JONS October 2013

OCTOBER 2013

www.AONNonline.org

VOL 4, NO 5

SPECIAL ABSTRACT ISSUE

Fourth Annual Navigation and Survivorship Conference Memphis, Tennessee • The Peabody Memphis

Categories Include: Category I: Patient Education Category II: Psychosocial Support Category III: Tracking Processes Across the Continuum of Care Category IV: Original Research Category V: Screening Programs for the Underserved Category VI: Community Outreach

Navigating Patients Across the Continuum of Cancer Care

tm

© 2013 Green Hill Healthcare Communications, LLC

Now enrolling Investigating ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Phase II Open-Label Study of the Efficacy and Safety of ABT-199 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Harboring the 17p Deletion N=100

ABT-199 is an investigational agent that has not been approved by regulatory agencies for the use under investigation in this trial.

Primary Endpoint

Secondary Endpoints

• Overall response rate

• • • • • • • •

Complete remission rate Partial remission rate Duration of response Progression-free survival Time to progression Overall survival Percentage of patients who move on to stem-cell transplant Safety and tolerability of ABT-199

Key Inclusion Criteria • Adult patients ≥18 years of age • Diagnosis of CLL that meets 2008 IWCLL NCI-WG criteria (relapsed/refractory after receiving ≥1 prior line of therapy and 17p deletion) • ECOG performance score of ≤2 • Adequate bone marrow function • Adequate coagulation, renal, and hepatic function, per laboratory reference range

NCT#01889186 Reference: ClinicalTrials.gov.

@ 2013 Genentech USA, Inc. All rights reserved. BIO0001961500 Printed in USA.

To learn more about this study, please visit www.ClinicalTrials.gov.

LETTER FROM LILLIE

Editor-in-Chief

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

Section Editors

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

Dear Reader, We are into the final countdown with just a few weeks before our 4th Annual AONN conference! This issue of JONS gives you a preview of the poster presentations that will be on display and presented at the meeting. There are 50 abstracts, each with a specific focus on the navigation or survivorship care process. The categories for abstracts are: Category Category Category Category Category Category

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

Prostate Cancer Frank delaRama, RN, MS, AOCNS

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

I: Patient Education II: Psychosocial Support III: Tracking Processes Across the Continuum of Care IV: Original Research V: Screening Programs for the Underserved VI: Community Outreach

Genetic Counseling

Cristi Radford, MS, CGC Gene Mavens, LLC Sarasota, FL

Healthcare Disparities Linda Fleisher, PhD, MPH

Each abstract is also a candidate for expanding its content and being considered for a future publication of JONS. In the December issue we will have the poster presentation winners by category.

As you read through them, give thought to how you might utilize this type of new knowledge and apply it in your navigation setting. I also hope that it triggers you to consider submitting an abstract of your own at next year’s AONN conference which will take place on September 18-21, 2014, in Orlando, Florida. (Mark your calendars now.) I hope to see you in November in Memphis. We have a great lineup of speakers, very innovative and thought-provoking presentations, networking opportunities for everyone, and there is a good chance that Elvis will be “in the building!” Please make a point of coming over to me and introducing yourself!

With kind regards,

Breast Health Navigator Novant Health Derrick L. Davis Cancer Center

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, MSN, FNP

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

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

AONN Research Committee Marcy Poletti, RN, MSN

Program Administrator, Oncology Services Wake Forest University Baptist Medical Center

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

Penny Widmaier, RN, MSN Nurse Navigator Botsford Cancer Center

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

JONS-online.com

MISSION STATEMENT

The Journal of Oncology Navi­gation & 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.

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TABLE OF CONTENTS

Russell Hennessy russell@greenhillhc.com

SPECIAL ABSTRACT ISSUE

Lou Lesperance lou@greenhillhc.com

Fourth Annual Navigation and Survivorship Conference

Managing Editor Lisa Neuman lneuman@the-lynx-group.com Copy Editor Rosemary Hansen Editorial Assistant Jennifer Brandt Production Manager Stephanie Laudien

President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris

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Category II: Psychosocial Support

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ategory III: Tracking Processes Across C the Continuum of Care

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Category IV: Original Research

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Category V: Screening Programs for the Underserved

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Category VI: Community Outreach

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OCTOBER 2013 • VOL 4, NO 5

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OCTOBER 2013 • VOLUME 4, ISSUE 5

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 ©2013 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-lynxgroup.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 mention 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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2ND ANNUAL

s JO erie View NS s o t -o nli he nli ne ne a .co t m

CONQUERING THE CANCER CARE CONTINUUM

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FIRST ISSUE IN THE 2013 SERIES

CONQUERING THE CANCER CARE CONTINUUM CONQUERING CANCER CARTHE I E CONT IN

A 6-part series The publishers of The Oncology Nurse-APN/PA, The Oncology Pharmacist, and Personalized Medicine in Oncology are proud to present our 2nd annual Conquering the Cancer Care Continuum series.

Upcoming topics include:

NEXT ISSUE

SECOND ANNUAL

SECON

D ISSUE ™ IN THE 2013 SE RIES SE C O N D ANN UA L

Changing the Image of Palliative Care Lillie D. Shockney, RN, BS, MAS

vention and relief of suffering by means of early identiam enthusiastic about this 6-part series titled Confication and impeccable assessment and treatment of quering the Cancer Care Continuum. Each edition of pain and other problems, physical, psychosocial, and CCCC will address an important topic in oncology RIES spiritual.” (http://www.who.int/cancer/ management and offer expert stakeE 2013 SE TH IN UE ISS palliative/en/).

Topics will IRD commentaries.

THholder For too long, however, the image of include: palliative care, pain manageNU AN - AL ND CO ™ palliative care has been tied exclusively ment, hospice SE care, comprehensive to end-of-life care and focused solely on treatment planning, survivorship care, pain control. and the role of biosimilars in supportLillie D. Sho ckney, RN, BS, MAS The articles that follow provide a ive care. In this issue, we address paln part 2 of our clear understanding of the intent of liative care.

Conquering series, the the Can palliative care today, with the primary Palliation in cancer care is a topic focus is on mat pain man cer Care Continuum agemen goalt.ofDes ending its identification that commonly makes people (medical wel ic improvements inabilitysolely l as surgical in pite drato overco procedures pharmaceu cancer provideddie for wh theile dying. providers as well as patients) uncom- we still me it effe l agecare designed to as tica nts, as have a lon ctively, fear in great help g way pai monly resp cess ing con Instead, palliative be assofortable. I recently had the opportunity to go ful on beh ™trol pain, care should ond that n. Family members, they will D.alf Shockney, of our patiRN,to be suctheir grea nesscare I wasLillie too, com theirforlov ents. ciated with quality-of-life alled to speak with members of our palliative recently BS,wat MAS one in grea test fear is having ute chi to wit t pai care team at Johns Hopkins and learned ern s of an old, black-a ng a few min- cancer patients and survivors, no mat- ease the sufferin n without a way nd-white movie. A to wes g. cow ter what their clinical outcome. that the word “palliative” comes from the word “palliare,” tfear these Family me boy had by a gunslin will be the mbers been sho ger, and as Your wit t fina nes cancer patients may not tell you about the side which means to disguise or cloak. Centuries ago,mp this word tor atte l ima s before the ted to rem the town docir loved oneges they Ma ove ny effects of treatment they are experiencing or about their was used for the drapes that covered afrom casket.

Although his chest, organizati dies. another cowthe bullet oped me ons have the wounde asu develdiscomfort due boy gav we continue to drape coffins—most memorably with the d man tice guidel rement tools and e to their cancer diagnosis or its treatment. a bottle of to drink ines for pracand a whicases In many flag—the drape is no longer referred to this term. ske they may simply assume that the discomhelping hisby teeth. I’m knife to bite betwee y providers the purpose of nwith the disease.” However, with the imeffectively age pain The World Health Organizationwas modified its sure orig-back infort how peo associated the “comes manday this ple coped provements its wit trea h in medicine and the power of science, it inal definition of palliative care as quo follows: “Palliative can wit tme r to num cer and nt. b them and h pain – liprovide you The following d toquality doesn’t to anymore.

Do not wait for your patients arti care is an approach that improveshar the of life somethhave call bite on. ing asking him to mation asso with a wealth of cles This is far him back MAS e idea a discussion wrotfrom ised he kney, RN, BS, about their symptoms; be proacof patients and their families facingTod the ay problems asall pat t sank l. how surpr and guidel ciated with the inforien.tsI whto initiate hear Lillie D. Shoc My and said se that o ent l environ of hospita est thatat the time you are planer initiate tive and thisrequ discussion sociated withthe life-threatening through thesoon pre- t,after that thoughines. They also pro tools a to even men did next edition illness, an me. whe atieHe at all on he nd the nt metto r itand to bring to you inuum series. This the inp mati be of the infor Lillie sure that tful care be taken mote orrespo a clinic visi for uni D. Shoey all ir was t is my privilege Cont doctor, all to ckney, I reiterated t with t the long journ Cancer Care options, are RN, cancer pat of us address wit enaskede. to by phon BS, talk abou we Conquering the es specifically on hospice Hopee-pain MA mea me com ����� �Green Communications, LLC together S sure Hill Healthcaretold plete a focus experienci ients the pain the h our of whethe ment toolhad had endured rtant to read. tha issue, which wife impo his t ng ly y are 30. pro r and vital and age the vides somdiagnosis at he y are presen imp to relieve ve to be gree. Pat will be initial e expression is one I belie tly in it. Pain stea lement ways herpain ien since addressed here tim n of her clini sica , descr and to iptio what to circ ts have trou what de- ness,phy ble,d how fully, concepts and better ways of it l endurancee, psychological ls away social on his le (a happy Base alert eve ed wel new r, tua limit as pain and l-be interpreting face or ing can make was bad in l cancer adopted ition and I lly absent for a ver cal cond gravely ill. quality of , and terminally il y thatface som the mornin and cause the she) ifwas life virntsad supporting our families. g but theirthe doctor adequate trea e patients. Accur y evide not their so I thou ate assessm tment for ment nee doctor. Fur took a pain pillwas ng an nowght patients and befohim that bad effectiv ent self thatthehecan d to be prioriti al years ago getti He himbeviewed by thermore, is thistold re com essetod see I recall sever es for all e pain managestring Bill. o di his cer fiel the any as srma winfo of us wor tion actu a man named and sometim one during the to linger after I feel con d. king in difficult ally e-mail from it Som ir visi d t?

Internet and next refide es the this foun it nt via ding is you me not. provok etim Certainly ion regaris, young had found he is ing and containwill find these arti one of the brief conversat es itthat ng that his whatwill stati cer me cles And to ing grea pat . assi cantho ients is the valu test fearfor wrote Mary a st you in breasstt can s exp metastatic brea reassessing able information ught fear of painstep welbut ressher is not a drug oncan l(He ed by as dev ng wife, Mary, had gressed to her liver, your curren tha andplaci now sufferin pro d- hospice. future pat eloping more effe t patients t calle g and cer that had . She was ctive ei ients eithe as special program this and now brain term befo fectre ively man have quality of life ways to help you d Lilliesleeping lungs, bone, r aged. Q had not hear n to explain some of by having hospital and D. Shockney, RN pain efI bega , BS, MAS currently in the awake, confused at © he 201)3As care, ther. ice Gre was hosp she en RN, of Hill fits Healthc kney, more than “had still my the key bene and are“Lill Lillie D. Shoc Comie, weight, but g said, mun losin t s, until MAS icat BS, time old. I ions, LLC fourth issu got very upse chemotherapy he or 6 and 8 years she sons, e doct 2 of been receiving the Co have nquerincann that die. We wrote that Continuum wife g theotCancer alone.” I then told him the last yesterday.” He s ser thiadd with care of her for nin re staff and I would work meet himies rescann ot raise them Caice ses Tre e and situ who had taken d him to com g Thro atio ir mTh atm that hosp omeand ugh . He said aske Follow Pland die but ent losing then. goa n ren for the about next steps a the 4 years had r Ca hileCancewoul ds who l of the team re these child room to talk ing are paont 2 er for wicle andy frien preC outcom is optimal him tore inuum.ly members rap morning in her onthe t would ling key art imes. role medical asized the im identify fami the cologis taking place,s to pro of the emph him vid I were .

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• Palliation • Pain management • Hospice care • Treatment planning • Survivorship care • Biosimilars in supportive care

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Introduc tion to O ncology Pain Ma nagem ent

CONTIN

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FOURTH

ISSUE IN THE 2013 SERIES SE CPa N nts D ANN ort to Otie pp Su UAL al itic ing Cr vid Pro : re Hospice Ca s and Familie

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. And the is paper or ele re is a new ctronically prescriptio kle in the wrinn instructio – n treatment planni ns to be fille by the pha – what wil rmacologi l this treatme ng process st or pharma d These ind nt cost? Wi patients hav cist. ividuals, ll e to experts in managem their treatme pay out of pocket for drug ent, i nt? Is the cost of trea mization, are nteraction, and opt ment worth it tintegral to the clinica the oncolo care team. to be achiev l outcomes gy You will ed? No pat soon read ients wan learn why. lea Lillie ve their fam D. Shockn and t to ey, RN, ily in dee alth p debt, and And speaki BS, MAS ough we hav ng of the tea e ent ere that the pat d era of person m, it is crit an excitin ient, and cer g ically imp aliz ortant tain family cases, be con of these new ed medicine, the cos compared members in t sidered me drugs is inc with treatme some mbers of the ning team. redibly hig nts we hav to in the We should h treatment e been acc past. Even not be doi plan we must be nustomed prior treatme ng things to bee doing things n dau nting from a patient; nt regime patients, of with a pat a cost perspe ns have ient. Thoug Everyone course, are ctive. wan h the not experts many have the right trea ts to make sure tha on oncolo desperatel t the patien gy care, y tried to tment at the sort by tur t gets become ex way. Now ning to the right time perts off a clinicians Internet and and for themse in the must realize right trying to det treatment’s lves what that treatme treatment sake is nev would be bes ermine nt for er wise and Thoughtf t for their ul decisio not the ns about mission. and patien treatm ts, oncolo gists, pharma ent are a must, cologists, palliative © 2013 Gre en Hill Hea lthcare Com munication s, LLC

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY I: Patient Education Developing Culturally Relevant Breast Cancer Resources—Getting Connected: African-Americans Living Beyond Breast Cancer Catherine Creme Henry, MA1; Arin Ahlum Hanson, MPH, CHES1; Patricia K. Bradley, PhD, RN2; Janine Guglielmino, MA1 Living Beyond Breast Cancer; 2Villanova University College of Nursing

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Background: Living Beyond Breast Cancer (LBBC) conducted focus groups of African-American women (AAW) affected by breast cancer and learned that they prefer culturally specific resources for education and support. The publication, Getting Connected: African-Americans Living Beyond Breast Cancer, was written to fill gaps in resources for AAW. In 2011, the second edition was published to reflect changes in breast cancer care, cancer disparities, and perceptions of breast cancer. Oncology nurses served as advisors to ensure quality-of-life aspects of care were included. Objectives: (1) To increase attendees’ level of knowledge and understanding about the consumer-based, participatory approach used to create a culturally specific resource. (2) To present methods to use the resource as an effective communication tool with African-American breast cancer survivors and families. (3) To enable attendees to share best practices for using tailored, culturally specific resources with women and families. Methods: (1) A qualitative, community-based participatory approach was used during the revision process for Getting Connected. It involved 3 components: (1) a national advisory committee of community leaders and healthcare providers (HCPs); (2) 5 focus groups with AAW (n=44) diagnosed within 2 years of the project; and (3) interviews of 8 informants who work with AAW. LBBC worked with community-based groups to hold focus groups in Philadelphia, Pennsylvania; Little Rock, Arkansas; and Chicago, Illinois. The groups were recorded, transcribed, and analyzed for salient themes.

Getting Connected was revised and redesigned using “plain language” principles. This edition of Getting Connected is a 50-page culturally relevant resource designed for and to be used by African-American breast cancer survivors, their caregivers and supporters, and their HCPs. Published in October 2011, this resource promotes informed decision-making, while providing support and inspiration. Results: More than 10,000 copies of the second edition have been distributed to HCPs and AAW affected by breast cancer. Evaluation feedback indicates that 92% of readers felt more prepared to connect and communicate with their HCPs; 85% of readers strongly related to the personal stories shared; all readers agreed that they would keep this resource for future reference; and 86% said they would seek other LBBC services. This feedback shows that the resource is useful for nurse navigators to use when working with AAW diagnosed with early-stage or metastatic breast cancer. Conclusions: Getting Connected addresses how to build trusting patient–provider relationships and live fully beyond breast cancer. AAW can use this resource to talk to loved ones about their support needs. Oncology nurse navigators can effectively meet the educational needs of AAW by relying on this up-to-date culturally relevant resource to help initiate quality-of-life discussions with AAW affected by breast cancer and present themes as icebreaker topics at support group meetings.

The Benefits of Early Nurse Navigation and Patient Education in the Care of Advanced Cancer Patients at Intermountain Healthcare Southwest Region Cheryl Bellomo, RN, OCN, CBPN-IC1; Deborah Christensen, RN, BSN, HNB-BC2 View Medical Center; 2Dixie Regional Medical Center

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Background: Patients and their families facing the diagnosis of cancer, especially advanced cancer, can feel lost, uncertain, overwhelmed, and fearful of the healthcare system. At Intermountain Healthcare Southwest Region, our goal is to provide patients and their families with a hand to hold throughout their cancer journey. The role of the nurse navigator is pivotal in providing patients with information to allow them to make the best informed decisions regarding their care, to remove barriers, and to assist patients in receiving treatment services in an equitable and timely manner to improve outcomes. Objectives: (1) Alleviate uncertainty and improve patient knowledge regarding oncology care. (2) Develop and implement a process to streamline scheduled appointments/consultations, tests, and procedures. (3) Involve the nurse navigator in patient care from the time of initial diagnosis/referral through the continuum of care. (4) Identify and address barriers to care. (5) Encourage patient treatment compliance through Continued on page 11 6

OCTOBER 2013 • VOLUME 4, ISSUE 5

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Jakafi is a registered trademark of Incyte Corporation. © 2013, Incyte Corporation. All rights reserved. RUX-1227f 07/13

Table 2: Worst Hematology Laboratory Abnormalities in the Placebo-controlled Studya Jakafi Placebo (N=155) (N=151) Laboratory All All b Grade 3 Grade 4 Grades Grade 3 Parameter Grades BRIEF SUMMARY: For Full Prescribing Information, see package insert. (%) (%) (%) (%) (%) INDICATIONS AND USAGE Jakafi is indicated for treatment of patients with intermediate or high-risk Thrombocytopenia 69.7 9.0 3.9 30.5 1.3 myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential Anemia 96.1 34.2 11.0 86.8 15.9 thrombocythemia myelofibrosis.

Neutropenia 18.7 5.2 1.9 4.0 0.7 CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS Thrombocytopenia, Anemia and Neutropenia Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia. [see Dosage and Administration (2.1) in Full Prescribing Information]. Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary [see Dosage and Administration (2.2) in Full Prescribing Information, and Adverse Reactions]. Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi. Severe neutropenia (ANC less than 0.5 X 109/L) was generally reversible. Withhold Jakafi until recovery [see Adverse Reactions]. Perform a pretreatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated [see Dosage and Administration (2.2) in Full Prescribing Information, and Adverse Reactions]. Risk of Infection Serious bacterial, mycobacterial, fungal and viral infections may occur.

Active serious infections should have resolved before starting therapy with Jakafi. Observe patients receiving Jakafi for signs and symptoms of infection and initiate appropriate treatment promptly. PML Progressive multifocal leukoencephalopathy (PML) has been reported with ruxolitinib treatment for myelofibrosis. If PML is suspected, stop Jakafi and evaluate. Herpes Zoster Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected [see Adverse Reactions].

ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Myelosuppression [see Warnings and Precautions]; • Risk of Infection [see Warnings and Precautions] Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Jakafi was assessed in 617 patients in six clinical studies with a median duration of follow-up of 10.9 months, including 301 patients with myelofibrosis in two Phase 3 studies. In these two Phase 3 studies, patients had a median duration of exposure to Jakafi of 9.5 months (range 0.5 to 17 months), with 88.7% of patients treated for more than 6 months and 24.6% treated for more than 12 months. One hundred and eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. In a double-blind, randomized, placebo-controlled study of Jakafi, 155 patients were treated with Jakafi. The most frequent adverse drug reactions were thrombocytopenia and anemia [see Table 2]. Thrombocytopenia, anemia and neutropenia are dose related effects. The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache [see Table 1]. Discontinuation for adverse events, regardless of causality, was observed in 11.0% of patients treated with Jakafi and 10.6% of patients treated with placebo.

Following interruption or discontinuation of Jakafi, symptoms of myelofibrosis generally return to pretreatment levels over a period of approximately 1 week. There have been isolated cases of patients discontinuing Jakafi during acute intercurrent illnesses after which the patient’s clinical course continued to worsen; however, it has not been established whether discontinuation of therapy contributed to the clinical course in these patients. When discontinuing therapy for reasons other than thrombocytopenia, gradual tapering of the dose of Jakafi may be considered [see Dosage and Administration (2.9) in Full Prescribing Information]. Table 1 presents the most common adverse reactions occurring in patients who received Jakafi in the double-blind, placebo-controlled study during randomized treatment.

Table 1: Adverse Reactions Occurring in Patients on Jakafi in the Double-blind, Placebo-controlled Study During Randomized Treatment Jakafi Placebo (N=155) (N=151) Adverse All All Grade 3 Grade 4 Grades Grade 3 Grade 4 Reactions Gradesa (%) (%) (%) (%) (%) (%) Bruisingb 23.2 0.6 0 14.6 0 0 Dizzinessc 18.1 0.6 0 7.3 0 0 Headache 14.8 0 0 5.3 0 0 Urinary Tract Infectionsd 9.0 0 0 5.3 0.7 0.7 Weight Gaine 7.1 0.6 0 1.3 0.7 0 Flatulence 5.2 0 0 0.7 0 0 Herpes Zosterf 1.9 0 0 0.7 0 0 a National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 b includes contusion, ecchymosis, hematoma, injection site hematoma, periorbital hematoma, vessel puncture site hematoma, increased tendency to bruise, petechiae, purpura c includes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s Disease, labyrinthitis d includes urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, kidney infection, pyuria, bacteria urine, bacteria urine identified, nitrite urine present e includes weight increased, abnormal weight gain f includes herpes zoster and post-herpetic neuralgia

Description of Selected Adverse Drug Reactions Anemia In the two Phase 3 clinical studies, median time to onset of first CTCAE Grade 2 or higher anemia was approximately 6 weeks. One patient (0.3%) discontinued treatment because of anemia. In patients receiving Jakafi, mean decreases in hemoglobin reached a nadir of approximately 1.5 to 2.0 g/dL below baseline after 8 to 12 weeks of therapy and then gradually recovered to reach a new steady state that was approximately 1.0 g/dL below baseline. This pattern was observed in patients regardless of whether they had received transfusions during therapy. In the randomized, placebo-controlled study, 60% of patients treated with Jakafi and 38% of patients receiving placebo received red blood cell transfusions during randomized treatment. Among transfused patients, the median number of units transfused per month was 1.2 in patients treated with Jakafi and 1.7 in placebo treated patients. Thrombocytopenia In the two Phase 3 clinical studies, in patients who developed Grade 3 or 4 thrombocytopenia, the median time to onset was approximately 8 weeks. Thrombocytopenia was generally reversible with dose reduction or dose interruption. The median time to recovery of platelet counts above 50 X 109/L was 14 days. Platelet transfusions were administered to 4.7% of patients receiving Jakafi and to 4.0% of patients receiving control regimens. Discontinuation of treatment because of thrombocytopenia occurred in 0.7% of patients receiving Jakafi and 0.9% of patients receiving control regimens.

Patients with a platelet count of 100 X 109/L to 200 X 109/L before starting Jakafi had a higher frequency of Grade 3 or 4 thrombocytopenia compared to patients with a platelet count greater than 200 X 109/L (16.5% versus 7.2%). Neutropenia In the two Phase 3 clinical studies, 1.0% of patients reduced or stopped Jakafi because of neutropenia. Table 2 provides the frequency and severity of clinical hematology abnormalities reported for patients receiving treatment with Jakafi or placebo in the placebo-controlled study.

Grade 4 (%) 0 3.3 1.3

a Presented values are worst Grade values regardless of baseline b National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0

Additional Data from the Placebo-controlled Study 25.2% of patients treated with Jakafi and 7.3% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in alanine transaminase (ALT). The incidence of greater than or equal to Grade 2 elevations was 1.9% for Jakafi with 1.3% Grade 3 and no Grade 4 ALT elevations. 17.4% of patients treated with Jakafi and 6.0% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in aspartate transaminase (AST). The incidence of Grade 2 AST elevations was 0.6% for Jakafi with no Grade 3 or 4 AST elevations.

16.8% of patients treated with Jakafi and 0.7% of patients treated with placebo developed newly occurring or worsening Grade 1 elevations in cholesterol. The incidence of Grade 2 cholesterol elevations was 0.6% for Jakafi with no Grade 3 or 4 cholesterol elevations.

