaboration and development of best practices for the improvement of patient access to care, evidence-based cancer treatment, and quality of life during and after cancer treatment. Cancer survivorship begins at the time of cancer diagnosis. One-on-one patient navigation should occur simultaneously with diagnosis and be proactive in minimizing the impact treatment can have on quality of life. Additionally, navigation should encompass community outreach to raise awareness targeted toward prevention and early diagnosis, and must encompass short-term survivorship care, including transitioning survivors efficiently and effectively under the care of their community providers. Vision: The vision of AONN+ is to increase the role of and access to skilled and experienced oncology nurses and patient navigators so that all cancer patients may benefit from their guidance, insight, and personal advocacy. Expanded AONN member benefits described include the AONN website, the Journal of Oncology Navigation & Survivorship, annual conference, webinars, local chapter support, and educational opportunities. The AONN website was enhanced to include educational resources and a community forum for idea exchange. “For you as navigators, the AONN website has a wealth of information that you can benefit from every day of the week, and every week of the year,” Lillie stated. In addition, Cancer Navigation News

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was launched. It is a timely and relevant newsletter delivered to AONN members every other week via e-mail. The first in a series of AONN educational webinars was broadcasted, “Medication Nonadherence: Causes and Solutions,” which was hosted by Lillie. More than 400 individuals participated in this webinar. The second webinar in this series, which was conducted in December 2013, was hosted by Sharon, and was titled “Barriers and Obstacles Navigators Face in Oncology Navigation.” Lillie also discussed the development of the AONN mobile application for smartphones, and explained that the new app allows users to view the AONN conference agenda, personalize their conference schedules, explore the exhibitor floor, learn the latest conference news, share experiences with fellow attendees using the Photo Gallery and Friends features, and rate AONN sessions and speakers. Throughout 2013, AONN leadership updated and expanded AONN’s Strategic Business Plan, which includes the organization’s business objectives (ie, knowledge enrichment, networking opportunities, career development), and describes specific strategies and tactics to fulfill those objectives. As she reviewed 2013 milestones, Lillie was thrilled to announce that AONN membership increased by more than 30% from 2012 to 2013. She recalled that when AONN started in 2009, approximately 100 people were members. Today, the association boasts more than 4000 members in every state of the United States and in every Canadian province. Lillie also proudly summarized statistics documenting the evolution of the annual AONN conference (Table). The conference expanded significantly compared with 2012 in terms of attendees, as well as educational offerings. Lillie highlighted the provision of travel grants to 6 AONN members, as well as the gala event that was introTable Statistics of AONN Annual Conferences 2012 Conference 371 Attendees 12 CE credits 35 Exhibitor booths 23 Posters 0 Travel grants awarded 0 Gala tickets sold 2 Product theaters 3 Corporate members

2013 Conference 550+ Attendees 15.5 CE credits 41 Exhibitor booths 55 Posters 6 Travel grants awarded 150+ Gala tickets sold 7 Product theaters 4 Corporate members

Source: Data on file.

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Fourth Annual AONN+ Conference

duced during the November 2013 meeting. She invited all audience members to attend the Fifth Annual AONN+ Conference, which will be held September 18-21, 2014, at the Walt Disney World Dolphin Hotel in Orlando, Florida. When discussing the importance of information-sharing and networking at the annual conference, Lillie noted that AONN+ may also conduct regional meetings in the future.

Figure 1 AONN Members by Cancer Type (%)

22 33

Key Features of the Organization

After summarizing AONN’s activities and accomplishments for 2013, Lillie shifted to a review of key features of the organization, starting with the Leadership Council. She emphasized that each person on the council has unique expertise and leadership skills, as well as the role of determining AONN’s strategic direction and tactical offerings. AONN currently has 1 committee, the Quality, Outcomes, and Performance Improvement (QOPI) Committee, which is chaired by Elaine Sein, RN, BSN, OCN, CBCN. The goals of the committee are to provide ongoing education, support through mentoring, resources and tools, as well as avenues for discussion regarding outcomes, performance improvement, and the research process. Lillie indicated that the QOPI Committee conducted a knowledge assessment survey of AONN members in 2013, the results of which are summarized on the AONN website. Based on the survey findings, which indicated a need for additional training regarding research methods and reporting, the QOPI Committee plans to provide education in the form of webinars, journal articles, and blogs on the QOPI community forum. The committee is also developing a mentorship program for navigators to receive one-onone support with outcomes-based research projects on an as-needed basis.

