JONS August 2013 by The Oncology Nurse

August 2013

www.AONNonline.org

Vol 4, NO 4

LITERATURE REVIEW

Current State of Care Transitions and Cancer Survivorship

QUALITY, OUTCOMES, AND PERFORMANCE IMPROVEMENT COMMITTEE About Elaine Sein, RN, BSN, OCN, CBCN

THE PATIENT’S VOICE

Adherence to Therapy at Home: The Personal Touch

Navigating Patients Across the Continuum of Cancer Care

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

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

Secondary Endpoints

• Overall response rate

• • • • • • • •

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

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

NCT#01889186 Reference: ClinicalTrials.gov.

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

LETTERS FROM LILLIE

Editor-in-Chief

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

Current State of Caner Transitions and Cancer Survivorship Dear Reader, I hope everyone has enjoyed their summer! We are now even closer to our 4th Annual AONN Conference in Memphis. I am hoping to see you there. We have a great lineup of experts to empower you with new knowledge and practical tools to make your navigation role better than ever—for you and for your patients! This issue of JONS contains great information for you! There is a very comprehensive article, submitted by Danelle Johnston, on the current state of care transitions and cancer survivorship. A topic important to all of us! You will also find an article dedicated to the subject of “adherence,” including a commentary. (Sometimes getting patients to do the right thing for themselves simply doesn’t happen and is riddled with barriers as to the causes for why it occurs.) I want everyone to get to know our Quality, Outcomes, and Performance Improvement (QOPI) Committee, so you will find in each issue of JONS information written by one of our QOPI members. This issue contains information about Elaine Sein, Senior Project Manager at Fox Chase Cancer Center Partners. In keeping with previous issues, I am providing the next installment of resources that are available to us from pharmaceutical companies that you likely are not familiar with and can benefit you and your patients. Be well, enjoy the approach of autumn, and start looking forward to us being together in November in Memphis!

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

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

™

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

Table of ConTents

Resources from Pharmaceutical Companies

6 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

Lillie D. Shockney, RN, BS, MAS

LITERATURE REVIEW

President/CEO Brian Tyburski

August 2013 • Vol 4, NO 4

urrent State of Care Transitions and Cancer C Survivorship Danelle Johnston, RN, MSN, OCN, CBCN

QUALITY, OUTCOMES, AND PERFORMANCE IMPROVEMENT COMMITTEE

About Elaine Sein, RN, BSN, OCN, CBCN

THE PATIENT’S VOICE

32 Adherence to Therapy at Home: The Personal Touch

MMA

COMMENTARY

33 Oral Adherence

Pam Goetz

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

August 2013 • Volume 4, Issue 4

ABOUT THE COVER Forever Fishing

Acrylic by a Family Member, Friend or Caregiver, 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

We Will

exhaust all possibilities.

We will…because patients are our priority. Celgene Patient Support® provides free and personalized assistance with patients’ access and reimbursement needs. With continual communication and consistent follow-through, your dedicated Celgene Patient Support® Specialist will streamline access to Celgene products by helping you and your patients with: • Benefits investigation

To Contact Celgene Patient Support®:

• Prior authorization

Call: 1-800-931-8691

• Appeal support

E-mail: patientsupport@celgene.com

• Medicare

Fax: 1-800-822-2496

• Co-pay assistance – Celgene Commercial Co-pay Program – Co-pay assistance through third-party organizations

Visit: www.CelgenePatientSupport.com Monday through Friday, 8:00 am to 7:00 pm ET

• Prescription status • Celgene free medication program • Celgene products and restricted distribution programs

4 out of 5 patients who requested assistance from Celgene Patient Support ® received their medication.

Resources from Pharmaceutical Companies

Resources of Potential Benefit to You and to the Patients You Navigate Part 3 of a 5-Part Series

Lillie D. Shockney, RN, BS, MAS, Johns Hopkins University School of Medicine, Baltimore, Maryland

atient Education, Advocacy & Resources (www.gene. com): The patient resources on this website include details on a range of Genentech-partnered programs for people faced with a variety of diseases, as well as disease education and information on coverage support. • Faces of Metastatic Breast Cancer (MBC) (http://faces ofmbc.org/): Genentech partnered with Living Beyond Breast Cancer, Metastatic Breast Cancer Network, and Metavivor and created Faces of MBC to recognize the 155,000 people living in the United States with MBC, a disease for which there currently is no cure. Faces of MBC features videos with perspectives from real women living with the disease and their supporters, as well as resources and information about the disease. Faces of MBC launched a Facebook application called “Circle of Support,” which allows friends, family, and caregivers to offer support and words of encouragement to loved ones with MBC. • Faces of Skin Cancer (http://www.facesofskincancer. org/): Genentech also partnered with the Skin Cancer Foundation, AIM at Melanoma, BCCNS Life Support Network, Melanoma International Foundation, and Melanoma Research Foundation to create Faces of Skin Cancer to learn more about the advanced skin cancer community and how best to support them. The Faces of Skin Cancer website includes video, audio, and stories from people in the advanced skin cancer community that highlight different emotional and physical aspects of advanced skin cancer. Visitors can show their support by sharing the stories with others and are invited to submit their own advanced skin cancer story.

• Partners for Good: Dream Foundation (http://www. gene.com/stories/partners-for-good-dream-founda tion): Genentech teams up with Partners for Good: Dream Foundation, the first and largest national wish-granting organization for adults, to fulfill wishes for individuals and their families facing life-threatening illness. • Stories (http://www.gene.com/stories): Patient stories provide perspectives on why Genentech does what they do, and why it matters. These stories are available in written form, slideshows, and videos. • Disease Education (http://www.gene.com/patients/dis ease-education): Genentech offers a directory of disease education resources to help patients and caregivers understand disease risk factors, signs and symptoms, and general treatment options. • Committed to Access (http://www.gene.com/patients/ patient-access): Genentech is committed to helping people access Genentech medicines whenever possible. “Committed to Access” offers a full range of programs and services to help make sure price is not a barrier for patients. • Medical Resources for Healthcare Providers (http:// www.gene.com/medical-professionals/medinfo): Healthcare provider questions and inquiries about Genentech medicines and clinical trials are fielded through an easy online submission form. • Herceptin for Nurses (http://www.herceptin.com/hcp/ nurses): This section of the Herceptin website contains useful information and resources to help oncology nurse navigators learn more about HER2-positive cancer and Herceptin. 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. 6

August 2013 • Volume 4, Issue 4

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 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)

•Risk of Infection: Assess patients for signs and symptoms of infection and initiate

appropriate treatment promptly. Serious infections should have resolved before starting therapy with Jakafi • 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-1227f 07/13

Table 2: Worst Hematology Laboratory Abnormalities in the Placebo-controlled Studya Jakafi Placebo (N=155) (N=151) Laboratory All All b Grade 3 Grade 4 Grades Grade 3 Parameter Grades BRIEF SUMMARY: For Full Prescribing Information, see package insert. (%) (%) (%) (%) (%) INDICATIONS AND USAGE Jakafi is indicated for treatment of patients with intermediate or high-risk Thrombocytopenia 69.7 9.0 3.9 30.5 1.3 myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential Anemia 96.1 34.2 11.0 86.8 15.9 thrombocythemia myelofibrosis. Neutropenia 18.7 5.2 1.9 4.0 0.7 CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS Thrombocytopenia, Anemia and Neutropenia Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia. [see Dosage and Administration (2.1) in Full Prescribing Information]. Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary [see Dosage and Administration (2.2) in Full Prescribing Information, and Adverse Reactions]. Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi. Severe neutropenia (ANC less than 0.5 X 109/L) was generally reversible. Withhold Jakafi until recovery [see Adverse Reactions]. Perform a pretreatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated [see Dosage and Administration (2.2) in Full Prescribing Information, and Adverse Reactions]. Risk of Infection Serious bacterial, mycobacterial, fungal and viral infections may occur. Active serious infections should have resolved before starting therapy with Jakafi. Observe patients receiving Jakafi for signs and symptoms of infection and initiate appropriate treatment promptly. PML Progressive multifocal leukoencephalopathy (PML) has been reported with ruxolitinib treatment for myelofibrosis. If PML is suspected, stop Jakafi and evaluate. Herpes Zoster Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected [see Adverse Reactions]. ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Myelosuppression [see Warnings and Precautions]; • Risk of Infection [see Warnings and Precautions] Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Jakafi was assessed in 617 patients in six clinical studies with a median duration of follow-up of 10.9 months, including 301 patients with myelofibrosis in two Phase 3 studies. In these two Phase 3 studies, patients had a median duration of exposure to Jakafi of 9.5 months (range 0.5 to 17 months), with 88.7% of patients treated for more than 6 months and 24.6% treated for more than 12 months. One hundred and eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. In a double-blind, randomized, placebo-controlled study of Jakafi, 155 patients were treated with Jakafi. The most frequent adverse drug reactions were thrombocytopenia and anemia [see Table 2]. Thrombocytopenia, anemia and neutropenia are dose related effects. The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache [see Table 1]. Discontinuation for adverse events, regardless of causality, was observed in 11.0% of patients treated with Jakafi and 10.6% of patients treated with placebo. Following interruption or discontinuation of Jakafi, symptoms of myelofibrosis generally return to pretreatment levels over a period of approximately 1 week. There have been isolated cases of patients discontinuing Jakafi during acute intercurrent illnesses after which the patient’s clinical course continued to worsen; however, it has not been established whether discontinuation of therapy contributed to the clinical course in these patients. When discontinuing therapy for reasons other than thrombocytopenia, gradual tapering of the dose of Jakafi may be considered [see Dosage and Administration (2.9) in Full Prescribing Information]. Table 1 presents the most common adverse reactions occurring in patients who received Jakafi in the double-blind, placebo-controlled study during randomized treatment. Table 1: Adverse Reactions Occurring in Patients on Jakafi in the Double-blind, Placebo-controlled Study During Randomized Treatment Jakafi Placebo (N=155) (N=151) Adverse All All Grade 3 Grade 4 Grades Grade 3 Grade 4 Reactions Gradesa (%) (%) (%) (%) (%) (%) Bruisingb 23.2 0.6 0 14.6 0 0 Dizzinessc 18.1 0.6 0 7.3 0 0 Headache 14.8 0 0 5.3 0 0 Urinary Tract Infectionsd 9.0 0 0 5.3 0.7 0.7 Weight Gaine 7.1 0.6 0 1.3 0.7 0 Flatulence 5.2 0 0 0.7 0 0 Herpes Zosterf 1.9 0 0 0.7 0 0 a National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 b includes contusion, ecchymosis, hematoma, injection site hematoma, periorbital hematoma, vessel puncture site hematoma, increased tendency to bruise, petechiae, purpura c includes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s Disease, labyrinthitis d includes urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, kidney infection, pyuria, bacteria urine, bacteria urine identified, nitrite urine present e includes weight increased, abnormal weight gain f includes herpes zoster and post-herpetic neuralgia