DRUG INTERACTIONS Drugs That Inhibit or Induce Cytochrome P450 Enzymes Ruxolitinib is predominantly metabolized by CYP3A4. Strong CYP3A4 inhibitors: The Cmax and AUC of ruxolitinib increased 33% and 91%, respectively, with Jakafi administration (10 mg single dose) following ketoconazole 200 mg twice daily for four days, compared to receiving Jakafi alone in healthy subjects. The half-life was also prolonged from 3.7 to 6.0 hours with concurrent use of ketoconazole. The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the corresponding ruxolitinib AUC following concurrent administration with ketoconazole. When administering Jakafi with strong CYP3A4 inhibitors a dose reduction is recommended [see Dosage and Administration (2.7) in Full Prescribing Information]. Patients should be closely monitored and the dose titrated based on safety and efficacy. Mild or moderate CYP3A4 inhibitors: There was an 8% and 27% increase in the Cmax and AUC of ruxolitinib, respectively, with Jakafi administration (10 mg single dose) following erythromycin, a moderate CYP3A4 inhibitor, at 500 mg twice daily for 4 days, compared to receiving Jakafi alone in healthy subjects. The change in the pharmacodynamic marker, pSTAT3 inhibition was consistent with the corresponding exposure information. No dose adjustment is recommended when Jakafi is coadministered with mild or moderate CYP3A4 inhibitors (eg, erythromycin). CYP3A4 inducers: The Cmax and AUC of ruxolitinib decreased 32% and 61%, respectively, with Jakafi administration (50 mg single dose) following rifampin 600 mg once daily for 10 days, compared to receiving Jakafi alone in healthy subjects. In addition, the relative exposure to ruxolitinib’s active metabolites increased approximately 100%. This increase may partially explain the reported disproportionate 10% reduction in the pharmacodynamic marker pSTAT3 inhibition. No dose adjustment is recommended when Jakafi is coadministered with a CYP3A4 inducer. Patients should be closely monitored and the dose titrated based on safety and efficacy.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C: There are no adequate and well-controlled studies of Jakafi in pregnant women. In embryofetal toxicity studies, treatment with ruxolitinib resulted in an increase in late resorptions and reduced fetal weights at maternally toxic doses.

Jakafi should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses of 15, 30 or 60 mg/kg/day in rats and 10, 30 or 60 mg/kg/day in rabbits. There was no evidence of teratogenicity. However, decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day. This dose results in an exposure (AUC) that is approximately 2 times the clinical exposure at the maximum recommended dose of 25 mg twice daily. In rabbits, lower fetal weights of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. In a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implantation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups for fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily).

Nursing Mothers It is not known whether ruxolitinib is excreted in human milk. Ruxolitinib and/or its metabolites were excreted in the milk of lactating rats with a concentration that was 13-fold the maternal plasma. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Jakafi, a decision should be made 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 Jakafi in pediatric patients have not been established. Geriatric Use Of the total number of myelofibrosis patients in clinical studies with Jakafi, 51.9% were 65 years of age and older. No overall differences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Renal Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in healthy subjects [CrCl 72-164 mL/min (N=8)] and in subjects with mild [CrCl 53-83 mL/min (N=8)], moderate [CrCl 38-57 mL/min (N=8)], or severe renal impairment [CrCl 15-51 mL/min (N=8)]. Eight (8) additional subjects with end stage renal disease requiring hemodialysis were also enrolled. The pharmacokinetics of ruxolitinib was similar in subjects with various degrees of renal impairment and in those with normal renal function. However, plasma AUC values of ruxolitinib metabolites increased with increasing severity of renal impairment. This was most marked in the subjects with end stage renal disease requiring hemodialysis. The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in metabolite exposure. Ruxolitinib is not removed by dialysis; however, the removal of some active metabolites by dialysis cannot be ruled out. When administering Jakafi to patients with moderate (CrCl 30-59 mL/min) or severe renal impairment (CrCl 15-29 mL/min) with a platelet count between 100 X 109/L and 150 X 109/L and patients with end stage renal disease on dialysis a dose reduction is recommended [see Dosage and Administration (2.8) in Full Prescribing Information]. Hepatic Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in healthy subjects (N=8) and in subjects with mild [Child-Pugh A (N=8)], moderate [Child-Pugh B (N=8)], or severe hepatic impairment [Child-Pugh C (N=8)]. The mean AUC for ruxolitinib was increased by 87%, 28% and 65%, respectively, in patients with mild, moderate and severe hepatic impairment compared to patients with normal hepatic function. The terminal elimination half-life was prolonged in patients with hepatic impairment compared to healthy controls (4.1-5.0 hours versus 2.8 hours). The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in ruxolitinib exposure except in the severe (Child-Pugh C) hepatic impairment cohort where the pharmacodynamic activity was more prolonged in some subjects than expected based on plasma concentrations of ruxolitinib. When administering Jakafi to patients with any degree of hepatic impairment and with a platelet count between 100 X 109/L and 150 X 109/L, a dose reduction is recommended [see Dosage and Administration (2.8) in Full Prescribing Information].

Jakafi is a registered trademark of Incyte Corporation. All rights reserved.

U.S. Patent No. 7,598,257 © 2011-2013 Incyte Corporation. All rights reserved.

Issued: June 2013 RUX-1216

FOURTH ANNUAL AONN CONFERENCE ABSTRACTS Continued from page 6

CATEGORY I: Patient Education

education and symptom management. Methods: (1) Implemented a patient care plan to include workup and staging with scheduling of appointments, tests, and procedures. (2) Referred patients to local/state/national services and programs based on identified barriers to care. (3) Developed standardized teaching packets for new patient visits and chemotherapy/radiation and met with patients and families to optimize the learning experience. (4) Provided patients with information on multidisciplinary services offered at the cancer centers to treat and rehabilitate the whole patient. (5) Provided patients and their families with information on support programs offered at the cancer centers.

Results and Conclusions: At Intermountain Healthcare Southwest Region, we observed the benefits of early nurse navigation in the care of our advanced cancer patients. Involving the navigator at the time of diagnosis has assisted patients in removing financial barriers to care, coordinating care in the scheduling of appointments/tests/procedures, and improving initial consultation and communication with the oncologist. Educational material regarding treatment and management of side effects alleviates anxiety, improves patient compliance, and enables patients to complete the recommended treatment. Education and resources empower patients with the tools they need to make informed decisions as well as be an active participant in their care. Patient care plans, patient education, and patient empowerment lead to improved outcomes for our patients.

A Powerful Toolkit Meeting the Diverse but Unique Needs of Young Women Diagnosed with Breast Cancer Stacy Lewis, BS, CHES Young Survival Coalition

Background: Each year, approximately 13,110 women under the age of 40 years are diagnosed with breast cancer, and 1200 die of the disease. There are approximately 250,000 breast cancer survivors living in the United States today who were diagnosed under age 40. About 10% of patients are diagnosed with metastatic disease. Young women face more aggressive cancers, lower survival rates, and struggle with unique psychosocial concerns. Yet, within this young population, there is a diversity of needs and experiences among those who are newly diagnosed, posttreatment, long-term survivors and/or those living with metastatic disease.Young Survival Coalition (YSC) is the premier global organization dedicated to the critical issues unique to young women and breast cancer. Our Navigator resource series provides a powerful “toolkit” to meet the varying needs of all young women diagnosed. Objective: To provide educational and organizational tools for young women diagnosed with breast cancer, at any stage of their journey, that provide pertinent knowledge and wisdom to empower these young women to be their own best health advocates.

Methods: YSC surveyed young women newly diagnosed with breast cancer (308), living with metastatic disease (300), posttreatment (268), and long-term (≥5 years postdiagnosis; 461) to determine their unique needs, concerns, and information requirements. We also utilized focus groups of these patient populations and workgroups composed of survey participants and psychosocial professionals to aid in drafting and refining our toolkit. Results: YSC developed 4 tools to help a young woman cope with her disease, wherever she is along her journey. The Newly Diagnosed Resource Kit provides a young woman with the information and tools to confront her disease, with pertinent definitions, explanations, and communication tips, as well as a binder to organize medical records and appointments. Our Metastatic Resource Kit helps a young woman understand her diagnosis, discusses treatment options, and provides tips on practical matters and maintaining quality of life. The Post-Treatment Navigator provides support for the young woman’s adjustment to breast cancer survivorship. Finally, our Long-Term Survivor Guide discusses issues most relevant to this population including long-term side effects and fear of recurrence. Each of our navigators provides practical and encouraging ways for young women surviving and living with breast cancer to be their own best advocate. Conclusions: Young women surviving breast cancer have varied needs. YSC has developed a “toolkit” of navigators and resources to meet those unique needs.

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CATEGORY I: Patient Education Identification and Management of Adverse Events Associated with Everolimus in Hormone Receptor–Positive Advanced Breast Cancer Jan Hronek, MSN, ACNP, AOCNP

Tennessee Oncology/Sarah Cannon Research Institute

Background: Oncology nurse navigators work closely with patients to assist in the management of breast cancer (BC) and help improve patient outcomes, ultimately affecting quality of life. Comprehensive knowledge of adverse events (AEs) of current treatment options and of management strategies is important for proper patient care. Everolimus (EVE), a mammalian target of rapamycin (mTOR) inhibitor, was approved in combination with exemestane (EXE) to overcome endocrine resistance in patients with hormone receptor–positive (HR+) advanced BC. Objectives: To evaluate safety data obtained at 18-month median follow-up during the BOLERO-2 trial and potential strategies to manage key AEs associated with EVE. Methods: BOLERO-2, a double-blind, placebo-controlled, phase 3 study evaluated EVE (10 mg/day) or placebo in combination with EXE (25 mg/day) in postmenopausal women (N=724) with HR+/human epidermal growth factor receptor 2 (HER2)-negative advanced BC refractory to letrozole or anastrozole. Results: Stomatitis (all grades) was the most common mTOR-related AE for EVE+EXE versus placebo (PBO)+EXE (59% vs 12%). Other common class-specific AEs (all grades) included infection (52% vs 25%), rash (39% vs 7%), noninfectious pneumonitis (16% vs 0%), and hyperglycemia with new-onset diabetes (16% vs 3%). Grade 3 class-effect AEs occurred in <10% of EVE+EXE–treated patients. Grade 4 infection (1.5%) and hyperglycemia (0.4%) were uncommon; no grade 4 stomatitis or noninfectious pneumonitis was observed. Of patients in the EVE+EXE and PBO+EXE groups, 38% and 3%, respectively, required ≥1 dose reduction because of AEs. Median duration of EVE dose interruption and reduction was 7 and 29 days, respectively. Treatment discontinuation as a result of AEs occurred in 26% and 5% of the EVE+EXE and PBO+EXE groups, respectively. Patient education is key in AE management. For stomatitis, a prophylactic treatment approach and proper oral hygiene allows for early recognition to minimize the effect. If stomatitis occurs, topical corticosteroids or mouthwashes containing anesthetics can be used. Noninfectious pneumonitis can be managed by use of combination radiographic imaging and oral corticosteroids and temporary cessation of treatment. Obtaining fasting serum glucose levels is recommended before initiating EVE and periodically after; optimal glycemic control should be achieved before EVE treatment. For severe AEs, dose modification may be necessary. Conclusions: EVEassociated AEs were mild to moderate, and infrequent grade 3/4 events were adequately managed using established recommendations and patient education. A thorough understanding of EVE/EXE-associated AEs and management will allow oncology nurse navigators to assess, implement, and manage treatment plans, thereby improving patient care. Supported by Novartis Pharmaceuticals Corporation.

Early-Stage Lung Cancer and Palliative Care Intervention

Anna Cathy Williams, RN, MSN, PHN; Betty Ferrell, PhD, FAAN; Rebecca Fujinami, RN, BS, OCN; Dan Raz, MD; Jae Kim, MD; Rupinder Sidhu, CSW City of Hope Medical Center

Background: In 2013, new lung cancer diagnoses and deaths were projected to be 229,000 and 159,500, respectively (American Cancer Society’s Facts and Figures 2013). These individuals and their families experience numerous symptom and quality-of-life (QOL) concerns. Patient education is essential to support in coping with multiple physical symptoms, psychological concerns such as depression, social concerns such as family burden, and spiritual issues associated with often advanced disease and poor prognosis. Objective: With rapidly evolving diagnostics and treatment methodology, patients with early-stage lung cancer (ESLC) are increasing in numbers. Although stage I-II patients are deemed “curable,” there lingers severe psychological distress, threats of recurrence, new primaries, and existing or imposed comorbidities due to the treatment itself. Consequently, the outlook remains tenuous for this population. With improving survival rates, it is imperative that patients with ESLC be fully assessed, aggressively managed, and followed up. Through a comprehensive care plan and interdisciplinary effort, healthcare professionals may be able to offer patients with ESLC stellar evidence-based intervention and a greater chance of possessing a sense of normalcy in their lifestyles. The purpose of this National Cancer Institute Program Project Continued on page 14 12

OCTOBER 2013 • VOLUME 4, ISSUE 5

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

Continued from page 12

CATEGORY I: Patient Education

Grant is to test the effects of a Palliative Care Intervention (PCI) on overall QOL and psychological distress, compare symptoms, patient assessment outcomes, and test the effects of the PCI on the healthcare system use compared with a usual care group. The long-term objective of this research is to provide evidence for change in the paradigm of care given to patients with ESLC and their caregivers across the cancer trajectory. Methods: The framework for the project combines patient-centered teaching principles and concepts from National Comprehensive Cancer Network Guidelines for ESLC as well as Distress Management and National Consensus Project Guidelines for Palliative Care. The project design includes 2 phases. Phase I provides usual care for 12 months postaccrual. Phase II is the PCI phase, which consists of a comprehensive evaluation review by an interdisciplinary team, 4 intervention sessions, and 4 follow-up phone calls. The intervention provides implementing standardized protocols, including symptom management and QOL assessment. Results: In Phase I, 103 patients were accrued. All stages were equivalent at baseline on demographic variables, and clinical and functional status.

Physical function fluctuated, along with a decrease in the total number of symptoms longitudinally. Conclusions: Pilot studies conducted in this lung cancer research program led to the development of a program project that aims to improve QOL and symptom management for patients with lung cancer and their caregivers. The PCI phase continues, and has shown great promise in efforts to provide palliative care early on.

Community Cancer Center Launches Oncology Rehab Program Demonstrating Improved Quality-of-Life Measures

Sue Potts, PT; Lea Powell, RN, MSN, OCN; Danelle Johnston, RN, MSN, OCN, CBCN; Gianna Laiola, RN, MSN, OCN; Shannon Lindop, RN, BSN, OCN; Mary Wickman, RN, PhD St Jude Centers for Rehabilitation & Wellness

Background: Evidence shows that patients undergoing cancer treatments suffer from a multitude of long-term symptoms and side effects that affect their daily quality of life. Our organization identified a gap in the rehabilitation needs of our cancer survivors. The Institute of Medicine has recognized that cancer rehabilitation is a distinct phase of survivorship care. Oncology Rehab Partners developed an oncology rehabilitation program (Survivorship Training and Rehabilitation [STAR]) that assists in managing acute and long-term side effects of cancer treatments and cancer symptoms. Evidence has shown that oncology rehabilitation increases overall functioning for cancer survivors.

Objectives: To demonstrate the effectiveness of the oncology rehabilitation program in decreasing pain and fatigue and improving functional abilities with an overall outcome of increasing quality of life. Methods: The Director of Oncology Services attended a survivorship conference and learned of the STAR program. Administration, rehabilitation team, interdisciplinary team, and physicians supported the adoption of the program. Oncology and rehabilitation staff (N=47) completed 10 self-directed modules of survivorship and rehabilitation training. The referral process was then implemented, and a Quickbase database was created to collect data on patients regarding physical and occupational outcomes. Measurement tools with established validity and reliability included the FACIT-Fatigue Scale, Borg Rating of Perceived Exertion Scale, and Eastern Cooperative Oncology Group Performance Status as well as patient self-reporting of pain, fatigue, and the standardized Six-Minute Walk Test. Data were entered into and analyzed using IBM SPSS 21 for Windows. Descriptive and correlational statistics were used to determine variable relationships.

Results: Ninety patients were referred to the STAR program. Of those, 84 initiated therapy (93%), 86% (n=72) completed the program, and 32% (n=23) completed the pre- and postmeasures for the program. Fourteen percent (n=12) did not finish the program because of the initiation of additional cancer treatment or because they self-discharged from the program. Mean scores showed improvements in fatigue (43.2%), perceived exertion (12.99%), activity tolerance (20.16%), and pain over time (21.6%). Pain improvement was correlated with decreased fatigue, r(15) = .68, P <.05.

Patients who reported a decrease in pain showed improved FACIT-Fatigue scores, r(15) = â&#x20AC;&#x201C;.68, P <.01, which also measures fatigue. Conclusions: The 6-week oncology rehabilitation program demonstrated significant improvement for patients regarding long-term results in quality of life. Opportunities for improvement include separating patient data into those currently undergoing active cancer treatment versus those who have completed treatment, increasing the use of a physical medicine and rehabilitation physician to support the healthy lifestyle commitment, and capturing patient discharge data.

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY I: Patient Education Best Practices for Cancer Survivor Education Programs

Elizabeth Hatcher, RN, BSN; Anne Willis, MA; Mandi Pratt-Chapman, MA; Shannon Colvin GW Cancer Institute at the George Washington University

Background: The transition off active treatment has been described as a “teachable moment” to prepare cancer survivors for the posttreatment phase; however, little is known about how to best educate cancer survivors. Cancer survivor education programs aim to prepare patients for the transition from active treatment to the posttreatment phase by providing information, support, and resources to empower survivors to cope effectively with these concerns. Finding the ideal time, setting, and delivery method for cancer survivor education programs is a challenge; survivors have competing priorities after completing treatment and may not have the same preferences for learning and support that they did during treatment. Many healthcare professionals seek to implement cancer survivor education programs but need guidance on the best practices. Objectives: The objective of the Best Practices for Cancer Survivor Education Programming Survey was to gather information on best practices for the strategies, structure, and content of education programs for survivors of any type of cancer. Methods: A 23-item Web-based survey was sent to healthcare professionals using a convenience sample and snowball method. Professionals who have developed or facilitate cancer survivor education programs were eligible. Participants were also given the option to identify themselves for a follow-up semistructured interview to probe further on their survivor education program structure, content, and delivery. Results: More Findings from the survey and interviews will be presented, including a summary of best practices related to specific topics in the respondent’s education program, the number of sessions, format and method of delivery, time of day, day of week, location, and information regarding successes, challenges, and adaptations to the program. Conclusions: Surveying cancer education providers regarding best practices for posttreatment survivor education will provide valuable information for other professionals designing and implementing these programs. This research serves as a catalyst for a dialogue regarding creating and sustaining effective programs to educate cancer survivors.

Improving Patient Readiness for Initial Chemotherapy Using a Nurse-Based Prehabilitation Teaching Protocol Deanna Xistris, APRN, AOCN

Stamford Hospital/Bennett Cancer Center

Background: Patients presenting for initial chemotherapy to the outpatient Medical Oncology Unit consistently raised questions and concerns regarding the therapy that required clinician time prior to starting therapy. This resulted in delay of start/finish times of therapy and secondary backlog of treatment space availability. This also caused delay for subsequent patients assigned to receive therapy. Patient readiness for the therapy and the nurse’s ability to meet identified needs/concerns were also limited by the short time frame during which needs were identified. A distinct “teaching visit” by an APRN following the Physician Consult was added to the process with the stated goal of identifying social, financial, and physical needs and concerns prior to the start of therapy and in a time frame that would allow for referral for appropriate interventions prior to the start of therapy. Objectives: To describe a best practices prehabilitation chemotherapy teaching protocol that is implemented at Stamford Hospital by nurses prior to the start of treatment. Methods: Prehabilitation interventions designed to prepare patients physically and emotionally for upcoming treatments have received considerable attention lately.1 Nurses at Stamford Hospital’s Bennett Cancer Center have implemented a chemotherapy teaching protocol that is part of the electronic medical record (EMR). This protocol was developed based on identification of factors observed to interfere with individual readiness for the start of therapy and efficiency of bed/chair utilization and responsiveness to patient/family needs. The protocol includes a distinct nursebased teaching visit—face to face with the patient—that is scheduled from 30 to 60 minutes. The protocol includes assessments, patient education, and screening for interventions. The protocol is also a screening tool that is used to recommend referrals—nutrition, counseling, physical therapy, lymphedema, integrated medicine, financial, home care, transportation, surgery (port placement). Referrals are automated into the EMR. The full assessment, requested

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY I: Patient Education referrals, and key individualized needs are available/visible to the “treating nurse” the day of initial therapy. Results: Medical oncologists now consistently refer for the APRN-directed prechemotherapy teaching visit. The treatment nurses report that the patients are presenting for the start of chemotherapy in a much less distressed state, and treatments are routinely started in a timely manner. The nurses also acknowledge they can target their teaching to the immediate chemotherapy-related issues with increased patient/family understanding and compliance with directions. Referrals and subsequent follow-through have increased based on the preassessment process. Conclusions: Nurses can and should be involved in prehabilitation interventions, ideally using protocols and tracking outcomes to improve cancer care. Early identification of an individual’s unique vulnerabilities prior to starting chemotherapy allows time and opportunity for referrals and interventions to mitigate identified limitations and thereby enhances treatment readiness, tolerance to therapy, and eased recovery posttherapy.

REFERENCE

1. Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013;92(8):715-727.

Radium-223 Dichloride (Radium-223) Handling, Administration, Safety, and Counseling Information for Use in Patients with Castration-Resistant Prostate Cancer and Symptomatic Bone Metastases Shelley Rio, ACNP-BC1; Mona M. Whaba2; Michael Tomblyn, MD3; E. David Crawford, MD4

University of Colorado Anshutz Medical Campus; 2Bayer HealthCare Pharmaceuticals; 3Algeta US; 4University of Colorado

1

Background: Radium-223 (formerly known as Alpharadin) is a novel alpha-emitting radiopharmaceutical that selectively targets bone metastases with high-energy, short-range (<100 µm; 2-10–cell diameters) alpha particles, and was recently approved by the US Food and Drug Administration for the treatment of patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases. In the randomized, phase 3 ALSYMPCA (Alpharadin in Symptomatic Prostate Cancer) trial, radium-223 was shown to prolong overall survival (OS) (median, 14.9 months vs 11.3 months; hazard ratio [HR] = 0.70; 95% confidence interval [CI], 0.58-0.83) and time to first symptomatic skeletal event (SSE) (median, 15.6 months vs 9.8 months; HR = 0.66; 95% CI, 0.52-0.83) among patients with bone-metastatic CRPC, and was associated with a highly favorable safety profile. Objectives: To present important handling, administration, safety, and patient counseling information obtained from ALSYMPCA concerning the use of radium-223 in patients with bone-metastatic CRPC. Methods: Eligible ALSYMPCA patients had progressive, symptomatic CRPC with ≥2 bone metastases and no known visceral metastases; were receiving best standard of care; and had either previously received, were unfit to receive, or declined docetaxel. Patients were randomized 2:1 to 6 injections of radium-223 (50 kBq/kg intravenously every 4 weeks; n=614) or matching placebo (n=307). The primary end point was OS; secondary end points included SSEs and safety. Results: Radium-223 is provided as a ready-to-use solution for intravenous administration, and requires only standard radiation shielding and radiation protection restrictions during handling and administration. Patients are treated on an outpatient basis, with few limitations on personal contact; caregivers should wear gloves and wash their hands after handling patients’ bodily fluids or soiled clothes, and patients should dispose of bodily waste in a toilet whenever possible and wear condoms if sexually active. In ALSYMPCA, radium-223 was associated with a low incidence of myelosuppression (ie, thrombocytopenia, 12% vs 6%; neutropenia, 5% vs 1%) and gastrointestinal adverse events (ie, diarrhea, 25% vs 15%; vomiting, 18% vs 14%) compared with placebo. Given the potential for additive myelosuppression, concomitant use of radium-223 with chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy is not recommended. Patients should be counseled to be compliant with blood cell count monitoring appointments while receiving radium-223, and patients with evidence of compromised bone marrow should be monitored closely for hematologic adverse events. Conclusions: Radium-223 is a novel, safe, and effective treatment for patients with CRPC with bone metastases. As with other radiopharmaceuticals, care should be taken to minimize external exposure to radium-223, and potential bone marrow toxicity should be monitored prior to each dose.

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OCTOBER 2013 • VOLUME 4, ISSUE 5

AONNonline.org

FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY II: Psychosocial Support The Kennedy Health System Oncology Patient Navigation Program: A Collaborative Oncology Certified Nurse and Oncology Certified Social Worker Patient Navigation Team Model Louise M. Baca, RN, MSN; Eric Gonzalez, RN, BSN, OCN Kennedy University Hospital

Attendees will be able to discuss 3 key benefits of implementing an oncology patient navigation team model. This oncology team model includes an oncology certified nurse and oncology certified social worker who work collaboratively in helping patients overcome medical and psychosocial barriers in the provision of quality cancer care.

As healthcare becomes more complex, the implementation of navigation programs, specifically oncology navigation programs, is fast becoming a mainstay in many healthcare organizations. The primary goal is to navigate oncology patients faced with increased medical, financial, and psychosocial issues, through the healthcare system. Currently, there are numerous and various models that include nurses, social workers, and/or laypersons, but a standard navigator model does not exist with regard to role delineation, requirements, and/or credentialing. With healthcare organizations focusing primarily on quality of care, meeting the needs of the patient and ultimately patient satisfaction, having an Oncology Patient Navigation Program that includes a certified oncology nurse has not only become paramount but is highly recommended or required in accredited cancer care programs.

