June 2013
www.AONNonline.org
Vol 4, No 3
Resources from Pharmaceutical Companies
Resources of Potential Benefit to You and to the Patients You Navigate
The Antecedents of Patient Navigation
Spanning Boundaries: System Dynamics, Externalities, and Patient Navigation
Addressing Disparities
Systematic Assessment of Cancer Patient Navigation in Appalachia
Navigating Patients Across the Continuum of Cancer Care
tm
Š 2013 Green Hill Healthcare Communications, LLC
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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CONQUERING THE CANCER CARE CONTINUUM CONQUERING CANCER CARTHE C E CONT I
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:
• Palliation • Pain management • Hospice care • Treatment planning • Survivorship care • Biosimilars in supportive care
™
Challenges Patients Face in Cancer Care: Implications for the Healthcare Team Lea Ann Hansen, PharmD, BCOP Associate Professor, Virginia Commonwealth University
cancer.1 More than half are living well beyond 5 years ancer is an illness associated with substantial physical, emotional, social, and financial ramafter diagnosis. Women comprise a majority of longifications for affected individuals and their term survivors due to the favorable outcomes with families. In a significant number of cases, the diagnosis breast, cervical, and uterine cancers.2 The number of of cancer is either preceded by a period people living with a history of cancer of gradual, nonspecific symptoms or is projected to grow considerably over
discovered by routine screening, and the next 20 years for 2 major reasons. individuals are then thrust into a First, the number of Americans over whirlwind of diagnostic testing, inage 65 is predicted to double between vasive procedures, and complicated the years 2000 and 2030.3 Consetreatments with very little warning or Lea Ann Han quently, as a disease primarily of older sen, Pha Associate opportunity to assimilate their circumProfessor, rmD, BCOP adults, cancer will also increase. SecVirginia Commond, stances. Frequently, a multidisciplinary as the effectiveness of cancer onweal versity ™ th Uni approach to treatment is necessary, retreatments improves, the number of he past dec ade has seen quiring patients to engage with numerthe utilizat a drapatients matic upscured of the disease will inion of spe urge in ous medical teams comprising several crease, even larger percentage cial types of ty pharma and an Medic are Moder cies for all Lea Annthe Hansen, rapeutic different specialties, often in different those for can will be living longer with disease nization Ac mo dalities, as “athe cer. The BCOP PharmD, t defined part D dru including cost of can a specialty locations. Many patients have beenabout $125 bill receiving multiple “linesâ€? of g with plan-n cer carewhile ceed $40 drug ion in 201 may rise from egotiated 0 0 to $20 prices tha relatively healthy prior to the cancer lion therapy (first-line, eventbyand second-line, etc) over time. per Themonth.â€? 2 Oth thethere7 bilend of the fine spe t exer health cial dru dec ade. demand plans ma gs differe fore are not sophisticated consumerstim ofe,medical overall specialtyserBy that for oncology services is expected totyiny dently. In gen drugs are accon predic ounhealthcare eral, they hig vices. Consequently, it is incumbent crease byted 48% by 2020, while the supply of oncologists t for 2 of h cost, adm to are every 5 pha inistered lars spent. 4or rma by 1 professionals to be able to facilitate patients’ transition will increase by only 14% based on current patterns. cy infu inje dolsion, require The purpos ction e of this arti special han to expand ersity intoBCO carePin order to minimize theirisdistress the need for a wide varietyor are used lain maxicle underscore dling, the evoluti These statistics en, PharmD, Commonwealth Univ for comple 80%, cialty pha on nia their clinical outcomes. Lea Ann Hans ssor, Virgimize x diseases e from 17% toand other support personnel torequire of rang the of ens health professionals spe rmacycatio Profe regim that special mo ption andnthe Associate on assumeach oral mediand can nitoring. functio term serv cology, how Anscomm Challenges exist beyond diagnosis play a part and every patient to re.2-4 t initial e in the around 50% In onmenthe itin enabling ever, the getreatment systemic treat ts would be an avera andwith agen mo r of to age scenario forperiod st ance nt can treatment as well. According to the National ceive quality care that addresses all of their needs disc nts com aantic mina cer dispensed uss nistr mon thee pot to oral he predo been renc by a special involved admi entthroughout adheindividandthat disease, has of the illness. Patients deial ofefit macy pro the traditionally (NCI), more million llen ty pharges oftothe highlythan 12cha s the continuum severityben vider (SP of cancer has Cancer Institute thesyst ate the otherapy by due P) are the pointwith er, ies indic em 5: high usinchem Stud targ from of ue. veno fine quality of care based on their ability to uals the United States are living a history of view ete untr nt. the intra new d agents of the patproven er the patie tion of py are that are ient. ly monitored for cancer thera tered ora adminisnnel who close lly. After adherence rates5 rence has trained perso in an The Evolu a system . Nonadhe w of the lite atic redures took place to 97% tio Green Hill Healthcare Communications,vie LLC rature, one When these proce infuDrugs an n of Sp15% ecialty iated with worse outcomes group of academic or in a hospital d assoc authors pro s and with oncologist’s office Pharmac Specialtbeen y posed the se state ation of the crit disea educ Lea of ical ber sive Ann mo y descriptors st in a num Hansen er hossion center, exten , high More of a spe There is drug to be 3 ician visitsPha rmD, BCO , ly was possible. cialty a lack of : increased phys stays, P consen patient and fami specialty ly comsus on the • High cos , longer hospital drug. The n rates ver, an increasing definition t (prescri Food andpitalizatio recently, howe not define ptions cos of a ased morof one or Druse than $600 ening, and incre g Ad d the term t more wors involves the use min • toDifficult istration has per month . Initialldisea mon situation synonymo medicatio ately one-third ) y, the.6 lab and self-admin roxim ns us n App catio wit del el was d— Special h biotechno tality ivery, suc more oral medi teins pro in the ualicati h as ly on-relate handling logy producs of allvirt med duced by eous therapies requiring n ts, either recombin two-third istered subcutan strict tem monoclon pro-to medicatio control t respondue ant DNA ations are perature al antibo ent. The direc — hospitaliztechnique dies produc home environm bridomas, admincost of $100 bil- Restricted location —at sa or ed dher but this acquisition and h ence for medicat cellular hy- ose of this ar- or distribu is no lon nonawit sibility for drug ion prepar 7 The purp Lillie D. Sho patients and ger theannu tion site the to ally. ation ng cas ckney, — e. The 200 lion sen, epts Han istration is shifti , BS,PMAS Lea AnnRN 7 ral conc Restricted locatio ork, if availribe gene netw desc ort to is BCO n supp for medic ticle ed to PharmD, their social than 20n ation adm research relat tration nt time, more part 2 of our inis rence and the able. At the prese ence, risk facConquregar ding patient adhe Greent.Hill incid approved for Hea The erin FDA seri lthc g are men ion, the ns es, are treat addit Com wed. ncererCare Co le 1). Inthe focus is on adherenceCa to canc oral medicatio lem will be reviemunications, LLC cancer (Tab pain manag prob matic tumo uum that treatment of nces of thisntin imprsrov ement examine the first-line ementstors, and conseque . Despite dra ts are used for subsequentlyinability to ove in pha other oral agen well asl surg rcome it effe this series will ment. Acrmaceu intica a number of dieclini last article to initia treatical proceduresThe rence and whcal l age ctively ile in ntsg,adhe design mizin Netor are refractory we still hav as maxi ed toices e a erlon helfor ensive Canc have relapsed monly resp great pain. Family , fearing they will gtheway tothe p control pai prehsful best pract Comces onal go me ond that the Nati to in on n, the ds be behalf of our suc compoun cording to ness their ir greatest mbers, too, comoutcomes. pat 25% of all I ien nloved one fea was ately ts. admi oxim rec arely wat pipelineent in great pai r is having to witwork, appr ching a few uteent 1 s and developm n withou of rch an . resea nease the suf min inue, blackOrga - oncology to contold likelymo and-wh World Health fering. Fam t a way to the trend isern by the ased ed so ite vie y, incre defin fear these west-ce was ily memb A cowboy n’s beistered orall lity come.s the Adheren will be the nsibi by to which a perso had respo nt a in adgun bee “exte be shift final images ers the slin n or not wit as sho ger, and as ness before With this diet, and/ cations may they mediatt ization in t2003 following a their loved irethe tow anticancertor empte n or, doctakin ensdthat Many org one dies. - g medication, possibility that to requ ove havi regim ially for ctly, especfrom his che rence torem long- the oped measu anizations have dev ministered corre another cow bullet ates of adhest, elestimwo rement too all the Over g. boy und tic dosin gave ed ls and pra e guideline s, LLC repeated to drink and man a botHealt cCommunication tle s for hcare of wh the hel iskey ping provid purpose of reen a kni feHill to bite his tee G ers
THE QUERING N O C ANCER CARE
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Conven ie The Imp nce, Challeng es a Patient ct of Specialty , and Cost Co Care nt Pharma cies on ainment:
C O N T I NT U U M C
SECOND ISSUE IN THE 2013 Therapy SERIES to Cancer SE C O N nadherence No of ct D ANN Impa UAL
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CONQUERING T CANCER CAREHE CONTI
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Introduc tion to O ncology Pain Ma nageme nt
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th. I’m betwee effecti age pain ass ociated wit vely manwas how peo sure back in the day n its treatm h cancer and this ent quor to numple coped with pain provide you . The following art – icle hard to bite b them and someth liwith a we ma alth of inf s ing on. tion associ orToday all This is far from ide and guidel ated with these tools ines. They hospital env patients who ent al. tha als er t thoughtfu o a an inpatie ironment, whether l care be tak promote sur nt unit or it e that all be Lillie D. Sho a clinic visi their doctor of us addres en to enckney, RN t can wit , , cer patien s BS, MAS pain measu are asked to comple h ts the pai with our experienc rement too te ing and imp n they are of whether l that provid a to relieve lement wa the it. Pain gree. Patien y are presently in es some expression ys pai physical end time, psycholog steals away social what to circ ts have trouble, how n, and to what deica ura l we nce ll-b le and can ma eing, and tually absent pain was bad (a happy face or a ever, interpreting ke quality ver of life virand adequa for some patients. cause they in the morning but y sad face) if their Accurate te treatment took a pai not so bad assessment ment nee for effectiv n doctor. Fur now bed to be pri e pain ma thermore, pill before coming orities for the cancer to see the is this info viewed by all of us wo nagefield. any rm rking in I feel confide and sometim one during their visi ation actually rent you wil t? Sometim es provoking l find these es it is, Certainly it is not. and arti con cle tain s thought will assist ing valuab cer patien one of the greatest fea you le informa ts is the fea rs tion that well as dev in reassessing you r of pain and expressed by canr current pat elo pin g mo suffering and future patien re effectiv ients as e the fectively ma ts have quality of life ways to help your naged. by having pain efŠ 2013 Gre en Hill He althcare Com munication s, LLC
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www.JONS-online.com JONSAsize CCC_060413
LETTERS FROM LILLIE
Editor-in-Chief
Lillie D. Shockney, RN, BS, MAS
Dear Reader, Although it may be summer, which is known for being a time that employees take vacations, we all know that there is no vacation for our patients who have been diagnosed and are undergoing treatment for their cancer. Other than those patients with metastatic disease who might be able to take a “drug holiday”—better known as a break from the toxic drugs for a period of time while their cancer seems to be a bit more stable—in general, cancer is with us during every season. Patients rely on their navigators no matter what the season, upcoming holiday, or your personal vacation plans, so thank you for being so committed to providing quality navigation to your patients so consistently, and with such compassion. This issue of JONS offers several special features. You will learn a new term called “boundary spanning” in an article from Pennsylvania State University. You will also learn about the work being done in Appalachia as it relates to ensuring that the navigator skills and knowledge “match” the needs and available resources. We are all familiar with making sure the right patient gets the right drug, at the right time, using the right method, and in the right setting. Well, we all need to bring to the attention of the leadership at our respective institutions the importance of doing something quite similar when it comes to navigation—identifying the skills, knowledge, and expertise needed of a navigator to carry out specific tasks and functions. There are tasks and functions that can be carried out very well by a lay navigator, but other tasks and functions require medical knowledge and expertise, which require nursing knowledge. Also in this issue is the next installment of the resources being provided by another pharmaceutical company that I have summarized for you; for this issue, I chose Merck Pharmaceuticals. We are very busy planning for our 4th Annual AONN Conference. It is marvelous to see how many of you have already registered to attend. I am personally looking forward to seeing familiar faces as well as new faces in November in Memphis. The networking opportunities are truly boundless, and the knowledge you will gain from the speakers we have lined up for you will be phenomenal. We hope you enjoy this issue. And remember, I am just a mouse click away if you need to personally reach out to me with questions or feedback about AONN. My e-mail is shockli@jhmi.edu.
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
Section Editors
Breast Cancer Sharon Gentry, RN, MSN, AOCN, CBCN Breast Health Navigator Novant Health Derrick L. Davis Cancer Center
Cancer Rehabilitation & Survivorship Julie Silver, MD Assistant Professor Harvard Medical School
Prostate Cancer Frank delaRama, RN, MS, AOCNS
Clinical Nurse Specialist Oncology/Genomics, Cancer Care Clinic Palo Alto Medical Foundation
Genetic Counseling
Cristi Radford, MS, CGC Gene Mavens, LLC Sarasota, FL
Healthcare Disparities Linda Fleisher, PhD, MPH
Asst VP, Office of Health Communications and Health Disparities Asst Prof, Cancer Prevention and Control Fox Chase Cancer Center
Health Promotion and Outreach Iyaad Majed Hasan, 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 Program
Penny Widmaier, RN, MSN Nurse Navigator Botsford Cancer Center
With kind regards,
Lillie D. Shockney, RN, BS, MAS Editor-in-Chief
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.
JONS-online.com journal of Oncology Navigation & Survivorship
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PUBLISHING STAFF
Senior Vice President, Sales & Marketing Philip Pawelko phil@greenhillhc.com Vice President/Director of Sales & Marketing Joe Chanley joe@greenhillhc.com Group Director, Sales & Marketing John W. Hennessy john@greenhillhc.com Publishers Cristopher Pires cris@engagehc.com Russell Hennessy russell@greenhillhc.com Lou Lesperance lou@greenhillhc.com
Table of ConTents
Resources from Pharmaceutical Companies
Managing Editor Lisa Neuman lneuman@the-lynx-group.com Copy Editor Rosemary Hansen Editorial Assistant Jennifer Brandt Production Manager Stephanie Laudien
8 Resources of Potential Benefit to You and to the Patients You Navigate
Chief Operating Officer Pam Rattanonont Ferris Vice President of Finance Andrea Kelly Director, Human Resources Blanche Marchitto Associate Editorial Director, Projects Division Terri Moore Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Travean Digital Programmer Michael Amundsen Senior Project Manager Andrea Boylston Project Coordinators Deanna Martinez Jackie Luma Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen Green Hill Healthcare Communications 1249 South River Road - Ste 202A Cranbury, NJ 08512 Phone: 732-656-7935 • Fax: 732-656-7938
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June 2013 • Volume 4, Issue 3
Lillie D. Shockney, RN, BS, MAS
The Antecedents of Patient Navigation
13 President/CEO Brian Tyburski
June 2013 • Vol 4, No 3
panning Boundaries: System Dynamics, Externalities, S and Patient Navigation Christopher Louis, MHA, PhD(c); Jonathan Clark, MS, PhD; Katelyn Holmes, BS; Betsy Aumiller, MEd, DEd; Eugene J. Lengerich, VMD, MS
Addressing Disparities
Systematic Assessment of Cancer Patient Navigation 34
in Appalachia Eugene J. Lengerich, VMD, MS; Betsy Aumiller, MEd, DEd;
Brenda C. Kluhsman, PhD, MSS; Marcyann Bencivenga, BA; Christopher Louis, MHA; Linda Fleisher, PhD, MPH; Electra D. Paskett, PhD; Mark B. Dignan, PhD, MPH
ABOUT THE COVER Breathing Room
Mixed Media by a Person Diagnosed with Cancer Michigan Artwork from the Lilly Oncology On Canvas: Expressions of a Cancer Journey Art Competition (www.LillyOncologyOnCanvas.com). 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-lynx-group.com. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $50.00; institutions, $90.00; single issues, $5.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. The ideas and opinions expressed in JONS do not necessarily reflect those of the editorial board, the editorial director, or the publisher. Publication of an advertisement or other product 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.