A Closer Look at AONN Members

Lillie then provided a synopsis of the practice demographics of AONN members, as obtained through surveys of members (Figure 1). One-third of AONN members indicated that they specialize in breast cancer navigation. “This is probably not terribly surprising, since this is where oncology navigation began,” Lillie stated. Hematologic malignancy navigation and lung cancer navigation are also common specialties among AONN members. When reviewing survey data regarding job titles, Lillie highlighted that the majority (68%) of AONN members are known as nurse navigators (Figure 2). Other titles included “manager,” “patient navigator,” and “case manager.” “I anticipate that we will see more and more people in ‘administrator,’ ‘supervisor,’ and ‘manager’ positions as more institutions expand their navigation programs,” Lillie predicted. Lillie indicated that “patient navigators” may or may not be nurses; some are social workers, and others are lay navi-

Breast Colorectal Lung Prostate Heme malignancies

14 16

Source: Data on file.

Figure 2 AONN Members by Job Title (%)

Nurse navigator Manager Patient navigator Case manager Administrator Educator

4 3

10 68

Source: Data on file.

gators or cancer survivors. “It does not matter what someone is called. It is really more important that you know what you are supposed to be doing, and that you have the right tools and resources to do it.” To conclude the survey data summary, Lillie stated, “Usually, an organization would need to be 8, 9, or 10 years old before it has reached this membership level. I hope that this means that AONN fulfills a need for you. We certainly want to continue to fulfill your needs, recognizing that, over time, your needs are going to change.”

Is “Navigator” a New Buzzword?

These survey data compelled questions from the audience regarding AONN’s plans to expand membership to include individuals who are involved with navigation, but who are not registered nurses. “We want this organization to not be limited to nurse navigators. It should meet the

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Fourth Annual AONN+ Conference

needs of all who are in the field of navigation, including lay or survivor navigators and social worker navigators,” Lillie responded. “We, as an organization, have had long discussions about fulfilling needs of navigators as a whole. AONN now says ‘nurse navigators,’ but we are looking to change it to say nurse & ‘patient’ navigators as well as add a plus sign to the end of that, so it will be AONN+. In this way, we show that the organization addresses the needs of all who are involved in the navigation process. Our flagship will always be nurse navigation, but we want to ensure that we are not leaving others out.” Lillie admitted, and audience members verified, that the multiplicity of navigator titles (eg, caseworker, community outreach worker, case manager) causes significant confusion among healthcare professionals, as well as patients and family members. “It seems that ‘navigator’ has become a buzzword. Is someone who calls himself or herself a ‘faithbased navigator’ really a navigator? Or are they doing community outreach? We need to make sure that we know what we are doing, why, how, when, and with whom. And then we need to put all this to paper. Otherwise, it will never be clear. You do not want duplication of effort, and you do not want gaps in care. Documenting this for yourselves and your community is a really wise thing to do.” Lillie observed that broadening the definition of oncology navigation professionals is particularly important as the number and scope of local AONN+ chapters expand. Professional networking, sharing of experiences and best practices, and collaborating on navigation-related research are optimized when all professionals who support cancer patients within a specific geographic vicinity are able to work together. At the time of the annual conference in November 2013, AONN had 2 local chapters, 1 in Arizona and 1 in North Texas. Today, AONN+ boasts 6 local chapters: Arizona, Kansas/Missouri, North Texas, Oklahoma City, Southwest Texas, and Upstate South Carolina.

Grant Recipients

Lillie concluded her portion of the presentation by recognizing the 6 travel grant recipients and bestowing the Third Annual Oncology Nursing Excellence (ONE) Award. The travel grants, which were sponsored by Daiichi-Sankyo, Genomic Health, Dendreon, and Onyx Pharmaceuticals, were awarded to navigators who submitted manuscripts to AONN+’s “Share Your Story” initiative. Each travel grant recipient described their experiences as navigators, including successes and challenges of their navigation programs. The 2013 travel grant winners included Libby Daniels, RN, OCN, Lexington Medical Center; LuAnn Roberson, RN, BSN, CBPN-IC, Assured Imaging; Laurie Rosa, BSN, RN, OCN, CBCN, CBPN-IC, Exeter Hospital Center for Breast Health; Joanne Smith, MSN,

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RN, CBHN, CMCN, Halifax Health Center for Oncology; Jan Tichenor, MSN, Medical City Dallas Hospital; and Sophia Yeung, BA, City of Hope. Among approximately 100 nominees, Libby Daniels, RN, OCN, was selected as the winner of the ONE Award. Nominees for this award, which was sponsored by Bayer HealthCare and the Patient Access Network Foundation, are recommended by their peers because they have displayed leadership and compassion, as well as commitment to evidence-based practices in their navigation practices. The other 3 finalists for the award were Susan Scherer, RN, BSN, OCN, Tampa, Florida; Elizabeth Hatcher, RN, BSN, Washington, DC; and Anna Cathy Williams, RN, BSN, PHN, Duarte, California.