The Kennedy Oncology Navigation Model includes an oncology certified nurse and an oncology certified social worker that work collaboratively as a patient navigation team. This model optimizes the care of the oncology patient, prevents gaps in the treatment planning/implementation process while demonstrating the benefits of an oncology nurse/social worker team that works collaboratively within their individual scopes of practice.

The Kennedy Cancer program has been utilizing the Oncology Nurse/Oncology Social Worker Navigator Model since 2010. Each discipline was hired simultaneously to work together as a team to navigate patients from diagnosis to treatment and beyond. The benefit of having an oncology nurse and an oncology social worker is that they work within their individual scopes of practice but are able to care for the patient as a whole, addressing medical, psychosocial, and financial concerns positively affecting patient outcomes.

The Kennedy Navigator Model has been extremely successful as evidenced by patient and physician satisfaction scores.

The implementation of this team model has resulted in positive patient outcomes associated with treatment compliance, financial resolution, symptom experience, functional status, and psychological distress.

The primary implication in using the oncology nurse/social worker model in a collaborative team effort ensures that all facets of the patient experience (ie, quality of life, performance status, patient satisfaction, and financial need) are not only identified but fully addressed utilizing resources throughout the continuum of care.

Model for Alleviating Socioeconomic Barriers to Treatment Utilizing Volunteers to Obtain Grants for Oncology Patients Patricia Gambino, RN, MSN; Nancy Jean Barnabei, BS, Cancer Survivor, Volunteer; Kimberly Smith, BA,Volunteer; Andrea Strouth, MSW, LSW Abramson Cancer Center

Background: Socioeconomic burdens create barriers to patient care that can distract and impede doctors from delivering prescribed medical treatment. When doctors and nurses encounter patients with cancer with overwhelming socioeconomic issues (eg, paying for medications, copays, insurance premiums, transportation, and meals), the doctors refer these patients to a nurse navigator (NN). We wanted to test a process in which student volunteers (SVs) secure grants for needy patients. Objective: To ascertain: (1) if a group of young volunteers working 4 hours per week could successfully interact with medical staff, patients, and grantors to secure grants; and (2) the number and value of the grants funded. Methods: A clear set of tools and workflow documents were created to train and supervise SVs, allow SVs to work efficiently and independently, and track grant application

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CATEGORY II: Psychosocial Support progress. Once a patient is referred to a NN, the NN screens the patient for grant eligibility. A case file is created, and the NN assigns an SV to work with the patient to apply for grant support. All activity related to patient applications is entered into a database (Grant Progress Tracker) that tracks grant progress, quantifies awards, and provides a chronicled narrative. Results: Patient satisfaction was substantially improved due to the personal care that SVs provided to patients. Patients expressed tremendous gratefulness for the much needed grants. During our 4-month trial, 5 SVs submitted 75 applications, securing grants for 33 patients, totaling $70,000, including medications, lodging, food delivery, respite, cell phones, homecare, and copays. The personal attention and grant resources allowed the patient to have a smoother treatment experience because fulfillment of basic needs was realized. Beyond our initial trial, SVs have continued to secure grants for needy patients and have raised a significant amount of additional funds and resources. We are waiting for the arrival of several new volunteers for fall 2013. We are eager to continue improving patient support in the Gastrointestinal Division of the Abramson Cancer Center.

Conclusions: There are three key elements to making this project successful. The first key part of the process is motivated and committed volunteers; they are invaluable to the system. We need volunteers who will provide patients with proper attention and persist with grant application follow-up. Second, an engaged supervisor is essential to train and coach the volunteers, and manage the Grant Progress Tracker. Third, patients need to be willing to assist with the application process by providing necessary financial information for the grants.

Onyx Pharmaceuticals 360™: A Support Program for Patients with Multiple Myeloma and Their Caregivers Jennifer Sharretts, MBA; Vicki Kennedy, LCSW Onyx Pharmaceuticals

Background: In 2008, the Institute of Medicine’s Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs outlined a framework to integrate psychosocial health services into routine care for patients with cancer. Opportunities tailored to address the unmet needs of patients with multiple myeloma emerged following publication of the report.

One of these, the Onyx Pharmaceuticals 360TM (Onyx 360) program, was developed and introduced in 2012 following the approval of single-agent carfilzomib in the United States for the treatment of patients with relapsed and refractory multiple myeloma. The goal of this innovative program was to deliver integrated biopsychosocial care with reimbursement assistance and to serve as a model for industry-sponsored patient access programs. Objectives: To describe the key features of Onyx 360, an industry-sponsored patient access program that emphasizes patient-centered navigation to personalized supportive resources. Methods: Onyx Pharmaceuticals convened focus groups with patients, caregivers, oncology nurses, oncology social workers, and practice managers, the results of which informed the design and development of the program. Oncology nurse advocates act as the primary sources of contact and liaise with healthcare professionals, payers, and community organizations on behalf of patients and their caregivers. Unique features of the program include transportation assistance, clinical support, and real-time referrals to key resources, including the Chronic Disease Fund, the International Myeloma Foundation, the Multiple Myeloma Research Foundation, and the Cancer Support Community (CSC). Consenting patients and caregivers are transferred to CSC, whose licensed mental health professionals conduct distress screening and offer patients and caregivers free supportive counseling, resource referral, group support, and treatment decision counseling. About 6 months after the introduction of Onyx 360, participants were asked to complete a satisfaction survey to assess the effectiveness of the program. Results: Results from the survey demonstrate that patients, caregivers, and providers (N=244) were “very satisfied” (89%) with the Onyx 360 experience. High satisfaction scores appear to be driven primarily by knowledgeable and courteous oncology nurse advocates. Conclusions: The Onyx 360 program is unique from standard reimbursement support programs in that it fully integrates access to biopsychosocial care with reimbursement support. Overall, this program attempts to establish a seamless delivery of care between patients and their families, caregivers, and healthcare teams to optimize patient care and treatment of patients with multiple myeloma. Preliminary results from an initial participant survey are encouraging; additional research is ongoing to assess the effect of the Onyx 360 program on clinical outcomes.

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OCTOBER 2013 • VOLUME 4, ISSUE 5

AONNonline.org

FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY II: Psychosocial Support Connecting with Gastrointestinal Patients and Families

Julie Pope, RN, BSN; Kathy Bowman, RN, BS; Joanne Henley, MDiv, BCC Novant Health

Background: In 2006, very few resources to support patients with gastrointestinal (GI) cancer existed in the Piedmont Triad area of North Carolina. Through conversations with patients and families on the treatment journey, the GI Oncology Nurse Navigator identified a need and responded to an expressed interest for a local program to enhance support and education for this population.

Objectives: 1. Create a safe, supportive environment for participants to share their stories.

2. Provide ongoing knowledge with access to supportive resources.

Methods: Planning Method: 1. Observed structure of closest support group, 90 miles away 2. Created mission statement with boundaries Mission statement: Provide a safe, respectful space for participants to share their stories, gain personal insight, education, and access to appropriate resources throughout their cancer journey 3. Assessed location for comfort, proximity to bathrooms, ambiance, position of seating with availability of refreshments 4. Decided on a monthly meeting schedule with group format.

Two methods applied as a basis of group model are: • The Group Theory - described as a method of inspiring hope, altruism, and common bonds • The Narrative Counseling Theory - described as a method of assisting patients/families in understanding that cancer does not define them The group structure: 6:00 pm: Introductions and announcements 10 minutes 6:10 pm: Education 30 minutes • topics based on patient and family • feedback and known emotional/spiritual needs 6:40 pm: Support - breaking out into (2) groups 40 minutes • Patient group • Caregiver group: each group facilitated by GI Oncology Nurse Navigator and/or Oncology Chaplain 7:20 pm: Closing - with inspiration and laughter 10 minutes Preplanned a year of monthly topics based on expressed patient/caregiver needs and interests, along with known physiological challenges while on cancer journey. Topics included: patient stories; journaling; ostomy care; intimacy; sexuality; faith, prayer, meditation; in the beginning…was chaos 5. Maintaining Contact – via e-mail, phone calls, and mail, monthly or as needed on an individual basis. Note: GI Oncology Nurse Navigators also were engaged with patients weekly, biweekly during treatments, or as needed.

Results: This group is ongoing and remains cohesive with members empowering each other through their shared experiences.

Surveys were given 1 year after the start of the group requesting participants to rate all topics within the first year as either “very helpful,” “helpful,” or “not helpful.” All topics were rated either “very helpful” or “helpful,” with no ratings of “not helpful.” As a part of the survey, the participants were given the opportunity to recommend topics for future groups. Topics suggested were: anxiety; hope; communicating with your physician and loved ones; faith and spirituality; riding the emotional roller coaster; chemo brain; organizing help; living will/ healthcare power of attorney; pain control; financial resources; insurance. Participants unanimously voted that finding others in similar situations and being given the opportunity to share was the best reward of attending this group. Conclusions: As we enter into our seventh year in October 2013, we have met and exceeded the above

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CATEGORY II: Psychosocial Support objectives. Working on the design for this support group required careful planning with lots of creativity for a group model that could stand the test of time with no funds. The GI Oncology Wellness Support Group, facilitated by 2 GI Oncology Nurse Navigators, has remained a unified group since its inception in October 2007. The relaxed atmosphere of the resource room overlooking the garden sets the tone of peace, with close proximity of the bathrooms providing a sense of security necessary for this population. Maintaining safe boundaries for all participatnts has been key in this group’s vitality. The group has been affected by changes in location and turnover in attendance secondary to completion/change in treatment regimen, progression of disease, or death. The resiliency of the group is evident in how quickly it regenerates with new members. The average of 24 participants attend each group, with larger attendance during the Christmas and Valentine’s Day meetings.

Caregivers of deceased patients stop by from time to time to maintain contact with this important source of stability and strength during their cancer journey. After the completion of 6 successful years, as we reflect, we have had the opportunity to consistently assess the needs within the group and offer such topics as: tool boxes for patients, survivors, and caregivers; memory boxes; Colon Cancer Alliance spokesperson; laughter; massage therapy; mindfulness. Bucket list: Letters to cancer; recreational therapy; acupuncture; being thankful/blessings; “Weathering the storm”; journey—where you’ve been, where you’re going; “Yes” or “No”—when you say “yes” to something, you are saying “no” to something else; Letting go, Moving forward (usually at New Year’s); Journey on the “train of life” (going on a trip—where would you go? who with? using senses); transformation; “tip” swap; music therapy; nutrition. It has been an important part of our role as navigators to maintain this sacred space and time for GI patients and their families. Our goal is to provide all participants with a breath of fresh air for 90 minutes once monthly, and equip them with tools to continue to utilize personal and community resources while on their ever-changing path. As GI Oncology Nurse Navigators it has been a privilege to work with such incredible people. We receive a blessing each time we gather and each one teaches us so much about living and dying.

Long-Term Breast Cancer Survivors Denise Schimming, MSN, RN, CNP; Diane Henry, RN, BSN Ohio State University

Background: Treatment and management helps survivors of breast cancer live long lives. We will continue to see increasing numbers of women who had breast cancer in their 40s and 50s living into their 80s and 90s. Historically, cancer survivors completing cancer treatment were referred back to their primary care provider. Our survivorship clinic supports the unique needs and provides a navigation relationship for the survivor with breast cancer. Managing symptoms of older breast cancer survivors can be challenging. Symptoms can be caused by late effects of cancer and cancer treatment.

Psychological and cognitive decline may occur as a natural cause of aging. Based on these issues, our survivorship clinic is well suited to differentiate these symptom profiles and support primary care providers. Objectives: Initiate a survivorship clinic for breast cancer survivors living beyond 10 years from diagnosis of breast cancer. Funding is provided through routine billing practices. Methods: The Supportive Care Screening tool, which included the Distress Thermometer from National Comprehensive Cancer Network for the first 4 months, was used to evaluate survivorship and determine survivorship needs. In the last 2 months, only the Supportive Care Screening tool was used, focusing on specific distress concerns and not overall distress. A referral program to other disciplines was established to address specific survivor concerns. Results: Within the first 6 months of the clinic’s opening, 56 patients were seen. Ages ranged from 40 to 87 years with a mean of 68.5 years and median age of 70 years. Supportive Care Screening (Distress) results showed moderate (21% patients) to severe distress (3% patients) in a total of 14 patients. No distress to mild distress (21% and 53%, respectively) was seen in a total of 42 patients. Of the 56 patients seen, 9 were referred to the following specialties: reconstructive surgery (n=3), genetics (n=3), oncology rehabilitation (n=1), registered dietitian (n=1), and gynecology (n=1).

Conclusions: Our population experienced sleep disturbances, muscle weakness/joint pain, grief, loss, and concerns related to body image and sexual functioning. This group also expressed concerns related to feelings of being overwhelmed, current health issues, fear of recurrence, financial concerns, family, and health issues of family members. Many of these experiences and concerns, scoring mild to moderate on the Supportive Care Screening, could be considered part of normal aging. It becomes very difficult to differentiate between surviving breast cancer, surviving breast cancer treatment, and normal aging. Further study may help to refine our knowledge about the breast cancer survivor living beyond 10 years.

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OCTOBER 2013 • VOLUME 4, ISSUE 5

AONNonline.org

FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY II: Psychosocial Support Distress Tool Use Before and After a Breast Cancer Multispecialty Team Clinic Appointment: Lessons Learned Loril Garrett, BSN, RN, OCN, CBPN-IC, CBCN Spectrum Health, Grand Rapids, Michigan

Background: The diagnosis and treatment of breast cancer causes levels of distress that vary from minimal to severe and have the potential to interfere with treatment. Distress, like pain, should be promptly recognized and managed.

Distress tool use and screening provides an opportunity to address the emotional, spiritual, social, practical, and physical needs of patients as they relate to their cancer experience. Less than 10% of cancer patients showing a significant level of distress are identified and referred for psychosocial help.1 Objective: To evaluate the impact of distress tool screening use with patients with breast cancer both before and after attending a breast cancer multispecialty team (MST) clinic appointment. Approach: MST clinic appointments are available weekly for patients with breast cancer at our facility.

They are able to see a surgeon, medical oncologist, radiation oncologist, social worker, breast nurse navigator (BNN), and genetic counselor, all in 1 visit. The team then conducts a conference and 1 member of the medical team reports the outcome of the discussion back to the patient. The BNN then provides a written plan of care to the patient at the conclusion of the visit. Distress tool screening was recognized as a way to further meet the care needs of our patients.

The National Comprehensive Cancer Network (NCCN) Distress Tool was identified as our distress screening method of choice. The tool was then modified for our use with permission from the NCCN to ease data collection. No content was altered. Distress tool screenings began in January 2010 as a means to objectively measure the distress level of patients attending our breast cancer MST team clinic and are given to patients upon their arrival. Individual interventions were developed to address needs identified on the distress tool, and referrals are made to the supportive care program as indicated by answers provided on the tool. Screening patients a second time, at the conclusion of their visit, was added in January 2011. A retrospective and observational study was conducted using data from the first 18 months (January 2011June 2012) of pre- and postvisit distress screening tool use at our facility. Methods: A distress tool was given to patients upon arrival to the breast cancer MST clinic. Patients were asked to rate their distress on a scale of 0 to 10. They were also asked to inventory themselves in the areas of practical, family, emotional, spiritual, and physical problems. The social worker and BNN provided education and reviewed the distress tool with each of the patients. Resources were provided and the patient’s problems were acknowledged. The BNN reported the patient’s numeric level of distress, along with their physical problems, to the physicians at the time of the team conference. The BNN provided interventions as needed and as directed by members of the MST to address the patient’s physical problems. The BNN also administered the distress tool a second time to patients at the conclusion of their visit. Patients were asked to provide only a numeric level of distress at that time. Results: A total of 271 patients completed a distress tool test prior to their appointment, and 267 patients completed a tool test at the conclusion of their appointment. Patients were found to have an overall average drop in distress by a value of 1.35, or 26%, from the beginning of their appointment to the end of their appointment. The average level of distress reported prior to their appointment was 5.20, and the average distress reported at the conclusion of their appointment was 3.85. The top 4 physical problems were found to be eating, fatigue, memory/concentration, and sleep. Insurance/financial and work/school were noted as the 2 top practical problems. The top 3 emotional problems listed were fears, nervousness, and worry. Dealing with a partner and dealing with children were the top 2 family problems. Only 3 patients reported spiritual/religious concerns in the 18-month time frame. Discussion: The BNN was able to follow up with patients, address care needs, and provide interventions, while keeping the patient’s distress level in mind, thus further personalizing their ongoing care. Patients were able to voice concerns in a non-intimidating manner thus alerting the medical staff to possible needs that otherwise may not have been identified. The identification of top patient problems and needs can lead to more specific and focused interventions and can serve to inform clinical practice. The numeric value given at the conclusion of the breast cancer MST clinic appointment can serve as a point of reference for future distress screening. From the Literature: “Improving all aspects of patient care, psychosocial as well as biological, must be pursued if progress in overall quality of cancer care is to be achieved.”2 Early identification of distress and supportive care referrals by nurses can help prevent severe distress in patients with breast cancer.3 Conclusion: Distress tool screening serves as a valuable resource to help reduce distress for patients with breast cancer attending a breast cancer MST clinic appointment through objectively identifying

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY II: Psychosocial Support needs, facilitating focused referrals, improving communication among and with the healthcare team, and alerting the need for timely interventions­—which all work together to help improve the overall care and well-being of the patients with breast cancer who we serve at our facility.

REFERENCES

1. H olland JC, Anderson B, Breitbart WS, et al. Distress management. J Natl Compr Canc Netw. 2010;8(4):448-485.

2. R odriguez MA, Tortella R, St. John C. Improving psychosocial care for improved health outcomes. J Healthc Qual. 2010;32(4):3-13.

3. H ammonds LS. Implementing a distress screening instrument in a university breast cancer clinic: a quality improvement project. Clin J Oncol Nurs.

2012;16(5):491-494.

Canada’s Diagnostic Assessment Programs: An Ontario Perspective Carol Gunsch, RN, BScN, CON(c); Barbara-Anne Maier, RN, BScN, CON(c) Grand River Hospital

Background: The diagnostic phase of the cancer journey is characterized by multiple clinicians, uncertainty, and anxiety. Cancer Care Ontario, the agency of the provincial Government of Ontario that is responsible for improving cancer services, also recognized that the diagnostic period can be “lengthy, uncoordinated, and distressing for patients” (Cancer Quality Council of Ontario 2007). As part of an ongoing review of the delivery of care for patients with cancer, it set out to address these concerns and, as part of the Ontario Cancer Plan (2008-2011), developing and piloting 7 Diagnostic Assessment Programs (DAPs) led by nurse navigators (NNs). Objectives: To present the quantitative and qualitative data collected over 1 year—10 metrics have been observed over the past year in the province of Ontario that demonstrate the benefits of nurse navigation within the setting of DAPs. The results will show that the impact of the NN through the use of a centralized referral process, professional triaging and assessment, symptom management, preparing patients for clinical consults, and helping patients reach an informed consent improve the patient experience during this phase of their cancer journey. Methods: The authors completed a literature review on the history and rationale for the development of DAPs, as well as the role of the NN within the programs. In addition, the authors reviewed the metrics that were established by the provincial body to measure the improvement and success of the programs. A standardized Patient Satisfaction Survey was one of the measurement tools developed by a team at Cancer Care Ontario. The purpose of the survey was to evaluate the impact of the NN on the quality of care and to measure the patient experience within a DAP. The survey was distributed by the DAP staff to all patients who had their care coordinated by an NN through a DAP. Instructions were given for the voluntarily completed surveys to be returned anonymously directly to Cancer Care Ontario. At the end of each quarter, the results were subsequently collated, summarized, and distributed by the provincial organization to Regional Cancer Program leadership. After review by senior leadership, the results were disseminated to the DAP staff for ongoing program evaluation and quality improvement.

Results: Qualitative and quantitative data summarizing the patient experience with the NN in the setting of a DAP has been measured. Using 10 specific metrics for evaluation, patients are invited to anonymously complete a survey summarizing the impacts of an NN-led DAP. Questions related to the impact of the NN on their understanding of the diagnostic process level of confusion and anxiety during the diagnostic process, as well as the availability of NNs during the process were evaluated. More than 70% of respondents reported a decreased level of anxiety throughout their diagnostic phase, and more than 80% reported a very satisfactory experience with the NN. Qualitative data and quotes directly related to the patient/provider experience will again argue the value added by the NN on the patient’s experience. Conclusions: In 2010, after reflection and analysis of the experience of the patient with cancer in the province of Ontario, a decision was made to develop a DAP pilot program to coordinate and expedite the care of patients with cancer. Seven DAPs (4 thoracic and 3 colorectal) were developed to meet goals, which included improving the patient experience. Based on the data and anecdotal evidence from patients and clinicians, the evidence argues that nurse navigation has improved the patient experience in DAPs. The pilot program has now been terminated and nurse navigation within DAPs has successfully been adopted in Ontario. At this time, there are 13 colorectal cancer, 15 lung/thoracic, and 9 prostate DAPs in Ontario. Nurse navigation in the setting of a DAP continues to grow across the province.

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OCTOBER 2013 • VOLUME 4, ISSUE 5

AONNonline.org

FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY II: Psychosocial Support The Role of Nurse Navigation in Streamlining Care to Facilitate the Purposeful Visit Barbara-Anne Maier, RN BScN, CON(c); Shady M. Ashamalla, MD, MSc, FRCSC; Darlene S. Fenech, BScH, MSc, MD, FRCS(C); Stan M. Feinberg, MD, FRCS, FACS; Peter K. Stotland, HBSc, MSc, MD, FRCSC; Andrew J. Smith, MD, MSc, FRCSC, FACS Centegra Gaver’s Breast Center

Background: Patients often experience feelings of uncertainty when facing a cancer diagnosis and waiting for treatment plans.

A nurse navigator (NN) has the potential to reduce uncertainty and the associated stress that accompanies the diagnosis of cancer by providing information, assisting with navigating the system, facilitating a purposeful visit (PV) with clinicians, and meeting the patient’s expectations and need for information. At a large tertiary cancer program in Toronto, Ontario, the Diagnostic Assessment Program (DAP) has been implemented to create an efficient patient-centered pathway that utilizes an NN for the presurgical management of colorectal cancer. Objectives: To describe the implementation and results of a colorectal cancer (CRC) management pathway that redefines the traditional model of care in Ontario. This poster will highlight strategies completed by the NN to decrease uncertainty and improve the psychosocial well-being of patients with CRC by coordinating a PV. Methods: After referral to the DAP, patients are contacted by the NN for assessment, support, and to outline a plan of care. To achieve a PV with the surgeon, one in which a definitive oncologic plan is recommended, the NN arranges all staging and restaging tests, as well as multidisciplinary cancer conference (MCC) discussions and consults.

Throughout the staging phase, psychosocial support and symptom management are provided for the patient via telephone practice. Patients referred to CRC surgeons at a single tertiary cancer program from May 2011 to December 2012 were followed prospectively. Dates of referral, first NN contact, clinic visits, PV, and MCC presentations were recorded. In addition, as part of the ongoing evaluation of the DAP, patient satisfaction questionnaires were distributed, completed anonymously, and returned to the provincial oversight body for collation. Results: More than 200 referrals were made to the DAP within the study time frame. Median time from referral to NN contact was 3 days. Median time from first NN contact to first clinical visit (with staging completed) was 10 days. Patients reported high satisfaction with the DAP through questionnaire completion and anecdotal comments. Patients reported that nurse navigation, as well as psychosocial support, helped to alleviate feelings of anxiety and uncertainty. There is ongoing data collection for additional patient satisfaction metrics. Conclusions: Coordinated navigation through the presurgical management of CRC allowed patients to receive expedited care that minimized visits and led to a PV. Along with providing psychosocial support and expediting all necessary tests and consults prior to first contact with the surgeon, this navigated patient-centered program decreases uncertainty and increases patient satisfaction.

Face-to-Face Networks: An Innovative Way to Connect Young Women Diagnosed with Breast Cancer Stacy Lewis, BS, CHES Young Survival Coalition

Background: Young Survival Coalition (YSC) is the premier global organization dedicated to the critical issues unique to young women and breast cancer. In its 15-year tenure, YSC has provided resources, connections, and outreach so that young women feel supported, empowered, and hopeful. It is YSC’s goal to ensure that no young woman goes through breast cancer alone. Young women diagnosed with breast cancer have a strong desire to connect in-person with other young survivors.

YSC has received frequent requests from young survivors to bring YSC to their local community. Initially, YSC developed a system of local affiliates in communities with a strong local survivor presence. These affiliates, at one time numbering 30, provided support and outreach in their community and raised funds to support their operations. The oversight needed of these affiliates, as well as the volunteer fundraising burden, made affiliate sustainability difficult. Young women in areas without a local affiliate continued to contact YSC and inquire about starting one. Objectives: To create a programmatic initiative where young women diagnosed with breast cancer can connect with and support each other in their local communities. Methods: Beginning in 2010, YSC undertook an internal study of its affiliate structure with a frank assessment of its strengths and weaknesses. YSC interviewed affiliate staff, key affiliate volunteers, and the national staff responsible for overseeing their operations.