AONNonline.org
In the newly metastatic CRPC patient who is asymptomatic or minimally symptomatic
STARTS THE FIGHT
AND HELPS HIS IMMUNE SYSTEM SUSTAIN* IT 1
• Targets and attacks prostate cancer cells • Statistically significant overall survival advantage1,2 • Sustained* immune response *A sustained immune response was seen out to 26 weeks in the pivotal study (the last time point measured).1 INDICATION: PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. IMPORTANT SAFETY INFORMATION: PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases. In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group. The most common adverse events (incidence ≥15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache. For more information on PROVENGE, please see Brief Summary of Prescribing Information on adjacent pages. www.PROVENGEHCP.com
PROVENGE® (sipuleucel-T) Suspension for Intravenous Infusion
Rx Only
BRIEF SUMMARY — See full Prescribing Information for complete product information
INDICATIONS AND USAGE: PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. DOSAGE AND ADMINISTRATION • For Autologous Use Only. • The recommended course of therapy for PROVENGE is 3 complete doses, given at approximately 2-week intervals. • Premedicate patients with oral acetaminophen and an antihistamine such as diphenhydramine. • Before infusion, confirm that the patient’s identity matches the patient identifiers on the infusion bag. • Do Not Initiate Infusion of Expired Product. • Infuse PROVENGE intravenously over a period of approximately 60 minutes. Do Not Use a Cell Filter. • Interrupt or slow infusion as necessary for acute infusion reactions, depending on the severity of the reaction. (See Dosage and Administration [2] of full Prescribing Information.) CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS • PROVENGE is intended solely for autologous use. • Acute infusion reactions (reported within 1 day of infusion) included, but were not limited to, fever, chills, respiratory events (dyspnea, hypoxia, and bronchospasm), nausea, vomiting, fatigue, hypertension, and tachycardia. In controlled clinical trials, 71.2% of patients in the PROVENGE group developed an acute infusion reaction. I n controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. The incidence of severe events was greater following the second infusion (2.1% vs 0.8% following the first infusion), and decreased to 1.3% following the third infusion. Some (1.2%) patients in the PROVENGE group were hospitalized within 1 day of infusion for management of acute infusion reactions. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group. Closely monitor patients with cardiac or pulmonary conditions. In the event of an acute infusion reaction, the infusion rate may be decreased, or the infusion stopped, depending on the severity of the reaction. Appropriate medical therapy should be administered as needed. • Handling Precautions for Control of Infectious Disease. PROVENGE is not routinely tested for transmissible infectious diseases. Therefore, patient leukapheresis material and PROVENGE may carry the risk of transmitting infectious diseases to health care professionals handling the product. Universal precautions should be followed. • Concomitant Chemotherapy or Immunosuppressive Therapy. Use of either chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. PROVENGE is designed to stimulate the immune system, and concurrent use of immunosuppressive agents may alter the efficacy and/or safety of PROVENGE. Therefore, patients should be carefully evaluated to determine whether it is medically appropriate to reduce or discontinue immunosuppressive agents prior to treatment with PROVENGE. • Product Safety Testing. PROVENGE is released for infusion based on the microbial and sterility results from several tests: microbial contamination determination by Gram stain, endotoxin content, and in-process sterility with a 2-day incubation to determine absence of microbial growth. The final (7-day incubation) sterility test results are not available at the time of infusion. If the sterility results become positive for microbial contamination after PROVENGE has been approved for infusion, Dendreon will notify the treating physician. Dendreon will attempt to identify the microorganism, perform antibiotic sensitivity testing on recovered microorganisms, and communicate the results to the treating physician. Dendreon may request additional information from the physician in order to determine the source of contamination. (See Warnings and Precautions [5] of full Prescribing Information.) ADVERSE REACTIONS 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 evaluation of PROVENGE is based on 601 prostate cancer patients in the PROVENGE group who underwent at least 1 leukapheresis procedure in four randomized, controlled clinical trials. The control was non-activated autologous peripheral blood mononuclear cells. The most common adverse events, reported in patients in the PROVENGE group at a rate ≥15%, were chills, fatigue, fever, back pain, nausea, joint ache, and headache. Severe (Grade 3) and life-threatening (Grade 4) adverse events were reported in 23.6% and 4.0% of patients in the PROVENGE group compared with 25.1% and 3.3% of patients in the control group. Fatal (Grade 5) adverse events were reported in 3.3% of patients in the PROVENGE group compared with 3.6% of patients in the control group. Serious adverse events were reported in 24.0% of patients in the PROVENGE group and 25.1% of patients in the control group. Serious adverse events in the PROVENGE group included acute infusion reactions (see Warnings and Precautions), cerebrovascular events, and single case reports of eosinophilia, rhabdomyolysis, myasthenia gravis, myositis, and tumor flare. PROVENGE was discontinued in 1.5% of patients in Study 1 (PROVENGE group n=341; Control group n=171) due to adverse events. Some patients who required central venous catheters for treatment with PROVENGE developed infections, including sepsis. A small number of these patients discontinued treatment as a result. Monitoring for infectious sequelae in patients with central venous catheters is recommended. Each dose of PROVENGE requires a standard leukapheresis procedure approximately 3 days prior to the infusion. Adverse events that were reported ≤1 day following a leukapheresis procedure in ≥5% of patients in controlled clinical trials included citrate toxicity (14.2%), oral paresthesia (12.6%), paresthesia (11.4%), and fatigue (8.3%). Table 1 provides the frequency and severity of adverse events reported in ≥5% of patients in the PROVENGE group of randomized, controlled trials of men with prostate cancer. The population included 485 patients with metastatic castrate resistant prostate cancer and 116 patients with non-metastatic androgen dependent prostate cancer who were scheduled to receive 3 infusions of PROVENGE at approximately 2-week intervals. The population was age 40 to 91 years (median 70 years), and 90.6% of patients were Caucasian. Table 1 Incidence of Adverse Events Occurring in ≥5% of Patients Randomized to PROVENGE PROVENGE (N = 601)
Any Adverse Event Chills Fatigue Fever Back pain Nausea Joint ache Headache Citrate toxicity Paresthesia Vomiting Anemia Constipation Pain Paresthesia oral Pain in extremity Dizziness Muscle ache Asthenia Diarrhea Influenza-like illness Musculoskeletal pain Dyspnea Edema peripheral Hot flush Hematuria Muscle spasms
Control* (N = 303)
All Grades n (%)
Grade 3-5 n (%)
All Grades n (%)
591 (98.3) 319 (53.1) 247 (41.1) 188 (31.3) 178 (29.6) 129 (21.5) 118 (19.6) 109 (18.1) 89 (14.8) 85 (14.1) 80 (13.3) 75 (12.5) 74 (12.3) 74 (12.3) 74 (12.3) 73 (12.1) 71 (11.8) 71 (11.8) 65 (10.8) 60 (10.0) 58 (9.7) 54 (9.0) 52 (8.7) 50 (8.3) 49 (8.2) 46 (7.7) 46 (7.7)
186 (30.9) 13 (2.2) 6 (1.0) 6 (1.0) 18 (3.0) 3 (0.5) 11 (1.8) 4 (0.7) 0 (0.0) 1 (0.2) 2 (0.3) 11 (1.8) 1 (0.2) 7 (1.2) 0 (0.0) 5 (0.8) 2 (0.3) 3 (0.5) 6 (1.0) 1 (0.2) 0 (0.0) 3 (0.5) 11 (1.8) 1 (0.2) 2 (0.3) 6 (1.0) 2 (0.3)
291 (96.0) 33 (10.9) 105 (34.7) 29 (9.6) 87 (28.7) 45 (14.9) 62 (20.5) 20 (6.6) 43 (14.2) 43 (14.2) 23 (7.6) 34 (11.2) 40 (13.2) 20 (6.6) 43 (14.2) 40 (13.2) 34 (11.2) 17 (5.6) 20 (6.6) 34 (11.2) 11 (3.6) 31 (10.2) 14 (4.6) 31 (10.2) 29 (9.6) 18 (5.9) 17 (5.6)
Grade 3-5 n (%) 97 (32.0) 0 (0.0) 4 (1.3) 3 (1.0) 9 (3.0) 0 (0.0) 5 (1.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 7 (2.3) 3 (1.0) 3 (1.0) 0 (0.0) 1 (0.3) 0 (0.0) 0 (0.0) 2 (0.7) 3 (1.0) 0 (0.0) 3 (1.0) 3 (1.0) 1 (0.3) 1 (0.3) 3 (1.0) 0 (0.0)
(Table 1 continued on next page.)
GBC_2013Conf_vertical_62512_Layout 1 7/11/12 11:38
Table 1 Incidence of Adverse Events Occurring in ≥5% of Patients Randomized to PROVENGE PROVENGE (N = 601)
Hypertension Anorexia Bone pain Upper respiratory tract infection Insomnia Musculoskeletal chest pain Cough Neck pain Weight decreased Urinary tract infection Rash Sweating Tremor
Control* (N = 303)
All Grades n (%)
Grade 3-5 n (%)
All Grades n (%)
Grade 3-5 n (%)
45 (7.5) 39 (6.5) 38 (6.3) 38 (6.3)
3 (0.5) 1 (0.2) 4 (0.7) 0 (0.0)
14 (4.6) 33 (10.9) 22 (7.3) 18 (5.9)
0 (0.0) 3 (1.0) 3 (1.0) 0 (0.0)
37 (6.2) 36 (6.0)
0 (0.0) 2 (0.3)
22 (7.3) 23 (7.6)
1 (0.3) 2 (0.7)
35 (5.8) 34 (5.7) 34 (5.7) 33 (5.5) 31 (5.2) 30 (5.0) 30 (5.0)
0 (0.0) 3 (0.5) 2 (0.3) 1 (0.2) 0 (0.0) 1 (0.2) 0 (0.0)
17 (5.6) 14 (4.6) 24 (7.9) 18 (5.9) 10 (3.3) 3 (1.0) 9 (3.0)
0 (0.0) 2 (0.7) 1 (0.3) 2 (0.7) 0 (0.0) 0 (0.0) 0 (0.0)
*Control was non-activated autologous peripheral blood mononuclear cells.
Cerebrovascular Events. In controlled clinical trials, cerebrovascular events, including hemorrhagic and ischemic strokes, were reported in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.
SECOND ANNUAL CONFERENCE
GLOBAL BIOMARKERS CONSORTIUM
™
Clinical Approaches to Targeted Technologies ™
October 4-6, 2013 The Seaport Boston Hotel 1 Seaport Lane Boston, MA 02210
(See Adverse Reactions [6] of full Prescribing Information.)
REGISTER TODAY AT
To report SUSPECTED ADVERSE REACTIONS, contact Dendreon Corporation at 1-877-336-3736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Dendreon Corporation Seattle, Washington 98101
GlobalBiomarkersConsortium.com WCMC_2013Conf_vertical_80612_Layout 1 11/13/12 2:4
SECOND ANNUAL CONFERENCE
2013 WORLD CUTANEOUS MALIGNANCIES CONGRESS TM
REFERENCES: 1. PROVENGE [package insert]. Dendreon Corporation; June 2011. 2. Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.
Melanoma Basal Cell Carcinoma Cutaneous T-Cell Lymphoma Squamous Cell Carcinoma Merkel Cell Carcinoma
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To register, please visit www.CutaneousMalignancies.com
Resources from Pharmaceutical Companies
Resources of Potential Benefit to You and to the Patients You Navigate Part 2 of a 5-Part Series
Lillie D. Shockney, RN, BS, MAS, Johns Hopkins University School of Medicine, Baltimore, Maryland
C
ontinuing with our series of various unbranded offerings provided by pharmaceuticals and other companies that provide diagnostics and treatments for cancer patients, this list below comes from Merck:
Resources: • Eating Well Through Chemo Cookbook • Chemo Companions • Managing Fatigue The Merck Academy topics listed below are presented from an Oncology perspective and impact: • Adherence to Prescription Medications • Applying Evidence-Based Medicine to Clinical Practice • Associated vs Causation/Observational and Interventional Designs • Critical Application of Biomarkers in Drug Development • Bringing Medications from Bench to Bedside: Myths and Realities • Overview of Vaccines • Preclinical Drug Discovery and Development • Principles of Clinical Trials • Safety and Pharmacovigilance
• Understanding Absolute Risk, Relative Risk, and Number Needed to Treat in Research and Practice • Understanding Comparative Effectiveness Research • Understanding Statistical Versus Clinical Significance Merck offers faculty speakers on the following topics. You would want to check with the company to review the slide decks in advance perhaps to see if these are branded or unbranded in content. • Chemotherapy-Induced Nausea and Vomiting— Pharmacokinetics • Pathway-Driven, Evidence-Based Oncology Care • Breast Cancer Treatment • Hepatitis C—Victrelis • Shingles • Fatigue Management • Temodar, Brain Tumors, MGMT • Human Stem Cell Transplantation Additionally, there is an online resource called Merck Medicus (www.merckmedicus.com). It is not for patients specifically; however, as a healthcare professional, you can go online and access educational material for patients. (If your center restricts the distribution of material with company logos, you may or may not be able to provide them to patients. Take a look at the content and determine what works for your needs.) g
get YOUR Nurse Navigation Progam profiled in JONS! We want to interview nurse navigators from around the country. It’s an easy process—just a short phone interview and some photos.
Contact: editorial@greenhillhc.com for information. 8
June 2013 • Volume 4, Issue 3
AONNonline.org
SHOULDN’T A PATIENT SUPPORT PROGRAM BE EASY TO NAVIGATE?
• REIMBURSEMENT SERVICES
• EDUCATION AND SUPPORT SERVICES
• BENEFIT VERIFICATIONS
• PATIENT ASSISTANCE
• DELIVERY COORDINATION
• CO-PAY ASSISTANCE
An uncommon condition requires a common solution— IncyteCARES IncyteCARES helps connect your patients with intermediate or high-risk myelofibrosis (MF), who qualify for the program, to ongoing support and resources during their treatment with Jakafi® (ruxolitinib). Indications and Usage Jakafi is indicated for treatment of patients with intermediate or high-risk MF, including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF. Important Safety Information
•Treatment with Jakafi can cause hematologic adverse reactions, including
thrombocytopenia, anemia and neutropenia, which are each dose-related effects, with the most frequent being thrombocytopenia and anemia • Monitor CBCs, and in patients with cytopenias, consider dose reductions, temporarily withholding Jakafi, or transfusions, as clinically indicated Please see additional Important Safety Information and the Brief Summary of Full Prescribing Information within this ad.
HELPING PATIENTS RECEIVING JAKAFI (ruxolitinib) STAY CONNECTED TO CARE ®
Patients living with intermediate or high-risk MF face many challenges. IncyteCARES is a program created by Incyte to connect patients who qualify for the program to ongoing support and resources during their treatment with Jakafi.
IncyteCARES HELPS PEOPLE BEING TREATED WITH JAKAFI ACCESS AND REIMBURSEMENT SERVICES
•Benefit verification •Prior authorization •Appeal support • Delivery coordination of Jakafi
•Co-pay assistance •Free medication programs • Referrals and assistance with independent not-for-profit organizations
PATIENT EDUCATION AND SUPPORT
• Access to trained nurses • Educational information to help teach your patients about their condition and Jakafi Patient packet
•
Visit www.IncyteCARES.com or call 1-855-4-JAKAFI (1-855-452-5234), Monday–Friday, 8 AM –8 PM ET, to learn more about how to connect your patients to IncyteCARES.
IncyteCARES: ASSISTING PROVIDERS AND PATIENTS IN OBTAINING ACCESS TO JAKAFI Enrollment sent to
95% of patients had insurance coverage for
Patients without insurance coverage were screened for patient assistance eligibility
94% of prior authorizations were approved for
86% of commercially insured patients had co-pays of less than $100/month
Information is based upon 1421 patients enrolled in IncyteCARES between April 1, 2012 and April 1, 2013.