The Key Priorities of AONN+, Looking Ahead

Sharon then took the podium to unveil the future of AONN+. She described the group’s key priorities for 2014: • Establishing AONN+ as the primary organization for navigation professionals • Developing, endorsing, and promoting cutting-edge oncology navigation practice standards. To achieve the first goal, AONN+ continues to expand educational opportunities, website resources, and printed materials for its membership. AONN+ also continues to collaborate with navigation leaders both throughout the United States and internationally, “reaching out to others to work with us.” Lillie’s visit with members of the Canadian organization, Community of Practice for Nurse Navigators, was highlighted as an example of AONN+’s international partnership and idea exchange. Sharon concluded the presentation by highlighting 3 examples of oncology navigation “in the headlines” during 2013: • Barriers to Breast and Colorectal Cancer Survivorship Care: Perceptions of Primary Care Physicians and Medical Oncologists in the United States • American Cancer Society (April 12, 2013): The Effect of Nurse Navigation on Timeliness of Breast Cancer Care at an Academic Comprehensive Cancer Center • Cable News Network (CNN) report (March 28, 2013): Helping Patients Navigate the Healthcare System. Given the continuing evolution of the healthcare system, cancer patients’ increasing autonomy in decision-making, the plethora of new technologies and medications available to treat cancer, and universal challenges with cost and access to care, it is clearly an exciting and demanding time to be an oncology navigator. AONN+ leadership is committed to connecting, supporting, and educating nurses and other professionals who function in this role. The organization’s activities in the year 2014 have and will continue to sustain and shape navigators’ ability to optimize care for people with cancer. g

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Y EA R A N N I V E R S A RY

FIFTH ANNUAL

Navigation and 5 Survivorship Conference YEAR

A N N I V E R S A RY

September 18-21, 2014 Walt Disney World Dolphin Hotel • Orlando, Florida

TO DATE, THE CONFERENCE HAS HAD MORE THAN:

1,700

107

Total Attendees

Abstracts

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

Expert Speakers

60 Abstracts Submitted

(only missed your first year). I submit a report

to provide new and motivating presentations. – 2013 Conference Attendee

93%

108

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

20 10 0

9 2010

2011

2012

2013

Year of Submission

“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

97%

97% of 2013 conference attendees rated the AONN+ Conference as Above Average or Excellent when compared with other continuing education activities

home. I arrived feeling we have a pretty good program and I am leaving with ideas to share to make it even better!” – Donna Moore Wilson, BSN, RN, CBCN Oncology Nurse Navigator Bon Secours Cancer Institute Richmond, Virginia AONN+ A-SIZE_22414

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Community Needs and Navigation Lisa A. Raedler, PhD, RPh

Memphis, TN—In order to ensure high-quality patient- centered healthcare, oncology navigators must know patients’ needs and understand the factors that influence whether and how those needs are met. Systematic assessment of cancer patients’ needs is integral to navigators’ role in addressing cancer patients’ needs effectively. In recognition of this tenet, the American College of Surgeons Commission on Cancer (CoC) has developed Standard 3.1: “A patient navigation process, driven by a community needs assessment, is established to address health care disparities and barriers to care for patients. Resources to address identified barriers may be provided either on-site or by referral to community-based or national organizations. The navigation process is evaluated, documented, and reported to the cancer committee annually. The patient navigation process is modified or enhanced each year to address additional barriers identified by the community needs assessment.”1 To comply with CoC Standard 3.1 in 2015, navigation programs will be asked to: • Conduct a community needs assessment (CNA) at least once during the 3-year survey cycle • Establish a patient navigation process that provides resources to overcome barriers to cancer care. Resources can be provided to cancer patients on-site or through referral to community-based or national organizations • Evaluate the patient navigation process each year, documenting findings and reporting these findings to the cancer committee • Modify the patient navigation process to address newly identified barriers to care. The CNA is the first step of the CoC process and must be documented for compliance with Standard 3.1. The Internal Revenue Service also requires nonprofit organizations with 501[c][3] designations to report details about the population served, as well as identified disparities and opportunities to fill those gaps in care. To help attendees of the Fourth Annual Conference of the Academy of Oncology Nurse & Patient Navigators to better understand this process, Jennifer Klemp, PhD, MPH, MA, Associate Professor of Medicine, Division of Clinical Oncology, Director of Cancer Survivorship, University of Kansas Cancer Center, presented “Community Needs and Navigation.” Specifically, Dr Klemp reviewed the steps in cancer- focused CNA, defining their scope and purpose, and out-