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CATEGORY II: Psychosocial Support YSC conducted a needs assessment and researched other organizations’ affiliate, regional, and grassroots structures.

Results: Based on this research and analysis, YSC launched its Face-to-Face (F2F) Networking program on April 1, 2013. This program allows a young survivor, located anywhere in the country, to start her own F2F network to connect young survivors in her community. The young survivor submits an application to YSC via its website, and once approved as an F2F Leader, receives a starter kit of materials and resources. The kit includes instructions for listing the network on Meet-up.com, a service paid for by YSC. Any young woman diagnosed with breast cancer seeking connection can search Meet-up to find a group or start her own. In just a little over 4 months, more than 60 F2F groups have been created across the country with additional applications pending. Feedback from F2F participants to date has been positive. Constituents are thrilled to have a means to connect with other young women in-person in their community. Conclusions: YSC’s F2F Networking program is a viable and innovative method of connecting young women affected by breast cancer, providing support and structure without the operational and fundraising demands of running a full-fledged affiliate. In just 4 months, YSC has doubled its local presence, bringing connections and support to more young women.

CATEGORY III: Tracking Processes Across the Continuum of Care Monitoring High-Risk Breast Cancer Patients in a Community Breast Health Center Through Implementation of a Plan of Care Tool Sara Hartke, RN, BSN, OCN Centegra Gaver’s Breast Center

Background: Initiation of a comprehensive high-risk breast cancer program at a community breast health center warranted the need for a plan of care document to monitor patients identified as high risk. Standardized care of patients at high risk for developing breast cancer (lifetime risk >20%) is necessary to ensure the highest quality care possible and can be effectively outlined using a plan of care tool. Objectives: Arrange patients identified as high risk for developing breast cancer so that they can be adequately monitored, and outline their individual prevention plans. Organize communications and eliminate potential confusion among a large multidisciplinary team. Produce greater continuity of care and revise current patient care practices to result in higher rates of screening breast magnetic resonance imaging (MRI) completion and reimbursement. Methods: A plan of care tool was created and reviewed by an interdisciplinary team. Four women identified as high risk for developing breast cancer using the Gail Model were selected and contacted to consent to participate in the pilot. Initial contact interview via e-mail/telephone was then initiated to obtain demographics, health history, and current prevention plan. Contact with the patient’s payer source was initiated once an MRI was requested. The plan of care tool was used to document all conversations and guide the process. Results: Three patients responded and participated. Two patients failed to respond after initial interview, despite several attempts via e-mail and telephone messages. One requested screening breast MRI and obtained preauthorization from a private insurance company but did not complete the examination due to a high deductible on her healthcare plan.

Conclusions: The tool effectively monitored interactions with the patients and outlined their individualized prevention plans by those working within the same setting; however, accessibility of the tool became an issue when needing to be accessed by providers that worked at another site within the healthcare system. Therefore, the use of the tool in paper form was not efficient. To make the tool more successful and easily accessible to the entire multidisciplinary team that interacts with the patients, it would need to be converted into an electronic form that can be accessed from any of the healthcare system sites. A small sample group and a time constraint of 10 weeks negatively impacted the outcome of the study. Lack of continued participation in the project resulted in inconclusive data. It is important to note that it is not unusual for this population of patients to need more time to accept the status of being considered high risk for developing breast cancer and what that means to them. Lack of completion of screening breast MRIs was a poor representation of improvement in the quality of care that the patient received and another method (perhaps a qualitative questionnaire to evaluate the patients’ perspective of the interactions and effects of the study would be a better option as patient satisfaction is a component of quality of care).

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY III: Tracking Processes Across the Continuum of Care Role of Patient Assessment, Navigation and Education in the Identification of Oncology Patients in Need of Rehabilitation Therapy Barbara R. McHale, RN, BS, OCN, CBCN; Sabrina Mosseau, RN, BS, OCN; Paula Burnor, PT, MS; Nancy Clemente, OTR/L; Anna Feldman, RN, OCN; Leslie Hurley, RN; Lauren Marcus, SLP; Denise Morris, PT; Sandra Sanderson, MSPT, CLT-LANA; Kelly Simpson, RN, OCN Samaritan Hospital Cancer Treatment Center, St Peters Health Partners

Background: At Samaritan Hospital Cancer Treatment Center, we realized that patients were not being referred to comprehensive therapy services in a timely manner. In our pursuit of patient-centered care, we identified the need for patients who were undergoing treatment, recently completed treatment, or living with unresolved issues as a result of their cancer treatment to have access to oncology rehabilitation. These unresolved issues include, but are not limited to, musculoskeletal pain, decreased strength and endurance, balance problems, fatigue, vertigo, limitations in range of motion, and speech/ swallowing issues. In 2012, meetings began to implement a highly trained, multidisciplinary oncology rehabilitation team that utilized evidence-based practice and measured patient outcomes. This team explored current and future state options.

Because we are a small community-centered practice, it was cost-prohibitive to purchase and implement a national program.

A service inventory was undertaken to identify current strengths and programs, including a robust physical, occupational, and speech therapy program; highly specialized lymphedema therapists; myotherapy; Healing Touch; a Pink Pilates program; and massage therapy. The major areas of concern were improving patient identification and access to oncology rehabilitation, assigning a navigator as point of contact and care coordination, educating patients and providers on available services, and development of a physical, occupational, and speech therapy evaluation and treatment care plan. This care plan is currently being piloted at Samaritan Hospital Cancer Center, but will be initiated at other centers across St. Peter’s Health Partners.

Also noted as important was incorporating evidence-based outcomes in the oncology rehabilitative treatment of our patients.

It is our goal to assist our patients in receiving treatment services in an equitable and timely manner, to remove barriers to their care, and to educate patients, thereby improving outcomes. Objectives: (1) Develop and implement a process to identify impairments and streamline patient access to oncology rehabilitation; (2) INCORPORATE a navigator in patient care from time of initial diagnosis through the continuum of care to assist in breaking down barriers to rehabilitation access; (3) ENCOURAGE physician and nursing awareness of the need for oncology rehabilitation through focused education sessions; and (4) INCREASE the percentage rate of oncology rehabilitation consults through a systematic approach to care. Methods: (1) Implemented a patient care plan to identify physical and occupational impairments. (2) In conjunction with the rehabilitation departments, a functional reference sheet was designed to be used as a guideline for standardized assessment. (3) Edited the medical oncology nursing assessment flow sheet to identify parameters for patient deficits in the areas of range of motion, gait, activities of daily living, dizziness, and swallowing. (4) Physician order sheet was updated to include referral information for oncology rehabilitation. (5) Standardized process that at each patient visit the oncology nurse utilized the functional reference sheet in conjunction with the nursing assessment form to identify patients with impairments. (6) Development of a standardized communication tool to track and trend oncology rehabilitation referrals and documentation of patient outcomes. (7) Worked collaboratively with “TruJoy” to place their bags in our preadmission testing department, to be given to postoperative mastectomy patients. These bags included educational materials, a reacher, specialized axillary pillows, a stress ball, and nonchemical soap and lotion. Our patients also received postmastectomy camisoles. Results: Implementation of this process has shown a 10% increase in patient referrals from the cancer center to the rehabilitative program in a 3-month interval compared with the previous year. The increase in patient referrals has led to an increase in volumes and downstream revenue for our facility. This process has allowed our facility to create a reimbursable oncology rehabilitation program. With the identification of impairments, the timely referral to our rehabilitative program, and the determination by our therapists of the patients’ needs, a treatment plan is developed. This process has been instrumental in promoting survivorship care through improved access to services. Conclusions: Oncology rehabilitation is a valuable service that positively impacts patients’ functional status, both physical and emotional. This program was implemented on February 1, 2013, and through evaluation, tracking outcomes, and a final analysis, we will prove the impact of a standardized functional assessment of all of our patients.

We have shown that it can be implemented in a community-based hospital with minimal cost through utilization of services and programs already available. With patient-centered, coordinated care we expect to see improved patient satisfaction in care delivery at our center.

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY III: Tracking Processes Across the Continuum of Care Across the Cancer Continuum: Tracking Processes Across the Continuum of Care Melissa Andres, BSN, RN, OCN, CBPN-C; Erika Kacer, BSN, RN, OCN St Vincent Health

Objectives: The overall mission of the St Vincent Cancer Care program is “to be the first choice provider of the most advanced cancer care, delivered by a highly skilled and compassionate team, serving in partnership with our patients and their loved ones, through and beyond their cancer journey.” To meet this mission, St Vincent had a vision to transcend cancer care to support the mind, body, and spirit of each person we serve throughout the continuum of their cancer journey. Background: In 2010, St Vincent piloted patient navigation to serve and support those patients with breast cancer. The goal was to develop a sound process for navigation, monitor the benefits and outcomes of navigation in this patient population, and then expand to all other cancer sites. In 3 years, the St Vincent Cancer Care program has expanded not only navigation, but has also added an outreach coordinator, imaging navigator, inpatient navigator, survivorship services, and a supportive care program. Methods: The breast navigation pilot was developed to proactively navigate patients with breast cancer. Rather than waiting for referrals, the navigator connected with patients at the time of diagnosis. The volume increased from 14 new referrals in the first quarter of 2010 to 133 new referrals by the end of 2010. Results: This showed the need to add additional navigators to meet the needs of our patients. We expanded our pilot to include all cancer sites, and our volume of referrals for navigation services increased from 133 in 2010 to 277 in 2011. In 2012, we had 804 new referrals, and in 2013 we have had 775 new referrals in the first 3 quarters. As our volume increased, we added additional navigators. Today we have 6 outpatient navigators and 1 inpatient navigator. In November, 2011, St Vincent also added survivorship support groups for patients and caregivers as well as a creative expressions art program, and the number of participants for survivorship services has increased 186% in 1 year.

Assessing Breast Cancer Survivorship Needs in the Community Pamela Goetz; Lillie Shockney, RN, BS, MAS Johns Hopkins Medicine, Sibley Memorial and Suburban Hospitals

Objectives: As community hospitals in the Johns Hopkins Medicine network, Sibley Memorial Hospital and Suburban Hospital recognize the importance of meeting the needs of patients with cancer after completing active treatment. With dedicated staff to develop survivorship programs following the Hopkins Baltimore, Maryland model that also address the specific needs of people in our service areas, focus groups were conducted with breast cancer survivors to determine what gaps in services they experienced, what their ongoing health concerns are, and what survivorship programming would be of interest to them. Methods: Women with stage 0 to stage III breast cancer were recruited by providers at the 2 hospitals.

Focus groups took place at each hospital and were facilitated by the Director of the Survivorship Programs at Johns Hopkins and the Oncology Survivorship Coordinator at the community hospitals, with a total of 13 survivor participants. The women completed a questionnaire to obtain “hard” data about treatments received, side effects, and interest in various survivorship programming. The facilitator led the group through a series of questions in an open-ended discussion. Results: Self-advocacy is recognized as a necessary skill to get access to care, identify reliable information about cancer, and find support resources.

Women wished for more sensitive and clearer communication from their providers. Sexual health problems are significant, yet no provider raised these as potential side effects or what to do about them. More than 75% of the participants have struggled with anxiety, depression, fatigue, insomnia, memory problems, skin changes, and vaginal dryness. Close to 70% worry about recurrence. Several of the participants expressed the need for case management, family support, and clarity about who, among their many oncology providers, they should go to for survivorship care. Conclusions: The hospitals’ care teams are dedicated to meeting the survivorship needs of our patients with breast cancer, and have begun to develop educational programs and offer navigation along the continuum that will address women’s needs, voiced during the focus groups. A 1-day survivorship retreat will take place in September, with presentations designed to provide practical help on how to regain control after completing active treatment for breast cancer. The agenda includes talks by experts on reclaiming your life, coping with late effects of therapy, maintaining a healthy weight through nutrition and exercise, reconnecting with a healthy sex life, learning about integrative health modalities, and hearing from a survivor panel on how they moved on. Results will be shared on the poster.

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY III: Tracking Processes Across the Continuum of Care Novice to Expert: Training Methods for the Cancer Center Treatment Navigators at Boston Medical Center Katie Finn, BA; Sheldon Reeves, AA; Kathryn Ankner, BA; Juliana Merhaut, MA; Robyn Souza, RN, MPH; Chris Andry, PhD; Kathleen Finn, MSN, NP Boston Medical Center

Boston Medical Center (BMC) is a private, nonprofit academic medical center with approximately 65% of patients coming from neighborhoods with the highest levels of mortality and health disparities. At BMC, Cancer Center Treatment Navigators (CCTNs) have succeeded in becoming valued members of the cancer center, helping patients with complex needs work their way from diagnosis into survivorship. Currently 4 CCTNs collectively receive approximately 36 new referrals per month with an average monthly workload of 80 patients per CCTN with approximately 3 identified barriers per patient. A key component to the success of this program lies in the comprehensive training curriculum developed by the CCTNs and their nurse mentors.

This training program became a standardized best practice in 2011 for BMC’s CCTNs. The CCTN training curriculum is divided into 3 phases. The first phase begins with general hospital orientation, trainings, and an introduction to the CCTN’s preceptor. The novice CCTN will then tour the hospital with their preceptor in order to understand the potential challenges a patient may face when navigating a large hospital campus.

The next phase focuses on providing an overview of BMC’s cancer program with an emphasis on understanding cancer and the potential impact the disease can have on a patient and their family. The novice CCTN will shadow specialties such as social work, clinical research nurses, and treatment nurses. The CCTN attends tumor boards, receives a comprehensive review of treatment algorithms, Standard Operating Procedures, and attends cancer support groups. After each meeting with a specialist or attendance at a group, the novice CCTN will meet with their preceptor to review and discuss the CCTN’s understanding of what was learned and how to incorporate that knowledge into their role.

The third and final phase of training includes specifics such as interviewing patients, identifying and addressing barriers to care, utilizing resources, documenting in the electronic medical record, customer service, and telephone triage. The CCTN spends a significant amount of time shadowing the experienced CCTN in all areas of the role. At the end of this phase, the CCTN will begin working independently under direct observation of their preceptor.

In conclusion, the curriculum is designed so that each phase of learning builds on the last, incorporating new skills with ongoing discussion between CCTN and preceptor. Competencies are assessed throughout the training period and include direct observations, quizzes on oncology knowledge, role-playing, and case presentations including review of chart documentation. In addition, continuing education is provided on an ongoing basis by the cancer care team members as well as by attendance at national conferences. A standardized training curriculum and ongoing education is paramount for a successful oncology patient navigation program.

Initial Results Tracking Patient Satisfaction in an Oncology Navigation Program Dorothy Morrone, RN, MS, OCN; Diane McHugh, RN, BSN, OCN; Laura Beaupre, RN, BSN, OCN, CBPN-IC; Kathleen Sevedge, RN, MS, AOCN; Jane Zubia, RN, OCN, CBPN-IC; Raizalie Roman-Rosado, RN, BSN, CMSRN; Maritza Y. Chicas, RN, BSN, PCCN Lehigh Valley Health Network

Background: Patient satisfaction is an important outcome measure in oncology navigation. Our cancer center participates in the National Cancer Institute Community Cancer Centers Program (NCCCP), which has a focus on patient navigation. The Navigation Assessment Tool developed by the NCCCP includes a section on Quality Improvement Measures supporting the importance of utilizing patient satisfaction data. The RN navigation team at Lehigh Valley Health Network developed and implemented a satisfaction survey in English and Spanish to evaluate aspects of navigation. Surveys were returned from 60 patients over a 6-month period. Objective: To evaluate patient satisfaction with navigation and use for process improvement.

Methods: Surveys from 4 NCCCP sites and Press Ganey questions used in the Cancer Center were reviewed. Navigators identified questions related to aspects of navigation, including communication, care coordination, referral to services, and support; operational issues such as ease of access to navigator and timely return of phone calls; and customer service items including

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY III: Tracking Processes Across the Continuum of Care courtesy and value of the navigator, and suggestions for improvement. Ten questions from NCCCP satisfaction surveys were incorporated into our survey. Eight additional questions were created. No Press Ganey questions were used. The final survey contains 18 questions: 15 using a 5-point Likert scale; 1 regarding number of contacts with the navigator and 2 fill-ins. In January 2012, upon discharge from navigation, patients were mailed a satisfaction survey, cover letter, and addressed, stamped envelope. Surveys returned between January and June 2013 were reviewed and tallied.

Results: A total of 394 surveys were mailed to patients. Sixty were returned (15% response rate). The average score of all questions was high; 4.7 of 5. The range of scores was 4.51 to 4.89. High-scoring questions related to customer service: courtesy; being treated like an individual; and overall experience with the navigator. Lower-scoring questions were related to aspects of navigation: “The support I got from my navigator helped me complete my treatment”; “My navigator provided support to my family when needed.” These questions also had a higher response of “nonapplicable.”

The fill-in question, “What did you like best about having a navigator?” received many positive comments. There were 3 suggestions for improvement. Conclusions: Overall patient satisfaction is high. The navigation team reviewed the results and chose 1 item for process improvement that was incorporated into their performance evaluation. Goal: Improve timeliness of phone calls to patients. The navigation team will review patient satisfaction every 6 months.

Funded by National Cancer Institute Contract No. HHSN261200800001E.

Mapping: A Quality Improvement Tool for Patient Navigators Heather Kapp, LICSW, MPH; Monica Dreyer, MA; Diana Garcia, BS; Leshia Hansen, RN, BSN; Elizabeth Hatcher, RN, BSN; Eva Ruiz, BS; Mandi Pratt-Chapman, MA George Washington University

Background: The GW Cancer Institute, in partnership with the GW Medical Faculty Associates and the GW Hospital, has built a comprehensive patient navigation service to assist patients across the cancer continuum.

Three lay navigators work as a team with a nurse navigator, a cancer center social worker, and a survivorship navigator to assist patients throughout their cancer experience. Objective: In 2013, the team embarked on a process mapping project for the breast cancer patient treatment flow. The objective was to identify gaps in care to implement quality improvement projects executed by the navigators. Methods: The navigators separately mapped the process in each clinic where they work. When completed, the patient flow across the continuum of care for the patients with breast cancer had been documented. The navigators met as a team with all the process maps to discuss how to best utilize each navigator without duplication. The team examined how referrals are made, when to refer to survivorship, the best process for barriers to care and distress screening, etc. Based on these discussions, quality improvement initiatives were prioritized and meetings were held with key stakeholders for buy-in and support. Results: Each navigator has quality improvement projects that stemmed from the process mapping, which will improve referrals to psychosocial support services and ensure patients’ access to follow-up care. A few of the quality enhancements are the following: (1) Improving loss to follow-up by calling patients after a missed screening test or any missed follow-up to inquire about barriers to completion of the diagnostic process. (2) Developing and implementing an educational presentation to decrease incorrect referrals with community clinics and to make the diagnostic process smoother for patients. (3) Implementing a process of mailing invitations to patients to offer them a survivorship clinic appointment. (4) Establishing a process for referring patients with barriers to care to the radiation oncology navigator. Conclusions: Mapping the breast patient’s process along the continuum helps prioritize quality improvement (QI) projects, defines how navigators can contribute to QI, and helps ensure navigators are focused on true navigation. We are early in the process of implementation; however, we believe this will improve patient care. As part of this process, a distress screening protocol has been implemented in partnership with the cancer center social worker, and the survivorship navigator has already noted an increase in referrals to the survivorship clinic. Key to the success of this project is improving the data tracking and measurement of the QI projects. GW Cancer Institute is currently working to implement an electronic database that will be critical to tracking the success of these quality improvements.

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SCIENTIFIC CONFERENCES 2013-2014:

AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Co-Chairpersons: Jeffrey A. Engelman, Lee J. Helman, and Sabine Tejpar October 19-23, 2013 • Boston, MA Twelfth Annual International Conference on Frontiers in Cancer Prevention Research Chairperson: Paul J. Limburg October 27-30, 2013 • National Harbor, MD Pediatric Cancer at the Crossroads: Translating Discovery into Improved Outcomes Co-Chairpersons: John M. Maris, Stella M. Davies, James R. Downing, Lee J. Helman, and Michael B. Kastan November 3-6, 2013 • San Diego, CA The Translational Impact of Model Organisms in Cancer Co-Chairpersons: Cory Abate-Shen, A. Thomas Look, and Terry A. Van Dyke November 5-8, 2013 • San Diego, CA Ninth Annual Personalized Medicine Conference Chairperson: Raju Kucherlapati November 6-7, 2013 • Boston, MA Advance registration deadline: Friday, October 11 Sixth AACR Conference on The Science of Cancer Health Disparitites in Racial/Ethnic Minorities and the Medically Underserved Co-Chairpersons: John D. Carpten, Christopher I. Li, and Olufunmilayo I. Olopade December 6-9, 2013 • Atlanta, GA Advance registration deadline: Thursday, October 24 CTRC-AACR San Antonio Breast Cancer Symposium Co-Directors: Carlos L. Arteaga, C. Kent Osborne, and Peter M. Ravdin December 10-14, 2013 • San Antonio, TX Early registration deadline: Thursday, October 31

AACR-IASLC Joint Conference on Molecular Origins of Lung Cancer Co-Chairpersons: Roy Herbst, Elisabeth Brambilla, Pasi Jänne, and William Pao January 6-9, 2014 • San Diego, CA Abstract submission and award application deadline: Monday, October 14 Advance registration deadline: Tuesday, November 26 AACR-Prostate Cancer Foundation Conference on Advances in Prostate Cancer Research Co-Chairpersons: Arul M. Chinnaiyan, William G. Nelson, June M. Chan, and Jonathan W. Simons January 18-21, 2014 • San Diego, CA Cancer Susceptibility and Cancer Susceptibility Syndromes Co-Chairpersons: Alan D. D’Andrea, Phillip A. Dennis, and Pier Paolo Pandolfi January 29-February 1, 2014 • San Diego, CA Abstract submission deadline: Wednesday, November 13 Advance registration deadline: Monday, December 9 RAS Oncogenes: From Biology to Therapy Co-Chairpersons: Frank McCormick, Dafna Bar-Sagi, and Channing J. Der February 24-27, 2014 • Lake Buena Vista, FL Abstract submission and award application deadline: Friday, December 6 Advance registration deadline: Monday, January 13 Cellular Heterogeneity in the Tumor Microenvironment Co-Chairpersons: Mary Helen Barcellos-Hoff, Michele De Palma, and M. Celeste Simon February 26-March 1, 2014 • San Diego, CA Abstract submission and award application deadline: Monday, December 16 Advance registration deadline: Monday, January 13 AACR Annual Meeting 2014 Chairperson: Scott W. Lowe April 5-9, 2014 • San Diego, CA

FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY III: Tracking Processes Across the Continuum of Care An Outcomes Management Process for Navigation Sharon Bartelt, RN, MSN, MBA, OCN, CPHQ, CSSBB Gibbs Cancer Center & Research Center

Background: Return on investment (ROI) is ever more critical in an environment of minimal healthcare dollars and limited resources, including full time equivalent allocation—to that end, a current database at Gibbs Cancer Center was utilized and further developed to track the interventions/referrals of oncology nurse navigators. The database allows nurse navigators to enter patient-specific data that track outcomes metrics, which in turn enables leadership to realize the value, both monetarily and in patient satisfaction outcomes. Objective: To develop a process of tracking outcomes metrics related to disease-specific nurse navigators in a community cancer center setting. Methods: Implementation of a team approach consisting of nurse navigators and the MIDAS database system administrator to brainstorm and develop the MIDAS Community Case Management module currently in use at Spartanburg Regional Healthcare System as the method of tracking navigation data. Results: The MIDAS Community Case Management module now has the ability to track each disease-specific nurse navigator datum related to interventions/referrals (ie, 6200 interventions/referrals by breast navigators in 2012; 4300 referrals/interventions by lung navigators in 2012), number of navigated patients by race, disease-specific navigated patients by cancer and noncancer, case hours by each disease-specific navigator, new patients, follow-up patients, patients presented at the multidisciplinary planning conferences, and patients who were admitted to the hospital or had an emergency center visit during navigation.

Conclusions: The MIDAS database clearly has been invaluable in tracking metrics related to ROI for each disease-specific navigator. As a result, a cost-savings can be calculated from the MIDAS data and can validate the nurse navigator role at Gibbs Cancer Center. Outcomes metrics include: Operational Indicators: Volume, Workload, Race/Ethnicity Referral origin.

Quality Indicators: Patient Satisfaction Data, Physician Satisfaction Data, Clinical Trials, Multidisciplinary Coordination.

ROI: Inpatient, Admissions, Observation Days, Navigation Driven Volume.

