JONS December 2013

DECEMBER 2013

www.AONNonline.org

VOL 4, NO 6

QUALITY, OUTCOMES, AND PERFORMANCE IMPROVEMENT (QOPI) COMMITTEE

FOURTH ANNUAL AONN+ CONFERENCE

PATIENT NAVIGATION FRAMEWORK DEVELOPMENT

Cancer Program Standards 2012 R 1.2 Navigation and Survivorship

Sharon Gentry, RN, MSN, AOCN, CBCN

Six Posters Take Top Honors at AONN+ Conference

Development of a Framework for Patient Navigation

Navigating Patients Across the Continuum of Cancer Care

tm

© 2013 Green Hill Healthcare Communications, LLC

Oncology On Canvas

SM

“Together they are stronger, brighter and no longer alone

in the journey of survivorship.”

From Creating Connections of Hope and Light by a Healthcare Professional and 2012 entrant

Announcing the 2014 Lilly Oncology On Canvas Art Competition

Call for Entries | Deadline: June 30, 2014 “Some see paint. Others see hope. What do you see?”

In 2004, more than 400 people across 23 countries saw those words and shared their cancer journeys with the world through art and narrative. Today, 10 years later, with more than 4,100 stories shared, many are still waiting to be told by the nearly 14 million cancer survivors today in the U.S.1 — in addition to millions of others who love and care for them.

The 2014 competition marks a year-long commemoration of the 10-year anniversary. Oncology On CanvasSM is a program that was started in 2004 by Lilly Oncology to help address a great, unmet need in cancer care—a need that goes beyond medicine—to help those affected by cancer cope with the emotional toll of the disease.

This biennial competition, presented by Lilly Oncology and the National Coalition for Cancer Survivorship (NCCS), invites people from the United States and Puerto Rico diagnosed with any type of cancer—as well as their families, friends, caregivers, and healthcare providers—to express, through art and narrative, the life-affirming changes that give their cancer journeys meaning.

1. American Cancer Society. Cancer Facts & Figures 2013. American Cancer Society Web site. http://www.cancer.org/Research/CancerFactsStatistics/ CancerFactsFigures2013/index. Accessed July 23, 2013.

ON87677 10/2013 PRINTED IN USA ©2013, LILLY USA, LLC. ALL RIGHTS RESERVED.

Winners’ prizes consist of donations made in their name to the cancer-related charities of their choice.

For further information about Lilly Oncology On Canvas, 2012 winners, an exhibit schedule and details on the competition— in addition to information on 10-year anniversary activities— please visit www.LillyOncologyOnCanvas.com, call 1-866-991-LOOC (5662), or e-mail artdirector@mylooc.com.

Follow us on Find us on

at Facebook.com/LillyOncologyOnCanvas.

Tune in to our Pin our

at twitter.com/LlyOncOnCanvas. channel at youtube.com/LlyOncOnCanvas.

boards at pinterest.com/LlyOncOnCanvas.

To learn more about cancer survivorship tools and resources, visit the NCCS website at www.canceradvocacy.org.

LETTERS FROM LILLIE

Editor-in-Chief

Lillie D. Shockney, RN, BS, MAS

Dear Reader, Happy Holidays to everyone, and Happy New Year from everyone at AONN+! We hope that the New Year is a happy and healthy one for you and your loved ones.

A few weeks later, I am still smiling and feeling very energized from our recent AONN+ Fourth Annual Conference in Memphis, TN, where we had 650 attendees this year— a new record! Such a record that we will have to switch to a larger hotel in Orlando, FL,— the Dolphin, a Disney World facility—to hold the AONN+ Fifth Annual Conference, which will be held in September 2014. With well over 4000 members before the conference and several hundred attendees who, before departing for home, joined the association as new members, we are anticipating even more growth in 2014. Amazing!

Now to tell you a little bit about this December issue of JONS. Sharon Gentry, RN, MSN, AOCN, CBCN, is our featured Leadership Council member this month. She has served as cochair of our conferences with me since we began AONN+, and we are so fortunate to have her expertise and leadership on the council.

As you may know from an e-mail you received a few weeks ago, we have undergone a much-needed name change. We expanded our organization’s name so that it more accurately reflects what we have been about since we became an organization 4 years ago—a professional organization for everyone involved in the navigation of patients with cancer, as well as those striving to get the underserved into cancer screening routines. Thus, a “plus sign” (+) now resides behind our original AONN acronym. With that in mind, please read Development of a Framework for Patient Navigation: Delineating Roles Across Navigator Types, which provides great insight into the thoughtful work being done to delineate navigation roles across the various professions that are involved with this process.

You will read more about our conference highlights, including the poster awardees’ work and a synopsis of our keynote speaker’s presentation. There is also an article written by a patient with cancer to keep us grounded and focused on why we chose the professional navigation role in which we serve, as well as a nurse’s commentary on this patient’s story.

There is also an article on cancer survivorship and the issues that surround meeting the magic 5-year mark as a survivor. We need to do away with the alleged magic of 5 years because, depending on the type of cancer and its stage, prognostic factors, and the treatments received, 5 quite frankly may be the wrong number of years to be assuming that everything will be fine going forward. Read about one patient’s anxiety in celebrating at all, fearing it will be a jinx for recurrence.

Speaking of magic, as I mentioned at the beginning of this letter, we will be at the Walt Disney World Dolphin Resort for our 5th anniversary celebration of AONN+ in September 2014. Please give serious thought to bringing your entire family, and arrive early or stay later to enjoy the magic that happens in Disney World! You can count on seeing some of the Disney characters at our conference. I can hardly wait!