lining methods for CNA implementation. She also showcased examples in which the aspects of the patient navigation process were enhanced by CNA findings. Her goal was to help navigators who are focused on meeting CoC standards, as well as those who wish to optimize patient care regardless of CoC accreditation. “Many of you are in hospital systems or organizations that are accredited by the CoC. But what if you work in a community-based practice, where meeting this accreditation standard is not part of your organization’s mission? The reality is that the CoC approach remains a benchmark for best practice.” To set the stage, Dr Klemp defined CNA as a process designed to identify the needs of populations served with the ultimate objective of improving healthcare disparities and gaps. In the context of cancer care, “needs” relate to cancer patients’ access, education, treatment, monitoring, and psychological support. Dr Klemp then reviewed the general steps associated with CNA, including: • Delineate the community served (primary service area) • Assess current cancer-related conditions and resources • Describe desired conditions (services, resources, etc) • Identify gaps in care, barriers to care, needs that are not being addressed, and areas to improve • Implement programs, services, and partnerships that target identified barriers. “You need to fully understand who is out there. What community are you serving? Who can you collaborate with? How can you establish those relationships?” When preparing for the CNA, Dr Klemp highlighted the importance of a working group, a committee of healthcare professionals dedicated to this phase of the oncology navigation program. She described that her cancer center has designated a working group responsible for conducting and reporting the CNA. This group is also part of our cancer committee. Navigators are uniquely qualified to take a leadership role in implementing the CNA, including identifying and recruiting members of the working group, developing a timeline of activities, and reporting findings. Given their extensive network of relationships among hospital personnel, navigators can foster idea- and information-sharing, help others appreciate the complexities of delivering care to a diverse population, and drive consensus regarding the nature of an oncology navigation program and its role in improving patient outcomes. Dr Klemp reminded the audience that while some of the

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Figure 1 University of Kansas Cancer Center CNA Timeline

2014 • Begin •B ased

data

initial CHNA on 2012

•P resent

CHNA progress at July/ October Cancer Committee Meeting

• Update

CHNA to include 2013 data • Present current CHNA at April 2014 Cancer Committee Meeting

pdate CHNA to U include 2014 data • Present retrospective 3-year CHNA at April 2015 Cancer Committee Meeting •

2013

2015

CNA indicates community needs assessment; CHNA, community health needs assessment.

Figure 2 University of Kansas Cancer Data Inputs

Data collection

Community health profiles

Key stakeholder interviews

Staff and community survey

Identify barriers and gaps in resources and current assets

steps in CNA can sound easy, such as “define the community served” and “develop a realistic timeline,” they can be quite challenging. To illustrate, she shared strategies and insights from her hospital’s CNA process, including the project timeline (Figure 1). “Our CNA working group started meeting at the beginning of 2013. By including specific milestones in our cancer committee meeting agendas, we knew that we must report to the committee every quarter. As part of our timeline, we also know that we need to update the CNA every 3 years.” Dr Klemp explained that the CNA is an almost continuous process: “Trying to collect these data all at once would be very cumbersome.”

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What data are important for the CNA? How do you collect these data? Dr Klemp described 3 data collection steps that she and her colleagues performed during the CNA process: (1) community health profiling, (2) a staff and community survey to identify current assets, as well as barriers and gaps in resources, and (3) key stakeholder interviews to develop and refine strategy (Figure 2). She outlined the tools that were used for this process, including written surveys and in-person interviews.