Assessing Prostate Cancer Survivorship Needs in the Community Pamela Goetz; Lillie Shockney, RN, BS, MAS Johns Hopkins Medicine, Sibley Memorial and Suburban Hospitals

Objectives: As community hospitals in the Johns Hopkins Medicine network, Sibley Memorial Hospital and Suburban Hospital recognize the importance of meeting the needs of cancer patients once they complete active treatment. With dedicated staff to develop survivorship programs, following the Hopkins Baltimore, Maryland model that also address the specific needs of people in our service areas, focus groups were conducted with prostate cancer survivors to determine what gaps in services they have experienced, what their ongoing health concerns are, and what kind of programming would be of interest to them. Methods: Participants for the focus group were recruited by physicians, social workers, nurses, and navigators at the 2 hospitals. Separate prostate cancer focus groups took place at each of the hospitals and were facilitated by the Director of the Survivorship Programs at Johns Hopkins and the Oncology Survivorship Coordinator at the 2 community hospitals. A total of 10 survivors, with 6 wives or partners attended. Of the 10 men, 2 had a local recurrence and 2 had advanced disease. The participants completed an anonymous questionnaire to obtain “hard” data about treatments received, side effects and level of impact, and interest in various survivorship programming. The facilitator led the group through a series of questions in an open-ended discussion. Results: In spite of spending a lot of time researching options, men often experience challenges in decision-making about treatment. One hundred percent of the men struggle with side effect treatment. Sexual dysfunction and/or incontinence are primary side effects that plague men, and they persistently seek ways to either prevent or resolve these problems. A majority of the men worry about recurrence or disease progression. The participants expressed a need for interdisciplinary, one-on-one decision-making support, in-depth posttreatment side effect management, and interest in evidence-based programs that would reduce stress, manage late and long-term treatment effects, help with stress reduction, or reduce risk of recurrence. Conclusions: The mission of the hospitals’ cancer care teams is to address the ongoing healthcare needs of our patients with prostate cancer, and will use the data from these focus groups to promote patient self-advocacy and to provide programs, education, and services to meet the needs of patients beyond active treatment. Quarterly survivorship education programs are planned, with the first addressing sexual health issues scheduled for October 2013.

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY III: Tracking Processes Across the Continuum of Care Developing an Oncology Nurse Navigation Process Along the Continuum of Care at the New Calaway Young Cancer Center at Valley View Hospital Mary Crann, RN, MSN, OCN; Diane Carnoali, LSW; Bart Carnoali, RN, BSN, MHSM, PMP Calaway Young Cancer Center at Valley View Hospital

Objective: It is the desire of the Calaway Young Cancer Center at Valley View to provide timely, appropriate care and reduce disparity for patients with cancer through the development of an oncology nurse navigator (ONN) program.

Background: A Community Needs Assessment, in conjunction with Cancer Committee leadership, served as a building block for the opening of a new cancer center with an ONN program. The Cancer Committee decided to initiate the ONN program with newly diagnosed patients with breast cancer and end with the presentation of a Survivorship Care Plan at the conclusion of active treatment. Methods: An intake form together with National Comprehensive Cancer Network Distress Tool will be used to identify and track barriers. Data will be collected to measure timeliness of care using American Cancer Society benchmarks. Metrics will be analyzed to measure success in reducing disparities.

Reports will be generated and presented to the Cancer Committee leadership on an annual basis. A subcommittee was formed to develop an algorithm for the nurse navigation process along the continuum of care. The process starts at diagnosis when the ONN receives a report of positive pathology. The ONN contacts the referring physician for permission to contact the patient, and within 3 days of diagnosis arranges for initial consult if one has not been made.

Barriers are identified and social work is notified of the newly diagnosed patient. The ONN accompanies the patient to the first appointment, reviews plan of care, makes additional appointments, educates, and empowers the patient to overcome barriers. All newly diagnosed patients with breast cancer are presented at weekly multidisciplinary team meetings and referrals are made for ancillary services. The ONN continues to educate, identify, and work on barriers along the continuum of care. At the end of active treatment, the patient is presented with a Survivorship Care Plan. The process will be reviewed by a subcommittee, and any required changes will be presented to the Cancer Committee. Conclusions: The ONN program will help patients receive timely care and reduce disparities for patients with cancer in the community. The plan is to expand the program into other specialty areas, giving all newly diagnosed patients with cancer better access to care. The ONN program is a key step in obtaining American College of Surgeons Commission on Cancer accreditation.

Building a Continuum of Care: The Breast Channel Amy E. Rettig, MSN, MALM, ACNS-BC, PMHNP-BC, CBCN® Ohio State University Medical Center

Background: In the ever-changing world of breast oncology, keeping up to date requires much independent study for the nurse navigator. Even comprehensive breast care centers, resource rich with interdisciplinary care teams available within one building, may have difficulty coming together as one larger team instead of independent disciplines. Two years ago, the Breast Cancer Clinical Nurse Specialist developed and implemented a weekly, 30-minute, informal, evidence-based forum for all healthcare persons involved in the breast cancer continuum of care to help the interdisciplinary team keep current. “The Breast Channel” is now moving forward into its third year full of potential. Objective: Attendees will understand how The Breast Channel can create an integrated, educated, and patient/family-focused staff caring for our patients with breast cancer. Nurse navigators will understand the advantages of having a well-informed continuum of care team. Methods: A 5-week focus group determined the optimal mechanism for providing education across a continuum of care. Real-time, audioconferencing with subsequent podcasting was found to be the most accessible and reasonable for all staff. New and emerging technologies provide the means for audioconferencing, podcast editing, and a podcast repository. Often these technologies are free to users. Results: A survey of the continuum of care team discovered that The Breast Channel, starting as a weekly, 30-minute teleconference podcasted for future listening, is now used for on-boarding new staff, Certified Breast Care Nurse® examination review, professional development, interdisciplinary collaborations, and patient education. An

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CATEGORY III: Tracking Processes Across the Continuum of Care independent reviewer evaluated 88 podcasts for key elements important for public listening: delivery, speech clarity, vocabulary, and technology. Twenty-two were considered immediately suitable for public listening with many others eligible after editing. Conclusions: Keeping the healthcare team, including nurse navigators, current in the rapidly changing oncology world has been facilitated by The Breast Channel. New and emerging technologies provide the means to create accessible information to all persons involved with the care of patients with breast cancer. Integrating different disciplines, including nonclinical departments, can be facilitated by simple audioconferencing and podcasts.

Oncology nurses have used this forum to review for certification in breast care as well as to develop their professional careers by presenting on current oncology nursing topics. Other disciplines have used The Breast Channel to on-board new staff and to enhance professional development. Future opportunities include allowing patients to access podcasts, conference information dissemination, and replication in other cancer continuums of care.

Developing a Cancer Rehabilitation Service Line Christine Conkling

Bassett Healthcare Network

Background: The Bassett Cancer Institute (BCI) is a comprehensive community cancer center in New York with approximately 1225 analytic cases per year. In 2011, BCI expanded its survivorship services with a strong nurse practitioner leader who then took another position in 2012. The survivorship program languished until a new nurse was hired to lead the program. Objective: Many survivorship programs are in flux due to changes in leadership, and this abstract describes how one program has faced this challenge and is now rebuilding. Methods: BCI has a survivorship program with a core component of a cancer rehabilitation service line through the STAR ProgramÂŽ certificationâ&#x20AC;&#x201D;launched in January 2012. The program had a robust beginning under the leadership of a nurse practitioner; however, after her departure in June 2012, the program languished, with only 16 referrals through year-end. BCI recognized that a strong leader was needed to continue the program and recruited a nurse with extensive experience in administration and community outreach who took on the role of revitalizing the program in December 2012. The multidisciplinary team was assessed, and new members were identified to ensure there was adequate representation from all disciplines. The team meets monthly to network, share experiences, break down barriers, and seek innovative ideas in an effort to increase referrals to the program. To increase awareness of the program, the new manager developed a presentation outlining the program benefits and began providing education to referring clinicians throughout the region. To streamline the referral process, there is a STAR Program referral in Epic available to the entire network. The program is focused on patient-centered care, and survivors have been invited to give feedback regarding the services. Results: August 2013 year-to-date rehabilitation referrals are 38 (an increase of approximately 140% compared with a similar interval in 2012), and projected referrals for 2013 are anticipated to be at least 75 new patients. Many of the new referrals have come from physicians who had never referred to the program before, suggesting widespread adoption among referral sources. Conclusions: Survivorship programs benefit from dedicated leadership and may suffer from staff turnover. New leaders may face significant challenges when attempting to revitalize a program after a change, and a strategic approach is helpful. BCI is focusing on screening protocols, updating website content so that survivors learn more about these services, giving formal lectures and having informal discussions with referral sources (particularly focusing on physicians and nurse navigators), and assessing the physical outcomes as well as the patient satisfaction outcomes of the people who go through the program.

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CATEGORY III: Tracking Processes Across the Continuum of Care Centralizing Imaging Review Prior to Initial Consultation for Breast Cancer Treatment Fran Spiro, RN, BA, BS, OCN Memorial Sloan-Kettering Cancer Center

Background: The Breast Surgery Service at Memorial Sloan-Kettering Cancer Center has 9 surgeons who see an average of 85 new consults each week. Patients are asked to provide all breast imaging studies from the past 3 years, including mammograms, sonograms, and magnetic resonance images for our radiologists to review. New patients frequently arrive having had biopsies elsewhere, with pre- and postprocedure imaging and reports. Traditionally, our Physician Referral Service asked patients to bring imaging materials to the consult appointment. Drawbacks to this process included receipt of incomplete imaging materials, making it impossible to form a definitive surgical plan; disruption of patient flow in the clinic, adding to wait times; and the need for repeat visits for patients to deliver missing studies, repeat imaging, and/or additional biopsies preoperatively. Objective: A new Early Film Submission (EFS) process was initiated in January 2011.

The goal was to have more complete information available to the surgeon before a new patient’s visit. This would allow for scheduling of any additional imaging or biopsies that were recommended on the day of the consultation, decrease patient wait times in the clinic, and facilitate formulation of a definitive surgical plan. Methods: New patients were asked to deliver imaging studies to the surgeon’s office 3 to 7 days before the initial consultation. Review of these cases was centralized through 1 nurse well versed in the diagnosis and surgical treatment of breast cancer. Her clinical expertise enabled her to assess the completeness of the film package, identify how best to obtain missing information, and guide newly diagnosed—often overwhelmed—patients through the maze of gathering clinical information for the consultation. Results: Centralizing the process through an experienced clinician resulted in standardization and improved accuracy of information provided to the reading radiologist and increased the number of radiology consult reports available for the surgeon at new visits. There was a significant decrease from 34 to 20 days between the initial patient visit and the date of surgery.

Office practice nurses, radiologists, and surgeons reported increased satisfaction with the EFS process in surveys taken at 3 and 6 months postinitiation. These positive findings increased use of the EFS process from 48% to 66%, as reflected in data collected in the first quarter 1 year before and 1 year after initiation. Conclusions: Having an identified clinical nurse for film review prior to breast cancer consultation resulted in better communication and coordination between the surgery and radiology departments, decreased disruptions to patient-focused nursing care during clinic, and shortened the time for a new patient to have surgery. Additional resources would allow for increased EFS volume, increased data assessment, and ability for the nurse to expand patient outreach.

Arizona Young Breast Cancer Survivor Support Initiative: Needs Assessment Mikala Edwards, MPA; Alisa Domb, RN; Sherry Gage; Paulla Miller John C. Lincoln Health Network

Background: More than 400 young women are diagnosed with breast cancer each year in the state of Arizona.

Young women face many unique challenges related not only to their disease and treatment, but also to their overall health, career, fertility, personal relationships, and finances. The Arizona Young Breast Cancer Survivor Support Initiative is a cooperative agreement between the Centers for Disease Control and Prevention and John C. Lincoln Health Foundation. The goal of this initiative is to evaluate Arizona programs and services that support young (<45 years of age) breast cancer survivors, their families, and caregivers. Objectives: (1) Identify needs of young breast cancer survivors throughout the state of Arizona; (2) Examine existing programs and services; and (3) Develop new programming to address unmet needs of this group. Methods: Establish the Arizona Young Breast Cancer Survivors Outreach Coalition and Arizona Breast Cancer Resource Guide committee to identify and review existing community services. Both of these groups are comprised of the target population, breast cancer organizations, and community members who represent the ethnic and racial diversity from the urban and rural populations of Arizona.

Members of these 2 groups identified individuals through personal and professional contacts and distributed the

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CATEGORY III: Tracking Processes Across the Continuum of Care online, www.surveymonkey.com/s/azbreastcancer, and paper versions of a needs assessment survey to all counties of the state. In addition, John C. Lincoln’s breast health awareness partnership with the local media known as “Buddy Check 12” publicized the survey and provided a link to the online survey. The hard copy survey was translated into Spanish. Results: One hundred seventeen surveys were completed and reviewed. Identified gaps in services were understanding diagnosis and treatment options; availability of resources and financial assistance; addressing feelings of negative body image, sexuality, and relationships after cancer; finding support for friends and family, and maintaining relationships; and connecting with other young survivors. Conclusions: Based on the results of the needs assessment, the initiative will host and provide programmatic materials and education pertinent to the geographic area, cultural background, and age of those constituents. In addition, education will be provided to the medical community, including patient navigators regarding available resources for young survivors. In addition to the outreach and personal programming, an online resource guide was developed and shared with sites through Arizona, www. azbreastcancer.org.

CATEGORY IV: Original Research Thriving Again: Development of a Proactive Survivorship Program for Young Jewish Breast Cancer Survivors Sharon Stahl, LMSW; Amy Mines Tadelis, Survivorship Program Supervisor Sharsheret

With the American College of Surgeons Commission on Cancer’s new accreditation standards calling for healthcare professionals to provide survivorship care plans to all cancer survivors by 2015,1 there is a pressing need for useful tools and programs to be developed and implemented on a national level. With funding from the Centers for Disease Control and Prevention, Sharsheret developed and launched Thriving Again, a breast cancer support and education program to address the needs of young (diagnosed <45) breast cancer survivors that includes a survivorship care plan to be used by patients and their healthcare providers, as well as other critical survivorship resources.

In developing Thriving Again, we engaged in a year-long review and analysis of the survivorship field, conducting a national survivorship survey of more than 1700 young breast cancer survivors to better understand their unique needs and the identification of best practices and resources addressing survivorship needs. The data collected allowed us to identify the resources already available to young survivors and their priority unmet needs, and to create new resources as part of a comprehensive program to address their unique concerns. Thriving Again has reached more than 1000 young breast cancer survivors, and includes a survivorship care plan, psychosocial and genetic support for young breast cancer survivors, and critical survivorship resources.

Using Thriving Again as a model, there is an opportunity to develop similar programs that address the needs of young men and women facing other types of cancer. This presentation will offer strategies for developing a comprehensive, proactive survivorship program that includes a survivorship care plan that can help organizations and facilities meet the Commission on Cancer’s guidelines for survivorship. Specifically, an overview of existing care plans will be offered as well as guidance in the development of a national needs assessment tool, translating research on priority needs for specific populations into practical tools, creation and implementation of a comprehensive survivorship program, and educating survivors and families affected by cancer and the healthcare professionals who care for them.

REFERENCE

1. P arry C, Kent EE, Mariotto AB, et al. Cancer survivors: a booming population. Cancer Epidemiol Biomarkers Prev. 2011;20(10):1996-2005.

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CATEGORY IV: Original Research The Effect of Survivorship Care Plans on Breast Cancer Patient’s Communication, Attitudes, and Self-Efficacy Pamela J. Vetter, MSN, RN, OCN Aspirus Regional Cancer Center

Background: The Institute of Medicine (IOM), in their report From Cancer Patient to Cancer Survivor: Lost in Transition, found cancer patients often lack the information they need to successfully navigate the transition from patient to survivor (2006). To assist patients in this endeavor, the IOM has recommended the use of a survivorship care plan (SCP) to help ensure patients are educated about their disease, side effects, necessary follow-up, and available resources, and are empowered to participate more in their care. The Commission on Cancer will soon be requiring SCPs for cancer programs to remain accredited despite a lack of research measuring overall efficacy. Objective: Determine if patients with breast cancer completing active cancer treatment who receive a SCP participate more in their care, maintain a more positive attitude, and are more knowledgeable about available resources than patients with breast cancer completing active treatment who do not receive a SCP. Methods: Patients with breast cancer completing treatment prior to and after SCP implementation were surveyed using a psychometrically sound tool, the Communication and Attitudinal Self-Efficacy scale for cancer, modified for survivorship. A pre-SCP survey was sent to all 24 patients with breast cancer who completed treatment in the 6 months prior to SCP implementation, and a post-SCP survey was sent to 28 of the 29 patients with breast cancer who completed treatment in the initial 6 months of SCP implementation. Results: Eight of 24 patients completed the initial survey (response rate [RR], 33.3%). In the post-SCP survey group, there were 16 respondents (RR, 57.1%). Post-SCP, all scores increased between 5.8% and 13.5%; the largest increases were seen in care participation and being able to request help. The smallest increases were seen in controlling negative feelings about cancer. Conclusions: The higher survey response rate post-SCP implementation may be due to patients having a better understanding of survivorship and therefore being more willing to complete the survey. The items showing the largest score increases are understandable, as they directly correlate with the purpose of the SCPs: communication and involvement in care, unlike maintaining a positive attitude, which was not a goal of SCPs, but perhaps a secondary benefit. The improved scores were encouraging; however, it was a small pilot project focusing on patients with breast cancer. It may be beneficial to perform a larger study to determine if the results can be replicated. Surveying patients diagnosed with other cancer types may also provide additional insight.

Nursing Implications Associated with Ibrutinib (PCI-32765), a First-in-Class, Oral Bruton’s Tyrosine Kinase (BTK) Inhibitor, When Used as a Single Agent in Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) Patients (Pts) Maria Badillo, RN, OCN, CCRP; Yiming Chen; Cynthia Jenkins; Michael Wang; Kristie Blum; Darrin Beaupre; Betty Chang; Mei Cheng; Susan King; Joanne Vanak; Weihong Chase MD Anderson Cancer Center

Background: With single-agent activity in early clinical trials in relapsed/refractory mantle cell lymphoma (R/R MCL), ibrutinib, a first-in-class, orally administered Bruton’s tyrosine kinase (BTK) inhibitor, was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in February 2013. The new drug application was submitted to the FDA on July 10, 2013.

Objective: PCYC-1104, an international, multicenter, open-label, phase 2 study, evaluated the efficacy and safety of ibrutinib in patients with R/R MCL. One hundred fifteen (50/65) patients were enrolled and 111 (48/63) patients were treated; enrolled patients included those who had received prior bortezomib (BTZ) treatment (n=50) and patients with no prior BTZ treatment (n=65).

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CATEGORY IV: Original Research Methods: One hundred fifteen R/R MCL patients were enrolled; 111 patients received a fixed, once-daily oral dose of ibrutinib 560 mg. Treatment continued until disease progression or unacceptable adverse events (AEs) occurred.

Results: • 110 patients who received ≥1 ibrutinib dose and had at least 1 postbaseline assessment were evaluated for efficacy; median number of cycles was 9 (range, 1-24).

• With an estimated median follow-up of 15.3 months (range, 1.9-22.3), 46 patients were still receiving treatment.

• Most AEs observed were grade 1/2; the most common nonhematologic AEs were diarrhea (50%), fatigue (41%), and nausea (31%); the most common grade ≥3 infection was pneumonia in 7 patients (6%).

• Grade 3/4 hematologic AEs included neutropenia (16%), thrombocytopenia (11%), and anemia (10%); grade 3 bleeding events occurred in 5 patients, with no grade 4 or 5 hemorrhagic events. Subdural hematomas were reported in 4 patients; all were associated with falls, head trauma, or both, and all 4 patients received either aspirin or warfarin within 2 days before or on the day of the event.

• An AE leading to discontinuation of therapy occurred in 8 patients (7%).

• The overall response rate (ORR) for all treated patients (n=111) was 68% (23 complete response [CR; 21%] and 52 partial response [PR; 47%]); the depth of response and the number of patients with CR increased over time; response to ibrutinib did not vary on the basis of baseline characteristics or the presence of risk factors.

• Estimated median response duration in responders (n=75) was 17.5 months (range, 0.0-19.6); median time to response was 1.9 months (range, 1.4-13.7) and median time to CR was 5.5 months (range, 1.7-11.5).

• Estimated median progression-free survival (PFS) in all treated patients was 13.9 months (range, 0.7-21.4); median PFS for subjects who achieved PR as a best response was 17.5 months, while the median PFS for subjects who achieved CR was not reached.

• At the time of publication, the median overall survival (OS) was also not reached; the estimated OS at 18 months was 58%.

• Independent Review Committee evaluation of the efficacy data demonstrated an ORR of 69% (21% CR; 48% PR) and median response duration of 19.6 months.

• 34% of patients exhibited a transient increase in absolute lymphocyte count (≥50% increase from baseline and >5000 cells/mm3) during ibrutinib treatment, with a peak count at a median of 4 weeks after treatment initiation; elevated lymphocyte levels decreased substantially toward the end of cycle 2 and tapered off in cycles 4 and 5.

Conclusions: • Ibrutinib is a highly active new agent showing single-agent activity in R/R MCL. • The favorable toxicity profile suggests that ibrutinib provides the opportunity for less intense and more effective treatment regimens than those currently available for MCL. • Nursing implications include education about: (1) new mechanism of action, (2) reduction in lymph nodes with associated rise in absolute lymphocyte count (lymphocytosis), (3) adherence to oral dosing (taking on an empty stomach; drug–drug interaction with CYP3A4/5 inhibitors; avoiding warfarin and equivalent vitamin K antagonists), and (4) consulting with their oncologist if surgery is required.

• Nursing advisory board recommendations will be shared with nurse navigators who will be asked to help patients navigate the authorization process for this new oral oncolytic and identify sources for patient copay and other financial assistance.

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CATEGORY IV: Original Research Oncology Nurse Navigator Competencies: Providing Direction to Improve Care Delivery The ONS Oncology Nurse Navigator Project Team; Lori McMullen, RN, MSN, OCN1; Teri A. Banman, RN, OCN2; Judy M. De Groot, RN, MSN, AOCN3; Susan T. Jacobs, RN, BSN, OCN; Dominique M. Srdanovic, RN, MA, OCN4; Heather Mackey, RN, MSN, AOCN5; Emily Franey5; Michele Galioto, RN, MSN5 University Medical Center of Princeton at Plainsboro; 2The University of Kansas Cancer Center; 3Penrose Cancer Center; 4Roy and Patricia Disney Family Cancer Center; 5Oncology Nursing Society

1

Background: The American College of Surgeons Commission on Cancer recognized that patient navigation is an important component in the ability to deliver patient-centered care and has added Standard 3.1 to its Cancer Program Standards. Patient navigation has been identified as a process to address healthcare disparities and barriers to obtaining optimal care. To fulfill that standard, close the gaps on fragmented care, and address potential barriers to care, cancer programs around the country are instituting navigation programs. In many of these programs, oncology nurse navigators (ONNs) are filling the role secondary to their education- and disease-specific training. Data from the 2010 Advisory Board demonstrate that the role of the navigator is held by a registered nurse or advanced practice nurse in 75% of cancer programs. Using the nursing process, nurses in the role of navigator are able to assess for psychosocial, educational, and physical needs, thereby providing a valuable contribution to the multidisciplinary, patient-centered treatment plan. The challenges faced by many ONNs include a dearth of evidence-based resources, professional standards, or competencies to support them as they are being hired and charged with developing programs without the foundation tools needed to support their work. Objective: ONNs have looked to the Oncology Nursing Society (ONS), their professional organization, to provide leadership as they struggle with role development. Supported by data collected in the 2010 ONS Nurse Navigator Survey and antidotal information from the ONS Nurse Navigator Special Interest Group (NNSIG), ONS identified the need to clearly define the role of an oncology nurse in the role of navigator as well as support growth of the role by developing core competencies.

Methods: A project team was assembled in August 2012. Starting with a thorough review of literature, the 7-member team met in November and began the process of clearly defining the role of the ONN. The team chose to work at developing core competencies suitable to a novice ONN, which is defined as an ONN with 1 to 2 years of experience. The literature review provided the evidence-based information necessary to develop a navigation framework that supports the ONN in her/his scope of professional practice. Within this scope of practice, the team divided the knowledge base and function of the ONN into 4 categories: professional role, education, coordination of care, and communication. These categories ultimately developed into a list of 47 ONN professional core competencies. To validate the competencies, a field review was conducted by members of the NNSIG. Reviewers were asked to determine if the competencies were considered core to the role of the ONN, were clearly written, and if they should be included as an ONN core competency. Reviewers were also asked for their input for competencies that were missed by the project team. A 29.2% response rate was realized. Following the field review, the team met to review each individual competency and make the necessary edits. Two competencies were deemed redundant by the field review and were subsequently dropped; 5 were combined to improve clarity, for a total of 40 ONN core competencies across the 4 categories. Ten expert reviewers were identified and agreed to complete a review of the ONN core competencies. These experts were chosen based on their years of experience and leadership role in oncology nurse navigation.

The expert reviewers were asked to comment on the flow, clarity, completeness, and appropriateness of the overall competency listings, as well as to provide further feedback on individual statements. Based on their feedback, additional edits were made, and a final count of 40 core competencies were produced to define the role of ONN. Results: The core competency project has resulted in several essential tools for ONNs and their employers: ONN core competencies, an ONN professional practice framework, and a clear definition of the role. ONN competencies include the fundamental knowledge, skills, and expertise required to proficiently participate in the care of patients with a past, current, or potential diagnosis of cancer; assist oncology patients, families, and caregivers to help overcome healthcare system barriers; and provide education and resources to facilitate informed decision-making and timely access to quality health and psychosocial care throughout all phases of the cancer continuum. Conclusions: The competencies provide resources for both ONNs and their employers as they develop and grow navigation programs.

To build on this momentum, the next step is to develop a nationally recognized education program to ensure that ONNs have the knowledge and skill set needed to function effectively in their role.