91% of patients referred to the IncyteCARES commercial co-pay assistance program were eligible for assistance Important Safety Information (continued)
•Patients should be assessed for the risk of developing serious bacterial, mycobacterial, fungal and viral infections
• The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache
Please see additional Important Safety Information and the Brief Summary of Full Prescribing Information within this ad. Jakafi is a registered trademark of Incyte Corporation. © 2013, Incyte Corporation. All rights reserved. RUX-1227 04/13
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 Grade 4 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 0 myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential Anemia 96.1 34.2 11.0 86.8 15.9 3.3 thrombocythemia myelofibrosis. Neutropenia 18.7 5.2 1.9 4.0 0.7 1.3 CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Thrombocytopenia, Anemia and Neutropenia Treatment a Presented values are worst Grade values regardless of baseline b National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 with Jakafi can cause hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia. A complete blood count must be performed before initiating therapy with Jakafi [see Dosage and Additional Data from the Placebo-controlled Study 25.2% of patients treated with Jakafi and 7.3% of Administration (2.1) in Full Prescribing Information]. Patients with platelet counts of less than 200 X 109/L patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in alanine transat the start of therapy are more likely to develop thrombocytopenia during treatment. Thrombocytopenia was aminase (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 generally reversible and was usually managed by reducing the dose or temporarily withholding Jakafi. If with placebo developed newly occurring or worsening Grade 1 abnormalities in aspartate transaminase clinically indicated, platelet transfusions may be administered [see Dosage and Administration (2.2) in Full (AST). The incidence of Grade 2 AST elevations was 0.6% for Jakafi with no Grade 3 or 4 AST elevations. Prescribing Information, and Adverse Reactions]. Patients developing anemia may require blood trans16.8% of patients treated with Jakafi and 0.7% of patients treated with placebo developed newly occurring or fusions. Dose modifications of Jakafi for patients developing anemia may also be considered. Neutropenia worsening Grade 1 elevations in cholesterol. The incidence of Grade 2 cholesterol elevations was 0.6% for (ANC less than 0.5 X 109/L) was generally reversible and was managed by temporarily withholding Jakafi Jakafi with no Grade 3 or 4 cholesterol elevations. [see Adverse Reactions]. Complete blood counts should be monitored as clinically indicated and dosing DRUG INTERACTIONS Drugs That Inhibit or Induce Cytochrome P450 Enzymes Ruxolitinib adjusted as required [see Dosage and Administration (2.2) in Full Prescribing Information, and Adverse is predominantly metabolized by CYP3A4. Strong CYP3A4 inhibitors: The C max and AUC of ruxolitinib Reactions]. Infections Patients should be assessed for the risk of developing serious bacterial, mycobac- increased 33% and 91%, respectively, with Jakafi administration (10 mg single dose) following ketoconazole terial, fungal and viral infections. Active serious infections should have resolved before starting therapy with 200 mg twice daily for four days, compared to receiving Jakafi alone in healthy subjects. The half-life was also Jakafi. Physicians should carefully observe patients receiving Jakafi for signs and symptoms of infection and prolonged from 3.7 to 6.0 hours with concurrent use of ketoconazole. The change in the pharmacodynamic initiate appropriate treatment promptly. Herpes Zoster Physicians should inform patients about early signs marker, pSTAT3 inhibition, was consistent with the corresponding ruxolitinib AUC following concurrent adminand symptoms of herpes zoster and advise patients to seek treatment as early as possible [see Adverse istration with ketoconazole. When administering Jakafi with strong CYP3A4 inhibitors a dose reduction is Reactions]. recommended [see Dosage and Administration (2.4) in Full Prescribing Information]. Patients should be ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under closely monitored and the dose titrated based on safety and efficacy. Mild or moderate CYP3A4 inhibitors: widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly There was an 8% and 27% increase in the Cmax and AUC of ruxolitinib, respectively, with Jakafi administration compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The (10 mg single dose) following erythromycin, a moderate CYP3A4 inhibitor, at 500 mg twice daily for 4 days, safety of Jakafi was assessed in 617 patients in six clinical studies with a median duration of follow-up of 10.9 compared to receiving Jakafi alone in healthy subjects. The change in the pharmacodynamic marker, pSTAT3 months, including 301 patients with myelofibrosis in two Phase 3 studies. In these two Phase 3 studies, inhibition was consistent with the corresponding exposure information. No dose adjustment is recommended patients had a median duration of exposure to Jakafi of 9.5 months (range 0.5 to 17 months), with 88.7% of when Jakafi is coadministered with mild or moderate CYP3A4 inhibitors (eg, erythromycin). CYP3A4 patients treated for more than 6 months and 24.6% treated for more than 12 months. One hundred and inducers: The Cmax and AUC of ruxolitinib decreased 32% and 61%, respectively, with Jakafi administration eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. In (50 mg single dose) following rifampin 600 mg once daily for 10 days, compared to receiving Jakafi alone in a double-blind, randomized, placebo-controlled study of Jakafi, 155 patients were treated with Jakafi. The healthy subjects. In addition, the relative exposure to ruxolitinib’s active metabolites increased approximately most frequent adverse drug reactions were thrombocytopenia and anemia [see Table 2]. Thrombocytopenia, 100%. This increase may partially explain the reported disproportionate 10% reduction in the pharmacoanemia and neutropenia are dose related effects. The three most frequent non-hematologic adverse reactions dynamic marker pSTAT3 inhibition. No dose adjustment is recommended when Jakafi is coadministered with were bruising, dizziness and headache [see Table 1]. Discontinuation for adverse events, regardless of a CYP3A4 inducer. Patients should be closely monitored and the dose titrated based on safety and efficacy. causality, was observed in 11.0% of patients treated with Jakafi and 10.6% of patients treated with placebo. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C: There are no adequate Following interruption or discontinuation of Jakafi, symptoms of myelofibrosis generally return to and well-controlled studies of Jakafi in pregnant women. In embryofetal toxicity studies, treatment with pretreatment levels over a period of approximately 1 week. There have been isolated cases of patients discon- ruxolitinib resulted in an increase in late resorptions and reduced fetal weights at maternally toxic doses. tinuing Jakafi during acute intercurrent illnesses after which the patient’s clinical course continued to worsen; Jakafi should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. however, it has not been established whether discontinuation of therapy contributed to the clinical course in Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses these patients. When discontinuing therapy for reasons other than thrombocytopenia, gradual tapering of the 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 teratodose of Jakafi may be considered [see Dosage and Administration (2.6) in Full Prescribing Information]. genicity. 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 Table 1 presents the most common adverse reactions occurring in patients who received Jakafi in the doublethe clinical exposure at the maximum recommended dose of 25 mg twice daily. In rabbits, lower fetal weights blind, placebo-controlled study during randomized treatment. of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of Table 1: Adverse Reactions Occurring in Patients on Jakafi in the Double-blind, Placebo-controlled 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. In Study During Randomized Treatment a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implanJakafi Placebo tation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups for (N=155) (N=151) fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest Adverse All All dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily). a Reactions Grades Grade 3 Grade 4 Grades Grade 3 Grade 4 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 b Bruising 23.2 0.6 0 14.6 0 0 reactions in nursing infants from Jakafi, a decision should be made to discontinue nursing or to discontinue Dizzinessc 18.1 0.6 0 7.3 0 0 the drug, taking into account the importance of the drug to the mother. Pediatric Use The safety and effecHeadache 14.8 0 0 5.3 0 0 tiveness of Jakafi in pediatric patients have not been established. Geriatric Use Of the total number of Urinary Tract Infectionsd 9.0 0 0 5.3 0.7 0.7 myelofibrosis patients in clinical studies with Jakafi, 51.9% were 65 years of age and older. No overall differWeight Gaine 7.1 0.6 0 1.3 0.7 0 ences 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 Flatulence 5.2 0 0 0.7 0 0 healthy subjects [CrCl 72-164 mL/min (N=8)] and in subjects with mild [CrCl 53-83 mL/min (N=8)], Herpes Zosterf 1.9 0 0 0.7 0 0 moderate [CrCl 38-57 mL/min (N=8)], or severe renal impairment [CrCl 15-51 mL/min (N=8)]. Eight (8) 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 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 hematoma, increased tendency to bruise, petechiae, purpura c includes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s Disease, labyrinthitis normal renal function. However, plasma AUC values of ruxolitinib metabolites increased with increasing d includes urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, kidney infection, pyuria, bacteria severity of renal impairment. This was most marked in the subjects with end stage renal disease requiring urine, bacteria urine identified, nitrite urine present hemodialysis. The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the e includes weight increased, abnormal weight gain corresponding increase in metabolite exposure. Ruxolitinib is not removed by dialysis; however, the removal f includes herpes zoster and post-herpetic neuralgia of some active metabolites by dialysis cannot be ruled out. When administering Jakafi to patients with Description of Selected Adverse Drug Reactions Anemia In the two Phase 3 clinical studies, median moderate (CrCl 30-59 mL/min) or severe renal impairment (CrCl 15-29 mL/min) with a platelet count time to onset of first CTCAE Grade 2 or higher anemia was approximately 6 weeks. One patient (0.3%) between 100 X 109/L and 150 X 109/L and patients with end stage renal disease on dialysis a dose reduction discontinued treatment because of anemia. In patients receiving Jakafi, mean decreases in hemoglobin is recommended [see Dosage and Administration (2.5) in Full Prescribing Information]. Hepatic reached a nadir of approximately 1.5 to 2.0 g/dL below baseline after 8 to 12 weeks of therapy and then Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in gradually recovered to reach a new steady state that was approximately 1.0 g/dL below baseline. This pattern healthy subjects (N=8) and in subjects with mild [Child-Pugh A (N=8)], moderate [Child-Pugh B (N=8)], or was observed in patients regardless of whether they had received transfusions during therapy. In the severe hepatic impairment [Child-Pugh C (N=8)]. The mean AUC for ruxolitinib was increased by 87%, 28% randomized, placebo-controlled study, 60% of patients treated with Jakafi and 38% of patients receiving and 65%, respectively, in patients with mild, moderate and severe hepatic impairment compared to patients placebo received red blood cell transfusions during randomized treatment. Among transfused patients, the with normal hepatic function. The terminal elimination half-life was prolonged in patients with hepatic median number of units transfused per month was 1.2 in patients treated with Jakafi and 1.7 in placebo impairment compared to healthy controls (4.1-5.0 hours versus 2.8 hours). The change in the pharmacotreated patients. Thrombocytopenia In the two Phase 3 clinical studies, in patients who developed Grade 3 dynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in ruxolitinib exposure or 4 thrombocytopenia, the median time to onset was approximately 8 weeks. Thrombocytopenia was except in the severe (Child-Pugh C) hepatic impairment cohort where the pharmacodynamic activity was generally reversible with dose reduction or dose interruption. The median time to recovery of platelet counts more prolonged in some subjects than expected based on plasma concentrations of ruxolitinib. When above 50 X 109/L was 14 days. Platelet transfusions were administered to 4.7% of patients receiving Jakafi administering Jakafi to patients with any degree of hepatic impairment and with a platelet count between and to 4.0% of patients receiving control regimens. Discontinuation of treatment because of thrombo- 100 X 109/L and 150 X 109/L, a dose reduction is recommended [see Dosage and Administration (2.5) in cytopenia occurred in 0.7% of patients receiving Jakafi and 0.9% of patients receiving control regimens. Full Prescribing Information]. 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% Jakafi is a registered trademark of Incyte Corporation. All rights reserved. versus 7.2%). Neutropenia In the two Phase 3 clinical studies, 1.0% of patients reduced or stopped Jakafi U.S. Patent No. 7,598,257 because of neutropenia. Table 2 provides the frequency and severity of clinical hematology abnormalities © 2011-2012 Incyte Corporation. All rights reserved. reported for patients receiving treatment with Jakafi or placebo in the placebo-controlled study. Issued: June 2012 RUX-1040a
The Antecedents of Patient Navigation
Spanning Boundaries: System Dynamics, Externalities, and Patient Navigation Christopher Louis, MHA, PhD(c), The Pennsylvania State University, University Park, PA Jonathan Clark, MS, PhD, The Pennsylvania State University, University Park, PA Katelyn Holmes, BS, The Pennsylvania State University, University Park, PA Betsy Aumiller, MEd, DEd, The Pennsylvania State University, Hershey, PA; Penn State Hershey Cancer Institute, Hershey, PA Eugene J. Lengerich, VMD, MS, The Pennsylvania State University, Hershey, PA; Penn State Hershey Cancer Institute, Hershey, PA Background: Patient navigation (PN) has emerged as a possible strategy to bridge gaps, overcome barriers, reduce delays, and improve outcomes across the cancer care continuum. However, we lack an explicit theoretical lens through which to view the emergence of patient navigators and the resulting roles they play. Purpose: To view PN through the lens of systems theory and the related theoretical themes of boundary spanning and social networks, and, drawing on these perspectives, to evaluate their usefulness for explaining observed patterns of behavior and to present a framework for understanding PN. Methodology/Approach: Nonprobability discriminative snowball sampling was used to identify 29 key informants in 6 contiguous Appalachian states. Our final sample consisted of 3 groups of informants: health system informants, community-based organization informants, and university-affiliated informants. We used directed content analysis to examine the extent to which patient navigator roles reflect the use of boundary spanning and social networking. Findings: Each group of informants discussed similar themes and characteristics with relative frequency. Patient navigators were found to be spanning boundaries and using their social networks to overcome negative externalities resulting from a variety of sources. We elaborate on these findings in our theoretical framework. Practice Implications: Our findings suggest that cancer patient navigators should build and use their social networks to span boundaries and overcome the negative externalities in the system. Our framework suggests that the need for these capabilities among navigators derives from 4 primary sources—the nature of patient problems, external influences, organizational boundaries, and individual behavior—and how they interact. Addressing the negative externalities associated with these issues reflects an ability to understand and respond to both macro- and microlevel issues across the cancer care continuum. These findings provide insights both for managers attempting to address underlying health system issues and for patient navigators who desire to be more effective.
C
oordinating care; overcoming patient, provider, and health system barriers; and reducing delays across the care continuum have been long-standing challenges for healthcare managers. Recent research suggests that patient navigation (PN) has emerged as a growing organizational and community-based strategy to combat these issues.1 Prior research has conceptualized PN programs primarily in terms of the activities patient navigators engage in and the functional roles they play to ensure smooth transitions across the continuum of care.1-3 It has been postulated that the value of PN programs may be tied to their ability to fit their approach to the characteristics and complexities of local systems.2,3 This perspective implies that the emergence of patient navigators is closely tied to the characteristics and complexity of the healthcare system itself. Despite this implication, we lack an explicit
theoretical lens through which to view the emergence of patient navigators and the roles they play. Simon has argued that the way organizations are structured and organized may result in “negative externalities” (eg, miscommunication, errors, barriers, delays) that arise from the inherent interdependencies that exist between the elements of an often complex system.4 While part of the administrative task is to minimize these externalities, organizations often fall short, and healthcare organizations are no exception. Indeed, there are substantial negative externalities that exist throughout healthcare processes.5,6 Accordingly, patients may benefit from entities that can not only make better sense of the patterns of interdependence across the care continuum, but also bridge gaps and overcome the barriers arising from the complexity of the healthcare system. Such capabilities have been the object
JONS-online.com journal of Oncology Navigation & Survivorship
13
THE ANTECEDENTS OF PATIENT NAVIGATION
of prior research on boundary spanning7-9 and social networking.10,11 In this study, we view PN through the lens of systems theory and outline the connection between systems theory, boundary spanning, and social networking within the context of cancer care. Further, we evaluate the extent to which these perspectives characterize PN programs. Based on this exploratory evidence, we propose a framework describing both the antecedents of PN programs and the functional roles played by patient navigators.
The concept of PN was initially introduced at Harlem Hospital Center in New York City in 1990 as an intervention to reduce inequities in cancer mortality. BACKGROUND and THEORETICAL FRAMEWORK The concept of PN was initially introduced at Harlem Hospital Center in New York City in 1990 as an intervention to reduce inequities in cancer mortality.12,13 Following promising results, which suggested that navigated patients completed a breast biopsy and received a diagnosis in a significantly shorter time than did nonnavigated patients, a large and growing number of organizations have employed PN as a strategy to combat inequities and inefficiencies seen in various types of cancer and other diseases.6 For example, Wells and colleagues found that many healthcare organizations across the United States have instituted PN to minimize delays in breast and cervical cancer diagnosis and treatment, but the paradigms employed vary greatly from site to site.1 Meanwhile, national attention has also honed in on PN, and many public (eg, Centers for Medicare & Medicaid Services; Health Resources and Services Administration) and private (eg, American Cancer Society, Avon Foundation for Women, Susan G. Komen for the Cure) funding agencies and publicly traded companies (eg, Pfizer Inc.) have allocated resources toward implementing the PN intervention model across the United States.6 Moreover, the Patient Protection and Affordable Care Act has broadly identified PN as a useful strategy to help coordinate services and provider referrals, improve access to healthcare services through community and organization partnerships, assist patients in overcoming barriers to care, and coordinate patient financial support.14 PN networks have also emerged on the national and local level, serving as conduits for communicating best practices and other successful PN strategies to broader audiences.
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June 2013 • Volume 4, Issue 3
The Role of System Interdependence Given that barriers to care as well as poor patient outcomes have long served as the impetus for PN programs, we begin by attempting to explain the system drivers of these problems. While other factors may be important, we will focus on issues with particular relevance to the organization and delivery of healthcare services, doing so through the lens of systems theory. Systems theory—and its practical application in systems thinking15—characterizes the complexity of a system based on the extent to which it is “dealing simultaneously with a sizable number of factors which are interrelated into an organic whole.”16 In the US delivery system, such complexity may be seen in the differentiation of providers (eg, the number of specialties and subspecialties) and provider organizations (eg, physician groups, hospitals, long-term care), and the degree to which they are interdependent. Prior research and our own observations suggest that, in health delivery systems, such interdependence derives from at least 2 categories of factors: (1) the nature of the patient’s problem to be solved,17 and (2) external influences.4,18 With respect to the latter, external influences (eg, regulatory agencies, payment systems, institutional pressures) may complicate relationships across the care continuum. As an example, administered pricing systems (eg, the diagnosis-related group system) can create payment disparities across service types, impacting the relative profitability of those services and creating financial interdependence between service providers. For example, research suggests that obstetric services are generally reimbursed at a level that makes providing these services relatively unprofitable, while the provision of cardiovascular and orthopedic care is generally profitable.19 Accordingly, the sustainable provision of obstetric care may depend on coupling it with more profitable services, such as cardiovascular or orthopedics, in the same organization. Thus, interdependence between otherwise independent service providers (in this case, obstetricians and cardiologists) may derive from influences originating outside the health delivery system. While such interdependence is real and relevant, it may seem peripheral to the importance of the patient’s problem itself. Patient conditions are often characterized by a high degree of uncertainty and necessitate a substantial degree of interaction between a diverse set of healthcare providers and other agents, such as physicians, hospitals, and therapists. For instance, cancer manifests itself in patients in varying degrees of severity, with accompanying implications for how treatment will proceed (eg, surgery, chemotherapy, radiation therapy) and which specialists and subspecialists will be involved. Moreover, patients with cancer often suffer from multiple comorbidities, requiring coordination across several different medical specialties. The characteristics of the patient’s underlying condition define
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The Antecedents of Patient Navigation
the problems to be solved, and the task of solving these problems generates interdependence between care providers across the continuum of care. What are the organizational implications of such underlying interdependence? Simon suggests that, within such interdependent subsystems, any organizational configuration (ie, division of decision-making responsibilities and labor) “creates externalities, which arise out of the interdependencies among the subsystems that are ignored.”4 While the object is to minimize these negative externalities, organizations often fall short. In healthcare, these negative externalities may include anything from inconsequential miscommunication, to diagnosis and treatment barriers, to medical errors (iatrogenesis) and even death. Simon emphasizes that, because of the underlying interdependencies in the system, the location of organizational boundaries (eg, between tasks, people, units, and organizations) plays a defining role in the extent of the externalities observed in the system.4 In addition to organizational configurations, individual behavior can also serve to exacerbate the boundaries within the system.20 Even under the impossible scenario whereby the perfect organizational configuration exists, behavioral inconsistencies by otherwise interdependent providers may result in poor coordination of care and barriers to diagnosis and treatment. In short, boundaries placed between otherwise interdependent subsystems—whether by configuration or individual behavior—may compromise the effectiveness and efficiency of their coordinated activities. It is no wonder that so much of the US healthcare debate revolves around the location of organizational boundaries, including the extent of specialization21,22 and the degree of system integration.23,24 These debates are fueled by the negative externalities in the system (eg, problems related to cost, quality, access). These externalities—in part derived from the misplacement of organizational boundaries and in part by individual behavior—may ultimately provide an explanation for why PN programs exist (ie, PN as a boundary-spanning mechanism) and the capabilities we might expect to find in effective patient navigators.