Description of Selected Adverse Drug Reactions Anemia In the two Phase 3 clinical studies, median time to onset of first CTCAE Grade 2 or higher anemia was approximately 6 weeks. One patient (0.3%) discontinued treatment because of anemia. In patients receiving Jakafi, mean decreases in hemoglobin reached a nadir of approximately 1.5 to 2.0 g/dL below baseline after 8 to 12 weeks of therapy and then gradually recovered to reach a new steady state that was approximately 1.0 g/dL below baseline. This pattern was observed in patients regardless of whether they had received transfusions during therapy. In the randomized, placebo-controlled study, 60% of patients treated with Jakafi and 38% of patients receiving placebo received red blood cell transfusions during randomized treatment. Among transfused patients, the median number of units transfused per month was 1.2 in patients treated with Jakafi and 1.7 in placebo treated patients. Thrombocytopenia In the two Phase 3 clinical studies, in patients who developed Grade 3 or 4 thrombocytopenia, the median time to onset was approximately 8 weeks. Thrombocytopenia was generally reversible with dose reduction or dose interruption. The median time to recovery of platelet counts above 50 X 109/L was 14 days. Platelet transfusions were administered to 4.7% of patients receiving Jakafi and to 4.0% of patients receiving control regimens. Discontinuation of treatment because of thrombocytopenia occurred in 0.7% of patients receiving Jakafi and 0.9% of patients receiving control regimens. Patients with a platelet count of 100 X 109/L to 200 X 109/L before starting Jakafi had a higher frequency of Grade 3 or 4 thrombocytopenia compared to patients with a platelet count greater than 200 X 109/L (16.5% versus 7.2%). Neutropenia In the two Phase 3 clinical studies, 1.0% of patients reduced or stopped Jakafi because of neutropenia. Table 2 provides the frequency and severity of clinical hematology abnormalities reported for patients receiving treatment with Jakafi or placebo in the placebo-controlled study.

Grade 4 (%) 0 3.3 1.3

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

Additional Data from the Placebo-controlled Study 25.2% of patients treated with Jakafi and 7.3% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in alanine transaminase (ALT). The incidence of greater than or equal to Grade 2 elevations was 1.9% for Jakafi with 1.3% Grade 3 and no Grade 4 ALT elevations. 17.4% of patients treated with Jakafi and 6.0% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in aspartate transaminase (AST). The incidence of Grade 2 AST elevations was 0.6% for Jakafi with no Grade 3 or 4 AST elevations. 16.8% of patients treated with Jakafi and 0.7% of patients treated with placebo developed newly occurring or worsening Grade 1 elevations in cholesterol. The incidence of Grade 2 cholesterol elevations was 0.6% for Jakafi with no Grade 3 or 4 cholesterol elevations. DRUG INTERACTIONS Drugs That Inhibit or Induce Cytochrome P450 Enzymes Ruxolitinib is predominantly metabolized by CYP3A4. Strong CYP3A4 inhibitors: The Cmax and AUC of ruxolitinib increased 33% and 91%, respectively, with Jakafi administration (10 mg single dose) following ketoconazole 200 mg twice daily for four days, compared to receiving Jakafi alone in healthy subjects. The half-life was also prolonged from 3.7 to 6.0 hours with concurrent use of ketoconazole. The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the corresponding ruxolitinib AUC following concurrent administration with ketoconazole. When administering Jakafi with strong CYP3A4 inhibitors a dose reduction is recommended [see Dosage and Administration (2.7) in Full Prescribing Information]. Patients should be closely monitored and the dose titrated based on safety and efficacy. Mild or moderate CYP3A4 inhibitors: There was an 8% and 27% increase in the Cmax and AUC of ruxolitinib, respectively, with Jakafi administration (10 mg single dose) following erythromycin, a moderate CYP3A4 inhibitor, at 500 mg twice daily for 4 days, compared to receiving Jakafi alone in healthy subjects. The change in the pharmacodynamic marker, pSTAT3 inhibition was consistent with the corresponding exposure information. No dose adjustment is recommended when Jakafi is coadministered with mild or moderate CYP3A4 inhibitors (eg, erythromycin). CYP3A4 inducers: The Cmax and AUC of ruxolitinib decreased 32% and 61%, respectively, with Jakafi administration (50 mg single dose) following rifampin 600 mg once daily for 10 days, compared to receiving Jakafi alone in healthy subjects. In addition, the relative exposure to ruxolitinib’s active metabolites increased approximately 100%. This increase may partially explain the reported disproportionate 10% reduction in the pharmacodynamic marker pSTAT3 inhibition. No dose adjustment is recommended when Jakafi is coadministered with a CYP3A4 inducer. Patients should be closely monitored and the dose titrated based on safety and efficacy. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C: There are no adequate and well-controlled studies of Jakafi in pregnant women. In embryofetal toxicity studies, treatment with ruxolitinib resulted in an increase in late resorptions and reduced fetal weights at maternally toxic doses. Jakafi should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses of 15, 30 or 60 mg/kg/day in rats and 10, 30 or 60 mg/kg/day in rabbits. There was no evidence of teratogenicity. However, decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day. This dose results in an exposure (AUC) that is approximately 2 times the clinical exposure at the maximum recommended dose of 25 mg twice daily. In rabbits, lower fetal weights of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. In a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implantation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups for fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily). Nursing Mothers It is not known whether ruxolitinib is excreted in human milk. Ruxolitinib and/or its metabolites were excreted in the milk of lactating rats with a concentration that was 13-fold the maternal plasma. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Jakafi, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The safety and effectiveness of Jakafi in pediatric patients have not been established. Geriatric Use Of the total number of myelofibrosis patients in clinical studies with Jakafi, 51.9% were 65 years of age and older. No overall differences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Renal Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in healthy subjects [CrCl 72-164 mL/min (N=8)] and in subjects with mild [CrCl 53-83 mL/min (N=8)], moderate [CrCl 38-57 mL/min (N=8)], or severe renal impairment [CrCl 15-51 mL/min (N=8)]. Eight (8) additional subjects with end stage renal disease requiring hemodialysis were also enrolled. The pharmacokinetics of ruxolitinib was similar in subjects with various degrees of renal impairment and in those with normal renal function. However, plasma AUC values of ruxolitinib metabolites increased with increasing severity of renal impairment. This was most marked in the subjects with end stage renal disease requiring hemodialysis. The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in metabolite exposure. Ruxolitinib is not removed by dialysis; however, the removal of some active metabolites by dialysis cannot be ruled out. When administering Jakafi to patients with moderate (CrCl 30-59 mL/min) or severe renal impairment (CrCl 15-29 mL/min) with a platelet count between 100 X 109/L and 150 X 109/L and patients with end stage renal disease on dialysis a dose reduction is recommended [see Dosage and Administration (2.8) in Full Prescribing Information]. Hepatic Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in healthy subjects (N=8) and in subjects with mild [Child-Pugh A (N=8)], moderate [Child-Pugh B (N=8)], or severe hepatic impairment [Child-Pugh C (N=8)]. The mean AUC for ruxolitinib was increased by 87%, 28% and 65%, respectively, in patients with mild, moderate and severe hepatic impairment compared to patients with normal hepatic function. The terminal elimination half-life was prolonged in patients with hepatic impairment compared to healthy controls (4.1-5.0 hours versus 2.8 hours). The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in ruxolitinib exposure except in the severe (Child-Pugh C) hepatic impairment cohort where the pharmacodynamic activity was more prolonged in some subjects than expected based on plasma concentrations of ruxolitinib. When administering Jakafi to patients with any degree of hepatic impairment and with a platelet count between 100 X 109/L and 150 X 109/L, a dose reduction is recommended [see Dosage and Administration (2.8) in Full Prescribing Information]. Jakafi is a registered trademark of Incyte Corporation. All rights reserved. U.S. Patent No. 7,598,257 © 2011-2013 Incyte Corporation. All rights reserved. Issued: June 2013 RUX-1216

Literature Review

Current State of Care Transitions and Cancer Survivorship Danelle Johnston, RN, MSN, OCN, CBCN, St. Jude Medical Center, Fullerton, CA Introduction: A review of the literature was done to evaluate the current evidence regarding the barriers that influence the transition of care in cancer survivorship and impact patient quality of life (QOL) and health outcomes. Methods: Scholarly articles and sources were searched to identify the barriers in cancer survivorship care. CINAHL, MEDLINE, PubMed, and Google Scholar were searched for the following terms: cancer survivorship, workforce shortage, cancer QOL, oncology nurse navigator, patient navigation, breast cancer survivors, cancer survivorship models of care, primary care providers, cancer care barriers to survivorship care, coordination of care, care transitions, and physician communication. The search was limited to articles in English from 2000 through 2012. The one recent exception was a landmark article on cancer survivorship model of care published in1985 that continues to have relevance and is recognized as the current model for cancer survivorship care. Results: The literature identifies that the needs of cancer survivors are unmet and there are multiple barriers that impede the care of the survivor. Projected substantial growth in the number of cancer survivors and a significant deficit in oncology providers raises the question, how can the needs of the cancer survivor be met today and in the future? Conclusions: Evidence-based strategies need to be developed by the oncology interdisciplinary team to overcome the obstacles that interfere with providing improved QOL and health outcomes. Quality survivorship care has gained national attention, and many healthcare organizations are hard at work identifying collaborative strategies to meet the growing needs of the cancer survivor and prevail over the barriers to providing quality survivorship care.