Community Health Profile

“The community health profile allows us to define our community, including the geography that we serve.” To do this, both primary and secondary data are needed. Dr Klemp explained that a key source of primary data is your hospital’s registrar. A registrar’s database can be queried to identify all analytic cases, or the current cancer population. Their data include patient demographics, diagnostic information, and their location. These data help navigators take a “snapshot” of the population served by the cancer center, including patients’ locations relative to the center’s predefined catchment area. Using a map of the Kansas City region, Dr Klemp outlined her committee’s approach to defining their primary service area. “We cover good portions of 2 states, Kansas and Missouri, but we decided to focus our CNA in the 6 county catchment area around Kansas City. Our hospital has 8 locations in these counties, so it was important to get a representative view of those counties.” When describing her hospital’s scope, Dr Klemp also noted that the rural network includes a prevention and survivorship clinic for geographically isolated cancer patients and providers. After the CNA working group has identified specific counties and towns as the primary service area, they can acquire and review benchmark data from national, regional, and state databases. “You can learn a lot about the particular counties in your area,” Dr Klemp advised. “There are great resources that already aggregate key data for you.” She noted the importance of considering information from the US Census Bureau, County Health Rankings, Comprehensive Cancer Control Plan, as well as the state health departments. The National Cancer Data Base, American Cancer Society, and Centers for Disease Control and Prevention can also provide robust statistics regarding specific geographies in the United States.

Staff and Community Survey

The next step after defining the primary service area is to collect data regarding the nature and scope of available resources for cancer patients, as well as resource needs and gaps. Dr Klemp shared an example of a survey that she and her colleagues developed and disseminated to healthcare

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professionals and administrators associated with the University of Kansas Cancer Center. They chose SurveyMonkey, a web-based survey, to prepare and disseminate the survey via the Internet. To enhance the likelihood of response, the survey included only 7 questions, including the following: • Which (University of Kansas) location is your primary workplace? • Do you regularly refer or suggest cancer patients and/or their caregivers to any of these support services (American Cancer Society, Cancer Action, Gilda’s Club, LIVESTRONG at the YMCA, support groups, etc)? • Do you refer or schedule cancer patients for any of the following services (cardiology, dermatology, genetic counseling, integrative medicine, etc)? • Where do you typically send or schedule cancer patients for the following services (dietetics, fertility preservation, lymphedema education, hospice, preventive screening, psychology, etc)? Dr Klemp highlighted the importance of listing specific services in these questions, “If they are not referring to Gilda’s Club, for example, maybe it is a teachable moment. The great part about a survey, whether it is with patients or your colleagues, is that it can be a data collection and a teaching tool at the same time.” She also focused on the importance of understanding if and how survivorship programs are functioning. “Part of the role of our survivorship program is to make sure that patient referrals are seamless. If we want our patients to be referred to cardiology, we must ensure that there is a resource in our hospital that can adequately support their care needs.” Dr Klemp then summarized some of the results of her CNA staff survey. She indicated that the majority of the 176 survey respondents were clinical staff members, as well as administrators (such as schedulers and healthcare technicians), management, and research staff. “We wanted anyone who touches that patient. A lot of times our schedulers have some of the best relationships with our patients, because they are the ones spending time with them before and after each visit, making sure that they get their schedules and instructions.” She showed survey results related to community support services, such as the American Cancer Society, Gilda’s Club, support groups, and others. While more than 90% of survey respondents referred cancer patients to Cancer Action, less than 30% were referred to Gilda’s Club and the LIVESTRONG program at the YMCA. Dr Klemp stated, “We cannot exist without our community resources, and we need to figure out how to best use them. Forming relationships with groups you do not currently work with and nurturing relationships with those that you do know are essential. You can use these survey data to prompt more questions: Why are we not referring to these organi-

zations? How do we help these organizations to meet patient needs and overcome barriers to access?” The staff survey also helped Dr Klemp and her colleagues to learn what programs were working well. “About a year ago, we started an outpatient palliative care program and we can see that those referrals have skyrocketed. These palliative care teams are at our academic center and in some of our community locations. We also have high levels of referral to our cardio-oncology program, which started in 2007. We want to keep that momentum for both acute care and screening.” Survey results also identified gaps in services for cancer patients in the Kansas City area, including complementary and alternative medicine, as well as sexual health counseling. Community practitioners specifically requested the need for more navigation and social work support. Dr Klemp described that many of these community practices are isolated in stand-alone facilities. They do not have the infrastructure of an academic center or hospital-based program. “We had to figure out how to build navigation and social work services into these stand-alone community practices,” Dr Klemp explained. “But we have also had to be realistic. A stand-alone community practice cannot offer the same exact services as an academic center. We are developing minimum standards for these stand-alone facilities now, knowing that the service offerings are going to evolve.” Dr Klemp’s staff survey also indicated that, as in other regions of the country, transportation is the most significant barrier to cancer care for people in the Kansas City area. Patients must drive significant distances to see their healthcare professionals, which is highly burdensome for them and their families. “These survey data are helpful, as you can see, in our program planning. We should not take next steps without this information to guide us.”