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A Critical Connection Between B-Cell Signaling and the Tumor Microenvironment* Until recently, research of B-cell malignancies has been focused primarily on the B cell itself.1 However, new insights have revealed that there are important interactions between the B cell and the extracellular microenvironment that are dependent on intracellular signaling pathways mediated by various kinases including Bruton’s tyrosine kinase (BTK).2,3 These interactions suggest an important role in B-cell homing, adhesion, and migration.4,5 Further elucidation of these processes could change how we view and approach B-cell malignancies.

BTK signaling pathways and the microenvironment*† FDC BCR TLR T cell MyD88

BTK

Lyn

CXCR4/5 PI3K

MSC

PIP3

Syk

BTK

G G

Nucleus

PLCγ2

B cell

BTK

DAG NF-κB

IP3

PKC Ca2+

*

Based on in vitro data.

Illustrations not to scale.

†

Pharmacyclics, Inc., and Janssen Biotech, Inc., are currently investigating BTK in search of insights that could improve the lives of patients with B-cell malignancies.

Visit us at www.BCellSignals.com.

BCR

THE ANTECEDENTS OF PATIENT NAVIGATION

CD79A CD79B

Prosurvival Signals Lyn

Syk

BTK PLCγ2

Nucleus

Normal and malignant B cells rely on multiple prosurvival pathways to avoid apoptosis.6-9 In B-cell malignancies, microenvironmental cues may inappropriately initiate signaling cascades through several kinases, including BTK, driving uncontrolled growth and survival of malignant B cells.5,10-13

NF-κB

B-Cell Homing Cells in the microenvironment secrete chemoattractant factors to promote the homing of B cells to lymphoid tissue.14 These factors act via signaling pathways involving BTK and other kinases.4,15

VCAM-1

Adhesion and Migration

VLA-4

The upregulation and increased migration of B cells may lead to retention of malignant cells in proliferative environments and the promotion of chemoresistance.16-18 BTK is an essential mediator of multiple adhesion and migration processes.4

References: 1. Burger JA. Nurture versus nature: the microenvironment in chronic lymphocytic leukemia. Hematology Am Soc Hematol Educ Program. 2011;2011:96-103.

2. Kil LP, de Bruijn MJW, van Hulst JA, Langerak AW, Yuvaraj S, Hendriks RW. Bruton’s tyrosine kinase mediated signaling enhances leukemogenesis in a mouse model for chronic lymphocytic leukemia. Am J Blood Res. 2013;3:71-83. 3. Pighi C, Gu T-L, Dalai I, et al. Phospho-proteomic analysis of mantle cell lymphoma cells suggests a pro-survival role of B-cell receptor signaling. Cell Oncol (Dordr). 2011;34:141-153. 4. de Gorter DJJ, Beuling EA, Kersseboom R, et al. Bruton’s tyrosine kinase and phospholipase C 2 mediate chemokine-controlled B cell migration and homing. Immunity. 2007;26:93-104. 5. Burger JA, Ghia P, Rosenwald A, Caligaris-Cappio F. The microenvironment in mature B-cell malignancies: a target for new treatment strategies. Blood. 2009;114:3367-3375. 6. Woyach JA, Johnson AJ, Byrd JC. The B-cell receptor signaling pathway as a therapeutic target in CLL. Blood. 2012;120:1175-1184. 7. Rauch M, Tussiwand R, Bosco N, Rolink AG. Crucial role for BAFF-BAFF-R signaling in the survival and maintenance of mature B cells.

PLoS One. 2009;4:e5456. 8. Gerondakis S, Grumont RJ, Banerjee A. Regulating B-cell activation and survival in response to TLR signals. Immunol Cell Biol. 2007;85:471-475.

9. Grumont RJ, Rourke IJ, O’Reilly LA, et al. B lymphocytes differentially use the Rel and nuclear factor B1 (NF- B1) transcription factors to regulate cell cycle progression and apoptosis in quiescent and mitogen-activated cells. J Exp Med. 1998;187:663-674. 10. Nishio M, Endo T, Tsukada N, et al. Nurselike cells express BAFF and APRIL, which can promote survival of chronic lymphocytic leukemia cells via a paracrine pathway distinct from that of SDF-1 . Blood. 2005;106:1012-1020. 11. Wiestner A. Emerging role of kinase-targeted strategies in chronic lymphocytic leukemia. Blood. 2012;120:4684-4691. 12. Herishanu Y, Pérez-Galán P, Liu D, et al. The lymph node microenvironment promotes B-cell receptor signaling, NF- B activation, and tumor proliferation in chronic lymphocytic leukemia. Blood. 2011;117:563-574. 13. Davis RE, Ngo VN, Lenz G, et al. Chronic active B-cell-receptor signalling in diffuse large B-cell lymphoma. Nature. 2010;463:88-92. 14. Okada T, Ngo VN, Ekland EH, et al. Chemokine requirements for B cell entry to lymph nodes and Peyer’s patches. J Exp Med. 2002;196:65-75. 15. Burger JA, Burger M, Kipps TJ. Chronic lymphocytic leukemia B cells express functional CXCR4 chemokine receptors that mediate spontaneous migration beneath bone marrow stromal cells. Blood. 1999;94:3658-3667. 16. Kurtova AV, Tamayo AT, Ford RJ, Burger JA. Mantle cell lymphoma cells express high levels of CXCR4, CXCR5, and VLA-4 (CD49d): importance for interactions with the stromal microenvironment and specific targeting. Blood. 2009;113:4604-4613.

17. Binsky I, Lantner F, Grabovsky V, et al. TAp63 regulates VLA-4 expression and chronic lymphocytic leukemia cell migration to the bone marrow in a CD74-dependent manner.

J Immunol. 2010;184:4761-4769. 18. Kurtova AV, Balakrishnan K, Chen R, et al. Diverse marrow stromal cells protect CLL cells from spontaneous and drug-induced apoptosis: development of a reliable and reproducible system to assess stromal cell adhesion-mediated drug resistance. Blood. 2009;114:4441-4450.

© Pharmacyclics, Inc. 2013 © Janssen Biotech, Inc. 2013 04/13 K08BR13002

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CATEGORY IV: Original Research Conquering the Complexities of Navigating Oncology Veteran Patients Sonya Curry, MSN, RN, ACNS-BC; Jennifer Smith, MSN, CNP Department of Veteran Affairs Medical Center

Background: Oncology nurse navigators (ONNs) are essential for quality cancer care. A comprehensive electronic tool can facilitate the ONN’s delivery of coordinated and timely quality care across the disease trajectory. This is especially important for vulnerable patient populations such as veterans. The Veterans Affairs (VA) Healthcare System has implemented an electronic care management tool (CMT) that (1) tracks the veteran’s cancer care; (2) facilitates communication with the veteran, ONN, oncology team, and other healthcare providers; and (3) provides a mechanism to monitor veteran outcomes. Objective: To describe how an innovative care management tracking tool facilitates the role of the ONN and improves the quality and efficiency of cancer care. Methods: The VA ONN is the point of contact for the veteran, his or her family, and providers from the time of diagnosis and throughout the cancer trajectory. The navigation process begins with telephone contact between the veteran and the ONN. Veteran barriers (ie, transportation, financial burdens, child care, and access to outside medical records) that could potentially interfere with timely cancer care and adherence to the treatment plan are identified and addressed. The ONN’s intake assessment is documented in the CMT, which links to the electronic medical record. Automatic alerts for any additional testing needed for diagnosis and treatment planning are sent to the primary care provider and the oncology team prior to the first visit. This reduces the number of visits to the VA, which decreases financial and travel burdens for the veteran. Following the initial oncology clinic appointment, the ONN documents the treatment plan in the CMT and reviews it daily to ensure timely care. Results: More than 100 veterans in the oncology clinic have been entered into the CMT. The electronic tool has improved the navigation process. The oncology team is able to communicate daily with each other, ensuring continuity of care. Primary care providers appreciate that the tool allows them to be engaged in the patient’s cancer care. The percentage of veteran missed appointments has decreased from 11% to 6.2% as a result of nurse navigation and the support of the tracking tool.

Conclusions: The CMT improves patient outcomes by providing an electronic mechanism for patient navigation and communication among oncology and healthcare team members.

Survivorship Navigation for Young Adults Shows Success Maria Marek, MTS, BA, RN; Christopher Hamilton, MPH Seton Cancer Survivor Center

Background: The Seton Cancer Survivor Center began an outreach to adolescent and young adult survivors aged 18 to 39 years in September 2011. Our goal is to improve the quality of life of young adult cancer survivors by addressing potential late effects as well as medical and psychosocial issues through multidisciplinary care. We plan to increase the young adults’ knowledge of their cancer treatment, teach skills to maintain good health, help navigate them to manage any late effects from their treatment, and assist them with finding resources for any medical or psychosocial needs.

Objectives: To improve patient outcomes by providing a clinical nurse navigator who would offer the patient a summary of cancer treatment and survivor care plan, help the patient find and establish care with a primary care physician, offer a survivor clinic with a focus on young adult survivors, and implement a wellness activity of exercise or nutrition improvement. Methods: Patient outcomes were measured by using a database (E Centaurus) to track the metrics in the objectives outlined above and to perform a comparison study of the patient usage of the emergency department services or hospitalization in the year prior to survivorship navigation. The nurse navigator had a target goal of completing a summary of cancer treatment and a survivor care plan within 3 months of enrolling a patient. The navigator also assisted the patient to coordinate care with a primary care provider who was also given a copy of the survivor’s care plan and summary. The nurse navigator meets the patient in the survivor clinic where each patient is seen by an internal medicine physician who specializes in caring for cancer survivors and is well versed in potential late effects and surveillance for young adult survivors. The physician and nurse enable the patient to plan for increasing patient physical activity or nutrition goals by offering information for various programs available to young adult survivors of

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CATEGORY IV: Original Research cancer. Results: Preliminary analysis showed that after 1 year of navigation for 74 patients, a direct cost-savings of $90,000 was achieved. Currently our efforts show that 97% of patients established care with a primary care physician within 3 months of navigation. Approximately 93% of patients navigated are given a treatment summary and care plan within 3 months of enrollment. Some wellness activity was initiated by 67% of patients within 12 months of enrollment, and 62% have reached the goal of a wellness activity. Patient satisfaction with the survivor clinic was rated as 96%, equaling “very good” or excellence overall. Conclusions: These efforts clearly demonstrate the effectiveness in improvement of health outcomes for an “at risk” population of young adult cancer survivors. It also demonstrates a reduction in the cost utilization for the emergency department and hospitalization services.

STAR Program Certification Course Improves Nurses’ Knowledge of Evidence-Based Cancer Rehabilitation and Survivorship Care Jeanne Simard, RN, MBA; Julie Silver, MD Oncology Rehab Partners

Objective: The objective of this study is to present pretest and posttest scores of nurses who have completed the STAR Program® Certification Course and to demonstrate the improvement in overall knowledge and expertise of cancer and cancer rehabilitation that the course provides. The STAR Program Certification includes training modules and protocols based on the latest research in cancer rehabilitation and survivorship care. As part of the precertification process, participants take the STAR Program Certification Course, which is an online course with 10 modules and a pre- and posttest.

The entire course generally takes participants between 20 and 30 hours to complete. Methods: In this study, an identical 50-question pretest and posttest was administered. There was no time limit to finish the modules. The tests were administered to all candidates. They could take the test as many times as necessary to obtain a passing score of 70%. The raw test scores were averaged and grouped according to participant discipline. A total of 2238 pretest scores were obtained from 2226 candidates who listed 39 healthcare disciplines (includes duplicates from the pretest total participant group).

Duplicates were removed from the nursing pre- and posttest data to give a true picture of the results. Fifty candidates did not record their discipline. Results: The average pretest score of all candidates was 46.3%. The category including “All Nurses” (registered nurse, nurse navigator, and nurse practitioner) numbered 456 for the pretest group and had an average score of 45.1%. This research only includes nurses who completed both the pretest and posttest. This pretest group numbered 269 and had an average score of 44.5% (Table). A total of 1391 participants comprised the total posttest group and took the test 1582 times. The postscore for “All Nurses” was 92.8% (N=269). The average postscore for all candidates (all disciplines) was 88.8% with a range of 0% to 100%. The test was taken once by 1287 candidates and multiple times by 104. Conclusions: The STAR Program Certification Course significantly increased nurses’ and other participants’ knowledge in evidence-based cancer rehabilitation and survivorship care. The average improvement between pretest and posttest scores was 108% for the “All Nurses” group. This study demonstrated significant improvement in nurses’ knowledge of cancer rehabilitation and survivorship after completing the STAR Program Certification Course.

Discipline All Nurses Including nurse navigators and nurse practitioners having completed both pretest and posttest

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Nurses Completing Pretest Pretest Score, % and Posttest, No.

Posttest Score, %

Improvement in Posttest Score, %

269

92.8

108

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY IV: Original Research Breast Cancer Nurse Navigator Facilitating Care Transitions in Cancer Survivorship Danelle Johnston, RN, MSN, OCN, CBCN St Jude Medical Center

Background: The Institute of Medicine has identified that cancer survivors lack coordinated care beginning at the time of their diagnosis and throughout the cancer care trajectory. The cancer survivor’s quality of life (QOL) and health outcomes are therefore impacted. The research question addressed in this study was: How is the breast cancer nurse navigator positioned to facilitate transitions along the breast cancer survivorship continuum that impact QOL in the domains of prevention, surveillance, intervention, and coordination? Objective: To gather data on the current state of the breast cancer nurse navigator’s role, attitudes/beliefs, and knowledge in facilitating care transitions for breast cancer survivors. Methods: An electronic descriptive survey instrument was developed based on the domains of survivorship. The survey was designed to evaluate how the breast cancer nurse navigator is currently positioned to facilitate a patient’s transitions through the cancer survivorship care continuum. The questionnaire allowed qualitative and quantitative data collection. The content validity of this 45-item scale was rated by 3 breast cancer nurse navigator experts. The scale level index (S-CVI), using the averaging approach, was calculated to be 0.94. A convenience sample of breast cancer nurse navigators was surveyed through the Academy of Oncology Nurse Navigators, which gave nationwide access to breast cancer nurse navigators (N= 986). The survey was entered into SurveyMonkeyTM to allow online delivery, and data were stored and analyzed using IBM SPSS Statistics 21 for Windows. Results: There was a 20% response rate (n=200) for breast cancer nurse navigators who participated in the survey. The rate for participants who completed the survey in its entirety was 12% (N=115). Participant fallout in survey completion was attributed to the length of the 77-item survey. The study provided evidence that the breast cancer nurse navigator had strong attitudes/beliefs that they can be positioned to facilitate survivorship care transitions, to eliminate barriers to care, and to impact survivors’ QOL. A low score (48%) for cancer survivorship knowledge validated a knowledge deficit among the navigators. There was variation in the role of the breast cancer nurse navigator in care transitions for the cancer survivor. Conclusions: The data obtained from this study support the hypothesis that there is a wide variation in role, attitudes/beliefs, and knowledge of the breast cancer nurse navigator in the cancer survivorship care continuum. This study identified that nurses place strong value in facilitating cancer survivorship care. Navigators intersect with the cancer survivor throughout the cancer care continuum, which places them in a prime position to facilitate survivorship care.

What Young Women Want: A National Needs Assessment of Young Women Affected

by Breast Cancer Arin Ahlum Hanson, MPH, CHES1; Janine E. Guglielmino, MA1; Kimlin Ashing-Giwa, PhD2 Living Beyond Breast Cancer; 2 City of Hope Medical Center

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Background: Ten percent of breast cancer cases occur in women who are younger than 45 years of age. Although younger women are less likely to be diagnosed, their treatment experience and psychosocial needs can differ, making it a significant public health concern for women diagnosed in this age group. There are limited national programs and resources that address the unique needs of young women. Living Beyond Breast Cancer conducted a comprehensive national needs assessment to identify the needs of women diagnosed with breast cancer before 45 years of age and to determine how young women prefer to receive emotional support and breast cancer information.

Objectives: • To identify the needs of women diagnosed with breast cancer who are younger than 45 years of age; • To assess the information and support needs of young women affected by breast cancer; • To evaluate subgroup differences regarding ethnicity, stage of breast cancer, time since diagnosis, and age at diagnosis; and • To identify existing gaps in program areas for young women.

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY IV: Original Research Methods: The needs assessment included 4 phases: (1) an environmental scan was conducted to identify existing resources for young women; (2) key informant interviews were conducted with 12 healthcare providers; (3) 4 focus groups were held with 32 women; and (4) a national survey was drafted using information collected from the interviews and focus groups. This 85-question survey was completed by 1474 women diagnosed with breast cancer who were younger than 45 years of age. The survey asked women where they go for emotional support and cancer information, how they want to receive support and information, and what information topics interest them and are available. Demographic and breast cancer treatment information was collected. Results: Living Beyond Breast Cancer engaged a diverse sample of young women from across the United States. It was concluded that there are limited national resources for young women. Ninety percent of the survey respondents said it was important to have health information about breast cancer tailored to their needs as young women; however, only 22% found it easy to find this type of information. Certain subgroups of young women reported having a more difficult time finding information and support, including women diagnosed before 30 years of age, African Americans, and women living with metastatic breast cancer. Many young women report lingering side effects—50% reported fatigue, sleep disruption, decreased interest in sex, and weight changes. Conclusions: More programs and resources should be developed to address the unique needs of young women affected by breast cancer. The needs and program gaps identified through these assessment results will help guide program development.

Interdisciplinary Team Education to Improve the Care of the Cancer Survivor Danelle Johnston, RN, MSN, OCN, CBCN; Gianna Laiola, RN, MSN, OCN St Jude Medical Center

Background: Due to improvements in technology, treatment, and screening, the National Cancer Institute (NCI) estimates that the number of patients with cancer could reach 18 million by 2020. The Institute of Medicine (IOM) reports that survivorship care is fragmented and the literature documents that healthcare providers frequently demonstrate a knowledge deficit in survivorship care needs. Based on this need, St. Jude Medical Center oncology professionals attended an NCI-funded conference entitled “Preparing Professional Nurses for Cancer Survivorship Care.”

Conference participants developed goals to be implemented at their institution, which were foundational for this study. Objectives: To assess the current interprofessional staff level of survivorship care knowledge and to evaluate the effectiveness of an education program in improving survivorship care knowledge. Methods: A review of the literature identified the needs of cancer survivorship, and topics were selected for an interprofessional education series. Individual course objectives were based on the IOM’s report “From Cancer Patient to Cancer Survivor.” Speakers were selected based on content expertise in cancer survivorship care. Coordination with the Clinical Education Department facilitated the provision of continuing education units, and participants included members of the interdisciplinary team.

Online registration and WebEx were offered for each presentation. Marketing strategies included flyers and advertising.

Pre- and posttest scores for each session were compared and contrasted across content sessions. Results: To date, 7 months of presentations have been offered and completed. The total number of participant attendance was 76 with a retention rate of 41% for those attending 3 or more sessions. Posttest scores (M = 88.68; standard deviation [SD] = 10.47) showed a 19% knowledge increase from pretest scores (M = 69.37; SD = 21.60). The posttest and increase in test scores were significantly correlated (P = .01); the interaction effect among posttest sessions was significant (F[6,66] = 4.13; P = .001). The majority of participant oncology work time (57%) was spent addressing survivorship needs. Conclusions: Barriers to attendance included scheduling, unpaid time, and knowledge deficit of survivorship care. For those who attended classes, retention was high. Nurse navigators and rehabilitation staff participated most frequently. Rehabilitation staff were recently certified in Survivorship Training and Rehabilitation, and they reported that the presentations continued to build on their cancer survivorship knowledge. Participants found value in the series, as evidenced by knowledge gained and satisfaction with the educational offering. Although attendees were experienced practitioners with longevity in their fields, survivorship care was identified as a significant educational need by participants.

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY IV: Original Research Nursing Implications of a New Oral Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765), for Use in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Patients (Pts) Weihong Chase, MSN1; Sharon Waymer, LPN1; Mona Stefanos, MD1; Margaret Lucas, BS1; John Byrd, MD1; Talia LaPushin, MPH1; Danelle James, MD, MS2; Betty Chang, PhD2; Cathy Zhou, MS2; Juthamas Sukbuntherng, PhD2; Susan King, MS2; Joanne Vanak, MSN3; Jeanne Lichty, BSN4 Ohio State University Medical Center; 2Pharmacyclics, Inc.; 3Janssen Biotech, Inc.; 4MD Anderson Cancer Center

1

Background: Ibrutinib, a first-in-class, orally administered Bruton’s tyrosine kinase inhibitor, has demonstrated single-agent activity in relapsed/refractory chronic lymphocytic leukemia (R/R CLL) small lymphocytic lymphoma (SLL) in early clinical trials. Ibrutinib first entered clinical trials in 2009, and based on results of early trials, ibrutinib was granted Breakthrough Therapy Designation for mantle cell lymphoma and 17p deletion CLL by the US Food and Drug Administration in February 2013; the new drug application was filed in the second quarter of 2013.

Objectives: The phase 1b/2, open-label multicenter study evaluated the safety, efficacy, pharmacokinetics, and pharmacodynamics of ibrutinib. As with all new treatments, ibrutinib has the potential to produce adverse events (AEs), which have implications for patient monitoring. Moreover, the drug’s novel mechanism of action (MOA) will also require education of nurses, who will often be responsible for educating patients.

Methods: In PCYC-1102, 85 R/R CLL/SLL patients received either ibrutinib 420 mg/day (n=51) or 840 mg/day (n=34) orally, once daily continuously until disease progression or unacceptable toxicity was noted.

Results: • Patients were generally considered to have high-risk disease, having received a median of 4 prior therapies.

• At a median follow-up of 20.9 months (range, 0.7-26.7), 64% of patients were still receiving treatment.

• Most AEs were grade 1/2 in severity; the most common were transient diarrhea, fatigue, and respiratory infection.

• The most common grade ≥3 AEs were pneumonia (10 patients; 12%) and dehydration (5 patients; 6%).

• Grade ≥3 infections occurred more frequently early in therapy; grade 3/4 hematologic toxicities were infrequent, with anemia in 5 patients (6%), neutropenia in 13 (15%), and thrombocytopenia in 5 (6%); grade ≥3 bleeding events occurred in 4 patients (5%).

• Lymphocytosis was typically noted by day 7; peaked at a median of 4 weeks, then slowly declined; this occurred concomitantly with reductions in lymph node and/or spleen size and often with improvement in cytopenias.

Most patients normalized or achieved a 50% reduction from baseline in their lymphocyte count.

• The overall response rate was 71%; the 26-month estimated median progression-free survival and overall survival rates were 75% and 83%, respectively.

Conclusions: • Ibrutinib is a highly active new agent showing single-agent activity in R/R CLL. • Nursing implications include education about: (1) new MOA, (2) rapid reduction in lymph nodes without tumor lysis syndrome, (3) lymphocytosis, (4) the importance of reporting signs and symptoms of infection and/ or bleeding, (5) adherence to oral dosing, (6) drug–drug interactions with CYP3A4/5 inhibitors, (7) avoiding warfarin or equivalent vitamin K antagonists, and (8) consulting their oncologist if surgery or an invasive procedure is required.

• Nursing advisory board recommendations will be shared with nurse navigators who will invariably be asked to help patients navigate through the authorization/approval process for this new oral oncolytic and to identify sources for patient copay and other financial assistance.

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Our goal is to make access to ZYTIGA®(abiraterone acetate) simple, convenient, and easy.

Support for you:

Support for your patients:

• Rapid assessment of patient eligibility/coverage • Prior authorization support • Concise benefit summary • Identification of specialty pharmacy provider

• Access to the ZytigaOne™ Instant Savings Program • Referral to a patient assistance program • Coordination with SPP for processing/delivery of medication • Educational materials and prescription reminders

Benefit Investigation

Care Coordination

Take advantage of ZytigaOne™ Support today.

1-855-ZYTIGA-1 (998-4421) Monday–Friday, 8:00 AM–8:00 PM ET ACCESS TO ZYTIGA® SIMPLIFIED FOR YOU AND YOUR PATIENTS Also available online at janssenaccessone.com

Please see Important Safety Information on back, and Brief Summary of Prescribing Information on adjacent pages.

Patient insurance benefit investigation is provided as a service by TheraCom, LLC and The Lash Group, Inc., under contract for Janssen Biotech, Inc. In this regard, TheraCom, LLC, and The Lash Group, Inc., assist healthcare professionals in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer and patient information provided by the healthcare provider under appropriate authorization following the provider’s exclusive determination of medical necessity.

Importantly, insurance verification is the ultimate responsibility of the provider. Third-party reimbursement is affected by many factors. Therefore, TheraCom, LLC, The Lash Group, Inc., and Janssen Biotech make no representation or guarantee that full or partial insurance reimbursement or any other payment will be available. This information is provided as an information service only. While TheraCom, LLC, and The Lash Group, Inc., try to provide correct information, they and Janssen Biotech make no representations or warranties, expressed or implied, as to the accuracy of the information. In no event shall TheraCom, LLC, The Lash Group, Inc., or Janssen Biotech or its employees or agents be liable for any damages resulting from or relating to the services. All providers and other users of this information agree that they accept responsibility for the use of this service.