review of the literature identified varying definitions of when a patient with cancer becomes a cancer survivor. Consensus defines a “survivor” as a person with cancer, from the time of diagnosis throughout his or her lifetime.1-5 Five-year cancer survival rates have been steadily rising, and various statistics have been reported, including an increase from 3 million survivors in 1971 to a projected 20 million by 2020.6,7 The American Cancer Society (ACS) projects 18 million cancer survivors by 2022,8 while the National Cancer Institute (NCI) estimates a 31% increase by 2020, which equals about 18.1 million survivors.9 This remarkable increase in cancer survivors can be attributed to the increased number of persons over the age of 65 years, earlier cancer detection, and improvements in technology and cancer therapies.10-14 Prior to 1985, there was little focus on cancer survivorship and many of the survivors’ needs went unaddressed.15 In 1985, Fitzhugh Mullan, a physician and cancer survivor, published an article that explored concepts of cancer survivorship that were subsequently adopted by the healthcare professional community as a model of practice.3 The National Coalition for Cancer Survivorship was founded in 1986 to heighten awareness and to address the unique needs of survivors, while empowering them to advocate for their needs.16 In 1996, the NCI established the Office of Cancer Survivorship (OCS). The OCS supports research to improve the quality of care that cancer survivors receive and to promote the education of healthcare professionals and survivors.15

Survivorship care continues to gain attention from the cancer community through the advocacy of organizations such as the Centers for Disease Control and Prevention (CDC) and the formerly named Lance Armstrong Foundation (now LIVESTRONG), which published A National Action Plan for Cancer Survivorship: Advancing Public Health Strategies in 2004.17 The Institute of Medicine (IOM)s 2006 report, From Cancer Patient to Cancer Survivor: Lost in Transition, addressed the extensive long-term needs of cancer survivors.18 In 2008, the Oncology Nursing Society (ONS) included caring for the long-term cancer survivor in its research agenda.15 Survivorship issues are becoming a higher priority at the national level as the IOM, CDC, NCI, and others actively advocate for research and education to address the needs of the growing numbers of cancer survivors. The IOM identified 4 major components of cancer survivorship care: prevention, surveillance, intervention, and coordination (Table).18 Prevention is defined as the promotion of healthy lifestyle behaviors for the patient with the goal of preventing cancer recurrence, a secondary cancer occurrence, or other late effects.18-20 Surveillance is defined as the monitoring and assessment of cancer spread, cancer recurrence, and secondary cancers; and physical and psychosocial late effects. Intervention addresses the management of symptoms from the effects of cancer and its treatment that impact the 4 domains of quality of life (QOL): physical, psychological, social, and spiritual.18-20 Coordination of care is the collaboration and communication between the oncology interdisciplinary team and the cancer survivor’s primary care phy-

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Table The IOM’s 4 Components of Cancer Survivorship Prevention

•P romotion of healthy lifestyle behaviors •G oal prevention of cancer recurrence, secondary cancer occurrence, or other late effects

Surveillance

• Monitoring and assessment of cancer spread, cancer recurrence, and secondary cancers • Monitoring and assessment of psychological physical and late effects

Intervention

• Management of symptoms that impact the 4 domains of QOL (physical, psychological, social, and spiritual)

Coordination

• Collaboration and communication with the oncology interdisciplinary team and the primary care physicians to ensure that the survivor’s care needs are met

IOM indicates Institute of Medicine; QOL, quality of life

sicians (PCPs) to ensure that the survivor’s needs are met.18-20 The IOM stated that it is critical to the survivor’s long-term health to facilitate the transition of care from active treatment to posttreatment care.18 As reported by Grant and colleagues,20 in 2006 the City of Hope developed and implemented the Survivorship Education for Quality Cancer Care program with funding from the NCI. The goal of the program was to initiate change in survivorship care through the participation of 204 multidisciplinary cancer care teams from around the United States. The teams developed goals for their institutional programs, and the progress toward those goals was tracked for 18 months. The goals encompassed program planning, prevention and detection, surveillance, interventions for symptoms associated with cancer therapy, and coordination of care. Study outcomes showed that primary goals were more frequently formulated in the program development domains and less frequently in the domains of prevention and detection. The biggest barrier identified for goal implementation was limited financial resources. The findings indicate that further emphasis will need to be placed on the development of survivorship programs that consistently incorporate all 4 domains of survivorship care. The study also outlined the steps to implement survivorship care, including an assessment of current resources available on survivorship, a survey of the needs of cancer survivors in specific populations, the identification of staff, and institutional priorities related to survivorship.20 Cancer survivorship must be recognized as a distinct phase

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in cancer care.18 To address the needs of survivors, a better understanding of the issues that cancer survivors face is needed.11 Strategies can then be developed to meet these needs and to care for cancer survivors. Currently, there is quite a bit of variance in the practice of how survivors are followed, and the IOM reports that many survivors are lost to follow-up.18 Therefore, evidence-based practice guidelines for follow-up and surveillance need to be developed to establish a standard of care for the cancer survivor.18 Ganz identified three Ps in survivorship care: palliation of ongoing symptoms, prevention of late effects of cancer treatment or secondary cancers, and health promotion to maximize future wellness.21 Aziz emphasized that regular follow-up is imperative to ensure the timely diagnosis and treatment of long-term complications, to prevent recurrence or secondary cancers, to detect comorbid conditions, and to offer health promotion strategies.19 His report stated, “The prevention of late effects, secondary cancers, and recurrence of primary disease requires watchful follow-up and optimal utilization of early detection screening techniques.”19 The interdisciplinary cancer team and PCPs need to identify and address needs at the onset of cancer diagnosis and offer timely interventions that will prevent or diminish potential or actual late and long-term effects.22,23 QOL can be improved for the survivor when survivorship care is initiated at the time of diagnosis.22

A Cancer Survivorship Model In the influential 1985 article by Mullan,3 “Seasons of Survival,” he described a model for cancer survivorship in which survivorship begins at diagnosis and requires early identification and intervention to positively impact QOL and patient outcomes. He identified the 3 seasons of survival as acute, extended, and permanent. Acute survival begins at the time of cancer diagnosis and goes through the completion of initial treatment. Throughout this season, anxiety and fear are common experiences because of the enormous impact the diagnosis has on the survivor’s life and future. Treatments and effects from the treatments dominate the survivor at this time. The transition from acute to extended survival is challenging. Mullan found that through the extended survival period the healthcare team tended to be ineffective in the facilitation of transition and preparation of the patient, failing to provide sufficient knowledge and education about projected needs.3 Extended survival is the period when the acute phase of care is completed and the patient enters watchful waiting with surveillance and possible intermittent therapy. This season is often associated with fear of recurrence and dealing with the long-term effects from treatments. Permanent survival is defined as “a period when the ac-

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tivity of the disease or the likelihood of its return is sufficiently small that the cancer can now be considered permanently arrested.” In this season, the problems faced by the survivor include finding or keeping employment, health insurance coverage and other financial issues, and experiencing the late effects of therapy. The “Seasons of Survival” provides clinicians a model to assist with the identification of their patients’ needs in the cancer survivorship trajectory.3 In 2011, Miller and colleagues6 redefined the “Seasons of Survival” model of care by adding 3 additional seasons: transition, chronic survivorship, and end of life. Transition acknowledges that a survivor evolves from cancer patient to survivor and must create a “new normal.” Chronic survivorship includes those who, as a result of the advances in cancer treatments, are living with chronic or metastatic disease. End of life distinguishes the time when cancer therapy is no longer effective and the disease progresses. The healthcare community needs to offer prevention, surveillance, intervention, and coordination in all seasons of survival.6

Medical Workforce Shortage The growing deficit of medical oncologists is estimated to reach 48% by 2020.10 This shortage will have a significant negative impact on the growing numbers of cancer survivors. Since 1997, there has been a 50% decline in the number of medical students choosing to practice as PCPs.12 Therefore, there is also a decrease in the number of PCPs who can assist with the care and management of the increased number of cancer survivors, which is anticipated to continue to grow by 1% per year.12 These projected workforce shortages, along with a continued decline in oncology specialists and PCPs, have resulted in a critical need to examine how care will be provided to cancer survivors. Cancer team specialists are challenged to develop innovative solutions to manage this problem. Erikson and colleagues10 conducted a study that surveyed oncologists, oncology fellows, and fellowship program directors. The study also reviewed data from the American Medical Association using Surveillance, Epidemiology and End Results data that were examined to evaluate the supply and demand for oncology services through 2020. The study concluded that there is a projected 48% increase in demand for oncologists and only a 14% increase in the supply of services. To ensure that there is access to cancer services, Erikson calls on the American Society of Clinical Oncology, policymakers, and the public need to address the gaps in care. This study identifies opportunities to address the deficit by increasing the number of oncology fellowships, the use of nonphysician clinicians, and the role of the PCP for survivorship care, and also by

designing a new cancer survivorship delivery of care model. Although the nurse navigator was not mentioned in this study, the breast nurse navigator is an emerging healthcare role that offers tremendous promise in bridging the survivorship care gap and is discussed later in this article. Time, poor coordination of care, and the growing shortage in their ranks were all identified as barriers to PCPs’ participation in patient care.24 It has been reported that many oncology specialists are not involving PCPs in the acute phase of treatment; therefore, when the patient transitions into survivorship, it is not easy for the PCP to become involved in the patient’s care again.13 A majority (60%) of cancer survivors are over 60 years of age, and most have chronic comorbidities that are not being addressed in the face of their cancer diagnosis. Clearly, this is a missed opportunity to engage the primary care team in the care of the patient with cancer.24,25 PCPs report that they lack knowledge in cancer surveillance, believe they are ill equipped to care for the patient with cancer, and are not clear about their role in the care of the cancer survivor.26,27

Since 1997, there has been a 50% decline in the number of medical students choosing to practice as primary care physicians. Miedema and colleagues13 conducted a study surveying 183 patients with cancer to assess their involvement and perceptions regarding their PCP and oncology care team as well as to identify gaps in care from the patient’s perspective. In this research, 35% of those surveyed stated that they were unsure who was responsible for managing their care after acute cancer therapy. Cancer follow-up counseling was reported to be deficient by 80% of those surveyed, who further stated that counseling from their PCP or cancer specialist was a significant unmet need. Dissatisfaction with follow-up care was also reported. The patients who were surveyed stated that continuity of care was important and that gaps in survivorship care must be identified and addressed.13 As demonstrated in the studies relating to the medical workforce shortage, the escalation in the need for oncology services is related to the aging population (those 65 years and older), an increase in the number of cancer survivors, and overall population growth.10,18 Although many oncologists who are currently in practice are reaching retirement age,10 one study reported that they often desire to remain active in the care of cancer survivors, and patients reported that they were dependent on their relationship with their oncologist.26 Both cancer specialists and PCPs are becom-

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ing burdened by the growing population of cancer survivors who need follow-up care.18 Oncologists are being challenged to expand their scope to address long-term health issues, yet only 20% are providing health promotion education and information to their patients.28 PCPs are not prepared to actively manage the care of cancer survivors without additional training in cancer surveillance and improved communication with oncology specialists.13 A growing shortage in the medical workforce calls for innovative strategies to bridge these gaps.