Identify and Interview Key Stakeholders

The final step in the CNA process is to interview key stakeholders, which really brings all of the other pieces together, according to Dr Klemp. She provided a diagram to help navigators categorize key stakeholders and determine their role in planning and decision-making (Figure 3). “You want to focus on individuals or organizations that have high influence (ability to impact the project) and high interest in participating in the process,” she explained. “We evaluated people’s and organization’s level of interest and influence, and then organized them in this grid. This does not mean those who have lower interest or lower influence are ignored. This just means that we focused on those who have more interest and influence.” From key stakeholder interviews conducted to date, Dr Klemp and her colleagues have learned patient care challenges revolve around access to services and collaboration

JONS-online.com journal of Oncology Navigation & Survivorship

Fourth Annual AONN+ Conference

Figure 3 Stakeholder Analysis

High influence, low interest

High influence, high interest

Low influence, low interest

Low influence, high interest

among staff members, as well as collaboration between the cancer center and the community-based organizations that provide support services. “The larger we grow, the more integrated our health systems become, the more complicated they become. This is where the navigation process is essential for helping patients into the system and helping them transition through the system.” Dr Klemp and her CNA working group have also

THIRD

learned that their cancer center’s strengths include exceptional quality of care, as well as the nature and volume of support services available. These are marketable features of the center that can be leveraged in formal advertising and educational venues, as well as informal communications and conversations. Upon completion of the CNA process, findings must be documented for the cancer committee and the CoC. The written report needs to summarize the patient population being served, list barriers to care that have been identified, and describe health disparities. It should review the navigation process, activities, and metrics that were used in the CNA, including results and outcomes, areas for quality improvement, and future plans based on the CNA. Dr Klemp concluded by reminding navigators of their integral part in defining and evolving the patient navigation process. Navigators appreciate disparities and barriers to care, continually formulate strategies to address barriers to care, and implement quality measures for practice improvement. With today’s changing healthcare models and cost pressures, Dr Klemp asserted, “We are going to be put in a position where we are going to need to know more and contribute more to our organization. Quoting Goethe, she reminded the audience, ‘Knowing is not enough, we must apply. Willing is not enough, we must do.’ ” g

Reference

1. Commission on Cancer. Cancer Program Standards 2012: Ensuring Patient- Centered Care. Version 1.2. http://www.facs.org/cancer/coc/programstandards 2012.pdf. Accessed June 2, 2014.

GLOBAL BIOMARKERS Clinical Approaches to CONSORTIUM Targeted Technologies ™

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Oct. 31 – Nov. 1, 2014 • Marriott Marquis • San Francisco, CA www.regonline.com/GBC2014

June 2014 • Volume 5, number 3

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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

Who Will Be the ONE? The Oncology Nurse Excellence Award Winner

The Oncology Nurse-APN/PA 速 (TON) is pleased to announce the 2014 ONE (Oncology Nurse Excellence) Award. This annual award recognizes an oncology nurse for outstanding contribution to oncology nursing practice, patient care, or education in 2014. The 4 leading nominees will be profiled online and in the August issues of TON and the Journal of Oncology Navigation & Survivorship 速 (JONS ). Readers will have an opportunity to nominate an individual online through July 15, 2014, and the winner will be announced at the Fifth Annual Academy of Oncology Nurse & Patient Navigators (AONN+) Conference, September 18-21, 2014, in Orlando, Florida, and profiled in the December issues of TON and JONS. The winner will also receive a plaque recognizing their contribution to oncology nursing, as well as a donation made to the charity of their choice in their name.

Nominate a nurse at

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Clinical trial tracker

New Clinical Trials Under Way

he following clinical trials are currently recruiting patients with colorectal cancer for inclusion in several investigations. Each trial description includes the NLM Identifier to use as reference with ClinicalTrials.gov.