Boundary Spanning Consistent with the Simon perspective on complex systems, empirical work suggests that, as system complexity and externalities increase, boundary-spanning behaviors become more prevalent.4,25 This idea is intuitive—where there are more boundaries, more boundary spanning will occur. Boundary spanning has been described as a bridging of intra- and interorganizational boundaries “by individuals who understand…both sides of the boundary, enabling them to search out information on one side and disseminate it on the other.”18 Such boundary-spanning behavior
is reflected in a study by Parker and Lemak, who suggest that patient navigators play an important role in communicating information that is then used to help accomplish individual- and system-level goals. 3 Indeed, such boundary-spanning behavior has been shown to improve organizational performance.8,9 Boundary-spanning roles typically incorporate the following 3 characteristics: (1) information selection, processing, translation, and transfer across organizational boundaries, (2) external representation and communication, and (3) internal representation and communication.7,18,26 The first characteristic—information selection, processing, translation, and transfer—refers to the full spectrum of cognitive and relational aspects involved in creating knowledge from information and the ability to communicate that knowledge across organizational boundaries.26 The second characteristic—external representation and communication—describes “all boundary roles that involve resource acquisition and disposal, political legitimacy and hegemony, and a residual category of social legitimacy and organizational image” among external agents,26 whereas the third characteristic—internal representation and communication—reflects similar boundary roles within one’s own organization.7,18,26
Conversely, boundary-spanning activities have also been linked to overcoming structural holes within social networks. Social Networking Research suggests that individuals in boundary-spanning roles, such as patient navigators, use their social networks as a conduit for communicating information across internal and external organizational boundaries, as described above.27 Organizations with agents who have networks that bridge structural holes (ie, separations between nonredundant contacts) have been found to learn faster and adapt more quickly to changing circumstances.11 Conversely, boundary-spanning activities have also been linked to overcoming structural holes within social networks.28 Social networks are, in themselves, subsystems and have been referred to as a sophisticated “…system of objects (eg, people, groups, organizations) joined by a variety of relationships.”29 Implicit in this definition is the idea that social networks may span all sides of organizational boundaries. The management of such relationships is essential in enabling the transfer of knowledge between agents30 and dealing with the complexities and interdependencies inherent in organizations.
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The Antecedents of Patient Navigation
Table 1 Summary of Key Informants by Informant Type Health System
Community-Based Organization
University-Affiliated
Number of informants
12
10
7
Number of patient navigators
6
5
0
Hospitals & Cancer Centers
Nonprofits & Coalitions
Universities
7, 8, 9, 11, 12, 15, 16, 19, 24, 25, 27, 29
6, 14, 17, 18, 20, 21, 22, 23, 26, 28
1, 2, 3, 4, 5, 10, 13
Types of organizations Informant numbers (order of interviews)
Social networks have also been tied to individual- and group-level performance.31 Inkpen and Tsang found that establishing more intimate, stable, and long-lasting relationships among agents within a network facilitates knowledge transfer across boundaries, a key component of organizational success.32 Moreover, Parker and colleagues suggest that patient navigators are engaged in a range of tasks and behaviors with a variety of agents in their social networks.2 For example, patient navigators were routinely found to be communicating and integrating information across organizational boundaries between internal and external agents.2 Behavior within social networks typically relates to the following 4 characteristics: (1) network size, or number of contacts in a network, (2) range or diversity of contacts, (3) scope of contacts, such as contacts in a single industry or social group, and (4) stability of contacts, which reflects the strength of ties, or the “closeness of social ties,” between agents in a network.2,10,33 To this list of network characteristics we add agent behaviors, which relate to “how” agents use their relationships within social networks.2 In the sections that follow, we examine the extent to which the characteristics of boundary spanning and social networks outlined above are observed in PN programs. In doing so, we ask: Do patient navigators serve as integrators, using their social networks to span boundaries and overcome the negative externalities of a complex health system? Or, do patient navigators “simply” represent mechanisms for managing care, ensuring proper utilization of services, and encouraging patient compliance? Although extremely useful, such a role suggests a narrower set of capabilities for PN. In contrast, the theory we have presented suggests a wider-ranging role for PN that specifically necessitates building and capitalizing on social networks that span provider and organizational boundaries to ensure effective and efficient care for patients with cancer.
METHODS We examined the emergence of the themes presented in our theoretical framework in interviews about PN among healthcare providers in Appalachia. Appalachia comprises
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420 counties in 13 states, ranging from southern New York to northern Mississippi. This primarily rural, mountainous region is characterized as having high cancer mortality rates.34,35 Moreover, access to healthcare services in Appalachia is hindered by a complex, fragmented infrastructure,36 inadequate cancer-control strategies,37 and a shortage of healthcare professionals.38 For example, there are only 2 National Cancer Institute–designated comprehensive cancer centers in Appalachia, and many hospitals are small community hospitals that contract with independent nonstaff physicians. In addition, prior research has also suggested that Appalachian residents are unique: Puckett found that people living in Appalachia are reliant on self, family, and friends, and have trusted relationships with people they know rather than with authority figures and highly trained professionals.39 The challenges faced by healthcare providers in Appalachia have spurred the need for a strategy that both effectively manages cancer care processes and understands the needs of local communities.
Data Collection We used nonprobability discriminative snowball sampling to identify key informants. In all, we interviewed 29 key informants who reside in 6 contiguous Appalachian states (Kentucky, New York, Ohio, Pennsylvania, Virginia, and West Virginia), and each informant represented 1 of 3 groups: (1) health system informants (n=12), (2) community-based organization informants (n=10), or (3) university-affiliated informants (n=7). Table 1 summarizes key informants by group. Informants within each group represented organizations with and without PN programs in place. Informants from organizations with PN programs were either patient navigators themselves or individuals who regularly interacted with the navigator. Informants at sites without PN programs were interviewed because their institution was contemplating a PN program or because they were knowledgeable about PN activity in their local health system. These individuals were included in our sample to provide an objective perspective different from that of those actively performing PN.
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The Antecedents of Patient Navigation
Table 2 Descriptions of Theoretical Themes Theoretical Themes and Characteristics
Description
Boundary Spanning
The bridging of intra- and interorganizational boundaries “by individuals who understand…both sides of the boundary, enabling them to search out information on one side and disseminate it on the other.”18
1. Information selection, processing, translation, and transfer
The full spectrum of cognitive and relational aspects involved in creating knowledge from information and communicating it across organizational boundaries.26
2. External representation and communication
“All boundary roles that involve resource acquisition and disposal, political legitimacy and hegemony, and a residual category of social legitimacy and organizational image” among external agents.7,18,26
3. Internal representation and communication
“All boundary roles that involve resource acquisition and disposal, political legitimacy and hegemony, and a residual category of social legitimacy and organizational image” among internal agents.26
Social Networks
The management of a sophisticated “…system of objects (eg, people, groups, organizations) joined by a variety of relationships.”7,18,26
4. Network size
The number of contacts within a network.33
5. Range of contacts
The diversity of contacts within a network.33
6. Scope of contacts
The contacts in a single industry or social group.10
7. Stability of contacts
The strength of ties or the “closeness of social ties” between agents in a network.10
8. Agent behaviors
“How” agents use their relationships within social networks.2
Three study investigators conducted audiotaped, semistructured telephone interviews between April and October 2010. Interviews began with a grand tour question broadly addressing PN programs in the informant’s community. Subsequent questions focused on various themes, including the patient navigator’s background and experience, job roles performed by patient navigators, barriers for patient navigators, strategies employed to overcome barriers, community outreach, communication, and champions and gatekeepers of PN programs. Interviews were conducted in an open-ended manner and were not specifically focused on the themes presented in this article; specifically, the terms boundary spanning and social network (and their related themes) were not explicitly addressed by interviewers. The average length of the interviews was approximately 60 minutes. Interview protocols are available from the authors on request.
Analytical Methods We used directed content analysis to analyze the interview data for boundary-spanning and social-network themes. This method of qualitative data analysis “starts with a theory or relevant research findings as guidance for initial codes.”40 The analysis process consisted of several steps to ensure reliability and validity. First, we created a predeter-
mined coding scheme based on the 8 key characteristics of boundary spanning and social networks (Table 2).2,7,10,18,26,29,33 Next, 2 investigators independently used the predetermined coding scheme to code 5 transcripts. In subsequent discussions, they reconciled ambiguous passages or where there was disagreement on codes applied to the interview text and clarified the coding scheme as needed. Then, the same 2 investigators independently coded each of the remaining 24 transcripts. Transcripts were coded using NVivo 9 (QSR International), a computer software package that supports qualitative and mixed methods research. This approach produced an acceptable level of interrater reliability, with Cohen’s k = .82.41 Each investigator prepared a short memorandum summarizing his or her findings across the themes.42 In total, more than 1900 coded units were applied to the text of the 29 transcripts. Finally, we performed t-tests to identify statistical significance across informant groups for each characteristic.
FINDINGS Table 3 summarizes the extent to which our interviews across the 3 groups of informants reflected the relevant conceptual characteristics and also identifies statistically significant differences between informant groups. For example, column 9 shows the frequency with which univer-
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The Antecedents of Patient Navigation
Table 3 Average Frequency of Coded Themes by Informant Type
Health System (n=12) (1)
Total
(2)
Community-Based Organization (n=10) (3)
(4)
P Value of Differences University-Affiliated (n=7) Between Categories (5)
(6)
(7)
(8)
(9)
Average # Average # Average # of Codes of Codes of Codes Assigned Assigned Assigned per 10 Total # of per 10 Total # of per 10 Total # of Pages of Codes Pages of Codes Pages of (4) (6) (6) Codes Assigned Transcripts Assigned Transcripts Assigned Transcripts vs (2) vs (2) vs (4)
Boundary Spanning Information selection, processing, translation and transfer
203
87
4.19
53
3.19
63
5.32
NS
NS
<.01
External representation and communication
165
65
3.15
50
3.03
50
5.32
NS
NS
<.01
Internal representation and communication
52
32
2.64
11
0.50
9
1.46
<.05
NS
NS
420
184
3.33
114
2.24
122
3.72
Network size
36
13
0.66
12
0.76
11
0.91
NS
NS
NS
Range of contacts
143
59
2.92
39
2.41
45
3.79
NS
NS
<.05
Scope of contacts
197
81
3.73
66
4.12
50
4.21
NS
NS
NS
Stability of contacts
134
64
3.09
44
2.72
26
2.21
NS
NS
NS
Agent behaviors
218
101
5.02
65
3.87
52
4.48
NS
NS
NS
Subtotal
728
318
3.08
226
2.78
184
3.12
Total
1148
502
3.21
340
2.51
306
3.42
Subtotal Social Networks
NS indicates not statistically significant. sity-affiliated informants discussed information selection, processing, translation, and transfer; external representation and communication; and range of contacts and how the frequency significantly differs from informants from community-based organizations. However, the magnitude of this difference was not substantial. Even in the most statistically significant scenario (eg, information selection, processing, translation, and transfer) where P <.01, university-affiliated informants referenced this characteristic only 2 more times for every 10 pages of interview text than did informants in community-based organizations. While these differences might reflect differences in professional emphasis, we are confident that they do not represent systematic divergence in the observed roles of patient navigators. In general, Table 3
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June 2013 â&#x20AC;˘ Volume 4, Issue 3
shows that, when 1 informant group focused on a given characteristic, the other 2 groups focused on the same characteristic with approximately the same frequency. Thus, we present our core findings according to the most frequently discussed characteristics across all 3 groups, rather than distinguishing between informant groups. Table 4 presents the overall frequency (from most frequent to least frequent) with which conceptual characteristics were reflected in our informant interviews. From this table, we observe that the top 2 characteristics reflect both boundary spanning (information selection, processing, translation, and transfer) and social networking (agent behaviors), suggesting a close relationship between the 2 in practice. Moreover, while some characteristics appear more frequently than others, in total the overall frequency
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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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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
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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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K08Z121119
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) 1 System/Organ Class All Grades 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 7 discomfort 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 terms Muscle spasms, Musculoskeletal pain, Myalgia, Musculoskeletal discomfort, and Musculoskeletal stiffness
2 Includes 3 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
2 Includes 3 Includes
events graded according to CTCAE version 3.0 terms Edema peripheral, Pitting edema, and Generalized edema terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness
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
The Antecedents of Patient Navigation
Table 4 Frequency of Coded Themes in Rank Order
Characteristics of Theoretical Themes
Number of Coded Units per 10 Pages of Transcripts
Agent behaviors
4.49
Information selection, processing, translation, and transfer
4.13
Scope of contacts
3.98
External representation and communication
3.40
Range of contacts
2.95
Stability of contacts
2.75
Internal representation and communication
1.62
Network size
0.76
Total
24.08
with which boundary-spanning and social-networking characteristics were reflected in our interviews was substantial, representing more than 24 mentions for every 10 pages, or nearly 2.5 mentions per page of transcript. We believe this provides preliminary evidence for the relevance of our framework in that the characteristics of boundary spanning and social networking appear to be highly prevalent in cancer PN. To illustrate further, we provide below more descriptive detail from our interviews for the top 4 characteristics: (1) agent behaviors, (2) information selection, processing, translation, and transfer, (3) scope and stability of contacts, and (4) external representation and communication. We also include findings from other characteristics as relevant. 1. Agent Behaviors (Social Networking) During the interviews, informants discussed agent behaviors more frequently than any other characteristic (4.49 coded units per 10 pages of interview text). Patient navigators were commonly found broadening and using their social networks to overcome barriers to cancer services (ie, transportation, health insurance), to bridge gaps in the healthcare system (ie, scheduling appointments for cancer services at different organizations, coordinating care), and, as one informant stated, “…[to] help navigate patients through the fragmentation” (Informant 19). Informants described various approaches navigators use to perform this role among internal and external agents. The following quote illustrates how one patient navigator initiated and fostered a strong relationship with an external agent:
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“Well, I will tell you this: that the most important and the best thing that I ever did when I got this job [as a patient navigator] is I went over to the Social Security office… and I did a presentation to them and told them what I did.…As a result of that, two of the workers over at the Social Security office, we formed a kind of a bond, and we got a system going so that all I had to do is, when I get a [patient] in my office, I pick up the telephone…they do the interview over the phone…and, bam, it is done and we have done it and gotten patients their [Medicaid] cards within two weeks.” (Informant 26)
Patient navigators were also found to have learned detailed information about patient circumstances and operational processes so that they may facilitate patients attending scheduled appointments. For example, one informant noted how she works with patients as follows: “…you also run into coordination-of-care issues like helping the patient remember doctor appointments, or schedule doctor appointments, or schedule a scan. …Sometimes, I will make the appointment for them, or if they are those [types of ] patients who have trouble remembering, I will just call them the day before and just say, ‘Don’t forget you have your test or your doctor’s appointment with whomever tomorrow at such and such time.’” (Informant 11) Another informant described how the patient navigator at her organization leverages her long-standing relationships with internal agents: “So if [patients] give [the patient navigator] permission, then she will assist in either ordering additional testing, getting them set up to see a surgeon, or… whatever the patient needs” (Informant 16). Similarly, another informant echoed these sentiments by saying, “…if someone comes in and says they don’t have a PCP for some reason…the navigator will work with them to find someone who is accepting patients that the report can be sent to” (Informant 15). Furthermore, the patient navigator’s connections to alternative healthcare providers (ie, physicians, home health agencies, hospice, etc) provide patients with direct links to resources that they may not have known about. One informant discussed the importance of connecting patients with palliative care providers: “…we have pulled together a circle-of-care team…it is increasing the awareness to palliative care and can
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The Antecedents of Patient Navigation
be for anybody who is going through cancer treatment and isn’t feeling good. And so Dr. B and I have had this discussion and I have started referring people to her…and that has been really successful.” (Informant 27) 2. Information Selection, Processing, Translation, and Transfer (Boundary Spanning) Interviews revealed how patient navigators often facilitated the role of information selection, processing, translation, and transfer (4.13 coded units per 10 pages of transcripts). As reflected in the quotes about agent behaviors above, informants frequently described the patient navigator’s role in gathering, synthesizing, and disseminating cancer-related information, which was used to improve the quality of care delivered to patients with cancer. For example, one informant stated, “…I maintain membership within the Oncology Nursing Society, and I am the one that then brings that information back here and trains the nurses, also lining up oncology in-services that benefit our IV clinic or nurses on our floors. Most of the time I find those [in-services] myself, but I also pick up on leads from them on what they feel like they need help with. So I kind of become their consultative person.” (Informant 12) Similarly, another patient navigator discussed how she joined a statewide networking group to gain access to new information and resources. In turn, she compared statewide initiatives with her organization’s practices in seeking to identify opportunities for improvement: “…Pfizer drug company had sponsored a navigator workshop, it was one of the first in the state.…I went and learned about a statewide initiative….We then got everyone into a networking group…they wanted to share resources…to find out well, what are you doing? Maybe I should be doing something better [at my organization]….” (Informant 7) Informants also identified patient navigators as important links between patients with cancer and their care providers. During a time when patients are inundated with new, cancer-specific information, patient navigators not only help patients with cancer formulate key questions to ask but also teach them how to interpret the answers. For example, one informant noted, “…I tell everybody that [patient navigators] are the missing link. They are that link that the patients
themselves can actually ask, ‘You know, I didn’t understand what the nurse said, I didn’t understand what the doctor said to me today, and I was afraid to ask the question.’ What the navigator can do is help them form those questions and actually write them down for them, and, if necessary, attend the next appointment with them to be able to talk to the provider, because a lot of times…the blood pressure goes sky high when they come in and they forget what they need to ask… so I feel like there is a link that helps [patients] to have the knowledge that they need to take care of themselves.” (Informant 13) Likewise, interviews reflected how patient navigators were essential in integrating patient needs with knowledge of community resources. The ability to (1) extract specific patient needs, (2) interpret how those needs can be met based on the availability of existing community resources, and (3) know how to quickly link patients with those resources were identified as valuable skills of the navigator. One informant supported this by saying,
“…I tell everybody that [patient navigators] are the missing link. They are that link that the patients themselves can actually ask, ‘You know, I didn’t understand what the nurse said, I didn’t understand what the doctor said to me today, and I was afraid to ask the question.’” “I think [patient navigators] definitely, definitely, definitely have to have a knowledge of the resources in the area, more than just the doctors and hospitals available…I don’t believe the navigator has to know all the resources that are available, but how to link them. So there should be a history or experience in working in the community services, an awareness of the resources in the area, because something can come up that has nothing to do with a cancer diagnosis that could prevent the patient from proceeding to the next step…the [patient navigator] needs to be beyond the medical and know the resources for the area.” (Informant 18) 3. Scope and Stability of Contacts (Social Networking) Interviews reflected the scope of contacts that patient navigators had within different industries or social groups
JONS-online.com journal of Oncology Navigation & Survivorship
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The Antecedents of Patient Navigation
(3.98 coded units per 10 pages of interview text). Those contacts most commonly referenced were patients with cancer themselves, along with healthcare organizations and professionals, community-based organizations, churches and other faith-based populations and organizations, and funding agencies. For example, one patient navigator noted how she developed a relationship with the members of local faith-based populations: “…the last three years I have worked with the Amish and Mennonite population…it took us this long to make inroads, but…we worked very hard to establish a trust and we have been transparent, we have been completely open with them, we promised we would not cross any lines that they did not feel comfortable with us doing. So we pretty much have operated within the cultural realm and not overstepped our boundaries.” (Informant 27)
Securing trusting relationships with physicians was a common theme in achieving PN program sustainability. Many informants also emphasized the importance of strengthening their relationships (stability of contacts) with various agents in their network (2.75 coded units per 10 pages of interview text). Securing trusting relationships with physicians was a common theme in achieving PN program sustainability. To develop stronger ties with the hospital’s medical staff, one patient navigator noted, “…at first no physician wanted to be involved… [the physician] felt like…if he recommended a mastectomy, that the navigator was going to say [to the patient], ‘Well, do you know about a lumpectomy or do you know you can go have plastic surgery out of town….’ So, we had a huge resistance….We didn’t overcome it until we got a surgeon…[who] had been part of other patient navigation programs, and he started just working with our navigator and building…a rapport. And now, he’s been here for…2 and a half to three years and has about 80% of the breast volume at our center. That’s why [the patient navigators] now see 80% of the breast patients.” (Informant 16) Moreover, several informants also described how strengthening relationships with internal agents through participation in and validation of hospital committees was vital to the long-term success of PN programs (Informants 11, 15, 16, 19, 24, and 25).