In a joint report, the Committee on Cancer Survivorship of the IOM and the National Research Council of the National Academies identified that the transitions into cancer survivorship are critical to QOL and health outcomes for the cancer survivor. Barriers to Survivorship Care There are many barriers that both the cancer survivor and the provider face. The IOM identified 6 that are outlined in Figure 118: A qualitative descriptive study25 surveyed 18 women who were aged 70 and older to identify barriers that they experienced while receiving care throughout the breast cancer trajectory. The researchers identified the following barriers: lack of patient information, care compounded by preexisting comorbid conditions, and multiple appointments with providers. The patients stated that they found the nurse navigator to be key in facilitating care and overcoming barriers to their cancer care. The study acknowledged that navigators positively impact patients’ care transitions as they move through the cancer care continuum. Communication in the fragmented healthcare system has broken down and is inadequate to facilitate seamless care transitions.29 Poor communication and care coordination continues to occur between oncology specialists and PCPs; and this is a central barrier in survivorship care.17 Fragmented healthcare systems, lack of consistent workflow, inadequate care transitions, and deficient outcome measures can be a hazardous combination for the patient with cancer.29 Other barriers that were identified in the literature are disparities in care; lack of education on the late and long-term effects that can prevent maximum health outcomes; and no identified medical home for the

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cancer survivor.23 Patients need to learn how to become empowered and engaged to actively participate in their own care.24,29

Care Transitions In a joint report, the Committee on Cancer Survivorship of the IOM and the National Research Council of the National Academies identified that the transitions into cancer survivorship are critical to QOL and health outcomes for the cancer survivor.18 The varied settings where care transitions occur for the breast cancer survivor include NCI–designated cancer centers, community cancer programs, and ambulatory care settings.20 Kantsiper and colleagues stated that “a well-executed hand off with information sharing and guidance from oncology specialists to PCPs would facilitate a smooth transition.”26 Coleman defines care transitions as “the movement patients make between healthcare practitioners and settings as their condition and care needs change during the course of a chronic or acute illness.”30 The information that is exchanged with each transition between the patient and his or her healthcare providers is necessary to ensure execution of the plan of care and appropriate coordination of care.29 However, inadequate communication between healthcare providers can lead to poor patient outcomes.29 Transitions theory provides a framework as to how one experiences and moves through changes.31 The transitions framework has 3 expected stages: endings, the neutral zone, and beginnings. Endings are the letting go of relationships, roles, and connections before creating new ones. The ending is leaving the known and may be accompanied by a sense of loss or grief.31,32 The neutral zone is a time of reflection and insight that is met with confusion, anxiety, and feeling lost.31,32 The final stage, beginnings, is the phase that offers the opportunity to create new understanding and purpose.31,32 While a survivor cannot be rushed through these stages, he or she must be committed to move through them in order to advance in the survivorship journey.32 To provide assistance and guidance, the healthcare practitioner needs to recognize the stages of transition as the cancer survivor moves from diagnosis through acute treatment and into long-term survivorship. Through the patient’s transition into survivorship, fear and anxiety are experienced, which prevents the survivor from progressing forward into living life fully.26,32,33 In 2011, the IOM reported that the average patient asks 5 or less questions during a 15-minute follow-up visit, which indicates that patients do not assume an active role in their care.24 Educating the patient at the time of diagnosis and throughout the trajectory of care is vital to empowering

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and preparing the patient for anticipated events and for the management of residual side effects and late effects from treatment. Survivors also need to be able to incorporate follow-up and surveillance activities into their life plan.33 Evidence shows that a patient who takes an active role in his or her care and cultivates patientâ&#x20AC;&#x201C;clinician communication has more positive health outcomes.24 Kantsiper and colleagues26 conducted a qualitative thematic study by holding focus groups with 21 cancer survivors, 15 PCPs, and 16 oncology specialists to explore the needs and priorities of the breast cancer survivor. Survivors said that they experienced anxiety and feelings of abandonment as they transitioned into survivorship. Both the cancer survivors and oncology specialists valued their relationship because they had acquired an invested connection. PCPs expressed their concerns about taking on the responsibility for surveillance and follow-up, related to their limited experience and knowledge in cancer survivorship care and the medical and legal implications. The study identified a breakdown in communication between patients, PCPs, and oncology specialists that inhibits seamless care transitions.26 Poorly coordinated care transitions can lead to increased utilization of the emergency department and hospital readmission rates, which leads to increased healthcare costs.34,35 Patients with chronic conditions can meet with up to 16 different providers in 1 year.29 Notably, patients who have complex healthcare conditions experience more care transitions, and the elderly are especially subject to being the most vulnerable population.29 Nurses help greatly to facilitate a care transition that ultimately improves care.32 The National Transitions of Care Coalition identified the following ways to facilitate transitions: improve communication between providers and patients, use electronic medical records, promote pharmacist involvement in medication reconciliation, and support professional care coordination and the development of performance measures that improve patient outcomes.35 Fragmented systems and poor communication heighten the risk for failure to meet the patientâ&#x20AC;&#x2122;s needs during transitions.35 The Agency for Healthcare Research and Quality conducted a recent survey with hospitals and discovered that 42% reported fragmented care.35 This occurred because of poor communication processes. Inadequate care transitions caused confusion about the patientâ&#x20AC;&#x2122;s condition and care, and resulted in duplicated tests, medication errors, inconsistent patient monitoring, delay in diagnosis, and lack of appropriate follow-up care. Inadequate care transitions also led to concerns with patient safety, quality of care, and health outcomes.35 To that end, the Centers for Medicare & Medicaid Services has provided a window of

arriers to cancer survivorship care as identified Figure 1 B by the Institute of Medicine18

Fragmented systems

Lack of effective survivorship delivery of care model

Poor coordination of care

Barrier to Survivorship Care Lacking surveillance guidelines

Lack of identified clinician for follow-up care Deficit in structures for coordinated communication

opportunity with the launch of an initiative that aims to improve the quality of care across settings by improving the transitions between settings.36

Coordination of Care It is vital that the patient with cancer receive seamless care throughout his or her cancer trajectory. However, because of the increasing shortage of medical oncologists, patients are not receiving coordinated care.10 The study by Kantsiper and colleagues identified the current state of survivorship care as fragmented and uncoordinated.26 Patients are placed at a heightened risk when cancer care is not coordinated and prevention and surveillance education is not given to the survivor.18 The study by Mayer and colleagues27 reported that 89% of cancer survivors prefer to receive follow-up care from their medical oncologist. The majority of PCPs (90%) stated that they are responsible for the general preventive care of cancer survivors in their practice, and 70% of the patients surveyed reported that their PCP has some responsibility for their follow-up survivorship care. Oncology specialists and PCPs both identified the need for better coordination of care, and clarity for the provider role and responsibilities in survivorship care.27 Fragmented and limited communication between oncology specialists and the PCPs can lead to suboptimal preventive care.27

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Care coordination encompasses the assessment of patient needs, the development and implementation of care, and the evaluation of the care plan.35-37 In coordinating care, the healthcare team needs to empower the patient and caregiver with education and information to facilitate the coordination of care.37 The IOM made a recommendation to develop and initiate the use of a survivorship care plan and treatment summary to facilitate care coordination within the fragmented healthcare system.18,24 The IOM identified a wide variation in how cancer survivors receive follow-up care and surveillance and, based on this variation, are recommending the utilization of a survivorship care plan and treatment summary.18 Oncology nurses reported that patients need more care coordination after their acute therapy is completed.35 The identified stakeholders for the survivorship care plan and treatment summary include the patient, the oncology specialist, and the PCP.14 The survivorship care plan and treatment summary should be a fluid document that is added to as shifts occur in the survivor’s care and management.14,22 The IOM recommendations for the components that should be included in the treatment summary are shown in Figure 2.

The essential items in the survivorship care plan include a follow-up care and management schedule, the providers responsible for follow-up, a list of symptoms of recurrence, and tests not routinely ordered. The essential items in the survivorship care plan include a follow-up care and management schedule, the providers responsible for follow-up, a list of symptoms of recurrence, and tests not routinely ordered.18,24 The survivorship care plan and treatment summary provides guidance for PCPs and other healthcare providers in caring for the cancer survivor.38 The survivorship care plan and treatment summary defines potential late and long-term effects for the breast cancer survivor. Long-term effects are defined as complications from treatment that remain well after the completion of acute therapy.19,37 Late effects include complications from treatment that occur months to years after the completion of acute therapy.19,39 For example, common side effects that breast cancer survivors experience are lymphedema, impaired fertility, premature menopause, an increased risk of osteoporosis, joint pain, stiffness, pain, fa-

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tigue, and distress.40 The completion of acute treatment signals the need for consistent and regular follow-up care to monitor for long-term and late-onset side effects, cancer recurrence, secondary malignancies, and to ensure that follow-up care, surveillance, and health promotion occur for the cancer survivor.40 Only 43% of all NCI-designated cancer centers provide survivorship care plans.14 Furthermore, the facilities that provide plans do not capture all of the IOM-recommended components.14 In 2012, the American College of Surgeons Commission on Cancer (CoC) added “Standard 3.3: Survivorship Care Plan” as part of the requirements for accreditation. The American College of Surgeons recognized the value of establishing a living document to facilitate education and care coordination to ensure that quality cancer care is provided.14 The National Accreditation Program for Breast Centers (NAPBC) developed standards for the delivery of breast care throughout the care trajectory; “Standard 2.5: Breast Cancer Surveillance” addresses surveillance and requires programs to institute a survivorship treatment summary and care plan for all breast cancer survivors.41 Survivorship care plans are recommended and endorsed by the President’s Cancer Panel, the CDC, and the LIVESTRONG Foundation.42 Noted barriers to providing survivorship care plans and treatment summaries include: • A lack of consensus in what should be included in the plan • No reimbursement by payers for a survivorship visit • A care-provider culture change that is needed to recognize standards of care in order to deliver quality cancer care • Technology, time, and resources allotted to create and administer the survivorship care plan and treatment summary.15,39 Diverse practice settings provide challenges to implementing a coordinated approach to the utilization of the survivorship care plan.43 Earle39 and Morgan15 recommend further research to validate the utilization of the survivorship care plan and treatment summary. Burg and colleagues44 conducted 4 focus groups with a total of 32 breast cancer survivors to evaluate the types of information they received from their oncologist about follow-up care. Participants stated they were unprepared for long-term survivorship and lacked adequate information on follow-up care, surveillance, potential side effects and their management, and secondary cancers. The women in this study experienced undue distress, frustration, and abandonment because they felt unprepared for the transition into survivorship. They conveyed that they valued the survivorship care plan and treatment summary; how-