Adjuvant Aflibercept for Metastatic Colorectal Cancer

This phase 2, randomized, open-label efficacy study aims to evaluate whether aflibercept can reduce the chance that metastatic colorectal cancer can grow back after finishing standard treatment. The study also examines the side effects of aflibercept and the effect on quality of life, and is expected to enroll 69 patients. Patients who are aged ≥18 years who have received first-line therapy for metastatic colorectal cancer are eligible to participate if other criteria are met. Those participating in the study will be randomized to receive aflibercept until progression for up to 2 years or observation with no intervention. The primary outcome for this study is disease-free survival in patients with advanced colorectal cancer who have undergone resection/ablation of all metastatic sites. Additional outcomes include adverse events for patients receiving adjuvant aflibercept up to 2 years’ duration, for patients who previously received systemic chemotherapy and surgical resection/ablation, as well as quality-of-life measurements and biomarkers in peripheral blood and fresh and archived tumor tissues. Study locations include California, Florida, New York, and Rhode Island. For more information, contact Kayla Rosati, EdM, Brown University, Providence, RI, at 401-863-3000 or Kayla_rosati@brown.edu. The NLM Identifier is NCT01669720.

RAD001, FOLFOX, and Bevacizumab in Treatment of Colorectal Carcinoma

The purpose of this phase 1/2 open-label, interventional study is to determine the safety and efficacy of using RAD001 (everolimus) in combination with FOLFOX (folinic acid, fluorouracil, oxaliplatin) and bevacizumab for the treatment of colorectal cancer. Everolimus has been in clinical development since 1996 as an immunosuppressant in solid organ transplantation; it has been in development for patients with certain malignancies since 2002. Patients who are aged ≥18 years with advanced or metastatic colorectal cancers for whom chemotherapy is indicated are eligible to participate if other criteria are met. All patients enrolled in the study will receive a combination therapy of everolimus, FOLFOX, and bevacizumab. The primary outcomes for this study are to evaluate pro-

gression-free survival in patients receiving this combination therapy for previously untreated metastatic or advanced colorectal cancers, as well as to determine the safety of the combination at specified doses. Other outcomes include a determination of the toxicity profile and response rates of the combination, as well as serum proteomic profiles of patients treated with this therapy. The study will be conducted at Huntsman Cancer Institute and Utah Cancer Specialists, both in Salt Lake City, UT. For more information, contact Marlene Mitchell, RN, at 801-587-4779 or marlene.mitchell@hci.utah.edu, or Cindy Davidson, APRN, at 801-587-5581 or cynthia.davidson@ hci.utah.edu. The NLM Identifier is NCT01047293.

Genistein in the Treatment of Metastatic Colorectal Cancer

The objective of this phase 1/2 interventional study is to assess whether combining genistein with the standard-ofcare chemotherapeutic regimens reduces chemotherapy resistance and improves the response rate of patients with newly diagnosed metastatic (stage IV) colon or rectal neoplasm. It is estimated that 24 patients will be enrolled. The response rate will be measured using the radiologic Response Evaluation Criteria in Solid Tumors criteria; progression-free survival will also be assessed. Patients who are aged ≥18 years with pathologically confirmed colon or rectal carcinomas, have a plan by their treating physician to receive FOLFOX or FOLFOX-Avastin, and have an Eastern Cooperative Oncology Group performance status ≤2 may be eligible to participate in the study if additional criteria are met. For more information, contact Randall F. Holcombe, MD, Icahn School of Medicine at Mount Sinai, New York, NY, at 212-659-5420 or randall. holcombe@mssm.edu. The NLM Identifier is NCT01985763.

Combination Therapy Assessment in Patients with KRAS and NRAS Wild-Type Cancer

The purpose of this phase 2 randomized trial is to assess combination therapy of PF-05212384 plus irinotecan compared with combination therapy of cetuximab plus irinotecan in patients with KRAS and NRAS wild-type metastatic colorectal cancer. Progression-free survival at 36 weeks will be evaluated as the primary outcome measure. Dose-limiting toxicities, objective response, and duration of response will also be evaluated. Criteria for inclusion include progression following treatment for colorectal cancer with irinotecan, oxalipla-

JONS-online.com journal of Oncology Navigation & Survivorship

Clinical trial tracker

tin, and fluoropyrimidine therapy in the metastatic setting; Eastern Cooperative Oncology Group performance status of 0, 1, or 2; and ≥1 measurable lesion by Response Evaluation Criteria in Solid Tumors. The trial is currently recruiting an estimated 159 patients in several states, including Alabama, California, Florida, and Missouri. For additional information about the trial and eligibility, contact the PfizerCT.gov call center at 800-718-1021. The NLM Identifier is NCT01925274.