Janssen Biotech assumes no responsibility for, and does not guarantee the quality, scope, or availability of the services including but not limited to reimbursement support services, patient education, and other support services. Each provider, not Janssen Biotech, is responsible for the services they provide. These support services have no independent value to providers apart from the product and are included within the cost of the product. © Janssen Biotech, Inc. 2013

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K08Z121119

INDICATION and IMPORTANT SAFETY INFORMATION about ZYTIGA® (abiraterone acetate) INDICATION ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

IMPORTANT SAFETY INFORMATION

K08Z121176

Contraindications ZYTIGA® (abiraterone acetate) is not indicated for use in women. ZYTIGA® can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant.

Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in blood pressure, hypokalemia, or fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition.

Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in study 1) or NYHA Class II to IV heart failure (in study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.

Adrenocortical Insufficiency (AI) AI was reported in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®.

Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

Hepatotoxicity Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function.

Increased ZYTIGA® Exposures with Food ZYTIGA® must be taken on an empty stomach. No food should be eaten for at least two hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA® is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state.

Adverse Reactions The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

Drug Interactions ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. In vitro, ZYTIGA® inhibits CYP2C8. There are no clinical data on its use with drugs that are substrates of CYP2C8. Patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate.

Based on in vitro data, ZYTIGA® is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors or inducers on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution during treatment with ZYTIGA®.

Use in Specific Populations Do not use ZYTIGA® in patients with baseline severe hepatic impairment (Child-Pugh Class C).

Please see Brief Summary of Prescribing Information on adjacent pages.

© Janssen Biotech, Inc. 2013

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ZYTIGA® (abiraterone acetate) Tablets Brief Summary of Prescribing Information.

INDICATIONS AND USAGE ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.

CONTRAINDICATIONS Pregnancy: ZYTIGA can cause fetal harm when administered to a pregnant woman. ZYTIGA is not indicated for use in women. ZYTIGA is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss [see Use in Specific Populations].

WARNINGS AND PRECAUTIONS Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess: ZYTIGA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1) in full Prescribing Information]. In the two randomized clinical trials, grade 3 to 4 hypertension occurred in 2% of patients, grade 3 to 4 hypokalemia in 4% of patients, and grade 3 to 4 edema in 1% of patients treated with ZYTIGA [see Adverse Reactions].

Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in the incidence and severity of these adverse reactions. Use caution when treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, e.g., those with heart failure, recent myocardial infarction or ventricular arrhythmia. Use ZYTIGA with caution in patients with a history of cardiovascular disease. The safety of ZYTIGA in patients with left ventricular ejection fraction < 50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) was not established because these patients were excluded from these randomized clinical trials [see Clinical Studies (14) in full Prescribing Information]. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with ZYTIGA. Adrenocortical Insufficiency: Adrenal insufficiency occurred in the two randomized clinical studies in 0.5% of patients taking ZYTIGA and in 0.2% of patients taking placebo. Adrenocortical insufficiency was reported in patients receiving ZYTIGA in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations [see Warnings and Precautions].

Hepatotoxicity: In the two randomized clinical trials, grade 3 or 4 ALT or AST increases (at least 5X ULN) were reported in 4% of patients who received ZYTIGA, typically during the first 3 months after starting treatment. Patients whose baseline ALT or AST were elevated were more likely to experience liver test elevation than those beginning with normal values. Treatment discontinuation due to liver enzyme increases occurred in 1% of patients taking ZYTIGA. No deaths clearly related to ZYTIGA were reported due to hepatotoxicity events.

Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with ZYTIGA, every two weeks for the first three months of treatment and monthly thereafter. In patients with baseline moderate hepatic impairment receiving a reduced ZYTIGA dose of 250 mg, measure ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the ULN, or the bilirubin rises above three times the ULN, interrupt ZYTIGA treatment and closely monitor liver function.

Re-treatment with ZYTIGA at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN [see Dosage and Administration (2.2) in full Prescribing Information].

The safety of ZYTIGA re-treatment of patients who develop AST or ALT greater than or equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown.

Increased ZYTIGA Exposures with Food: ZYTIGA must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state. The safety of these increased exposures when multiple doses of abiraterone acetate are taken with food has not been assessed [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

ZYTIGA® (abiraterone acetate) Tablets ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Hypertension, Hypokalemia, and Fluid Retention due to Mineralocorticoid Excess [see Warnings and Precautions].

• Adrenocortical Insufficiency [see Warnings and Precautions].

• Hepatotoxicity [see Warnings and Precautions].

• Increased ZYTIGA Exposures with Food [see Warnings and Precautions].

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

Two randomized placebo-controlled, multicenter clinical trials enrolled patients who had metastatic castration-resistant prostate cancer who were using a gonadotropin-releasing hormone (GnRH) agonist or were previously treated with orchiectomy. In both Study 1 and Study 2 ZYTIGA was administered at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active treatment arms. Placebo plus prednisone 5 mg twice daily was given to control patients.

The most common adverse drug reactions (≥10%) reported in the two randomized clinical trials that occurred more commonly (>2%) in the abiraterone acetate arm were fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) reported in the two randomized clinical trials that occurred more commonly (≥2%) in the abiraterone acetate arm were anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

Study 1: Metastatic CRPC Following Chemotherapy: Study 1 enrolled 1195 patients with metastatic CRPC who had received prior docetaxel chemotherapy. Patients were not eligible if AST and/or ALT ≥ 2.5X ULN in the absence of liver metastases. Patients with liver metastases were excluded if AST and/or ALT > 5X ULN. Table 1 shows adverse reactions on the ZYTIGA arm in Study 1 that occurred with a ≥2% absolute increase in frequency compared to placebo or were events of special interest. The median duration of treatment with ZYTIGA was 8 months.

Table 1: Adverse Reactions due to ZYTIGA in Study 1 ZYTIGA with Placebo with Prednisone (N=791) Prednisone (N=394) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % Musculoskeletal and connective tissue disorders Joint swelling/discomfort2 29.5 4.2 23.4 4.1 Muscle discomfort3 26.2 3.0 23.1 2.3 General disorders Edema4 26.7 1.9 18.3 0.8 Vascular disorders Hot flush 19.0 0.3 16.8 0.3 Hypertension 8.5 1.3 6.9 0.3 Gastrointestinal disorders Diarrhea 17.6 0.6 13.5 1.3 Dyspepsia 6.1 0 3.3 0 Infections and infestations Urinary tract infection 11.5 2.1 7.1 0.5 Upper respiratory tract infection 5.4 0 2.5 0 Respiratory, thoracic and mediastinal disorders Cough 10.6 0 7.6 0 Renal and urinary disorders Urinary frequency 7.2 0.3 5.1 0.3 Nocturia 6.2 0 4.1 0 Injury, poisoning and procedural complications Fractures5 5.9 1.4 2.3 0 Cardiac disorders Arrhythmia6 7.2 1.1 4.6 1.0 Chest pain or chest discomfort7 3.8 0.5 2.8 0 Cardiac failure8 2.3 1.9 1.0 0.3 1 Adverse

events graded according to CTCAE version 3.0 terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness 3 Includes terms Muscle spasms, Musculoskeletal pain, Myalgia, Musculoskeletal discomfort, and Musculoskeletal stiffness 2 Includes

ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

4 Includes

1 Adverse

terms Edema, Edema peripheral, Pitting edema, and Generalized edema 5 Includes all fractures with the exception of pathological fracture 6 Includes terms Arrhythmia, Tachycardia, Atrial fibrillation, Supraventricular tachycardia, Atrial tachycardia, Ventricular tachycardia, Atrial flutter, Bradycardia, Atrioventricular block complete, Conduction disorder, and Bradyarrhythmia 7 Includes terms Angina pectoris, Chest pain, and Angina unstable.

Myocardial infarction or ischemia occurred more commonly in the placebo arm than in the ZYTIGA arm (1.3% vs. 1.1% respectively).

8 Includes terms Cardiac failure, Cardiac failure congestive, Left ventricular dysfunction, Cardiogenic shock, Cardiomegaly, Cardiomyopathy, and Ejection fraction decreased Table 2 shows laboratory abnormalities of interest from Study 1. Grade 3-4 low serum phosphorus (7%) and low potassium (5%) occurred at a greater than or equal to 5% rate in the ZYTIGA arm.

Table 2: Laboratory Abnormalities of Interest in Study 1 Abiraterone (N=791) Placebo (N=394) Laboratory All Grades Grade 3-4 All Grades Grade 3-4 Abnormality (%) (%) (%) (%) Hypertriglyceridemia 62.5 0.4 53.0 0 High AST 30.6 2.1 36.3 1.5 Hypokalemia 28.3 5.3 19.8 1.0 Hypophosphatemia 23.8 7.2 15.7 5.8 High ALT 11.1 1.4 10.4 0.8 High Total Bilirubin 6.6 0.1 4.6 0 Study 2: Metastatic CRPC Prior to Chemotherapy Study 2 enrolled 1088 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy. Patients were ineligible if AST and/or ALT ≥ 2.5X ULN and patients were excluded if they had liver metastases.

Table 3 shows adverse reactions on the ZYTIGA arm in Study 2 that occurred with a ≥ 2% absolute increase in frequency compared to placebo.

The median duration of treatment with ZYTIGA was 13.8 months.

Table 3: Adverse Reactions in ≥5% of Patients on the ZYTIGA Arm in Study 2 ZYTIGA with Placebo with Prednisone (N=542) Prednisone (N=540) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % General disorders Fatigue 39.1 2.2 34.3 1.7 Edema2 25.1 0.4 20.7 1.1 Pyrexia 8.7 0.6 5.9 0.2 Musculoskeletal and connective tissue disorders Joint swelling/ discomfort3 30.3 2.0 25.2 2.0 Groin pain 6.6 0.4 4.1 0.7 Gastrointestinal disorders Constipation 23.1 0.4 19.1 0.6 Diarrhea 21.6 0.9 17.8 0.9 Dyspepsia 11.1 0.0 5.0 0.2 Vascular disorders Hot flush 22.3 0.2 18.1 0.0 Hypertension 21.6 3.9 13.1 3.0 Respiratory, thoracic and mediastinal disorders Cough 17.3 0.0 13.5 0.2 Dyspnea 11.8 2.4 9.6 0.9 Psychiatric disorders Insomnia 13.5 0.2 11.3 0.0 Injury, poisoning and procedural complications Contusion 13.3 0.0 9.1 0.0 Falls 5.9 0.0 3.3 0.0 Infections and infestations Upper respiratory tract infection 12.7 0.0 8.0 0.0 Nasopharyngitis 10.7 0.0 8.1 0.0 Renal and urinary disorders Hematuria 10.3 1.3 5.6 0.6 Skin and subcutaneous tissue disorders Rash 8.1 0.0 3.7 0.0

events graded according to CTCAE version 3.0 terms Edema peripheral, Pitting edema, and Generalized edema 3 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness 2 Includes

Table 4 shows laboratory abnormalities that occurred in greater than 15% of patients, and more frequently (>5%) in the ZYTIGA arm compared to placebo in Study 2. Grade 3-4 lymphopenia (9%), hyperglycemia (7%) and high alanine aminotransferase (6%) occurred at a greater than 5% rate in the ZYTIGA arm.

Table 4: Laboratory Abnormalities in > 15% of Patients in the ZYTIGA Arm of Study 2 Abiraterone (N = 542) Placebo (N = 540) 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Laboratory Abnormality Grade % % % % Hematology Lymphopenia 38.2 8.7 31.7 7.4 Chemistry Hyperglycemia1 56.6 6.5 50.9 5.2 High ALT 41.9 6.1 29.1 0.7 High AST 37.3 3.1 28.7 1.1 Hypernatremia 32.8 0.4 25.0 0.2 Hypokalemia 17.2 2.8 10.2 1.7 1Based on non-fasting blood draws Cardiovascular Adverse Reactions: In the combined data for studies 1 and 2, cardiac failure occurred more commonly in patients treated with ZYTIGA compared to patients on the placebo arm (2.1% versus 0.7%). Grade 3-4 cardiac failure occurred in 1.6% of patients taking ZYTIGA and led to 5 treatment discontinuations and 2 deaths. Grade 3-4 cardiac failure occurred in 0.2% of patients taking placebo. There were no treatment discontinuations and one death due to cardiac failure in the placebo group.

In Study 1 and 2, the majority of arrhythmias were grade 1 or 2. There was one death associated with arrhythmia and one patient with sudden death in the ZYTIGA arms and no deaths in the placebo arms. There were 7 (0.5%) deaths due to cardiorespiratory arrest in the ZYTIGA arms and 3 (0.3%) deaths in the placebo arms. Myocardial ischemia or myocardial infarction led to death in 3 patients in the placebo arms and 2 deaths in the ZYTIGA arms.

DRUG INTERACTIONS Effects of Abiraterone on Drug Metabolizing Enzymes: ZYTIGA is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. In a CYP2D6 drug-drug interaction trial, the Cmax and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). If alternative treatments cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate drug [see Clinical Pharmacology (12.3) in full Prescribing Information].

In vitro, ZYTIGA inhibits CYP2C8. There are no clinical data on the use of ZYTIGA with drugs that are substrates of CYP2C8. However, patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate.

Drugs that Inhibit or Induce CYP3A4 Enzymes: Based on in vitro data, ZYTIGA is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Avoid or use with caution, strong inhibitors and inducers of CYP3A4 during ZYTIGA treatment [see Clinical Pharmacology (12.3) in full Prescribing Information].

USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category X [see Contraindications].: ZYTIGA can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. While there are no adequate and well-controlled studies with ZYTIGA in pregnant women and ZYTIGA is not indicated for use in women, it is important to know that maternal use of a CYP17 inhibitor could affect development of the fetus. Abiraterone acetate caused developmental toxicity in pregnant rats at exposures that were lower than in patients receiving the recommended dose. ZYTIGA is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advise females of reproductive potential to avoid becoming pregnant during treatment with ZYTIGA.

ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

In an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6-17). Findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses ≥10 mg/kg/day, decreased fetal ano-genital distance at ≥30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/ day. Doses ≥10 mg/kg/day caused maternal toxicity. The doses tested in rats resulted in systemic exposures (AUC) approximately 0.03, 0.1 and 0.3 times, respectively, the AUC in patients.

Nursing Mothers: ZYTIGA is not indicated for use in women. It is not known if abiraterone acetate 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 ZYTIGA, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of ZYTIGA in pediatric patients have not been established.

Geriatric Use: Of the total number of patients receiving ZYTIGA in phase 3 trials, 73% of patients were 65 years and over and 30% were 75 years and over. No overall differences in safety or effectiveness were observed between these elderly patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Patients with Hepatic Impairment: The pharmacokinetics of abiraterone were examined in subjects with baseline mild (n = 8) or moderate (n = 8) hepatic impairment (Child-Pugh Class A and B, respectively) and in 8 healthy control subjects with normal hepatic function. The systemic exposure (AUC) of abiraterone after a single oral 1,000 mg dose of ZYTIGA increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function.

No dosage adjustment is necessary for patients with baseline mild hepatic impairment. In patients with baseline moderate hepatic impairment (ChildPugh Class B), reduce the recommended dose of ZYTIGA to 250 mg once daily. If elevations in ALT or AST >5X ULN or total bilirubin >3X ULN occur in patients with baseline moderate hepatic impairment, discontinue ZYTIGA treatment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

The safety of ZYTIGA in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA. For patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Clinical Pharmacology (12.3) in full Prescribing Information].

Patients with Renal Impairment: In a dedicated renal impairment trial, the mean PK parameters were comparable between healthy subjects with normal renal function (N=8) and those with end stage renal disease (ESRD) on hemodialysis (N=8) after a single oral 1,000 mg dose of ZYTIGA. No dosage adjustment is necessary for patients with renal impairment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

OVERDOSAGE There have been no reports of overdose of ZYTIGA during clinical studies.

There is no specific antidote. In the event of an overdose, stop ZYTIGA, undertake general supportive measures, including monitoring for arrhythmias and cardiac failure and assess liver function.

Storage and Handling: Store at 20oC to 25oC (68oF to 77oF); excursions permitted in the range from 15oC to 30oC (59oF to 86°F) [see USP controlled room temperature].

Based on its mechanism of action, ZYTIGA may harm a developing fetus.

Therefore, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves [see Use in Specific Populations].

• Patients receiving GnRH agonists should be informed that they need to maintain this treatment during the course of treatment with ZYTIGA and prednisone.

• Patients should be informed that ZYTIGA must not be taken with food and that no food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. They should be informed that the tablets should be swallowed whole with water without crushing or chewing. Patients should be informed that taking ZYTIGA with food causes increased exposure and this may result in adverse reactions.

• Patients should be informed that ZYTIGA is taken once daily and prednisone is taken twice daily according to their physician’s instructions.

• Patients should be informed that in the event of a missed daily dose of ZYTIGA or prednisone, they should take their normal dose the following day. If more than one daily dose is skipped, patients should be told to inform their physician.

• Patients should be apprised of the common side effects associated with ZYTIGA, including peripheral edema, hypokalemia, hypertension, elevated liver function tests, and urinary tract infection. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION. • Patients should be advised that their liver function will be monitored using blood tests.

• Patients should be informed that ZYTIGA may harm a developing fetus; thus, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves. Patients should also be informed that it is not known whether abiraterone or its metabolites are present in semen and they should use a condom if having sex with a pregnant woman. The patient should use a condom and another effective method of birth control if he is having sex with a woman of child-bearing potential. These measures are required during and for one week after treatment with ZYTIGA.

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) • Patients should be informed that ZYTIGA and prednisone are used together and that they should not interrupt or stop either of these medications without consulting their physician.

Manufactured by: Patheon Inc. Mississauga, Canada Manufactured for: Janssen Biotech, Inc. Horsham, PA 19044 © Janssen Biotech, Inc. 2012 Revised: December 2012 2000005445 K08Z121174A

FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY IV: Original Research Patient Navigation: Blending Imaging and Oncology in Breast Cancer Jeannine Arias, RN MSN, MBA, AOCNS, CBCN Adventist Midwest Health System

Background: Patient navigation (PN) in cancer care refers to the individualized care provided to patients with breast cancer, their families, and caregivers to ease multiple barriers and facilitate timely access to qualified medical and psychosocial care.

The relatively new PN concept has become a healthcare buzzword as organizations strive to increase program efficiencies and system retention rates. Objective: To evaluate the optimization of our regionalized imaging/oncology PN service program.

Specifically, the evaluation process examines imaging/oncology volumes, retention rates, and integration rates of our service lines after 2 years of phased PN implementation. Methods: Our review and evaluation were performed through the following initiatives: (1) Identify key stakeholders, patient groups, and current resources. (2) Define the scope of the PN involvement, job description, necessary educational preparation, and expectations. (3) Identify the current PN process. (4) Identify gaps, obstacles, and barriers to patients and families. (5) Determine program scope, cost, and implementation strategy. (6) Perform a needs assessment. (7) Develop a plan to bridge weaknesses in the current process. (8) Develop a plan to address the weaknesses. (9) Implement strategies. (10) Develop program outcome measures based on identified gaps and national quality-of-care standards. (11) Evaluate for future goals. Results: Immediate onset of PN services, timely treatment, and follow-up remain pivotal in patient satisfaction, outcome measures, retained volumes, quality improvements, and cost-effectiveness. Our recall rate, positive predictive value, false predictive value, and cancer detection rate are well controlled and mirror or better benchmark data. Our imaging volumes have increased 22% and our surgical/oncology volumes have increased 355%. Two of our 3 centers have earned the national accreditation programs for breast centers. The PN employees have been nationally certified in PN. Conclusions: Performing a systematic evaluation is vital in the identification of the programâ&#x20AC;&#x2122;s strengths and weaknesses. Regionally, our combined efforts have strengthened our cohesiveness and raised the bar with a friendly competitive spirit.

Patient Navigation Role Delineation Anne Willis, MA; Elisabeth Reed, MPA; Heather Kapp, MSW, LICSW; Elizabeth Hatcher, RN, BSN; Mandi Pratt-Chapman, MA George Washington University

Background: Community health workers (CHWs), patient navigators (also sometimes called lay navigators), and nurse and social work navigators all play critical roles in removing barriers to care and addressing health disparities. CHWs are embedded in the community, nurse and social work navigators are embedded in the healthcare institution, and patient navigators often serve to bridge the community and the healthcare system. With the rapid growth in the number of navigation programs and lack of consensus on terms and definitions, a need exists to clarify terms, roles and responsibilities, and differences across these 3 navigator types. Much progress has been made in defining competencies, roles, and responsibilities for CHWs and nurse and social work navigators, while less has been done for patient navigators. Objective: To fill the gap in the identification of competencies, roles, and responsibilities of patient navigators, this project sought to describe common functions across the 3 navigator types and delineate the distinct role each plays in the community and healthcare system. Methods: We used a 3-step method to delineate the navigation roles. First, we searched the literature, web-based documentation of established competencies, and publicly accessible training curricula to gather already-defined competencies, roles, activities, and/or tasks across the 3 navigator types. Then we created a Framework for Navigation, where we identified competency domains from the search (eg, cultural competency, care coordination, removing barriers to care) and mapped the competencies, roles, activities, and/or tasks to each domain for each navigator type. Finally, we brought together a group of CHWs, patient navigators, nurses, and social workers to define each competency domain to highlight the similarities across the 3 navigator types and to identify the key differences in roles for each navigator type. Results: The project resulted in a draft Framework for Navigation that specifies the commonalities and differences between CHWs, patient navigators, and nurse and social work navigators. Conclusions: This project is an important step toward standardizing the scope of work of patient navigators. The next steps will be to gather consensus on the differences across navigator types, clarifying patient navigation roles and responsibilities, and developing competencies for patient navigators.

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY V: Screening Programs for the Underserved Trial of a Cervical/HPV Hispanic Screening Robin Atkinson, RN, BSN, OCN, GYN, Oncology Nurse Navigator Novant Health, Derrick L Davis Cancer Center

Background: Cervical cancer can be prevented with regular screening tests and follow-up. The 2 screening tests utilized are the Pap smear, which looks for cell changes on the cervix that might become cervical cancer if they are not treated appropriately, and the human papillomavirus (HPV) test, which screens for the virus that can cause these cell changes. Data from the Centers for Disease Control and Prevention 2004-2008 shows a higher incidence of HPV-related cervical cancer for the Hispanic population. A study of cervical cancer incidence and mortality in North Carolina also reflects this trend and revealed reasons for lack of screening as no insurance and low economic status. Our community data reflect this national and state trend with local Hispanic women citing uneasiness with the Pap examination process, especially if conducted by a male physician. Our cancer center outreach concern is the lack of available free cervical screening clinics for the underserved, uninsured group of Hispanic women. Objective: In our regional cancer center, the Hispanic population does not reflect the increased numbers of HPV cervical cancers seen in the state or national trend. We are missing this population. The objective was to implement a trial of free Pap screening to the population of Hispanic women who would otherwise not seek healthcare. A goal was to make the screening comfortable for the patient, easily accessible, and conducted within a reasonable time frame.

Methods: A free community-based screening was offered to women of Hispanic decent over the age of 30 years in an accessible community Oncology Specialist Gynecological Clinic setting during evening hours. The women were recruited by a Hispanic patient advocate who worked in the local community cancer care facility. Recruitment was conducted in local churches, beauty shops, and wellness seminars that targeted the Hispanic population. The women signed up via phone or in person, and a letter was sent to the patient as a reminder before the event. The patient advocate called 1 to 2 days prior to the screening to confirm attendance. Clients were encouraged to obtain a babysitter if needed or bring someone with them to watch their children. Interpreters were used to help each individual woman complete the forms and make sure the personal information received upon registration was correct.

Healthy snack bags were given to each participant since this was an evening screening. In each examination room we had a physician or midlevel RN and an interpreter. The staff volunteers consisted of: 2 Gyn oncology physicians (1 male and 1 female); 1 Gyn oncology nurse navigator; 1 Gyn oncology nurse practitioner; 2 Gyn oncology physician assistants; 5 Gyn oncology RNs; 1 Gyn oncology CNA; 2 Gyn oncology CMAs; 2 laboratory technicians to process the Pap smear and paperwork; 2 community volunteers from the local cancer care facility; and 8 interpreters.

A Pap smear with thin Prep and HPV was used as the screening tool. Results: Thirty-eight women enrolled and 34 attended the evening clinic. There were 21 normal findings and 13 abnormal screenings.

Findings

Follow-up Action

1 Trichomonas + HPV positive

Referred to Health Care Access* for appointment referral

8 Paps normal but HPV positive

Follow-up with Pap and HPV testing in 1 year

1 ASCUS + HPV positive

Needs coloposcopy through Health Care Access

1 ASCUS HPV not performed due to insufficient amount of DNA in specimen

Follow up with Pap and HPV in 6 months

1 Low-grade squamous intraepithelial lesion, mild dysplasia, HPV positive

Needs coloposcopy through Health Care Access

1 Atypical squamous cell, cannot exclude high-grade intraepithelial lesion

Needs coloposcopy through Health Care Access

Health Care Access is an agency that screens and schedules clients for free care in a local community clinic.

ASCUS indicates atypical squamous cells of undetermined significance.