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ever, they would have preferred to receive such documents at the time of diagnosis. Findings from this study indicate that survivorship care plans can facilitate better coordination of care. Morgan15 conducted a literature and website review of data on cancer survivorship, QOL, and survivorship care plans. The review identified that cancer survivorship care requires a multidisciplinary approach and that healthcare providers need to have knowledge about possible long-term complications.15 These findings further support that survivorship care plans facilitate communication among providers, promote a standard of care, inform patients on cancer terminology, lead patients to community resources and support groups, and provide a schedule for follow-up care.15

Oncology Nurse Navigators In 2010, the ONS and the National Association of Social Workers (NASW) published a joint position statement on patient navigation reinforcing the concept that survivors should be offered individualized assistance to help with eliminating barriers to care throughout the cancer care continuum.45 The C-change 2009 defined navigation as “individualized assistance offered to patients, families, and caregivers to help overcome healthcare system barriers and facilitate timely access to quality health and psychosocial care from prediagnosis through all phases of the cancer experience.”45 The IOM reported that oncology-certified nurses are underutilized as a communication resource, and that when patients and caregivers communicate with these nurses, QOL can improve.24 Case46 defined navigation as “…a process by which nurses assess individual needs, plan for education, coordination, communication and support, implement effective transitions through the illness trajectory; and evaluate the effect on patient, family and organizational outcomes.”46 In 2010, research determined that the oncology nurse can be utilized to implement interventions to directly impact survivorship care.20 The IOM has also determined that further exploration is greatly needed regarding the utilization of PCPs and nonphysician clinicians in the facilitation of care and management of the cancer survivor.24 Also in 2010, Shockney rolled back the curtain to explore the evolution of navigation over the past 4 decades, beginning in the 1970s and 1980s, when nurses performed utilization reviews to evaluate and monitor medical needs in the inpatient setting.47 In the 1990s, case management was introduced to increase efficiency. Nurses helped to coordinate, monitor, and evaluate care, supported patient adherence to treatment, and helped patients gain access to resources. Related to the findings of hearings conducted by the ACS, the first patient navigation model was developed

Figure 2

T he essential components of a cancer survivorship plan as recommended by the IOM

Cancer Survivorship Care Plan and Treatment Summary Essential Items Tumor Characteristics

Diagnostic Test Dates of Treatment (initiation and completion) Types of Treatment (agent, regimen, and doses) Clinical Trials (if participated in) Response to Toxicities

Psychosocial Services

Supportive Services Follow-up Care and Management Schedule List of Symptoms of Recurrence Contact Information of Care Providers IOM indicates Institute of Medicine

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by Dr Harold Freeman in 1990 to address health disparities of the poor and eliminate barriers to care.48 Since the inception of patient navigation, its role has transformed and expanded to reach across the care continuum, identifying and reducing barriers to care and facilitating screening and diagnosis. The role of a navigator can be filled by a peer, layperson, social worker, or nurse.49 The terms used in the literature to describe a navigator include cancer/oncology patient navigator, breast cancer patient navigator, case manager, and patient navigator.50 Navigation is multifaceted and involves an assessment of barriers to care, an assessment of compliance to treatment, and the coordination of care. Navigation also addresses patient concerns and questions, patient education, advocacy, and sideeffect management.47-49 A study conducted by Campbell and colleagues indicates that navigation increases patient satisfaction while removing barriers to facilitate care across the cancer trajectory.50 Ideally, the nurse navigator should be the consistent healthcare provider who can coordinate care along the continuum.51

The terms used in the literature to describe a navigator include cancer/ oncology patient navigator, breast cancer patient navigator, case manager, and patient navigator. The CoC has identified patient navigation as an integral part of the delivery of care to the cancer survivor. In its Cancer Program Standards of 2012, which is to be phased in by 2015, the CoC requires accredited programs to have navigation as a component. “Standard 3.1: Patient Navigation Process” requires an identified process for patient navigation that recognizes needs through a community needs assessment and addresses healthcare disparities and barriers to care.41 The NAPBC has instituted “Standard 2.2: Patient Navigation,” which requires an identified navigation process for the movement of the breast cancer survivor through the cancer care trajectory.52 NAPBC identifies in this standard that the patient navigator must have received specialized training in breast care to be competent and effective. These national professional organizations recognize the value of patient navigation, and now navigation is becoming a standard in cancer care delivery. In 2009, the National Coalition of Oncology Nurse Navigators (NCONN) published the “Oncology Nurse Navigator Core Competencies.”53 The oncology nurse navigator’s first encounter with a patient should provide education about the cancer care

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continuum and an interdisciplinary team model, which will help the patient accept this transition.33 Shockney raises a salient question, who will handle the long-term care needs of cancer survivors? Because oncology care is experiencing an increase in cancer survivors and a shortage of oncologists, the nurse navigator can play a vital role in developing a survivorship care transition model and facilitating and coordinating the implementation of the survivorship care plan and treatment summary.33 Marbach and Griffie54 surveyed 40 cancer survivors grouped by disease and conducted a thematic analysis that looked at patient preference for receiving information about survivorship care plans. The authors identified that oncology nurses are best positioned to assess a survivor’s individual and unique needs and provide effective methods of education.54 In the study, patients reported experiencing fear and anger and feeling overwhelmed at the time of consultation. This produced confusion about multidisciplinary team roles.54 Patients stated that they wanted a survivorship care plan and would feel comfortable in receiving their care plan and treatment summary from an oncology nurse.54 The study concluded that nurses can have a pivotal role in the development, delivery, and clarification of the survivorship care plan and treatment summary and facilitate care coordination.54 Patients with cancer have stressed that the oncology nurse navigator is key in facilitating transitions in care, providing patient education, fostering understanding of the plan of care, and facilitating multidisciplinary team communication throughout the care continuum.25,55 The experienced oncology nurse is best qualified and suited for the role of nurse navigator across the cancer trajectory.56 Patient navigators have improved patients’ access to care, facilitation and coordination of care, and management of side effects, which has decreased complications and increased patients’ and families’ QOL.56 The navigator is the connection between care providers and offers seamless care and proposes strategies to improve patient outcomes.57 The oncology nurse navigator is optimally positioned to facilitate transitions in a cancer survivor’s care that lead to improved QOL and health outcomes.

Summary Significant strides have been made in the care and treatment patients with cancer receive. This is evident by an increasing number of patients who become cancer survivors. The report American Cancer Society Cancer Treatment & Survivorship facts & figures, 2012-2013 projects substantial increases in survivors over the next decade.8 Yet, currently, survivors’ physical, psychological, social, and spiritual needs are not being met, which is impact-

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ing their QOL and health outcomes. Quality survivorship care is at the forefront of the national agenda for cancer care. The IOM as well as several national professional organizations—including the Academy of Oncology Nurse Navigators—are making significant efforts to place the needs of cancer survivors at the top of the agenda and to develop evidence-based strategies to address the current barriers to care. The barriers identified in the literature include workforce shortages, communication deficiencies, poor coordination of care, fragmented systems, lack of identified clinicians for follow-up surveillance, lack of evidence-based surveillance guidelines, and an effective survivorship delivery of care model.18 After careful review of the literature, it is evident that medical oncologists and PCPs are not equipped to meet the needs of the survivors alone. Nurse navigators provide a solution to eliminate care barriers. The question is, how are oncology nurse navigators positioned to provide a transition of care throughout the cancer trajectory, provide education, care coordination, and facilitate excellence of care that would provide the greatest impact on QOL and health outcomes? Evidence supports the role of the oncology-certified nurse as directly impacting QOL for patients, because patients spend more time with their oncology nurses and receive ongoing education and support from the nurse.55 Nurse navigators play an important and valuable role in the facilitation of communication with the multidisciplinary team and directly coordinate care for the cancer patient.20,33,55,56 The identified barriers to survivorship care call for evidence-based solutions to care coordination. The evidence supports the concept that trained and certified oncology nurse navigators are best qualified to facilitate the transitions in care that can directly impact patients’ QOL and health outcomes while providing a solution to the growing deficits in oncology and survivorship care providers. g Author Disclosure Statement Danelle Johnston, RN, MSN OCN, CBCN, St. Jude Medical Center, 2151 N. Harbor Boulevard, Fullerton, CA 92855; e-mail Danelle.johnston@stjoe.org. Disclosure The author has nothing to disclose.

References

1. Centers for Disease Control and Prevention. Basic information about cancer survivorship. http://www.cdc.gov/cancer/survivorship/basic_info/ index.htm. Updated July 1, 2013. Accessed August 15, 2013. 2. Doyle N. Cancer survivorship: evolutionary concept analysis. J Adv Nurs. 2008;62(4):499-509. 3. Mullan F. Seasons of survival: reflections of a physician with cancer. N Engl J Med. 1985;313(4):270-273.