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While this agent behavior falls under the category of social networking, it also crosses over to internal representation and communication, a key boundaryspanning characteristic, and was described as being an important capability in fostering these relationships. For example, one informant noted, “…I sit on a lot of committees here at the hospital that have nothing to do with my job, that are more like employee-based committees…—like our service-excellence team, our community-benefit team— just to kind of keep my face in front of other employees. Because when you are the second-largest employer in the county, your employees know other people who have cancer…so if I am sitting in a meeting across from someone in our accounting office and they say, ‘You know what? I should really have my aunt talk to you, because she was just diagnosed and what a great resource you’d be.’” (Informant 11) 4. External Representation and Communication (Boundary Spanning) Interviews revealed external representation and communication as a primary mechanism for maintaining a presence in the community and disseminating information to and from external agents (3.40 coded units per 10 pages of interview text). Informants described how engagement and education of external agents, especially local physicians and their office staffs, are paramount to sustaining the PN program. One informant described his organization’s strategy in maintaining visibility in physician offices: “One of the things we ask [our patient navigator] to do is visit at least five physician offices per month… And we want her to…talk to the office managers, practice managers, physicians—anyone who will listen about what she is trying to do and what she wants to do.” (Informant 16) Similarly, another patient navigator discussed how physicians were initially reluctant to embrace the PN program at one hospital because they did not understand its purpose. However, after the navigator collaborated with the medical staff leadership, the community doctors changed their perspective. She described this scenario by acknowledging, “[Community physicians] didn’t want me talking to patients…they didn’t understand what I would be doing, and that’s where the doctors who are the champions came in, and they really had to explain the
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The Antecedents of Patient Navigation
process of patient navigation….I also did a presentation at a medical staff meeting for over a hundred physicians, and Dr. G. also presented with me so [community physicians] knew what patient navigation was all about and the value of it to their patients and their practices….I think when they saw me presenting with Dr. G., they knew that it was going to be okay.…” (Informant 24) Several informants also discussed the importance of attending and/or participating in community and general education programs, such as health fairs and speaking engagements (Informants 8, 9, 15, 16, 19, and 25), community healthcare coalitions (Informants 12 and 16), local organization board membership (Informant 11), church groups (Informant 24), and local planning committees (Informant 12). Furthermore, participation in local and national PN network webinars, conferences, and other meeting groups was believed to be a growing avenue in communicating best practices across navigators (Informant 7).
Summary of Findings These findings support the idea that patient navigators play a wide-ranging, integrating role, using their social networks to span boundaries in an effort to overcome the negative externalities in the cancer care system. We have argued that these negative externalities are the result of at least 4 key factors involving provider interdependence. This interdependence—which is determined by (1) the patient’s problem to be solved and (2) external influences, and interacts with (3) organizational configurations, and (4) individual provider behavior— helps characterize the extent to which boundaries and barriers exist in the system. Our interviews reflected many of these factors. We include a few examples here to emphasize the important role these factors play in defining the need for PN and the boundary-spanning role patient navigators play. One informant described the nature of the patient problems their regional health system deals with as follows: “…a lot of our people in this region put off healthcare until they can’t anymore, so they don’t access healthcare until they are symptomatic….After they have been diagnosed with cervical cancer…we also find out they have obesity and heart disease and diabetes.” (Informant 2) Patient needs were also a common theme. One patient navigator described how patient needs can complicate things (even for navigators):
“So, [the radiation oncologist] brought [a rectal cancer patient] in to me and she left and I said [to the patient] ‘Okay, the doctor told me that she has given you prescriptions.’ He gets in his wallet and he pulls it out, and I bet you there were ten prescriptions in his wallet. [He] hands them to me and says he doesn’t know what to do with these….I typed up very detailed [instructions] on this paper how to get to [the pharmacy] in his area, and he lives right there….I get a call from the group that I was sending him to…and [they] said this man was found in the courthouse clutching your directions….She said everyone in the community knows this family and they are illiterate. Here I had taken all that time and didn’t ask the right questions and it never occurred to me….” (Informant 26)
These findings support the idea that patient navigators play a wideranging, integrating role, using their social networks to span boundaries in an effort to overcome the negative externalities in the cancer care system. Another informant indicated that low Medicaid reimbursement rates can affect access to care in their area: “…one of our doctors, an oncologist here, does not take Medicaid, any Medicaid” (Informant 24). This reflects how both external influences and individual provider behavior can influence patient experiences. Finally, another informant revealed that fragmented organizational configurations still exist, despite the collective interdependence between the providers: “Well, we are right now a little fragmented….We are located in some different locations….We are kind of the old structure; we have got medical oncology offices here, which are independent; and you have got radiation oncology, which is a hospital-based department; and we have a new medical oncologist who is coming in to help us build our program, which will also refer a secondary oncologist to work with that person.” (Informant 19) Together, these examples support the idea that the need for patient navigation (ie, due to negative externalities) emerges from the interdependence in the system and how PN interacts with provider configurations and behavior.4
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The Antecedents of Patient Navigation
Figure The Antecedents and Functional Role of Patient Navigation (PN)4,43
s s
Individual Provider Behavior
s
s
Social Networks • Network Size • Range of Contacts • Scope of Contacts • Stability of Contacts
Negative Externalities (eg, boundaries, barriers)
s
Provider Interdependence
Positive Externalities (eg, health, wellness, affordability)
s
s
The Patient’s Problem to Be Solved
s
Organizational Configurations
s
External Influences
Boundary Spanning (Patient Navigation) • Information Selection, Processing, and Translation • External Representation and Communication • Internal Representation and Communication • Agent Behaviors (Networking)
The Health Delivery System A system has a definable function or set of functions and is comprised of many purposeful, interdependent parts (eg, individuals, organizations). The number of those parts and how they interact characterizes the system’s complexity (Simon, 1973; Bar-yam, 1997). The Environment
DISCUSSION and PRACTICE IMPLICATIONS Discussion The theory and evidence we have presented suggest a strong link between the structure of systems and the use of social networks to span organizational boundaries. Our exploratory findings suggest that patient navigators serve an integrating role, building and using their social networks to span these boundaries and overcome barriers to care. Our theory suggests that such behavior results from negative externalities that emerge from system interdependencies. The Figure depicts these relationships, providing a framework that reflects both why PN emerges (negative externalities) and the roles we might expect patient navigators to play (boundary spanning within social networks).4,43 Specifically, our model suggests that a given health system (in this case, the cancer care system)4,43 may be characterized by a degree of provider interdependence that emerges both from the environment (external influences) and the object of the system’s existence (the patient’s problem to be solved). Organizational configura-
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tions (eg, differentiation and integration among providers) and individual provider behaviors (eg, their choices and interactions with others) interact with these interdependencies to produce externalities, both positive and negative. Negative externalities specifically result when organizational configurations and provider behaviors conflict with the underlying interdependencies (eg, the needs of the patient),44 thus giving rise to the need for boundary spanning. Based on our findings, our model further proposes that boundary spanners (ie, patient navigators) must work to build and capitalize on their social networks to overcome these externalities, theoretically generating positive outcomes for patients. This framework makes 2 important contributions to our understanding of health systems and the emergence of PN. First, drawing on systems theory, we provide formal insight into how organizational configurations and individual provider behaviors contribute to the problems plaguing the industry. Our framework specifies the broad sources of complexity (interdependence, exter-
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The Antecedents of Patient Navigation
nalities) observed in the healthcare system—(1) the patient’s problem to be solved, (2) external influences, (3) organizational configurations, and (4) individual provider behavior—and how exogenous factors (1 and 2) interact with endogenous organizational behavior (3 and 4) to produce the negative outcomes so often observed in the health delivery system. This aspect of our framework is consistent with recent empirical evidence suggesting that the efficiency of certain organizational configurations depends on the nature of the patient problems being solved.17 Second, our framework presents PN as an artifact of system dynamics. We specifically integrate theories on social networking and boundary spanning to describe the roles and activities of patient navigators, reflecting an understanding of system dynamics at both a macro level (external influences, organizational configurations) and a micro level (patient needs, individual provider behavior, provider interdependence). Systems thinking has been described as “the art of seeing the forest and the trees” and the ability to “act locally and think globally.”15,45 At a macrolevel, patient navigators engage in information selection, processing, translation, and transfer to make sense of and adapt to changes in the broader healthcare landscape, such as changes in payment systems, for example. In doing so, patient navigators often face microlevel challenges associated with the complex relationships between a variety of internal and external agents. Our interviews suggest that navigators approach these challenges through their awareness of agent behaviors and their use of external representation and communication, and that their ability to understand and manipulate their social networks is essential in helping their patients overcome the barriers inherent in the cancer care system.
Study Limitations Similar to other exploratory studies of this nature, our study is not without its limitations. First, our sample was small and focused on Appalachia, which may limit the generalizations that may be drawn from the study. Nonetheless, our sample included a broad range of regions within Appalachia and an array of individuals working in health systems with varying characteristics. Although Appalachia’s substantial rural population, documented high cancer mortality rates, and shortage of healthcare professionals indicate complex circumstances throughout the region, these complicated circumstances are not necessarily unique to this region. While the specifics may differ across regions, we have no reason to believe that the general antecedents prompting the emergence of PN in Appalachia differ greatly from those of other regions of
the United States. Second, our study was not designed for causal inference, despite our framework specifying causal directions. Given that the intent of this research was to be exploratory and propositional in nature, future research is needed to further understand the relationships displayed in our framework. Finally, because our interview sample included nonnavigators, information bias may be present. It is possible that informants who are not actively participating in navigation duties and are only in observational roles may differ in their perceptions of what navigators do, leading to systematically different responses to similar interview questions. However, the results presented in Table 3 suggest that the magnitude of differences across the informant categories is small. For example, the university-affiliated informant group, which included no navigators, made slightly more references to the characteristics of boundary spanning and social networking than did the other informant groups in 5 of the 8 categories (per 10 pages of text). While these differences may reflect a PN knowledge base by individuals outside of those routinely performing PN, we believe that their inclusion may, in fact, provide a more objective perspective on these programs.
While the specifics may differ across regions, we have no reason to believe that the general antecedents prompting the emergence of PN in Appalachia differ greatly from those of other regions of the United States. Practice Implications Despite these limitations, we believe that, by specifying the antecedents of PN, our study may offer valuable insights for managers and navigators regarding the role of cancer PN in health delivery systems. The important social-networking and boundary-spanning capabilities patient navigators need to traverse the barriers in the system reflect systems thinking and underscore the relevance of understanding “big picture” issues, aggressively managing social networks, and seeking to bridge gaps between interdependent providers, in addition to performing the tactical duties required of patient navigators.3 These capabilities encompass a broader view of the patient navigator role, a more relational role, which involves the mastery of both macro- and microlevel capabilities. These conclusions have clear implications for selecting and training patient navigators. Despite these implications, however,
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The Antecedents of Patient Navigation
informants described how current hiring practices are based primarily on less sophisticated means (eg, training, education, and a candidate’s general interest level). One informant acknowledged: “…the people that have been historically hired into these [patient navigator] positions were just put there because they have a general interest…. Then the organizations reevaluate and see what problems they were having operationally and fix them from there….That’s how we’ve evolved to focus on the things we do….[Instead] organizations should think strategically and hire based on the capabilities of the person.” (Informant 1) In moving toward a more focused, capabilities-based hiring process, delivery systems may experience a better fit between the nature of the task and the navigator’s capabilities.
Our framework suggests that greater attention to system dynamics on the part of leaders—and more specifically, greater attention to the nature of patient problems and patient needs—may lead to improvements in organizational configurations and organizational behavior. Our framework also provides insight for system leaders about system dynamics and the sources of negative externalities observed in the system, providing leaders with a model for thinking about how to address the underlying causes. Indeed, patient navigation may be viewed as a transaction cost that arises because existing, fragmented organizational configurations leave to markets what may be done more efficiently within organizations.45 The same observation may be made about other emerging innovations aimed at improving coordination of care and overcoming barriers (eg, case management). From a system dynamics perspective, these innovations emerge because organizations fail to account for the interdependence between providers. Our framework suggests that greater attention to system dynamics on the part of leaders—and more specifically, greater attention to the nature of patient problems and patient needs46— may lead to improvements in organizational configurations and organizational behavior. g
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Acknowledgments: This research was funded by the Appalachia Community Cancer Network (ACCN) (3U01 CA114622-S1), and technical assistance was provided by the Community Sciences and Health Outcomes (CSHO) Core of the Penn State Hershey Cancer Institute. The authors wish to thank the project managers of ACCN and other key informants at our field sites who were interviewed for this study. We also wish to thank Diane Brannon, PhD, Marianne Hillemeier, PhD, and Barbara Gray, PhD, for their contributions on previous iterations of this manuscript. This study was approved by the Scientific Review Committee of the Penn State Hershey Cancer Institute and the Milton S. Hershey Medical Center (HMC) Institutional Review Board. All interviewees agreed to the terms of the informed consent prior to participating in this research. Disclosures: All authors report nothing to disclose. Corresponding Author: Christopher Louis, MHA, PhD(c), Department of Health Policy and Administration, The Pennsylvania State University, 504A Ford Building, University Park, PA 16802; cjl247@psu.edu.
REFERENCES
1. Wells KJ, Battaglia TA, Dudley DJ, et al. Patient navigation: state of the art or is it science? Cancer. 2008;113(8):1999-2010. 2. Parker VA, Clark JA, Leyson J, et al. Patient navigation: development of a protocol for describing what navigators do. Health Serv Res. 2010;45(2):514-531. 3. Parker VA, Lemak CH. Navigating patient navigation: crossing health services research and clinical boundaries. Adv Health Care Manage. 2011; 11:149-183. 4. Simon HA. Applying information technology to organization design. Public Adm Rev. 1973;33(3):268-278. 5. Vargas RB, Ryan GW, Jackson CA, Rodriguez R, Freeman HP. Characteristics of the original patient navigation programs to reduce disparities in the diagnosis and treatment of breast cancer. Cancer. 2008;113(2):426-433. 6. Paskett ED, Harrop JP, Wells KJ. Patient navigation: an update on the state of the science. CA Cancer J Clin. 2011;61(4):237-249. 7. Tushman ML. Special boundary roles in the innovation process. Adm Sci Q. 1977;22(4):587-605. 8. Ancona DG, Caldwell DF. Bridging the boundary: external activity and performance in organizational teams. Adm Sci Q. 1992;37(4):634-665. 9. Tsai W. Social capital, strategic relatedness and the formation of intraorganizational linkages. Strategic Manage J. 2000;21(9):925-939. 10. Shortell SM, Rundall TG. Physician-organization relationships: social networks and strategic intent. In: Mick SS, Wyttenbach ME, eds. Advances of Health Care Organization Theory. San Francisco, CA: Jossey-Bass; 2003:141-174. 11. Burt RS. Structural holes and good ideas. Am J Sociol. 2004;110(2):349-399. 12. Freeman HP. A model patient navigation program. Oncol Issues. 2004; (19):44-47. 13. Freeman HP. Patient navigation: a community based strategy to reduce cancer disparities. J Urban Health. 2006;83(2):139-141. 14. Patient Protection and Affordable Care Act. HR 3590, 111th Cong, 2nd Sess (2009-2010). www.govtrack.us/congress/bills/111/hr3590/text. Accessed February 21, 2012. 15. Senge PM. The Fifth Discipline: The Art & Practice of the Learning Organization. New York, NY: Doubleday; 1990. 16. Weaver W. Science and complexity. Am Sci. 1948;36(4):536-544. 17. Clark JR. Comorbidity and the limitations of volume and focus as organizing principles. Med Care Res Rev. 2012;69(1):83-102.