*

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY V: Screening Programs for the Underserved The Table reflects the abnormal screenings and the follow-up. All results were reviewed by a Gyn oncologist, and recommendations for follow-up were given by the Gyn oncologist. Each abnormal result was called by the Gyn nurse navigator with the support of Hispanic patient advocate. Also, an education session by the Gyn nurse navigator and the Hispanic patient advocate was offered for all women with abnormal screenings to emphasize the importance of follow-up care. Twelve of thirteen (92%) participants attended the session. Personal diagnostic questions were answered privately with individuals to protect their health information. Conclusions: (1) The clinic was a success with attendance participation of 89% from those enrolled. This was due to our Hispanic patient advocate who worked individually with each attendee and conducted reminder calls and letters. (2) It was economically feasible with the cost of $58 for healthy snack bags. The volunteer time cost for those working in the evening clinic was 2 hours. (3) All positive screenings had a follow-up plan for patients that did not incur cost to them. (4) Patient satisfaction surveys are pending. The feedback will influence the next screening for this designated population.

Cancer Genetic Counseling and Testing: Genetic Counselors’ Perspectives on Patient Access, Resources, and Follow-Up Care Mary Lou Woodford, RN, MBA, CCM; K. Habin; J. Boucher; M. Underhill; D. Lundquist; D. Guillaume Cancer1Source

Background: The prominence of cancer genetics testing is outpacing current patient access, resources, and follow-up care by trained healthcare professionals, including oncology nurses. Significant concerns include the impact of predictive genetic testing on patient outcomes involving cancer surveillance, detection, and preventive care in the community (including those at a younger age). The purpose of this research was to describe genetic counselors’ perspectives on patient access, resources, and follow-up care related to cancer genetic counseling and genetic testing.

The study aims were to: (1) Explore cancer genetic counselors’ experiences with patient access to predictive genetic testing, health information needs, and follow-up psychosocial support and counseling; (2) Describe strategies utilized by cancer genetic counselors to facilitate genetic counseling and testing for cancer predisposition syndromes, including experiences with the GIFFTS program; and (3) Identify needs for future research and community interventions to assist genetic counselors in providing cancer genetic counseling and testing within underserved, at-risk communities. Methods: A cross-sectional qualitative focus group method was used with clinical genetic counselors (CGCs). Eligible CGCs who participated in the study provided predictive genetic testing and counseling services within the past 5 years for identified at-risk patients for cancer susceptibility. A cross-sectional cohort of 3 focus groups included a total of 20 participants. Descriptive survey and qualitative content data were analyzed for common themes from focus group interview responses. Results: The results of qualitative responses revealed the following emerging themes: Navigating the System of Genetic Testing and Counseling, including subthemes of Access and Referrals, Barriers and Resources, Psychosocial Needs, and Patient/Provider Preparation. Navigating the System of Genetic Testing and Counseling was described by genetic counselor participants who identified referral, finances, knowledge, and preparation as key areas of need along with the impacts on high-risk patients (including the underor uninsured) accessing follow-up preventive care. Conclusions: In summary, additional resources are necessary to address the needs of patients and providers, including the underinsured and uninsured, undergoing predictive cancer genetic testing and counseling as a result of a community. Genetics education and training are needed for all healthcare professionals, including oncology nurses, regarding care provision to a high-need and underresourced patient community. The study findings will be used in the development of patient-centered interventions aimed at reducing disparities in cancer genetics and preventive healthcare solutions.

JONS-online.com

JOURNAL OF ONCOLOGY NAVIGATION & SURVIVORSHIP

53

FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

CATEGORY VI: Community Outreach Breast Intraoperative Radiation Therapy (IORT): New Intraoperative Treatment for Early-Stage Breast Cancer Eliminating Weeks of External Beam Radiation Gregory M. Graves, MD; Joyce A. Eaker, MD; Nitin Rohatgi, MD; Jeannine Graves, RN, MPA, CNOR, OCN Sutter Health

Objectives: To introduce a technological advance in the outpatient setting for early-stage breast cancer. This treatment approach is timely in terms of access to comprehensive breast care that is affordable, timely, and decreases exposure to healthy tissue and organs. Successful patient navigation with this treatment option results in a shorter acute care treatment phase with surgery, radiation, and chemotherapy/hormonal therapy transit shortened by several weeks. Methods: Sutter Medical Center, Sacramento, treats 300 new patients with invasive breast cancer and 85 with ductal carcinoma in situ annually. In November 2011, we developed a multidisciplinary breast team that launched our IntraBeam Breast IORT program. Our goal was to treat 50 patients the first year. We treated 57 in the first 14 months. All patients were treated on an outpatient basis. We followed the Targit-A criteria for patient selection. The retrospective patient analysis follows. Results: Patient range: 51-93 years; mean, 68 years (8 patients >80 years of age); tumor size: 6 mm-27 mm; (mean, 14 mm); wound complications: infection: 1, hematomas: 2, uncomplicated seromas: 10; operating room time: 90-130 minutes per procedure; positive lymph nodes: 3/57 (5%); patients receiving breast irradiation after Breast IORT: 6/57 (10.5%); cosmetic results: good-excellent: >90% (based on verbal patient reporting); cost-savings per case: $7000; contribution margin: $150,000. We are in the process of entering our patients in the Targit-R Rad Cap retrospective registry trial for outcome analysis of all Breast IORT cases in the United States. Conclusions: Breast IORT using the IntraBeam unit provides a safe and cost-effective method for the treatment of early-stage breast cancer. Critical to program outreach and success has been the role of the RN Navigator. The navigator provides patient education; referring physician education; care coordination between surgery, radiology, radiation oncology and medical oncology; and follow-up data collection and analysis.

Evaluative measures include time reduction from one intervention point to the next, improved patient care for long-term survival, improved patient satisfaction, improved cost-savings per case, and qualification for use as an accountable care organization treatment approach. Clinical pathway guidance is a hallmark of oncology navigation.

Providing an accelerated process from suspicion to diagnosis and treatment via nurse navigation eliminates fragmentation of care that is common for patients with breast cancer. Inclusion in this treatment option provides patients with supportive care starting with diagnosis through and including survivorship.

The Advocacy Connector: Bridging the Knowledge Gap Joanne Vanak, RN, MSN1; Ellen Ivey, BS2; John Kerrane, MS, RPh3; Susan King, RN, MS, OCN4 Janssen Services, LLC; 2Johnson & Johnson Healthcare Systems, Inc.; 3Janssen Services, LLC; 4Pharmacyclics, Inc.

1

Background: There is a knowledge gap between the capabilities of advocacy groups and healthcare providers (HCPs) and patients. The need to create awareness about valuable resources, available through not-for-profit organizations, for HCPs, patients, and caregivers led to the creation of our project titled “Advocacy Connector” (www.advocacy connector.com). Advocacy Connector is a web-based resource that links patients and HCPs to a variety of advocacy groups that will serve to address a host of patient needs (eg, emotional and educational needs and financial support).

Initially, this resource will focus on the area of oncology. Objective: To help connect oncology patients with relevant advocacy group resources, either on their own or with the assistance of their HCPs. Methods: Not-for-profit state and national level advocacy groups focusing on services directed toward oncology patients across the United States were given a survey to complete. Information regarding state-level advocacy groups was gleaned from the 12 states with the highest incidence rates of cancer (California, Florida, Texas, New York, Pennsylvania, Ohio, Illinois, Michigan, North Carolina, New Jersey, Georgia, and Virginia). The groups were asked if they would participate in an online resource that would highlight the capabilities of their respective organizations. The advocacy groups identified their key services, the results of which were then reviewed and validated by an independent vendor. Results: The Advocacy Continued on page 56 54

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The Elodia Kehm Chair of Hematology Professor of Medicine Director, Lymphoma Program Rush University Medical Center/Rush University Chicago, IL

Sonali M. Smith, MD

Associate Professor Section of Hematology/Oncology Director, Lymphoma Program The University of Chicago Medical Center Chicago, IL

Mitchell R. Smith, MD, PhD Director of Lymphoid Malignancies Program Taussig Cancer Institute Cleveland Clinic Cleveland, OH

Steve M. Horwitz, MD

Assistant Attending Medical Oncologist Lymphoma, Cutaneous Lymphomas, T-Cell Lymphoma Memorial Sloan-Kettering Cancer Center New York, NY

Supported by an educational grant from Celgene Corporation

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NOVEMBER 15-17, 2013 CONFERENCE CO-CHAIRS Lillie D. Shockney, RN, BS, MAS AONN Program Director University Distinguished Service Associate Professor of Breast Cancer Departments of Surgery and Oncology Administrative Director, Johns Hopkins Clinical Breast Programs Administrative Director, Johns Hopkins Cancer Survivorship Programs Department of Surgery and Oncology Associate Professor, JHU School of Medicine Departments of Surgery, Oncology, and Gynecology Associate Professor, JHU School of Nursing Johns Hopkins Avon Foundation Breast Center Baltimore, MD

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

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CATEGORY VI: Community Outreach

Connector is a compilation of information from both state- and national-level advocacy groups, specifically focused on the following cancer-related diseases: prostate, ovarian, breast, colorectal, and lung, as well as leukemia, lymphomas, and myelomas. Advocacy Connector is organized so that patients and HCPs can easily access information about each advocacy group according to the type of services they provide for each type of cancer. Available information includes: help lines, alternative and complementary therapies, research, caregiver support, clinical trial information, counseling, end-of-life care, financial assistance, legal/insurance assistance, men’s health, pain management and palliative care, screening and early detection, spiritual support, survivorship, travel services, veteran services, wellness, nutrition and exercise, women’s health, and young adult cancer support. Materials may be printed for home use by patients and caregivers. Telephone numbers for the resources are included in the printed information for those who have no access to computers. Information is also available in non-English languages (eg, Spanish). Conclusions: We believe the Advocacy Connector will help bridge the knowledge gap by increasing awareness of the extent of services offered by oncology advocacy groups and thereby increase patient knowledge, access to services, and overall satisfaction.

Implementation of a Lung Computer Tomography Cancer Screening Program at Frederick Memorial Hospital Margaret Siebeneichen, BA, BSN, RN; Paul Chomiak, MD; Mark Soberman, MD, MBA, FACS Frederick Memorial Hospital

Background: Lung cancer is the third most common cancer and the leading cause of cancer death in the United States.1 Smoking is the most important risk factor for lung cancer, resulting in approximately 85% of all lung cancer cases in the United States.2 Approximately 37% of US adults are current or former smokers.2 The incidence of lung cancer increases with age, occurring most commonly in patients aged 55 years or older. Lung cancer has a poor prognosis, and an estimated 160,340 Americans were expected to die from lung cancer in 2012 accounting for approximately 28% of all cancer deaths.3 The majority of lung cancer cases are non–small-cell lung cancer (NSCLC),2 and most screening programs focus on the detection and treatment of early-stage NSCLC. Screening for lung cancer in a high-risk patient population would identify earlier-stage tumors and may improve lung cancer–specific survival.4 The National Lung Screening Trial (NLST) provided the first definitive evidence that screening for lung cancer with low-dose computed tomography (LDCT) decreases lung cancer mortality in certain high-risk groups.5 Methods: Frederick Memorial Hospital created a process for screening high-risk patient populations using an LDCT. Patients can self-refer to the program; no physician order is necessary. Patients are screened for eligibility as per the NLST criteria (recently modified to be in concordance with the Prostate, Lung, Colorectal and Ovarian Screening Trial data) by a nurse navigator. If appropriate, the navigator sets up the screening appointment. Computed tomography (CT) scans are read by a radiologist and a thoracic surgeon. The nurse navigator contacts the patient and informs him or her of the results.

Written copies of results, with a letter explaining the findings, are also mailed to the patient and the primary care physician.

Depending on the findings, the patient is given recommendations for follow-up. The following data points were collected: total number of inquiries, total number of patients screened, patient demographics of the screened population, total time spent from initial inquiry to date of screening, total time of scan to recommendations, screening study results, and outcomes. Results: From December 2012 to June 2013, there were 103 inquiries about the lung cancer screening program; 64 patients qualified for the program and were screened using LDCT, 50% of patients were female, 47% were active smokers, 53% were former smokers, and 94% had been exposed to secondhand smoke. The total time from intake to performance of the screening CT scan for Q1 2013 was 5.7 days and Q2 2013 was 3.8 days. The total time from CT scan to recommendations offered in Q1 2013 was 3.3 days; in Q2 2013, it was 2.4 days. Thirty-one percent of patients had a benign/normal scan, 42% were identified with an indeterminate pulmonary nodule, 7% of patients were identified with a finding worrisome for lung cancer, and 10% were identified with “other” abnormal CT scan findings. Thirty-one percent of patients received a recommendation to continue annual CT screening, 42% were referred to either a pulmonologist or thoracic surgeon for longitudinal radiographic surveillance as per American College of Chest Physicians guidelines, 17% were referred to thoracic surgery for evaluation and intervention, 6% were referred to thoracic surgery for evaluation and intervention, and 6% were referred to a specialist or primary Continued on page 58 56

OCTOBER 2013 • VOLUME 4, ISSUE 5

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CONQUERING THE CANCER CARE CONTINUUM

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CONQUERING THE CANCER CARE CONTINUUM CONQUERING CANCER CARTHE I E CONT IN

A 6-part series The publishers of The Oncology Nurse-APN/PA, The Oncology Pharmacist, and Personalized Medicine in Oncology are proud to present our 2nd annual Conquering the Cancer Care Continuum series.

Upcoming topics include:

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SECOND ANNUAL

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D ISSUE ™ IN THE 2013 SE RIES SE C O N D ANN UA L

Changing the Image of Palliative Care Lillie D. Shockney, RN, BS, MAS

vention and relief of suffering by means of early identiam enthusiastic about this 6-part series titled Confication and impeccable assessment and treatment of quering the Cancer Care Continuum. Each edition of physical, psychosocial, and CCCC will address an important topic in oncology S pain and other problems, spiritual.” (http://www.who.int/cancer/ management and offer expert stake2013 SERIE E TH IN ISSUE Topics will palliative/en/).

IRD commentaries.

THholder For too long, however, the image of include: palliative care, pain manageNU AL AN ND ™ palliative care has been tied exclusively ment, hospice care, comprehensive SE CO to end-of-life care and focused solely on treatment planning, survivorship care, pain control. and the role of biosimilars in supportLillie D. Sho ckney, RN, BS, MAS The articles that follow provide a ive care. In this issue, we address paln part 2 of clear understanding of the intent of liative care. our Conque series, the ring the Can palliative care today, with the primary Palliation in cancer care is a topic focus is on mat pain man cer Care Continuum agemen goalt.ofDes ending its identification that commonly makes people (medical wel ic improvements inabilitysolely l as surgical in pite drato overco procedures pharmaceu cancer provideddie for wh theile dying. providers as well as patients) uncom- we still me it effe l agecare designed to as tica nts, as have a lon ctively, fear in great help g way to go pai monly resp ing con Instead, palliative be assofortable. I recently had the opportunity cessful on beh ™trol pain, care should ond that n. Family members, they will D.alf Shockney, of our patiRN,to be suctheir grea nesscare I wasLillie too, com theirforlov ents. ciated with quality-of-life alled to speak with members of our palliative rece BS,wat test fear is MAS one in having to utes of an ntly ching a few witold, black-a care team at Johns Hopkins and learned ern min- cancer patients and survivors, no mat- ease the great pain withou nd-white t movie. A suff erin west-clinical outcome. g. Family a way to cowboy ter what their that the word “palliative” comes from the fear these byword a gun“palliare,” memb will be the slinger, and had been shot final images ers patients may not tell you about the sidewitness before which means to disguise or cloak. Centuries ago,mp this word as theYour tor atte towncancer they their loved ted to rem docMa from one ny organi effects was used for the drapes that covered a casket. hisAlthough theof treatment they are experiencing or about their chest, ano ove zations hav dies. oped me ther cow bullet the wounde e develasu discomfort due boy gav we continue to drape coffins—most memorably with the d man tice guidel rement tools and e to their cancer diagnosis or its treatment. a bottle of to drink ines for pracand a whicases In many flag—the drape is no longer referred to this term. ske they may simply assume that the discomhelping hisby teeth. I’m knife to bite betwee y providers the purpose of nwith the disease.” However, with the imeffectively age pain The World Health Organizationwas modified its sure orig-back infort how peo associated the “comes ma day this ple its cop wit trea h cancer nin medicine and the power of science, it inal definition of palliative care as quo follows: “Palliative ed witprovements tment. r to num and b them and h pain – liprovide you The following har d doesn’t anymore. Do not wait for your patients arti care is an approach that improves thetoquality of life somethhave call bite on. ing to mation asso with a wealth of cles This is far him asking him to MAS back e idea wrotfrom ised he kney, RN, BS, about their symptoms; be proacof patients and their families facingTod the ay problems asall pat t sank l.a discussion and guidel ciated with the inforhow surpr ien.tsI whto initiate hear Lillie D. Shoc My and said se that o ent l environ of hospita est thatat the time you are planer initiate tive and thisrequ discussion sociated withthe life-threatening through thesoon pre- t,after that thoughines. They also pro tools men did next edition illness, an inp anda to even me. whe to you atieHe at all mote tful care on he nd the bring nt This r to s. mati it uni respo lege be to serie infor Lillie sure t or be me their was a clinic visi for taken to D. Shoey that all all of the t is my privi Continuum doctor, ckney, I reiterated t with t the long journ Cancer Care options, RN, cancer pat of us address wit enaskede. to by phon BS, MA talk are we sure Conquering the es specifically on hospice Hopee-pain mea me abou com ����� �Green Hill Healthcare Communications, LLC told plet red together S e a had endu focus experienci ients the pain the h our to read. of whethe ment toolhad thaand issue, which t prohis ly important r vidwife he at age 30. es al diagn to relieve ng and implement y are ve to be vital gree. Pat they are presen e exposis will be initisom is one I belie tly in ressofion it. Pain stea herpain ways ien since addressed here tim n her clini sica , descr and to iptio what to circ ts have trou what de- ness,phy ble,d how fully, concepts and better ways of it l endurancee, psychological ls away social on his le Base alert (a eve ed hap wel tuaI lly abs limit pain was inte rpreting ly ill. adopted as newterminally ill cancer ition r,and ent for somand can make qua l-being, and bad in the py face cond a ver calor grave and y thatface lity of life cause the she) ifwas ntsad supporting our families. g but theirthe doctor adequate trea e patients. Accur y took a mornin virevide was not ght their so ate tme pain me doc and thou bad asse I an nt nt nts tor. pill ng now for nee ssment patie Fur befohim that effectiv self thatthehecan d to be prioriti al years ago getti He himbeviewed by thermore, is thistold re com essetod see I recall sever es for all e pain managestring Bill. o di his cer fiel the any as srma winfo of us wor tion actu a man named and sometim one during the to linger after I feel con d. king in net and difficult ally e-mail from it Som ir visi d t? re- this next fident you es foun via the Inter etim will find Certainly it is not. ion regaris,ding pro had found me his young is ing and con hevok brief conversat es itthat whatwill stating that taining valu these articles tho cer patien one of the greatest canwrote to me Mary. And a st you in ught breasstt can ts is the butassi fearfor able info step s exp a drug metastatic brea reas not fear wel had ress is rma , sess , on r l ed e of tion v Mary as dev ing your painnow ng her by canwife, her li that (He andplaci current pat sufferin progressed to d hospice. future pat eloping more effe calle g and ients as cer that had . She was ctive ei ients eithe special program this and now brain term befo fectre ively man have quality of life ways to help you d Lilliesleeping lungs, bone, r aged. Q had not hear n to explain some of by having hospital and D. Shockney, RN pain efI bega , BS, MAS currently in the awake, confused at © he 201)3As care, ther. ice Gre was en fits Hea of hosp kney, RN, more than she lthcare“Lill key beneHill but “had still ie, my the ht, Lillie D. Shoc Com weig g said, municat t and until BS, MAS times, losin fourth issu got very upse chemotherapy he or 8 years old. I ions, LLC and ving 6 recei sons, e doct 2 of Conquerin been die. We have then told him that she wrote that the Colast g theotCa wife cann the ntinuum ser yesterday.” He e.” I nce alonre s with thiadd care of her for nin I would work meet himies rescann ot raise themr Caice ses Tre e and situ staff and who had taken d him to com g Thro atio ir mTh atm that hosp omeand ugh . He said aske Follow Pland die but ent losing then. goa n ren for the about next steps a the 4 years had r Ca hileCancewoul ds who l of the team re these child room to talk ing are paont 2 er for wicle andy frien preC outcom is optimal him tore inuum.ly members rap morning in her onthe t would ling key art imes. cologis role g place,s to providhim identify fami medical asized the im he t takin of y emph all were the s help e insighraise these boys. I Th ere that usu ad discussion clinor are – adical pha that types gistofas e rma help him t into the duck doct said in a row nowsom d s col abrief woul . The me cal whenever these was very oo gh considerations ly beenetc. mberhe of all Though “going to he plin that have absThou nce of getting power of attorney, ent so wasthe mu porta ing, but can no but this time no ary ltid work this historiier to tea isci- e directive, will, on long m andrkin zed that longer rem theng went vanc med, he reali died just husbwo treatments were to izz.” col 5t ain whel The lab wan the over so. ora ren find Pat ously hosp to know abo tivelyhe was obvi der rec but I can’t ients . Though she put my wife on ut the pros en very soon ndat tio drug Herceptinommeabou hownseff-treatm d the of treatme and cons aboutdid have to happ entme anything write, “I foun nt, risks and ing mets?”

Can you tell pla,nn benefits, wh their quality drug Hospizz. are liver and lungoptions. Gone thebrain day, s, is for at or of life wil fective this drug l be while oncology spe they should be, when s, LLC treatment on as well as afte cialists me n Hill Healthcare Communication rely passed r treatme – either comple © 2013 Gree

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• Palliation • Pain management • Hospice care • Treatment planning • Survivorship care • Biosimilars in supportive care

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Introduc tion to O ncology Pain Ma nagem ent

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ted. And the on paper or nt is on re is a new electronic prescriptio kle in the ally – wrinn instructio n treatment planni ns to be fille by the pha – what wil rmacologi l this treatme ng process st or pharma d These ind nt cost? Wi patients hav cist. ividuals, ll e to pay out experts in managem of the poc ir trea ket dru ent, i for tment? Is g the cost of mization, are nteraction, and opt ment worth treatit integral to the clinica the oncolo care team. to be achiev l outcomes gy You will ed? No pat soon read ients wan learn why. leave their Lillie D. Sho and t to ckney, RN family in dee , although we p debt, and And speaki BS, MAS have entere ng of the tea that the pat d an excitin era of person m, it is crit ient, and cer g ically imp aliz ortant tain family cases, be con of these new ed medicine, the cos compared members in t sidered me drugs is inc with treatme some mbers of the ning team. redibly hig nts we hav to in the We should h treatment e been acc past. Even not be doi plan we must be nust prio ng om bee thi r ed treatment doing things ngs to a pat n daunting regimens ient; from a cos patients, of with a pat have t perspectiv ient. Thoug Everyone course, are e. wan h the not experts many have the right trea ts to make sure tha on oncolo desperatel t the patien gy care, y tried to tment at the sort by tur t gets become ex way. Now ning to the right time perts off a clinicians Internet and and for themse in the right must realize trying to det treatment’s lves what that treatme treatment sake is nev would be bes ermine nt for er wise and Thoughtf t for their ul decisio not the mis ns about sion. and patien treatm ts, oncolo gists, pharma ent are a must, cologists, palliative © 2013 Gre en Hill Hea lthcare Com munication s, LLC

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FOURTH ANNUAL AONN CONFERENCE ABSTRACTS

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CATEGORY VI: Community Outreach

care physician for evaluation of abnormal “other” findings. Conclusions: Individuals at an increased risk for lung cancer have been shown to benefit from LDCT screenings, although some uncertainty remains about the potential harms of screening. In fact, the US Preventive Services Task Force has very recently endorsed CT screening for lung cancer. The involvement of a multidisciplinary team that includes a thoracic surgeon is essential in order to minimize unnecessary surgical procedures and procedure-related morbidity, and to determine the best surgical technique for resection.4 The involvement of a nurse navigator decreases the time for inquiry to completed screen and also eliminates the performance of inappropriate screens. The nurse navigator is the touch point for these patients, and maintains a database to ensure the findings and recommendations are communicated and acted upon, so that patients do not “fall through the cracks” of the healthcare system.

REFERENCES

1. American Cancer Society. Cancer Facts & Figures 2013. Atlanta, GA: American Cancer Society; 2013. http://www.cancer.org/research/cancerfacts figures/ cancerfactsfigures/cancer-facts-figures-2013. Accessed, July 15, 2013.

2. Humphrey L, Deffebach M, Pappas M, et al. Screening for lung cancer: systematic review to update the U.S. Preventive Screening Task Force Recommendation Statement. Evidence Synthesis No. 105. AHRQ Publication No. 13-05196-EF-1. Rockville, MD: Agency for Healthcare Research and Quality, 2013.

3. American Lung Association. Lung Cancer Fact Sheet. Washington, DC: American Lung Association. http://www.lung.org/lung-disease/lung-cancer/resources/ fact-figures/lung-cancer-fact-sheet.html. Accessed August 13, 2013.

4. Jones D, Minor G, Internal communications. CT Screening for Lung Cancer.

5. Rocco G, Allen M, Altorki N; STS Task force on CT screening. Clinical statement on the role of the surgeon and surgical issues related to CT screening programs for lung cancer. Ann Thorac Surg. 2013;96:357-360, et al.

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