4. National Coalition for Cancer Survivorship. Our mission. http://www. canceradvocacy.org/about-us/our-mission/. Accessed July 31, 2013. 5. National Cancer Institute. NCI dictionary of cancer terms. http://www. cancer.gov/dictionary?cdrid=450125. Accessed May 23, 2013. 6. Miller K, Ben-Aharon I, Haines L. Seasons of survival; redefining the paradigm for cancer survivorship for 2011. J Oncol Navigat Surviv. 2011;2(5):12-15. 7. Mariotto AB, Yabroff KR, Shao Y, et al. Projections of the cost of cancer care in the United States. J Natl Cancer Inst. 2011;103(2):117-128. 8. American Cancer Society. Cancer treatment & survivorship facts & figures 2012-2013. http://www.cancer.org/acs/groups/content/@epidemiology surveilance/documents/document/acspc-033876.pdf. Accessed July 30, 2013. 9. National Cancer Institute. Cancer costs projected to reach at least $158 billion in 2020. http://www.cancer.gov/newscenter/newsfromnci/2011/Cost Cancer2020. Accessed July 30, 2013. 10. Erikson C, Salsberg E, Forte G, et al. Future supply and demand for oncologists: challenges to assuring access to oncology services. J Oncol Pract. 2007;32(2):79-86. 11. Fairley TL, Pollack LA, Moore AR, Smith JL. Addressing cancer survivorship through public health: an update from the Centers for Disease Control and Prevention. J Womens Health (Larchmt). 2009;18(10):1525-1531. 12. Manolakis PG, Skelton JB. Pharmacists’ contributions to primary care in the United States collaborating to address unmet patient care needs: the emerging role for pharmacists to address the shortage of primary care providers. Am J Pharm Educ. 2010;74(10):S7. 13. Miedema B, MacDonald I, Tatemichi S. Cancer follow-up care. Patients’ perspectives. Can Fam Physician. 2003;49:890-895. 14. Salz T, Oeffinger KC, McCabe MS, et al. Survivorship care plans in research and practice. CA Cancer J Clin. 2012;62:101-117. 15. Morgan MA. Cancer survivorship: history, quality-of-life issues, and the evolving multidisciplinary approach to implementation of cancer survivorship care plans. Oncol Nurs Forum. 2009;36:429-436. 16. National Coalition for Cancer Survivorship. Timeline of achievements. http://www.canceradvocacy.org/about-us/what-weve-done/. Accessed August 8, 2013. 17. A National Action Plan for Cancer Survivorship: Advancing Public Health Strategies. Centers for Disease Control and Prevention; Lance Armstrong Foundation. http://www.cdc.gov/cancer/survivorship/pdf/plan.pdf. Accessed August 15, 2013. 18. Hewitt M, Greenfield S, Stovall E, eds. From Cancer Patient to Cancer Survivor: Lost in Transition. National Cancer Policy Board. Institute of Medicine. Washington, DC: The National Academies Press. http://www.nap.edu/ catalog/11468.html. Published 2006. Accessed August 15, 2013. 19. Aziz NM. Cancer survivorship research: state of knowledge, challenges and opportunities. Acta Oncol. 2007;46:417-432. 20. Grant M, Economou DD, Ferrell BR. Oncology nurse participation in survivorship care. Clin J Oncol Nurs. 2010;14(6):709-715. 21. Ganz PA. The ‘three Ps’ of cancer survivorship care. BMC Med. 2011;9:14. 22. Shockney LD. It’s (supposed to be) a wonderful life: a case study demonstrating the positive impact of survivorship care. J Oncol Navig Surviv. 2011;2(6):39-41. 23. Pratt-Chapman M, Simon MA, Patterson AK, et al. Survivorship navigation outcome measures: a report from the ACS Patient Navigation Working Group on survivorship navigation. Cancer. 2011;117(suppl):3575-3584. 24. Institute of Medicine. Patient-Centered Cancer Treatment Planning: Improving the Quality of Oncology Care: Workshop Summary. Washington, DC: The National Academies Press. http://www.nap.edu/openbook.php?record_ id=13155. Published 2011. Accessed August 15, 2013. 25. Pieters HC, Heilemann MV, Grant M, Maly RC. Older women’s reflections on accessing care across their breast cancer trajectory: navigating beyond the triple barriers. Oncol Nurs Forum. 2011;38(2):175-184. 26. Kantsiper M, McDonald EL, Geller G, et al. Transitioning to breast cancer survivorship: perspectives of patients, cancer specialists, and primary care providers. J Gen Intern Med. 2009;24(suppl 2):S459-S466. 27. Mayer EL, Gropper AB, Neville BA, et al. Breast cancer survivors’ perceptions of survivorship care options. J Clin Oncol. 2012;30(2):158-163. 28. Demark-Wahnefried W, Aziz NM, Rowland JH, Pinto BM. Riding the crest of the teachable moment: promoting long-term health after the diagnosis of cancer. J Clin Oncol. 2005;23(24):5814-5830.

JONS-online.com journal of Oncology Navigation & Survivorship

Literature Review

29. Lattimer C. When it comes to transitions in patient care, effective communication can make all the difference. Generations. 2011;35(1):69-72. 30. Coleman EA. Care transitions is a team sport, and yet all too often we don’t know who our teammates are, or how they can help. The Care Transitions Program. http://www.caretransitions.org/definitions.asp. Accessed May 27, 2012. 31. Bridges W. Transitions Making Sense of Life’s Changes. 2nd ed. New York, NY: Da Capo Press; 2004:3-5;105,133,157. 32. Rancour P. Using archetypes and transitions theory to help patients move from active treatment to survivorship. Clin J Oncol Nurs. 2008;12(6): 935-940. 33. Shockney L. Where does navigation fit into long-term survivorship care? J Oncol Navigat Surviv. 2010;1(4):1-2. 34. Coleman EA, Smith JD, Frank JC, et al. Preparing patients and caregivers to participate in care delivered across settings: the Care Transitions Intervention. J Am Geriatr Soc. 2004;52(11):1817-1825. 35. National Transitions of Care Coalition. Improving transitions of care. http://www.ntocc.org/Portal/0/PDF/Resources/PolicyPaper.pdf. Accessed December 10, 2012. 36. Ventura T, Brown D, Archibald T, et al. Improving care transitions and reducing hospital readmissions: establishing the evidence for community-based implementation strategies through the Care transitions theme. Remington Report. January-February 2010:24-30. 37. National Transitions of Care Coalition. Transitions of Care Measures. http://www.ntocc.org/Portals/0/PDF/Resources/TransitionsOfCare_Mea sures.pdf. Accessed December 10, 2012. 38. Shockney L. Breast Cancer Survivorship Care: A Resource for Nurses. Sodbury, MA; Jones & Bartlett Publisher. 2011;16-17. 39. Earle CC. Failing to plan is planning to fail: improving the quality of care with survivorship care plans. J Clin Oncol. 2006;24(32):5112-5116. 40. Siegel R, DeSantis C, Virgo K, et al. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 2012;62(4):220-241. 41. American College of Surgeons. Cancer Program Standards 2012: Ensuring Patient-Centered Care. http://www.facs.org/cancer/coc/programstan dards2012.pdf. Accessed August 8, 2013. 42. Hewitt ME, Bamundo A, Day R, Harvey C. Perspectives on post-treatment cancer care: qualitative research with survivors, nurses, and physicians. J Clin Oncol. 2007;25(16):2270-2273. 43. Smith SL, Singh-Carlson S, Downie L, et al. Survivors of breast cancer:

patient perspectives on survivorship care planning. J Cancer Surviv. 2011;5(4):337-344. 44. Burg MA, Lopez ED, Dailey A, et al. The potential of survivorship care plans in primary care follow-up of minority breast cancer patients. J Gen Intern Med. 2009;24(supp 2):S467-S471. 45. Oncology Nursing Society, the Association of Oncology Social Work, and the National Association of Social Workers Joint Position on the Role of Oncology Nursing and Oncology Social Work in Patient Navigation. http://www.ons.org/Publications/Positions/Navigation. Accessed August 8, 2013. 46. Case MA. Oncology nurse navigator. Clin J Oncol Nurs. 2000;15(1):33-40. 47. Shockney LD. Evolution of patient navigation. Clin J Oncol Nurs. 2010;14(4):405-407. 48. Freeman HP, Rodriguez RL. History and principles of patient navigation. Cancer. 2011;117(suppl 15):3539-3542. 49. Gilbert JE, Green E, Lankshear S, et al. Nurses as patient navigators in cancer diagnosis: review, consultation and model design. Eur J Cancer Care (Engl). 2011;20(2):228-236. 50. Campbell C, Craig J, Eggert J, Bailey-Dorton C. Implementing and measuring the impact of patient navigation at a comprehensive community cancer center. Oncol Nurs Forum. 2010;37(1):61-68. 51. Pedersen A, Hack TF. Pilots of oncology health care: a concept analysis of the patient navigator role. Oncol Nurs Forum. 2009;37(1):55-60. 52. National Accreditation of Breast Centers. Program standards. http:// www.napbc-breast.org/standards/2012standardsmanual.pdf. Accessed January 6, 2013. 53. Francz S, Simpson K. Oncology nurse navigators: a snapshot of their educational background, compensation, and day-to-day roles and responsibilities. Oncology Issues. 2013;Jan/Feb:36-42. 54. Marbach TJ, Griffie J. Patient preferences concerning treatment plans, survivorship care plans, education and supportive services. Oncol Nurs Forum. 2011;38(3):335-342. 55. Korber SF, Padula C, Gray J, Powell M. A breast navigator program: barriers, enhancers, and nursing interventions. Oncol Nurs Forum. 2011; 38(1):44-50. 56. Wilcox B, Bruce SD. Patient navigation: a “win-win” for all involved. Oncol Nurs Forum. 2010;37:21-25. 57. Gentry S. Navigation principles across the continuum. J Oncol Navigat Surviv. 2012;3(4):30-34.

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August 2013 • Volume 4, Issue 4

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

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

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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

K08Z121176

Contraindications ZYTIGA® (abiraterone acetate) is not indicated for use in women. ZYTIGA® can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant. Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in blood pressure, hypokalemia, or fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in study 1) or NYHA Class II to IV heart failure (in study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly. Adrenocortical Insufficiency (AI) AI was reported in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations. Hepatotoxicity Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function. Increased ZYTIGA® Exposures with Food ZYTIGA® must be taken on an empty stomach. No food should be eaten for at least two hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA® is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state. Adverse Reactions The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion. The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia. Drug Interactions ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. In vitro, ZYTIGA® inhibits CYP2C8. There are no clinical data on its use with drugs that are substrates of CYP2C8. Patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate. Based on in vitro data, ZYTIGA® is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors or inducers on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution during treatment with ZYTIGA®. Use in Specific Populations Do not use ZYTIGA® in patients with baseline severe hepatic impairment (Child-Pugh Class C). Please see Brief Summary of Prescribing Information on adjacent pages.