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18. Tushman ML, Scanlan TJ. Boundary spanning individuals: their role in information-transfer and their antecedents. Acad Manage J. 1981;24 (2):289-305. 19. Horwitz JR. Making profits and providing care: comparing nonprofit, for-profit, and government hospitals. Health Aff (Millwood). 2005;24(3):790801. 20. Ashkenas R. Simplicity-minded management: a practical guide to stripping complexity out of your organization. Harv Bus Rev. 2007;85(12):101109, 146. 21. Herzlinger R. Market-Driven Health Care: Who Wins, Who Loses in the Transformation of America’s Largest Service Industry. New York, NY: Perseus Books; 1997. 22. Porter M, Teisberg E. Redefining Health Care: Creating Value-Based Competition on Results. Boston, MA: Harvard Business School Press; 2006. 23. Enthoven AC, Tollen LA. Competition in health care: it takes systems to pursue quality and efficiency. Health Aff (Millwood). (Suppl): 2005:W5420–W5-433. 24. Enthoven AC, Crosson FJ, Shortell SM. ‘Redefining health care’: medical homes or archipelagos to navigate? Health Aff (Millwood). 2007; 26(5):1366-1372. 25. Dollinger MJ. Environmental boundary spanning and information processing effects on organizational performance. Acad Manage J. 1984;27(2):351-368. 26. Aldrich H, Herker D. Boundary spanning roles and organization structure. Acad Manage Rev. 1977;2(2):217-230. 27. Manev IM, Stevenson WB. Balancing ties: boundary spanning and information and influence in the organization’s extended network of communication. J Bus Commun. 2001;38(2):183-205. 28. Friedkin NE. Information flow through strong and weak ties in intraorganizational social networks. Social Networks. 1982;3:273-285. 29. Tichy NM, Tushman ML, Fombrun C. Social network analysis for organizations. Acad Manage Rev. 1979;4(4):507-519. 30. Reagans R, McEvily B. Network structure and knowledge transfer: the effects of cohesion and range. Administrative Sci Q. 2003;48(2):240-267. 31. Sparrowe RT, Liden RC, Wayne SJ, Kraimer ML. Social networks and the performance of individuals and groups. Acad Manag J. 2001;44(2):316-325. 32. Inkpen AC, Tsang EWK. Social capital, networks, and knowledge transfer. Acad Manage Rev. 2005;30(1):146-165. 33. Burt RS. Toward a Structural Theory of Action: Network Models of Social Structure, Perception, and Action. New York, NY: Academic Press; 1982.
34. Centers for Disease Control and Prevention (CDC). Cancer death rates—Appalachia, 1994-1998. MMWR Morb Mortal Wkly Rep. 2002; 51(24):527-529. 35. Yao N, Lengerich EJ, Hillemeier MM. Breast cancer mortality in Appalachia: reversing patterns of disparity over time. J Health Care Poor Underserved. 2012;23(2):715-725. 36. Strover S, Oden M, Inagaki N. Telecommunications and rural economies: findings from the Appalachian region. Paper presented at: 29th Research Conference on Communication, Information and Internet Policy (TPRC); October 27-29, 2001; Alexandria, VA. http://arxiv.org/ftp/cs/pa pers/ 0109/0109090.pdf. Accessed May 10, 2013. 37. Ward AJ, Coffey Kluhsman B, Lengerich EJ, Piccinin AM. The impact of cancer coalitions on the dissemination of colorectal cancer materials to community organizations in rural Appalachia. Prev Chronic Dis. 2006;3(2):1-13. 38. Behringer B, Friedell G, Dorgan K, et al. Understanding the challenges of reducing cancer in Appalachia: addressing a place-based health disparity population. Cal J Health Promot. 2007;5(special issue):40-49. 39. Puckett A. “Let the girls do the spelling and Dan will do the shooting”: literacy, the division of labor, and identity in a rural Appalachian community. Anthropol Q. 1992;65(3):137-147. 40. Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15(9):1277-1288. 41. Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas. 1960;20:37-46. 42. Charmaz K. Constructing Grounded Theory: A Practical Guide Through Qualitative Analysis. Thousand Oaks, CA: Sage Publications; 2006. 43. Bar-yam Y. Dynamics of Complex Systems. Boulder, CO: Westview Press; 1997. 44. Clark J, Singer S, Kane N, Valentine M. From striving to thriving: systems thinking, strategy, and the performance of safety net hospitals [published online ahead of print May 25, 2012]. Health Care Manage Rev. doi: 10.1097/HMR.0b013e31825ba9ab. 45. Williamson OE. Strategy research: governance and competence perspectives. Strategic Manage J. 1999;20(12):1087-1108. 46. Hernandez SE, Conrad DA, Marcus-Smith MS, Reed P, Watts C. Patient-centered innovation in health care organizations: a conceptual framework and case study application. Health Care Manage Rev. 2013;38(2):166-175.
Submit a Manuscript! www.AONNonline.org/manuscripts The ONLY journal focused on patient navigation and survivorship care in oncology patients If you have any questions about the Journal of Oncology Navigation & Survivorship, please contact our editorial department at
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JONS-online.com journal of Oncology Navigation & Survivorship
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Call for Papers The Journal of Oncology Navigation & Survivorship® (JONS), launched in 2010, is the nation’s first peer-reviewed clinical journal for Oncology Nurse Navigators. As this critical area of specialty and expertise grows, research and sharing of best practices are integral to both improving the clinical care of cancer patients as well as expanding the existing literature and knowledge base. Our goal at JONS is to help facilitate that growth.
Readers are invited to submit articles that fit into the following topics: • Patient Education • Navigation Processes and Outcomes Measures • Continuity of Care • Working with a Multidisciplinary Oncology Team • Screening Programs • Transitional Processes into Survivorship Care • Community Outreach • Long-Term Follow-Up • Psychosocial Issues • Patient Surveillance • Emotional Support • Patient Adherence • Facilitation of Treatment Decision Making • Any other topic relevant and of importance • Tumor Board Processes to the specialty • Caring for the Underserved Papers can be in the following form: • Original Research • Review Article (a synopsis/review of current literature in a specific area of research) • Case Study • “How To” article designed to transfer successes to fellow practitioners
Each manuscript is subject to an internal review to see that it fits the scope of and mission of our journal. Papers that pass the initial review could be subject to a blinded peer review; final acceptance is based on that review. If you are interested in submitting a paper or have any questions, please feel free to visit our website www.JONS-online.com or e-mail our editorial department at jbrandt@the-lynx-group.com
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June 2013 • Volume 4, Issue 3
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Addressing Disparities
Systematic Assessment of Cancer Patient Navigation in Appalachia Eugene J. Lengerich, VMD, MS; Betsy Aumiller, MEd, DEd; Brenda C. Kluhsman, PhD, MSS, All from the Department of Public Health Sciences, College of Medicine, The Pennsylvania State University, Hershey, PA, and Penn State Hershey Cancer Institute, Hershey, PA Marcyann Bencivenga, BA, Department of Public Health Sciences, College of Medicine, The Pennsylvania State University, Hershey, PA Christopher Louis, MHA, Department of Health Policy and Administration, College of Health and Human Development, The Pennsylvania State University, University Park, PA Linda Fleisher, PhD, MPH, Fox Chase Cancer Center, Philadelphia, PA Electra D. Paskett, PhD, College of Medicine and Comprehensive Cancer Center, The Ohio State University, Columbus, OH Mark B. Dignan, PhD, MPH, College of Medicine and Department of Internal Medicine, University of Kentucky, Lexington, KY Background: Patient navigation (PN) has been proposed to address disparities in cancer mortality. Appalachia is largely rural with a population characterized by a high poverty rate and limited access to healthcare. The study objectives were to systematically assess ongoing cancer PN programs and the perceived needs related to PN in Appalachia so that hospitals and public health or community-based organizations could enhance cancer PN programs. Methods: We used a qualitative study design with semistructured telephone interviews of key informants at institutions/ programs with and without PN in Appalachia. Subjects were selected by nonprobability discriminative snowball sampling. We used directed content analysis to identify thematic units. Results: Between April and October 2010, 29 key informants completed the interview, 15 (51.7%) at a site with PN and 14 (48.3%) at a site without PN. In Appalachia, PN was conducted mostly by full-time health professionals, primarily registered nurses, and personal attributes, such as knowing the community and working well with multiple parties, were important. Personal attributes were particularly important to working successfully with Appalachian residents because the Appalachian culture is one of self-reliance, family, and community. PN was occurring at hospitals and cancer centers, as well as at voluntary organizations. Conclusions: The skills of patient navigators in Appalachia should match the responsibilities for the position; skills in community engagement and cultural sensitivity are particularly important. Lack of transportation and financial resources are substantial barriers. PN programs in Appalachia should have realistic expectations that are concordant with the needs and resources of Appalachian communities.
E
ncompassing 420 counties in 13 states from southern New York to northern Mississippi, Appalachia is largely rural with a population characterized by a high poverty rate, a low educational level, a high rate of uninsurance or underinsurance, and limited access to healthcare. All pose substantial barriers to cancer screening, diagnosis, and treatment and are associated with increased cancer mortality.1-4 Poverty and limited health insurance coverage reduce the ability of cancer patients to receive medical care.5,6 Low education levels are indicative of reduced basic knowledge about cancer and limited informa-
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tion-seeking and decision-making skills.7 Overall, rural areas have fewer healthcare professionals and cancer facilities.1,3 Rural geography means that residents may be geographically isolated, must travel a long distance and for a long time to cancer treatment and services, and lack systems of public transportation.2,4 Indeed, cancer mortality, especially from cancers of the lung, cervix, colon, and rectum, is typically higher in Appalachia than in the remainder of the United States.8-14 Patient navigation (PN) has been proposed as a method to address disparities in cancer mortality experienced by
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Addressing Disparities
some populations.15-18 PN has been described as the oneon-one support and guidance offered to persons with an abnormal cancer screening or a new cancer diagnosis.18 The support enables patients to access the cancer care system, overcome financial and transportation barriers, and facilitate timely quality care provided in a culturally sensitive manner.19 PN targets those who are most at risk for delays in care, including racial and ethnic minorities and those from low-income populations. In 2005, the Patient Navigator, Outreach and Chronic Disease Prevention Act was enacted and the Patient Navigation Research Program (PNRP) of the National Cancer Institute (NCI) funded 9 research institutions to study the impact and cost-effectiveness of PN.19,20 The PNRP primary outcomes to evaluate PN include time to completion of diagnostic resolution, time to initiation of primary therapy, patient satisfaction, quality of life, and cost-effectiveness; secondary outcomes include time to completion of therapy, quality of care, navigator characteristics, and task and social network analysis.19 Most of the previous PN research has been limited to urban populations.21,22 Of the few PN reports in rural areas, several have focused on American Indians.21,23,24 In a study in both rural hospitals and an urban hospital in western Pennsylvania, patient navigators focused the majority of their time on patients at the urban hospital,25 with the final result of the intervention being a small, insignificant reduction in the number of days from initial referral to completion of radiation therapy treatments for patients in the navigated group.26 In addition to the limited number of published results on the impact of PN among rural populations, there is also a dearth of literature on the organizational structure, management, and administration of PN programs. While most definitions of PN described it in the one-on-one context, Vargas and colleagues viewed PN as a system, as opposed to a person, comprising primarily navigators and directors.27 While there have been reviews of individual studies on the impact of PN,21,22 we are unaware of reports in the scientific literature that compare and contrast the structure, management, and administration of various PN programs. Moreover, the extant literature on PN is scant in identifying the organizational barriers to program implementation and is limited in providing information about the evaluation of PN programs.21 Thus, organizations starting or modifying a PN program have limited guidance from the scientific literature to guide their strategy. Despite the limited scientific literature on impact or operation, the number of and support for PN programs and patient navigators is increasing. Recently, state-based comprehensive cancer plans have included the development of PN programs, and state-based networks of patient naviga-
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tors have been developed. For example, in Pennsylvania, the Pennsylvania Navigator Network uses Web-based seminars and other technology-enhanced approaches to share navigation strategies and provide navigators with continuing education.28 In addition, PN training programs have been created.29 Professional organizations, such as the National Coalition of Oncology Nurse Navigators (NCONN), have been created to promote excellence in oncology patient care by fostering collaborative relationships and professional development among oncology nurse navigators and all healthcare disciplines locally, regionally, and nationally.30 The Commission on Cancer of the American College of Surgeons, in its 2012 Cancer Program Standards, established the Standard 3.1 for a PN Process by 2015. To be in compliance, a cancer program must have established a PN process and identified resources to address cancer patient barriers. After establishment, the PN process must be modified or enhanced each year so that it addresses additional barriers identified by a required community needs assessment.31 As a community-based research network, the Appalachia Community Cancer Network (ACCN), like its predecessors, conducts cancer intervention research that is tailored to the unique characteristics of Appalachia.3,32-36 Funded by the NCI and headquartered at the University of Kentucky, the ACCN uses a community-based approach to develop and test effective strategies to reduce the excess cancer burden in Appalachian Kentucky, New York, Ohio, Pennsylvania, Virginia, and West Virginia. Recognizing that little is known about the unique needs of PN programs and cancer patients in this area, the objectives of the current study were to systematically assess ongoing cancer PN programs and the perceived needs related to PN among cancer patients in rural Appalachia so that hospitals and public health or community-based organizations could develop or enhance cancer PN programs for rural Appalachia.
Methods We conducted a qualitative study of PN in rural Appalachia using semistructured telephone interviews of key informants at institutions/programs (hereafter referred to as sites) with and without PN in Appalachia.37 Subjects were selected by nonprobability discriminative snowball sampling. The initial interviewees were the regional program managers at academic institutions in 5 states associated with the ACCN, who then referred us to potential interviewees at other sites with and without PN. All study methods and materials were approved by the Scientific Review Committee of the Penn State Hershey Cancer Institute and the Milton S. Hershey Medical Center Institutional Review Board. Informed consent was ob-
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Addressing Disparities
tained from all subjects prior to participation in any research-related activities. The data were collected by 2 interviewers, and no incentive was offered to the interviewees. During each interview, the interviewer followed a semistructured interview guide with questions related to actual PN (for interviewees at sites with PN) or perceived or desired PN (for interviewees at sites without PN). Broad interview question topics focused on the characteristics of the interviewee and other navigators at the site, the characteristics of the PN program, barriers and successful strategies to navigating cancer patients, and ways of establishing and running PN programs in Appalachia. We also asked interviewees at sites with PN to provide us with copies of materials related to their PN program, including needs assessments, brochures, training manuals and materials, data tracking forms and reports, and patient resource materials. Each interview lasted approximately 60 minutes and was audiotaped. We used directed content analysis to identify thematic units from the transcripts and submitted PN material.38 Two investigators independently reviewed data from the initial 5 interviewees, identifying emerging themes from which an 8-page codebook was constructed and used to code the remaining data, with regular checks for interrater reliability. Biweekly coder meetings assured the continued development of consistent themes. The final set of categorical themes resulting from the data were (1) knowledge, awareness, and culture of patients; (2) cost, health insurance, and medication assistance for patients; (3) the impact of geography and physical environment on patients; and (4) provider and health system issues related to PN. We report data separately for interviewees at sites with PN and sites without PN.
Results Characteristics of Patient Navigators in Appalachia Between April and October 2010, a total of 29 key informants representing the Appalachian area of 5 states completed the interview, 15 (51.7%) at a site with PN and 14 (48.3%) at a site without PN (Table 1). At a majority of sites with PN, health professionals, mostly registered nurses, conducted the PN, and slightly more than half (60%) of the patient navigators were employed full-time. At sites without PN, approximately 2 of 3 (64.3%) interviewees reported that patient navigators should be health professionals only, with the majority reporting a desire for registered nurses. The vast majority (78.6%) of interviewees from a site without PN reported that the patient navigator should be employed full-time. Interviewees also reported characteristics of patient navigators (Table 1). The majority of attributes were personal, including working well with multiple parties, being com-
passionate, being flexible, and going above and beyond. One interviewee from a site without PN supported these personal attributes by stating, “because…they [the patient navigators] are indigenous to the community, I think there is a little more innate trust with those folks. They can have those difficult conversations and say, ‘Let’s prevent other bad things from occurring.’” In the area of knowledge, patient navigators were expected to know about the community as well as about cancer.
Characteristics of Patient Navigation Programs in Appalachia Although interviewees reported targeting several different cancer types, more than half (51.7%) reported breast cancer as the target cancer site (Table 2). Interviewees at sites with and without PN also reported that when considering the entire continuum of cancer care, diagnosis and treatment were the primary focus areas of PN programs. All interviewees (100%) at sites with PN reported that they focused on diagnosis, compared with half (50%) of interviewees from sites without PN. Moreover, nearly half (46.7%) of interviewees from sites with PN emphasized the importance of the posttreatment phase, including survivorship and end-of-life care, while only 3 (21.4%) interviewees from sites without PN shared that view.
Barriers to PN were related to patients and to provider/health systems. Transportation was the most commonly reported barrier for cancer patients, as reported by 90% of all interviewees. Barriers to Navigation of Cancer Patients in Appalachia Barriers to PN were related to patients and to provider/ health systems. Transportation was the most commonly reported barrier for cancer patients, as reported by 90% of all interviewees (Table 3). One interviewee described the transportation challenge by saying, “…500 miles round trip is the average. For people that are way, way down in the farthest little triangle of Virginia, bumping right up against Tennessee, those folks are traveling.… I think it’s like 7 hours one way.” Another interviewee discussed transportation barriers by saying, “The other major one [barrier], I would say, in this area is transportation.… We have patients coming to us from all over the place…so getting here every day for radiation for 6 weeks takes its toll.”
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Addressing Disparities
Table 1 Characteristics of Cancer Patient Navigators in Appalachia
Total
Characteristics of Patient Navigators at Sites with PN (n=15)
Perceived Characteristics of Patient Navigators at Sites without PN (n=14)
#
#
%
#
%
18
9
60.0
9
64.3
Layperson
9
6
40.0
3
21.4
Health professional and layperson
2
1
6.7
1
7.1
15
7
46.7
8
57.1
4
3
20.0
2
14.3
Registered nurse
5
5
33.3
0
0.0
Bachelor’s degree
10
5
33.3
5
35.7
Master’s degree
11
2
13.3
10
64.3
Associate’s degree
1
1
6.7
10
0.0
Unknown
3
3
20.0
10
0.0
Paid, full-time
20
9
60.0
11
78.6
Paid, part-time
5
3
20.0
2
14.3
Unpaid/volunteer
4
4
26.7
0
0.0
Knows the community
7
5
33.3
2
14.3
Works well with multiple parties
7
4
26.7
2
14.3
Compassionate
6
3
20.0
3
21.4
Knowledgeable about cancer
6
3
20.0
3
21.4
Flexible
5
3
20.0
2
14.3
Goes above and beyond
5
3
20.0
2
14.3
Builds trust easily
4
3
20.0
1
7.1
Persistent
4
3
20.0
1
7.1
Caring
3
3
20.0
0
0.0
Prior experience with patient barriers to cancer care
3
2
13.3
2
14.3
Training Of those classified as health professionals
Registered nurse Social worker Education
Employment
Attributes*
PN indicates patient navigation. *Respondents could report multiple attributes.