Colorectal Cancer Umbrella Protocol

The Assessment of Targeted Therapy Against Colorectal Cancer screening protocol trial is testing for biomarkers in patients with metastatic or unresectable, locally advanced colorectal cancer. The primary end point of interest is the rate of successful biomarker determination. Study participants who are eligible for inclusion will undergo a blood draw for biomarker test and will be asked whether they are able to perform normal daily activities (ie, performance status). In addition, a leftover sample of tumor tissue will be collected from a previous procedure, if available, and participants will be asked to fill out a questionnaire about their cancer symptoms. Researchers are attempting to determine whether certain biomarkers can be used to help predict which cancer drugs may work better than other drugs in different people with colorectal cancer. This study is recruiting 660 patients and is taking place at the University of Texas MD Anderson Cancer Center in Houston. For more information about the trial and criteria for participation, contact the Principal Investigator, Scott Kopetz, MD, at 713-792-2828. The NLM Identifier is NCT01196130.

Chemokine-Modulatory Regimen for Recurrent Resectable Colorectal Cancer

The objective of this randomized phase 1/2 study is to evaluate the safety of combination therapy with interferon, celecoxib, and rintatolimod in patients with recurrent colorectal cancer. This will also test whether the above combination can help the immune system to fight the tumors. The treatment group consists of a chemokine- modulating regimen plus surgery, and chemokine modulatory regimen before surgical resection; the control group comprises surgical resection only, performed as standard of care for the disease. To be eligible for inclusion, patients should be aged ≥18 years, have isolated hepatic metastasis, complete resection based on preoperative imaging, and meet additional

June 2014 • Volume 5, number 3

criteria. Fifty patients will be recruited for this trial. For more information, contact Principal Investigator Amer H. Zureikat, MD, at 412-623-7931 or zureikatah@upmc. edu. The NLM Identifier is NCT01545141.

Surgery Plus Sulindac or Surgery Alone

In this phase 2, prospective, randomized, double-blind trial, investigators are assessing whether sulindac improves treatment outcomes in patients undergoing surgery for advanced colorectal cancer. Patients in the treatment group will get sulindac 1 tablet twice daily, and patients in the control group receive placebo 1 tablet twice daily. Patients with histologically confirmed colorectal adenocarcinoma with metastatic disease confined to the liver, or limited extrahepatic intraabdominal disease, as well as patients with hepatic and intraabdominal metastases measurable with computed tomography, magnetic resonance imaging, and/or positron emission tomography scan are eligible for inclusion. The study will be conducted at the National Institutes of Health (NIH) Clinical Center in Bethesda, MD, and 57 patients may be recruited. For more details about the trial and inclusion/exclusion criteria, contact the NIH Clinical Center, National Cancer Institute/Surgery Branch Recruitment Center at 866-820-4505 or ncisbirc@mail. nih.gov. The NLM Identifier is NCT01856322.

Irinotecan and BKM120 in Patients with Previously Treated Advanced Disease

The purpose of this phase 1 trial is to evaluate combination therapy of irinotecan and BKM120 in patients with advanced colorectal cancer who did not respond to or become intolerant of ≥1 line of therapy for advanced colorectal cancer and who are candidates for irinotecan therapy. The primary outcome measure is maximum tolerated dose in 28 days; approximately 30 patients will be enrolled in this study. Patients who are aged ≥18 years with histologically or cytologically confirmed metastatic or unresectable adenocarcinoma of the colon or rectum with measurable disease, Eastern Cooperative Oncology Group performance status ≤2 (Karnofsky >60%), and absolute neutrophil count ≥1.5 × 109/L, platelets ≥100 × 109/L, hemoglobin >9 g/dL may be eligible for participation. For more information on inclusion criteria and study details, contact Principal Investigator Joaquina Baranda, MD, at 913-5886077 or jbaranda@kumc.edu, or Stacey Purinton, RN, at 913-588-2545 or spurinton@kumc.edu. The NLM Identifier is NCT01304602. g

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The Academy of Oncology Nurse & Patient Navigators (AONN+) invites you to share your story of how cancer has affected you or a loved one. These stories will serve as a forum to build awareness and be a source of inspiration and reassurance to others. Select stories will be featured on the AONN+ website and in future issues of the Journal of Oncology Navigation & Survivorship ÂŽ.

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A legacy of innovation, partnership, and patient care

Lilly Oncology is committed to making a meaningful difference for patients by answering the complex questions of cancer care. Weâ&#x20AC;&#x2122;re partnering with organizations all over the world to provide valued resources and support. To learn more, visit www.LillyOncology.com.

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