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ZYTIGA® (abiraterone acetate) Tablets Brief Summary of Prescribing Information. INDICATIONS AND USAGE ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. CONTRAINDICATIONS Pregnancy: ZYTIGA can cause fetal harm when administered to a pregnant woman. ZYTIGA is not indicated for use in women. ZYTIGA is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss [see Use in Specific Populations]. WARNINGS AND PRECAUTIONS Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess: ZYTIGA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1) in full Prescribing Information]. In the two randomized clinical trials, grade 3 to 4 hypertension occurred in 2% of patients, grade 3 to 4 hypokalemia in 4% of patients, and grade 3 to 4 edema in 1% of patients treated with ZYTIGA [see Adverse Reactions]. Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in the incidence and severity of these adverse reactions. Use caution when treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, e.g., those with heart failure, recent myocardial infarction or ventricular arrhythmia. Use ZYTIGA with caution in patients with a history of cardiovascular disease. The safety of ZYTIGA in patients with left ventricular ejection fraction < 50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) was not established because these patients were excluded from these randomized clinical trials [see Clinical Studies (14) in full Prescribing Information]. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with ZYTIGA. Adrenocortical Insufficiency: Adrenal insufficiency occurred in the two randomized clinical studies in 0.5% of patients taking ZYTIGA and in 0.2% of patients taking placebo. Adrenocortical insufficiency was reported in patients receiving ZYTIGA in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations [see Warnings and Precautions]. Hepatotoxicity: In the two randomized clinical trials, grade 3 or 4 ALT or AST increases (at least 5X ULN) were reported in 4% of patients who received ZYTIGA, typically during the first 3 months after starting treatment. Patients whose baseline ALT or AST were elevated were more likely to experience liver test elevation than those beginning with normal values. Treatment discontinuation due to liver enzyme increases occurred in 1% of patients taking ZYTIGA. No deaths clearly related to ZYTIGA were reported due to hepatotoxicity events. Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with ZYTIGA, every two weeks for the first three months of treatment and monthly thereafter. In patients with baseline moderate hepatic impairment receiving a reduced ZYTIGA dose of 250 mg, measure ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the ULN, or the bilirubin rises above three times the ULN, interrupt ZYTIGA treatment and closely monitor liver function. Re-treatment with ZYTIGA at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN [see Dosage and Administration (2.2) in full Prescribing Information]. The safety of ZYTIGA re-treatment of patients who develop AST or ALT greater than or equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown. Increased ZYTIGA Exposures with Food: ZYTIGA must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state. The safety of these increased exposures when multiple doses of abiraterone acetate are taken with food has not been assessed [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

ZYTIGA® (abiraterone acetate) Tablets ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Hypertension, Hypokalemia, and Fluid Retention due to Mineralocorticoid Excess [see Warnings and Precautions]. • Adrenocortical Insufficiency [see Warnings and Precautions]. • Hepatotoxicity [see Warnings and Precautions]. • Increased ZYTIGA Exposures with Food [see Warnings and Precautions]. Clinical Trial Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Two randomized placebo-controlled, multicenter clinical trials enrolled patients who had metastatic castration-resistant prostate cancer who were using a gonadotropin-releasing hormone (GnRH) agonist or were previously treated with orchiectomy. In both Study 1 and Study 2 ZYTIGA was administered at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active treatment arms. Placebo plus prednisone 5 mg twice daily was given to control patients. The most common adverse drug reactions (≥10%) reported in the two randomized clinical trials that occurred more commonly (>2%) in the abiraterone acetate arm were fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion. The most common laboratory abnormalities (>20%) reported in the two randomized clinical trials that occurred more commonly (≥2%) in the abiraterone acetate arm were anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia. Study 1: Metastatic CRPC Following Chemotherapy: Study 1 enrolled 1195 patients with metastatic CRPC who had received prior docetaxel chemotherapy. Patients were not eligible if AST and/or ALT ≥ 2.5X ULN in the absence of liver metastases. Patients with liver metastases were excluded if AST and/or ALT > 5X ULN. Table 1 shows adverse reactions on the ZYTIGA arm in Study 1 that occurred with a ≥2% absolute increase in frequency compared to placebo or were events of special interest. The median duration of treatment with ZYTIGA was 8 months. Table 1: Adverse Reactions due to ZYTIGA in Study 1 ZYTIGA with Placebo with Prednisone (N=791) Prednisone (N=394) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % Musculoskeletal and connective tissue disorders Joint swelling/discomfort2 29.5 4.2 23.4 4.1 Muscle discomfort3 26.2 3.0 23.1 2.3 General disorders Edema4 26.7 1.9 18.3 0.8 Vascular disorders Hot flush 19.0 0.3 16.8 0.3 Hypertension 8.5 1.3 6.9 0.3 Gastrointestinal disorders Diarrhea 17.6 0.6 13.5 1.3 Dyspepsia 6.1 0 3.3 0 Infections and infestations Urinary tract infection 11.5 2.1 7.1 0.5 Upper respiratory tract infection 5.4 0 2.5 0 Respiratory, thoracic and mediastinal disorders Cough 10.6 0 7.6 0 Renal and urinary disorders Urinary frequency 7.2 0.3 5.1 0.3 Nocturia 6.2 0 4.1 0 Injury, poisoning and procedural complications Fractures5 5.9 1.4 2.3 0 Cardiac disorders Arrhythmia6 7.2 1.1 4.6 1.0 Chest pain or chest discomfort7 3.8 0.5 2.8 0 Cardiac failure8 2.3 1.9 1.0 0.3 1 Adverse

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

ZYTIGA® (abiraterone acetate) Tablets

4 Includes

1 Adverse

terms Edema, Edema peripheral, Pitting edema, and Generalized edema 5 Includes all fractures with the exception of pathological fracture 6 Includes terms Arrhythmia, Tachycardia, Atrial fibrillation, Supraventricular tachycardia, Atrial tachycardia, Ventricular tachycardia, Atrial flutter, Bradycardia, Atrioventricular block complete, Conduction disorder, and Bradyarrhythmia 7 Includes terms Angina pectoris, Chest pain, and Angina unstable. Myocardial infarction or ischemia occurred more commonly in the placebo arm than in the ZYTIGA arm (1.3% vs. 1.1% respectively). 8 Includes terms Cardiac failure, Cardiac failure congestive, Left ventricular dysfunction, Cardiogenic shock, Cardiomegaly, Cardiomyopathy, and Ejection fraction decreased Table 2 shows laboratory abnormalities of interest from Study 1. Grade 3-4 low serum phosphorus (7%) and low potassium (5%) occurred at a greater than or equal to 5% rate in the ZYTIGA arm. Table 2: Laboratory Abnormalities of Interest in Study 1 Abiraterone (N=791) Placebo (N=394) Laboratory All Grades Grade 3-4 All Grades Grade 3-4 Abnormality (%) (%) (%) (%) Hypertriglyceridemia 62.5 0.4 53.0 0 High AST 30.6 2.1 36.3 1.5 Hypokalemia 28.3 5.3 19.8 1.0 Hypophosphatemia 23.8 7.2 15.7 5.8 High ALT 11.1 1.4 10.4 0.8 High Total Bilirubin 6.6 0.1 4.6 0 Study 2: Metastatic CRPC Prior to Chemotherapy Study 2 enrolled 1088 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy. Patients were ineligible if AST and/or ALT ≥ 2.5X ULN and patients were excluded if they had liver metastases. Table 3 shows adverse reactions on the ZYTIGA arm in Study 2 that occurred with a ≥ 2% absolute increase in frequency compared to placebo. The median duration of treatment with ZYTIGA was 13.8 months. Table 3: Adverse Reactions in ≥5% of Patients on the ZYTIGA Arm in Study 2 ZYTIGA with Placebo with Prednisone (N=542) Prednisone (N=540) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % General disorders Fatigue 39.1 2.2 34.3 1.7 Edema2 25.1 0.4 20.7 1.1 Pyrexia 8.7 0.6 5.9 0.2 Musculoskeletal and connective tissue disorders Joint swelling/ discomfort3 30.3 2.0 25.2 2.0 Groin pain 6.6 0.4 4.1 0.7 Gastrointestinal disorders Constipation 23.1 0.4 19.1 0.6 Diarrhea 21.6 0.9 17.8 0.9 Dyspepsia 11.1 0.0 5.0 0.2 Vascular disorders Hot flush 22.3 0.2 18.1 0.0 Hypertension 21.6 3.9 13.1 3.0 Respiratory, thoracic and mediastinal disorders Cough 17.3 0.0 13.5 0.2 Dyspnea 11.8 2.4 9.6 0.9 Psychiatric disorders Insomnia 13.5 0.2 11.3 0.0 Injury, poisoning and procedural complications Contusion 13.3 0.0 9.1 0.0 Falls 5.9 0.0 3.3 0.0 Infections and infestations Upper respiratory tract infection 12.7 0.0 8.0 0.0 Nasopharyngitis 10.7 0.0 8.1 0.0 Renal and urinary disorders Hematuria 10.3 1.3 5.6 0.6 Skin and subcutaneous tissue disorders Rash 8.1 0.0 3.7 0.0