Income or personal finance issues were the second most commonly reported barriers. From sites with PN, 3 of 4 (75%) interviewees reported income or personal finance barriers compared with more than 4 of 10 (42.9%) at sites without PN. One interviewee described the income barri-
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June 2013 • Volume 4, Issue 3
ers by saying, “When you are talking about socioeconomic status, it really runs the gamut. We have got people who have been low income their whole lives, and they still are, and they have gotten this diagnosis on top of that. We have people who are employed full-time, have excellent
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Addressing Disparities
Table 2 Characteristics of Cancer PN Programs in Appalachia
Total
Actual Characteristics of PN Programs at Sites with PN (n=15)
Perceived Characteristics of PN Programs at Sites without PN (n=14)
#
#
%
#
%
21
12
80.0
9
64.3
15
9
60.0
6
42.9
Cervical cancer
4
3
20.0
1
7.1
Lung cancer
1
0
0.0
1
7.1
Diagnosis
22
15
100.0
7
50.0
Treatment
19
11
73.3
2
57.1
General education
14
8
53.3
0
42.9
Prevention education
13
7
46.7
5
42.9
Survivorship
10
7
46.7
10
21.4
End of life
10
7
46.7
10
21.4
2
2
13.3
10
0.0
Hospital
19
11
73.3
8
57.1
Cancer center
12
7
46.7
5
35.7
Multiple organizations
10
4
26.7
6
42.9
Other
8
4
26.7
3
21.4
Academic health center
5
1
6.7
4
28.6
County health department
4
2
13.3
2
14.3
Local coalition
3
1
6.7
2
14.3
Cancer type Any cancer site Site-specific navigation Breast cancer
Continuum of cancer services*
Palliative care Program affiliations*
PN indicates patient navigation. *Respondents could report multiple attributes.
insurance, whose lives just kind of crumble because they can’t work anymore, their insurance goes away, and they have nothing.” Similarly, interviewees reported that a lack of knowledge of cancer diagnosis and treatment was a patient barrier that persists in Appalachia. Of the 15 interviewees from sites with PN, 6 (40%) reported a lack of knowledge, whereas 5 (35%) of the 14 interviewees from sites without PN reported this same barrier. One navigator stated, “I would like to have 5 minutes with every single patient.… They [providers] cannot make a determination of who is going to need my help simply by seeing if they are insured or not insured.” Knowledge of
proper use of medication and potential side effects of medication were also reported as patient barriers. In addition, patient knowledge, awareness, and cultural issues were freqently reported as patient barriers. Barriers were not limited to patient-level issues but included provider and health system issues, such as access to cancer services, health system/cancer center processes, and fragmented infrastructure. One interviewee noted, “Who wants to travel to one place to get blood and then travel to this place to get an x-ray and radiation and then from there, after you are wiped out from that…go back up to the doctor’s office and then sit there for hours. A pa-
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Addressing Disparities
Table 3 Barriers to PN in Appalachia* Actual Barriers at Sites with PN (n=15)
Total #
Perceived Barriers at Sites without PN (n=14)
#
%
#
%
Patient barriers related to knowledge, attitude, and culture Lack of knowledge
11
6
40.0
5
35.7
Low health literacy
8
6
40.0
2
14.3
Cultural acceptance of patient navigation
7
2
13.3
5
35.7
Pride
7
2
13.3
5
35.7
Fear/denial
6
2
13.3
4
28.6
Time
6
3
20.0
3
21.4
Fatalistic attitude
4
1
6.7
3
21.4
Lack of trust
4
2
13.3
2
14.3
Child/family care
4
0
0.0
4
28.6
Lack of caregiver support
3
3
20.0
0
0.0
Resistance to care
3
0
0.0
3
21.4
Patient barriers related to cost, health insurance, and medication assistance Income/personal finances
18
12
80.0
6
42.9
Health insurance
17
11
73.3
6
42.9
Medication
16
10
66.6
6
42.9
26
14
93.3
12
85.7
Distance to cancer services
4
1
6.7
3
21.4
Lodging
2
2
13.3
0
0.0
Access to cancer services
9
5
33.3
4
28.6
Awareness of PN
7
5
33.3
2
14.3
Health system/cancer center processes
5
3
20.0
2
14.3
Delay across care continuum
3
0
0.0
3
21.4
Undeveloped infrastructure
2
0
0.0
2
14.3
Patient barriers related to geography and physical environment Transportation
Provider and health system barriers to PN
PN indicates patient navigation. *Respondents could report multiple attributes.
tient navigator sees her role is to help these people get through the system better and have better outcomes.” General awareness of PN was also suggested by 1 of 4 interviewees as a provider and health system barrier. One informant discussed this barrier by saying, “[Patients are] not really totally understanding what patient navigation really is because there is such a broad definition out there. People tend to think it is this individual walking them
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June 2013 • Volume 4, Issue 3
through this journey, or a caregiver, or an individual that is helping out, rather than navigating them through the difficulties and the issues that they may come up against like insurance, pharmaceutical, or nutritional issues.”
Strategies to Overcome Barriers to PN in Appalachia Nearly half (48.3%) of the interviewees reported providing transportation assistance for individual patients, including
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Addressing Disparities
Table 4 Strategies to Overcome Barriers to PN in Appalachia* Total
Actual Strategies to PN at Sites with PN (n=15)
#
#
Perceived Strategies to PN at Sites without PN (n=14)
%
#
%
Strategies for patient barriers related to knowledge, attitude, and culture Provide timely information
8
5
33.3
3
21.4
Build trust with patients/community
4
3
20.0
1
7.1
Strategies for patient barriers related to cost, health insurance, and medication assistance Provide medication assistance
11
7
46.7
4
28.6
Provide general financial assistance
10
6
40.0
4
28.6
Coordinate health insurance for patient
4
3
26.7
0
0.0
Provide reimbursement for gas and travel
3
2
13.3
1
7.1
8
53.3
6
42.9
Strategies for patient barriers related to geography and physical environment Provide transportation assistance
14
Strategies for provider and health system barriers to PN programs Increase awareness of physicians
6
6
40.0
0
0.0
Collaborate with social workers/RNs
6
5
33.3
1
7.1
Join hospital committees
3
2
13.3
1
7.1
PN indicates patient navigation; RN, registered nurse. *Respondents could report multiple attributes.
8 (53.3%) of 15 interviewees from sites with PN, compared with 6 (42.9%) of 14 interviewees from sites without PN (Table 4). One interviewee offered these solutions to the problems of travel and lodging: “Because they are traveling a very long distance…we have grant funds available to help them pay for lodging.… The round trip is probably 2 gas tanks full or more.… We have Shell gift cards.” Moreover, 7 (46.7%) of the 15 interviewees from sites with PN reported providing medication assistance. Another navigator described the importance of providing available resources as a strategy, explaining that pharmaceutical companies help make a difference. For example, if a patient is paying $800 per month for medications and the navigator, in cooperation with a pharmaceutical company, is able to obtain those medications at no cost, “that can significantly change someone’s life.” At sites without PN, 4 (28.6%) interviewees reported this same solution. One interviewee described how a community physician contributes to the PN program by saying, “He’s our cancer liaison physician. He’s done a lot of education, and he has actually started a compassion fund here in our area, so that the navigator would have resources to help pay for transportation or medication.... He held events, actually 3 different events, to raise money for the cause, so he’s a champion.”
Discussion We found that PN in Appalachia is being conducted mostly by full-time health professionals, primarily registered nurses, and that personal attributes, such as knowing the community and working well with multiple parties, were regarded as important. Personal attributes are particularly important to working successfully with Appalachian residents because the Appalachian culture is one of a reliance on self, family, and community.3 When compared with existing PN sites, we found that sites without a PN program reported these personal attributes and transportation and finance issues less frequently as barriers, suggesting an underappreciation of the important characteristics of patient navigator and the magnitude of these barriers for patient care. Most PN programs in our study addressed all cancer types and were affiliated with multiple organizations, including public health and voluntary groups. Along the cancer continuum, sites with a PN program emphasized the diagnosis and treatment phases, while sites without a PN program reported a more even distribution. In a review of the literature, PN was found to be most effective in increasing participation in cancer screening and adherence to diagnostic follow-up care following an abnormality, with less evidence of their effectiveness in reducing late-stage
JONS-online.com journal of Oncology Navigation & Survivorship
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Fourth Annual Navigation and
November 15-17, 2013 • The Peabo PRELIMINARY AGENDA* FRIDAY, NOVEMBER 15 12:00 pm - 12:30 pm Welcome • Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS 12:30 pm - 2:00 pm PRE-CONFERENCE WORKSHOPS Basic Navigation Track • Tricia Strusowski, MS, RN • Nicole Messier, RN, BSN OR Advanced Navigation Track • Elaine Sein, RN, BSN, OCN, CBCN • Danelle Johnston, RN, MSN, OCN, CBCN 2:00 pm - 2:45 pm BREAK IN THE EXHIBIT HALL 2:45 pm - 3:30 pm General Session 1: Top 10 Best Practices • Moderators – Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS 3:30 pm - 5:00 pm Administrator’s Track • Mandi Pratt-Chapman, MA • Michele O’Brien, MSN, ACNS-BC, RN, BA OR
5:00 pm - 6:00 pm 6:00 pm - 8:00 pm
Case Manager’s Track FREE TIME Welcome Reception/Posters in the Exhibit Hall
SATURDAY, NOVEMBER 16 6:30 am - 7:30 am
Breakfast/Product Theater (non–CME-certified activity) 7:45 am - 8:00 am Welcome and Introductions • Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS 8:00 am - 8:30 am General Session 2: The Future of AONN (The AONN Business Meeting) • Sharon Gentry, RN, MSN, AOCN, CBCN • Lillie D. Shockney, RN, BS, MAS 8:30 am - 9:15 am General Session 3: Community Needs and Navigation • Lillie D. Shockney, RN, BS, MAS, on behalf of the Global Breast Health Initiative • Jennifer Klemp, PhD, MPH, MS 9:15 am - 10:00 am General Session 4: Development and Application of Evidence-Based Guidelines in Cancer Care: The NCCN Perspective • Liz Danielson, MHA 10:00 am - 10:45 am BREAK IN THE EXHIBIT HALL 10:45 am - 11:30 am Keynote: Update on Guidelines • Linda Ferris, PhD 11:45 am - 12:45 pm Lunch/Product Theater (non–CME-certified activity) 1:00 pm - 1:45 pm General Session 5: Onco-Politic Barriers • Dan O’Connor 1:45 pm - 2:30 pm General Session 6: Addressing Disparities of Care • Swann Arp Adams, PhD, MS • Michelle Weaver Knowles, RNC, BSN
2:30 pm - 3:15 pm 3:15 pm - 3:45 pm 3:50 pm - 4:35 pm
4:35 pm - 5:20 pm 5:30 pm - 7:30 pm
General Session 7: Oncology Medical Home BREAK IN THE EXHIBIT HALL General Session 8: Meeting the Needs of the Adult and Child Survivor Throughout the Life Span • Christy Roberts, RN, BSN, OCN General Session 9: The Role of Complementary Therapies in Navigation • Linda Lee, MD, AGAF Poster Award Reception
SUNDAY, NOVEMBER 17 6:30 am - 7:30 am
Breakfast/Product Theater (non–CME-certified activity) 7:45 am - 8:00 am Welcome and Introductions • Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS 8:30 am - 8:45 am General Session 10: Navigator’s Role in Tumor Boards • Laurie Mathis, RN, BS, MAS 8:45 am - 10:30 am DISEASE SITE–SPECIFIC BREAKOUTS • Breast Cancer Navigation & Survivorship • Karen Dow Meneses, PhD, RN, FAAN • Vinnie Myers • Thoracic Oncology Navigation • Gean Brown, RN, OCN • GI & Colorectal Cancer Navigation • Darcy Doege, RN, BSN • Kristen Vogel, MS, CGC • GYN Cancers Navigation • Penny Daugherty, BSN, RN, OCN • Prostate Cancer Navigation • Head, Neck, & Neuro Navigation • Tamara Bowen, RN, BSN, MHA • Pediatric Oncology • Kathy Ruble, RN, CPNP, PhD • Hematology/Oncology Navigation • Melanoma Navigation • Sherry Riggins, RN, BSN, OCN 10:30 am - 11:15 am BREAK IN THE EXHIBIT HALL 11:15 am - 12:00 pm General Session 11: Understanding the Role of the Primary Care Physician • Michael Kolodziej, MD 12:15 pm - 1:15 pm Lunch/Product Theater (non–CME-certified activity) 1:30 pm - 2:15 pm General Session 12: Navigator’s Role in End-of-Life Care • Lillie D. Shockney, RN, BS, MAS 2:15 pm - 3:00 pm General Session 13: Music & Medicine: A Dynamic Partnership • Deforia Lane, PhD, MT-BC 3:00 pm - 3:15 pm Conclusion of the Conference/Final Remarks • Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS *Preliminary agenda, subject to change.
Survivorship Conference
ody Memphis • Memphis, Tennessee CONFERENCE CO-CHAIRS Program Director: Lillie D. Shockney, RN, BS, MAS University Distinguished Service Associate Professor of Breast Cancer Depts of Surgery and Oncology Adm Director, Johns Hopkins Breast Center Adm Director, Johns Hopkins Cancer Survivorship Programs Associate Professor, JHU School of Medicine Depts of Surgery, Oncology & Gynecology and Obstetrics Associate Professor, JHU School of Nursing Baltimore, MD
FACULTY* Swann Arp Adams, PhD, MS Tamara Bowen, RN, BSN, MHA Gean Brown, RN, OCN
Penny Daugherty, BSN, RN, OCN Darcy Doege, RN, BSN Karen Dow Meneses, PhD, RN, FAAN Linda Ferris, PhD Sharon Gentry, RN, MSN, AOCN, CBCN
Jennifer Klemp, PhD, MPH, MS Michael Kolodziej, MD Deforia Lane, PhD, MT-BC Linda Lee, MD, AGAF
CONFERENCE OVERVIEW
AONN’s Fourth Annual Conference will continue to advance the navigation profession by expanding the scope of educational sessions, networking opportunities, and poster presentations. In addition, this year’s conference will address the evolving challenges of program improvement, the role of personalized medicine, and implementing best practices in navigation, survivorship, and psychosocial care.
TARGET AUDIENCE
This activity was developed for oncology nurse navigators, patient navigators, social workers, and case managers.
CONTINUING EDUCATION INFORMATION
Learning Objectives Upon completion of this activity, the participant will be able to: • Discuss the evolution of the role of navigation in healthcare. • Assess strategies for navigating diverse patient populations by cancer type and environmental factors. • Define methods for providing patient support and guidance in the age of personalized cancer care. • Evaluate best practices regarding survivorship and psychosocial care.
Nicole Messier, RN, BSN Vinnie Myers Michele O’Brien, MSN, ACNS-BC, RN, BA
Liz Danielson, MHA
Danelle Johnston, RN, MSN, OCN, CBCN
Sharon Gentry, RN, MSN, AOCN, CBCN Breast Nurse Navigator Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, NC
Laurie Mathis, RN, CBCN, OCN
Dan O’Connor Mandi Pratt-Chapman, MA Sherry Riggens, RN, BSN, OCN Christy Roberts, RN, BSN, OCN Kathy Ruble, RN, CPNP, PhD Elaine Sein, RN, BSN, OCN, CBCN Lillie D. Shockney, RN, BS, MAS Tricia Strusowski, MS, RN Kristen Vogel, MS, CGC Michelle Weaver Knowles, RNC, BSN *For full information visit www.aonnonline.org
SPONSORS
This activity is jointly sponsored by Medical Learning Institute Inc, Center of Excellence Media, LLC, and Core Principle Solutions, LLC.
COMMERCIAL SUPPORT ACKNOWLEDGMENT
Grant requests are currently being reviewed by numerous supporters. Support will be acknowledged prior to the start of the educational activities.
REGISTERED NURSE DESIGNATION
Medical Learning Institute Inc. Provider approved by the California Board of Registered Nursing, Provider Number 15106, for up to 16.25 contact hours.
2013 CONFERENCE REGISTRATION
www.aonnonline.org /conference
L-AONN-13_Ksize 50813
Addressing Disparities
diagnosis, overcoming delays in initiation of cancer treatment, or improving long-term outcomes in cancer survivorship.22 Our findings support previous literature reports of PN in Appalachia addressing the early stages of the cancer continuum. Interestingly, we found some evidence that PN programs in Appalachia are focusing on the later stages of the cancer continuum as well. The quantitative evaluation of PN in Appalachia was reported infrequently by sites with PN, whereas sites without PN infrequently reported the need for evaluation data. Interviewees who discussed evaluation typically discussed it in the context of nonspecific data items, such as type of services provided and type of cancer, or individual case reports. Sites with PN reported developing simple tracking tools for their own use. In addition, sites with PN reported limited time for evaluation, particularly because it may reduce the amount of time available for PN. Quantitative and more specific outcome data, such as time from diagnosis to initiation of treatment and cost of the program, will help justify PN to hospital and clinic managers in budget preparation and review.
The findings from this study and other PN research in rural areas could be used by the ACCN, rural hospitals, and public health organizations to tailor PN programs to the unique needs and cancer resources in rural Appalachia. The study was limited by several features. First, the sample was relatively small and not population-based, so it may not be representative of all of Appalachia or generalizable to other populations. However, as a qualitative study, the primary objective was to provide information about the characteristics of PN in Appalachia, which has not been reported previously. Second, the study relied upon selfreport information, which could lead to information bias. However, the ACCN has a long-standing relationship with community-based organizations and rural hospitals in Appalachia such that interviewees may have been more inclined to report more accurately and fully than if the study had not been associated with the ACCN. Third, standard definitions of PN have not yet been universally accepted. For example, Vargas and colleagues described PN as a system, not a person,27 while the NCONN has made a well-drawn distinction between oncology nurse navigators and lay navigators.30 In addition, interviewees
44
June 2013 â&#x20AC;˘ Volume 4, Issue 3
may have interpreted our questions with their own understanding of PN. However, the study had a number of strengths. First, the study targeted a medically underserved population with recognized cancer health disparities. Second, while the sampling strategy was not population-based, it was systematic and included sites without PN. Thus, it presents information on the perspective of sites that might develop tailored PN programs and related research initiatives for Appalachia. Third, we did not restrict or prescribe the possible responses or the number of responses of interviewees. Last, our exploratory research design was appropriate in understanding the current state of PN in Appalachia, as prior literature has been deficient regarding rural areas. In conclusion, we found that PN along the cancer continuum is occurring in Appalachia and that several considerations are important for Appalachia. First, the skills of patient navigators should match the responsibilities for the position; in particular, community engagement and cultural sensitivity are important competencies for a patient navigator in Appalachia. Second, the focus of PN along the cancer continuum should be broad, including preventive and early detection stages. This broad approach reflects the needs of rural communities where medical specialization is more limited than in urban communities. Third, lack of resources, such as transportation and finances, appear to be substantial barriers to care for cancer patients in Appalachia. Fourth, ongoing evaluation of PN in Appalachia appears limited but is critical to fully understand the impact of PN in Appalachia. Fifth, a lack of clarity in defining PN and PN programs suggests that future research should develop methods to understand this difference and its impact on PN. Finally, hospitals and cancer centers are not the only location for PN programs in Appalachia, as lay navigation and multiple agency approaches are being utilized. In summary, PN programs in Appalachia should have realistic expectations of the duties and skills of patient navigators that are concordant with the needs and resources of Appalachian communities. The findings from this study and other PN research in rural areas could be used by the ACCN, rural hospitals, and public health organizations to tailor PN programs to the unique needs and cancer resources in rural Appalachia. g Acknowledgments: The authors are grateful to the project managers of the Appalachian Community Cancer Networkâ&#x20AC;&#x201D; Dierdre Robinson, MSW, at University of Kentucky; Darla Fickle, MA, at The Ohio State University; Sharon Dwyer, MS, at Virginia Polytechnic Institute; and Stephenie Kennedy, MA, at West Virginia Universityâ&#x20AC;&#x201D;and the 25 other individuals interviewed for this study. Special thanks to Harold P. Free-
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Addressing Disparities
man, MD, founder of the patient navigation movement and president and founder of Ralph Lauren Cancer Center for Cancer Care and Prevention, who provided ad hoc consultation to the project. This study was funded by the Appalachia Community Cancer Network (U01 CA114622), and technical assistance was provided by the Community Science and Health Outcomes Core of the Penn State Hershey Cancer Institute. Disclosures: Authors have nothing to disclose. Corresponding author: Eugene J. Lengerich, VMD, MS, Professor of Public Health Sciences, Family & Community Medicine, and Health Policy & Administration, The Pennsylvania State University, 600 Centerview Drive, Suite 2200, Mailstop A210, Hershey, PA 17033-0855; e-mail: elengerich@ psu.edu.
References
1. Appalachian Regional Commission. The Appalachian Region. http:// www.arc.gov/appalachian_region/TheAppalachianRegion.asp. Accessed June 13, 2013. 2. Behringer B, Friedell GH. Appalachia: where place matters in health. Prev Chronic Dis. 2006;3(4). http://www.cdc.gov/pcd/issues/2006/oct/06_0067.htm. Accessed June 13, 2013. 3. Couto RA, Simpson NK, Harris G, eds. Sowing Seeds in the Mountains: Community-Based Coalitions for Cancer Prevention and Control. Bethesda, MD: National Institutes of Health; 1994. NIH monograph 94-3779. 4. Behringer B, Friedell GH, Dorgan KA, et al. Understanding the challenges of reducing cancer in Appalachia: addressing a place-based health disparity population. Californian J of Health Promotion. 2007;5:40-49. http:// www.cjhp.org/Volume5_2007/IssueSp/040-049-behringer.pdf. Accessed June 12, 2013. 5. Freeman HP, Reuben SH. Voices of a Broken System: Real People, Real Problems. President’s Cancer Panel: Report of the Chairman 2000-2001. National Institutes of Health. National Cancer Institute; 2001. http://deainfo.nci. nih.gov/advisory/pcp/archive/pcp00-01rpt/PCPvideo/voices_files/PDFfiles/ PCPbook.pdf. Accessed June 11, 2013. 6. Freeman HP, Chu KC. Determinants of cancer disparities: barriers to cancer screening, diagnosis, and treatment. Surg Oncol Clin N Am. 2005; 14(4):655-669. 7. US Department of Health and Human Services. Office of Disease Prevention and Health Promotion. National Action Plan to Improve Health Literacy. Washington, DC; 2010. http://www.health.gov/communication/hlaction plan/pdf/Health_Literacy_Action_Plan.pdf. Accessed June 11, 2013. 8. Hall HI, Rogers JD, Weir HK, et al. Breast and cervical carcinoma mortality among women in the Appalachian region of the US, 1976-1996. Cancer. 2000;89(7):1593-1602. 9. Centers for Disease Control and Prevention (CDC). Cancer death rates: Appalachia, 1994-1998. MMWR Morb Mortal Wkly Rep. 2002;51(24):527529. 10. Hendryx M, O’Donnell K, Horn K. Lung cancer mortality is elevated in coal-mining areas of Appalachia. Lung Cancer (Amsterdam, Netherlands). 2008;62(1):1-7. 11. Wingo PA, Ries LA, Giovino GA, et al. Annual report to the nation on the status of cancer, 1973-1996, with a special section on lung cancer and tobacco smoking. J Natl Cancer Inst. 1999;91(8):675-690. 12. Chen J, Roth RE, Naito A, et al. Geovisual analytics to enhance spatial scan statistic interpretation: an analysis of U.S. cervical cancer mortality. Int J Health Geogr. 2008;7:57. http://www.ij-healthgeographics.com/content/ 7/1/57. Accessed June 13, 2013. 13. Appalachia Community Cancer Network. The cancer burden in Appalachia 2009. http://www.accnweb.com/docs/2009/CancerBurdenAppala chia2009.pdf. Accessed June 12, 2013.
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14. Lengerich EJ, Tucker TC, Powell RK, et al. Cancer incidence in Kentucky, Pennsylvania, and West Virginia: disparities in Appalachia. J Rural Health. 2005;21(1):39-47. 15. Freeman HP. Patient navigation: a community centered approach to reducing cancer mortality. J Cancer Educ. 2006;21(suppl 1):S11-S14. 16. Freeman HP. Patient navigation: a community based strategy to reduce cancer disparities. J Urban Health. 2006;83(2):139-141. 17. Freeman HP, Muth B, Kerner JF. Expanding access to cancer screening and clinical follow-up among the medically underserved. Cancer Pract. 1995;3(1):19-30. 18. National Cancer Institute. Center to Reduce Cancer Health Disparities. Annual report on cancer health disparities: fiscal year 2011. http:// crchd.cancer.gov/attachments/2011AR_508.pdf. Accessed June 13, 2013. 19. Freund KM, Battaglia TA, Calhoun E, et al. National Cancer Institute Patient Navigation Research Program: methods, protocol, and measures. Cancer. 2008;113(12):3391-3399. 20. Patient Navigator Outreach and Chronic Disease Prevention Act of 2005. Public Law 109–18. http://www.gpo.gov/fdsys/pkg/PLAW-109publ18/ html/PLAW-109publ18.htm. Accessed June 13, 2013. 21. Paskett ED, Harrop JP, Wells KJ. Patient navigation: an update on the state of the science. CA Cancer J Clin. 2011;61(4):237-249. 22. Wells KJ, Battaglia TA, Dudley DJ, et al. Patient navigation: state of the art or is it science? Cancer. 2008;113(8):1999-2010. 23. Kanekar S, Petereit D. Walking forward: a program designed to lower cancer mortality rates among American Indians in western South Dakota. S D Med. 2009;62(4):151-153, 155-157, 159. 24. Guadagnolo BA, Petereit DG, Helbig P, et al. Involving American Indians and medically underserved rural populations in cancer clinical trials. Clin Trials. 2009;6(6):610-617. 25. Lin CJ, Schwaderer KA, Morgenlander KH, et al. Factors associated with patient navigtors’ time spent on reducing barriers to cancer treatment. J Nat Med Assoc. 2008;100(11):1290-1297. 26. Schwaderer KA, Proctor JW, Martz EF, et al. Evaluation of patient navigation in a community radiation oncology center involved in disparities studies: a time-to-completion-of-treatment study. J Oncol Pract. 2008;4(5): 220-224. 27. Vargas RB, Ryan GW, Jackson CA, et al. Characteristics of the original patient navigation programs to reduce disparities in the diagnosis and treatment of breast cancer. Cancer. 2008;113(2):426-433. 28. Pennsylvania Patient Navigator Network. http://pubweb.fccc.edu/panav net/. Accessed June 13, 2013. 29. Calhoun EA, Whitley EM, Esparza A, et al. A national patient navigator training program. Health Promot Pract. 2010;11(2):205-215. 30. National Coalition of Oncology Nurse Navigators. NCONN Web site. http://www.nconn.org/. Accessed June 13, 2013. 31. Commission on Cancer, American College of Surgeons. Cancer Program Standards 2012: Ensuring Patient-Centered Care. http://www.facs.org/cancer/ coc/programstandards2012.pdf. Accessed June 25, 3013. 32. Friedell GH, Rubio A, Maretzki A, et al. Community cancer control in a rural, underserved population: the Appalachian Leadership Initiative on Cancer Project. J Health Care Poor Underserved. 2001;12(1):5-19. 33. Bencivenga M, DeRubis S, Leach P, et al. Community partnerships, food pantries, and an evidence-based intervention to increase mammography among rural women. J Rural Health. 2008;24(1):91-95. 34. Kluhsman BC, Bencivenga M, Ward AJ, et al. Initiatives of 11 rural Appalachian cancer coalitions in Pennsylvania and New York. Prevent Chronic Dis. 2006;3(4):A122. 35. Lengerich EJ, Kluhsman BC, Bencivenga M, et al. Development of community plans to enhance survivorship from colorectal cancer: community-based participatory research in rural communities. J Cancer Surviv. 2007;1(3):205-211. 36. Lengerich EJ, Wyatt SW, Rubio A, et al. The Appalachia Cancer Network: cancer control research among a rural, medically underserved population. J Rural Health. 2004;20(2):181-187. 37. Patton MQ. Qualitative Research & Evaluation Methods. 3rd ed. Thousand Oaks, CA: Sage Publications; 2002. 38. Hsieh H-F, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15(9):1277-1288.
AONNonline.org
ANNUAL CONFERENCE
"! ! !
! Professor Rob Coleman, MBBS, MD, FRCP Yorkshire Cancer Research Professor of Medical Oncology Director, Sheffield Cancer Research Centre Associate Director, National Institute for Health Research Cancer Research Network Department of Oncology, Weston Park Hospital Sheffield, United Kingdom
* 3:00 pm - 7:00 pm
Registration
5:30 pm - 7:30 pm
Welcome Reception and Exhibits
7:00 am - 8:00 am
Symposium/Product Theater
8:15 am - 8:30 am
Welcome to the Second Annual Conference of the Global Biomarkers Consortiumâ&#x20AC;&#x201D;Setting the Stage for the Meeting Professor Rob Coleman, MBBS, MD, FRCP
8:15 am - 11:45 am
General Session I â&#x20AC;˘ Personalized Medicine in Oncology: Evolution of Cancer Therapy from Nonspecific Cytotoxic Drugs to Targeted Therapies â&#x20AC;˘ Taking Stock of Molecular Oncology Biomarkers â&#x20AC;˘ Genomics â&#x20AC;˘ Bioinformatics â&#x20AC;˘ Validating Biomarkers for Clinical Use in Solid Tumors - Professor Rob Coleman, MBBS, MD, FRCP â&#x20AC;˘ Validating Biomarkers for Clinical Use in Hematologic Malignancies Jorge E. Cortes, MD â&#x20AC;˘ The Challenges of Biomarker-Based Clinical Trials â&#x20AC;˘ Keynote Lecture: Understanding Cancer at the Molecular Level
12:00 pm - 1:00 pm
Symposium/Product Theater/Exhibits
1:15 pm - 4:30 pm
This activity is jointly sponsored by Medical Learning Institute Inc, Center of Excellence Media, LLC, and Core Principle Solutions, LLC.
General Session II â&#x20AC;˘ Introduction to Case Studies - Jorge E. Cortes, MD â&#x20AC;˘ Case Studies: Optimal, Value-Based Use of Molecular Biomarkers in Oncology: The Expertâ&#x20AC;&#x2122;s Perspective on How I Treat My Patients, Part I â&#x20AC;˘ Lung Cancer â&#x20AC;˘ Breast Cancer â&#x20AC;˘ Multiple Myeloma â&#x20AC;˘ Prostate Cancer â&#x20AC;˘ Leukemia â&#x20AC;˘ Lymphoma â&#x20AC;˘ Panel Discussion: Management Controversies and Accepted Guidelines for the Personalized Management of Solid Tumors and Hematologic Malignancies â&#x20AC;˘ Keynote Lecture: The Medical-Legal Issues Surrounding the Use of Biomarkers in Oncology
4:30 pm - 6:30 pm
Meet the Experts/Networking/Exhibits
Jorge E. Cortes, MD Chair, CML and AML Sections D.B. Lane Cancer Research Distinguished Professor for Leukemia Research Department of Leukemia, Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TX
The only global meeting dedicated to advancing the understanding of value and clinical impact of biomarker research in oncology. Guided by the expertise of leaders in this field, participants will receive a thorough understanding of the current and future landscape of the relevance of tumor biomarkers and how to effectively personalize cancer care in the clinical setting.
This meeting will be directed toward medical oncologists and hematologists, pathologists, geneticists, advanced practice oncology nurses, research nurses, clinical oncology pharmacists, and genetic counselors involved in the management of patients with solid tumors or hematologic malignancies, and interested in the use of molecular tumor biomarkers to help optimize patient care.
Upon completion of this activity, the participant will be able to: â&#x20AC;˘ Assess emerging data and recent advances in the discovery of molecular biomarkers and their impact on the treatment of patients with solid tumors or hematologic malignancies â&#x20AC;˘ Discuss the role of molecular biomarkers in designing personalized therapy for patients with solid tumors or hematologic malignancies â&#x20AC;˘ Outline the practical aspects of integrating molecular biomarkers into everyday clinical practice in the treatment of patients with cancer
Grant requests are currently being reviewed by numerous supporters. Support will be acknowledged prior to the start of the educational activities.
7:00 am - 8:00 am
Symposium/Product Theater
8:15 am - 11:45 am
General Session III â&#x20AC;˘ Review of Saturdayâ&#x20AC;&#x2122;s Presentations and Preview of Today - Jorge E. Cortes, MD â&#x20AC;˘ Case Studies: Optimal, Value-Based Use of Molecular Biomarkers in Oncology: The Expertâ&#x20AC;&#x2122;s Perspective on How I Treat My Patients, Part II â&#x20AC;˘ Melanoma â&#x20AC;˘ Colorectal Cancer and Other GI Malignancies â&#x20AC;˘ MDS â&#x20AC;˘ Myeloproliferative Neoplasms â&#x20AC;˘ Keynote Lecture: Promises and Challenges of Personalized Medicine in Improving Cancer Care â&#x20AC;˘ Tumor Board: Challenging Cases in the Use of Biomarkers in Managing Solid Tumors (attendee-contributed cases) â&#x20AC;˘ Tumor Board: Challenging Cases in the Use of Biomarkers in Managing Hematologic Malignancies (attendee-contributed cases)
12:00 pm - 1:00 pm
Symposium/Product Theater/Exhibits
1:15 pm - 3:00 pm
General Session IV â&#x20AC;˘ Keynote Lecture: Making Personalized Medicine a Reality: The Realization of Genomic Medicine â&#x20AC;˘ The Future of Personalized Medicine: Measuring Clinical Outcomes â&#x20AC;˘ Cost-Effective Technologies That Can Drive Therapeutic Decision Making â&#x20AC;˘ Regulatory Perspectives on PMO â&#x20AC;˘ PMO: The Payerâ&#x20AC;&#x2122;s Perspective â&#x20AC;˘ Panel Discussion: Can We Afford PMO? A Value-Based Analysis â&#x20AC;˘ Practical Considerations in Incorporating PMO into Everyday Cinical Management â&#x20AC;˘ Reimbursement Challenges â&#x20AC;˘ Closing Remarks
3:00 pm
Departures
The Medical Learning Institute Inc designates this live activity for a maximum of 12.5 AMA PRA Category 1 Creditsâ&#x201E;˘. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Medical Learning Institute Inc and the Center of Excellence Media, LLC. The Medical Learning Institute Inc is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Medical Learning Institute Inc Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 12.5 contact hours.
The Medical Learning Institute Inc is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Completion of this knowledge-based activity provides for 12.5 contact hours (1.25 CEUs) of continuing pharmacy education credit. The Universal Activity Number for this activity is (To be determined).
CONFERENCE REGISTRATION
EARLY BIRD REGISTRATION NOW OPEN! $175.00 until June 30, 2013
www.globalbiomarkersconsortium.com
*Agenda is subject to change.
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