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

Table 4 shows laboratory abnormalities that occurred in greater than 15% of patients, and more frequently (>5%) in the ZYTIGA arm compared to placebo in Study 2. Grade 3-4 lymphopenia (9%), hyperglycemia (7%) and high alanine aminotransferase (6%) occurred at a greater than 5% rate in the ZYTIGA arm. Table 4: Laboratory Abnormalities in > 15% of Patients in the ZYTIGA Arm of Study 2 Abiraterone (N = 542) Placebo (N = 540) 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Laboratory Abnormality Grade % % % % Hematology Lymphopenia 38.2 8.7 31.7 7.4 Chemistry Hyperglycemia1 56.6 6.5 50.9 5.2 High ALT 41.9 6.1 29.1 0.7 High AST 37.3 3.1 28.7 1.1 Hypernatremia 32.8 0.4 25.0 0.2 Hypokalemia 17.2 2.8 10.2 1.7 1Based on non-fasting blood draws Cardiovascular Adverse Reactions: In the combined data for studies 1 and 2, cardiac failure occurred more commonly in patients treated with ZYTIGA compared to patients on the placebo arm (2.1% versus 0.7%). Grade 3-4 cardiac failure occurred in 1.6% of patients taking ZYTIGA and led to 5 treatment discontinuations and 2 deaths. Grade 3-4 cardiac failure occurred in 0.2% of patients taking placebo. There were no treatment discontinuations and one death due to cardiac failure in the placebo group. In Study 1 and 2, the majority of arrhythmias were grade 1 or 2. There was one death associated with arrhythmia and one patient with sudden death in the ZYTIGA arms and no deaths in the placebo arms. There were 7 (0.5%) deaths due to cardiorespiratory arrest in the ZYTIGA arms and 3 (0.3%) deaths in the placebo arms. Myocardial ischemia or myocardial infarction led to death in 3 patients in the placebo arms and 2 deaths in the ZYTIGA arms. DRUG INTERACTIONS Effects of Abiraterone on Drug Metabolizing Enzymes: ZYTIGA is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. In a CYP2D6 drug-drug interaction trial, the Cmax and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). If alternative treatments cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate drug [see Clinical Pharmacology (12.3) in full Prescribing Information]. In vitro, ZYTIGA inhibits CYP2C8. There are no clinical data on the use of ZYTIGA with drugs that are substrates of CYP2C8. However, patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate. Drugs that Inhibit or Induce CYP3A4 Enzymes: Based on in vitro data, ZYTIGA is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelﬁnavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Avoid or use with caution, strong inhibitors and inducers of CYP3A4 during ZYTIGA treatment [see Clinical Pharmacology (12.3) in full Prescribing Information]. USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category X [see Contraindications].: ZYTIGA can cause fetal harm when administered to a pregnant woman based on its mechanism of action and ﬁndings in animals. While there are no adequate and well-controlled studies with ZYTIGA in pregnant women and ZYTIGA is not indicated for use in women, it is important to know that maternal use of a CYP17 inhibitor could affect development of the fetus. Abiraterone acetate caused developmental toxicity in pregnant rats at exposures that were lower than in patients receiving the recommended dose. ZYTIGA is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advise females of reproductive potential to avoid becoming pregnant during treatment with ZYTIGA.

ZYTIGA® (abiraterone acetate) Tablets

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

Quality, Outcomes, and Performance Improvement (QOPI) Committee

About Elaine Sein, RN, BSN, OCN, CBCN Senior Project Manager Fox Chase Cancer Center Partners Chair, Quality, Outcomes, and Performance Improvement Committee Academy of Oncology Nurse Navigators

began my journey in oncology nursing more than 40 years ago and have never looked back. My passion for care coordination of oncology patients began with my own experience as a breast cancer patient at 22 years of age. In the 1970s, there was little support for patients with breast cancer, especially young patients. In collaboration with our breast cancer−specific social worker, I developed a mastectomy rehabilitation program for newly diagnosed patients with breast cancer at Fox Chase Cancer Center. That began my role as a patient care coordinator navigating patients from the point of diagnosis through treatment. I performed many of the activities that nurse navigators do today, including individualized preoperative education; postoperative classes regarding drain care, exercises, hand and arm care, and psychosocial adjustment to diagnosis; connecting patients with community resources to support their needs; and providing ongoing support as needed.

My passion for care coordination of oncology patients began with my own experience as a breast cancer patient at 22 years of age. I have held several different positions over the years, but making sure we provide patient-centric care for our patients has always been my highest priority. I have always had a soft spot in my heart for patients with breast cancer and survivors. Through the Oncology Nursing Society (ONS), I have worked on various project teams to enhance breast cancer care; authored a chapter in the second edition of the ONS Site-Specific Cancer Series: Breast Cancer, entitled, “Building Breast Centers of Excellence Through Patient Navigation and Care Coordination”; and chaired the Oncology Nursing Certification Corporation Task Force for the Certified Breast Cancer Nurse credentialing that occurred in 2009. I am also a member of the leadership team for the Pennsylvania Patient Navigator Network. Approximately 10 years ago, I joined Fox Chase Cancer Center Partners as a clinical liaison to the commu-

August 2013 • Volume 4, Issue 4

nity hospitals in Pennsylvania and New Jersey that link with Fox Chase Cancer Center for oncology services. At that time, community hospitals were creating the position of breast care coordinator, and I saw the opportunity to support this role through education. “Developing the role of the breast care coordinator in a community setting” was my Leadership Development Institute project for the ONS, and I can enthusiastically say this project has seen no end point but has evolved from 6 breast navigators in 2003 to 26 navigators in breast, lung, gastrointestinal, gastrourinary, gynecologic, head and neck, and generalists in 2013. We meet quarterly for role development, education, sharing of best practices, and networking. The Fox Chase Cancer Center Partners’ nurse navigator group has sponsored a conference for breast program development, authored a navigation manual for nurses new to the role of breast navigation, and developed a multi-institution research project in collaboration with Fox Chase Cancer Center entitled Measuring Quality Improvement in Breast Cancer Care at Fox Chase Cancer Center Partner Institutions. The primary objective of this project was to benchmark participating institutions against each other and national benchmarks. Secondary objectives included assessment of causes for variance, impact of patient preference for treatment options, and time to care. The third objective was to explore the role nurse navigation plays in realtime quality metrics addressed at the cancer committee level. Key outcomes included the ability of the navigator to capture and report real-time data and variances regarding patient preference or medical reasons for noncompliance to the cancer committee and real-time quarterly reports provided data that promoted practice and process change. This prospective quality study demonstrated the positive impact that clinical navigation has in assessing and evaluating quality care metrics as a member of the multidisciplinary team. It was presented at the AONN conference last year where it won the original research award as well as at the American Society of Clinical Oncology’s first quality care conference in the fall of 2012. I firmly believe the role of the navigator in care coordination has a huge impact on patient care across the

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Quality, Outcomes, and Performance Improvement (QOPI) Committee

care continuum; however, we need to continually provide evidence that will ensure the sustainability of the navigator role in an ever-changing healthcare environment. One way is to work together on outcomes-based

We are seeking abstract submissions for this year’s conference that provides a forum to showcase the work you are doing within your own navigation programs. projects at both the community and national levels to ensure the longevity of this role. AONN has launched a Quality, Outcomes, and Performance Improvement Committee to provide support to navigators to look at

Navigation & outcomes-based projects in a broad sense and provide the mentorship needed to bring these local projects to fruition. We just disseminated a survey to the membership to assess the understanding of the various aspects of outcomes-based performance improvement and research projects. Our goal is to develop educational programs and mentorship support to increase the navigator’s comfort level with the development of their own projects. We have monthly conference calls and will be meeting during the November conference in Memphis to engage new members. We are seeking abstract submissions for this year’s conference that provides a forum to showcase the work you are doing within your own navigation programs. I encourage anyone with an interest in learning more to contact me and add the Quality, Outcomes, and Performance Improvement Committee meeting to your AONN conference itinerary. g

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.

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.

August 2013 • Volume 4, Issue 4

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SCIENTIFIC CONFERENCES 2013-2014:

Advances in Ovarian Cancer Research: From Concept to Clinic Co-Chairpersons: David G. Huntsman, Douglas A. Levine, and Sandra Orsulic September 18-21, 2013 • Miami, FL Frontiers in Basic Cancer Research Chairperson: Scott W. Lowe Co-Chairpersons: Joan S. Brugge, Hans Clevers, Carol L. Prives, and Davide Ruggero September 18-22, 2013 • National Harbor, MD Advances in Breast Cancer Research Co-Chairpersons: Carlos L. Arteaga, Jeffrey M. Rosen, Jane E. Visvader, and Douglas Yee October 3-6, 2013 • San Diego, CA AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Co-Chairpersons: Jeffrey A. Engelman, Lee J. Helman, and Sabine Tejpar October 19-23, 2013 • Boston, MA Twelfth Annual International Conference on Frontiers in Cancer Prevention Research Chairperson: Paul J. Limburg October 27-30, 2013 • National Harbor, MD Pediatric Cancer at the Crossroads: Translating Discovery into Improved Outcomes Co-Chairpersons: John M. Maris, Stella M. Davies, James R. Downing, Lee J. Helman, and Michael B. Kastan November 3-6, 2013 • San Diego, CA The Translational Impact of Model Organisms in Cancer Co-Chairpersons: Cory Abate-Shen, A. Thomas Look, and Terry A. Van Dyke November 5-8, 2013 • San Diego, CA

Sixth AACR Conference on The Science of Cancer Health Disparitites in Racial/Ethnic Minorities and the Medically Underserved Co-Chairpersons: John D. Carpten, Christopher I. Li, and Olufunmilayo I. Olopade December 6-9, 2013 • Atlanta, GA CTRC-AACR San Antonio Breast Cancer Symposium Co-Directors: Carlos L. Arteaga, C. Kent Osborne, and Peter M. Ravdin December 10-14, 2013 • San Antonio, TX AACR-IASLC Conference on Molecular Origins of Lung Cancer Co-Chairpersons: Roy Herbst, Elisabeth Brambilla, Pasi Jänne, and William Pao January 6-9, 2014 • San Diego, CA AACR-Prostate Cancer Foundation Conference on Advances in Prostate Cancer Research Co-Chairpersons: Arul M. Chinnaiyan, William G. Nelson, June M. Chan, and Jonathan W. Simons January 18-21, 2014 • San Diego, CA Cancer Susceptibility and Cancer Susceptibility Syndromes Co-Chairpersons: Alan D. D’Andrea, Phillip A. Dennis and Pier Paolo Pandolfi January 29-February 1, 2014 • San Diego, CA RAS Co-Chairpersons: Dafna Bar-Sagi, Channing Der, and Frank McCormick February 24-27, 2014 • Lake Buena Vista, FL AACR Annual Meeting 2014 Chairperson: Scott W. Lowe April 5-9, 2014 • San Diego, CA

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

2:00 pm - 2:45 pm 2:45 pm - 3:30 pm

3:30 pm - 5:00 pm

Advanced Navigation Track • Elaine Sein, RN, BSN, OCN, CBCN • Danelle Johnston, RN, MSN, OCN, CBCN BREAK IN THE EXHIBIT HALL General Session 1: Top 10 Best Practices • Moderators – Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS 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

Breast Nurse Navigator Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, NC

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

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