With kind regards,

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

Section Editors

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

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

Prostate Cancer Frank delaRama, RN, MS, AOCNS

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

Genetic Counseling

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

Healthcare Disparities Linda Fleisher, PhD, MPH

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

Health Promotion and Outreach Iyaad Majed Hasan, MSN, FNP

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

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

AONN Research Committee Marcy Poletti, RN, MSN

Program Administrator, Oncology Services Wake Forest University Baptist Medical Center

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

Penny Widmaier, RN, MSN Nurse Navigator Botsford Cancer Center

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.

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

JOURNAL OF ONCOLOGY NAVIGATION & SURVIVORSHIP

3

PUBLISHING STAFF Senior Vice President, Sales & Marketing Philip Pawelko ppawelko@the-lynx-group.com Vice President/Director of Sales & Marketing Joe Chanley jchanley@the-lynx-group.com Group Director, Sales & Marketing John W. Hennessy jhennessy2@the-lynx-group.com Publishers Russell Hennessy rhennessy@the-lynx-group.com Cristopher Pires cpires@the-lynx-group.com Director, Client Services Lou Lesperance llesperance@the-lynx-group.com Editorial Director Kristin Siyahian ksiyahian@the-lynx-group.com Managing Editor Lisa Neuman lneuman@the-lynx-group.com Copy Editor Rosemary Hansen Editorial Assistant Jennifer Brandt Production Manager Stephanie Laudien

THE LYNX GROUP President/CEO Brian Tyburski Chief Operating Officer Pam Rattanonont Ferris Vice President of Finance Andrea Kelly

TABLE OF CONTENTS

RESOURCES FROM PHARMACEUTICAL COMPANIES

Associate Editorial Director, Projects Division Terri Moore

Resources of Potential Benefit to You and to the Patients 6

11 Sharon Gentry, RN, MSN, AOCN, CBCN FOURTH ANNUAL AONN+ CONFERENCE

Six Posters Take Top Honors at AONN+ Conference 14 Cancer Program Standards 2012 R 1.2 Navigation and 16

Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean

Survivorship: What’s Happening in the Field?

Lisa A. Raedler, PhD, RPh

PATIENT NAVIGATION FRAMEWORK DEVELOPMENT

Development of a Framework for Patient Navigation: 20

Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno

You Navigate: Part 4 of a 5-Part Series

Lillie D. Shockney, RN, BS, MAS

QUALITY, OUTCOMES, AND PERFORMANCE IMPROVEMENT (QOPI) COMMITTEE

Director, Human Resources Blanche Marchitto Associate Director, Content Strategy & Development John Welz

DECEMBER 2013 • VOL 4, NO 6

Delineating Roles Across Navigator Types

nne Willis, MA; Elisabeth Reed, MPA; Mandi Pratt-Chapman, MA; A Heather Kapp, MPH, LICSW; Elizabeth Hatcher, RN, BSN; Virginia Vaitones, MSW, OSW-C; Stacy Collins, MSW; Jennifer Bires, LICSW, OSW-C; Etta-Cheri Washington

THE PATIENT’S VOICE

The Devil Is in the Details 28

MMA

Commentary:

34

A Nurse’s Voice

Penny Widmaier, RN, MSN

Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Manager Andrea Boylston Jini Gopalaswamy Project Coordinators Jackie Luma Deanna Martinez IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen

GREEN HILL HEALTHCARE COMMUNICATIONS, LLC 1249 South River Road - Ste 202A • Cranbury, NJ 08512 Phone: 732-656-7935 • Fax: 732-656-7938

4

DECEMBER 2013 • VOLUME 4, ISSUE 6

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

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

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

Primary Endpoint

Secondary Endpoints

• Overall response rate

• • • • • • • •

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

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

NCT#01889186 Reference: ClinicalTrials.gov.

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

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

RESOURCES FROM PHARMACEUTICAL COMPANIES

Patient Resources from Bristol-Myers Squibb

Part 4 of a 5-part series of resources available from various pharmaceutical companies Lillie D. Shockney, RN, BS, MAS, Johns Hopkins University School of Medicine, Baltimore, Maryland Side Effects Tracker Tool: This is a working guidebook specific for the drug Ixempra, that provides the various side effects the drug can cause as well as how to potentially manage that side effect. There is also information regarding how to prevent several side effects (eg, use a nailstrengthening fingernail polish to diminish the development of brittle or cracked nails). This tracking guide is part of a larger document that educates patients on how to communicate with their oncology team as well as provides other internet resources for education and support.

Financial Resources: For cancer patients taking the drug Sprycel, this company offers a 7-day pill organizer, as well as a copay assistance brochure and card. This card can start your patient off with a free 30-day supply.

Booklet on: Understanding Your Healthcare Benefits.

Probably nothing is more confusing than trying to decipher what a patient owes or will need to anticipate paying for their cancer treatments. This booklet provides information in layman’s terms on how the public and private insurance “works” and, in turn, how to determine what portion of the patient’s medical bills will likely be the patient’s responsibility. It goes into specific detail for patients who are Medicare recipients.

Ixempra Involve Me Program Patient Kit: This kit enables you to enroll a patient into a program that provides educational materials for patients taking this drug. There is also phone support by a nurse when questions arise, and

information about other possible resources for support.

The company also offers a special fatigue measurement tool that can be useful for the patient to complete and share with her oncology team as a communication piece when coming to her next appointments.

The company also offers a special fatigue measurement tool that can be useful for the patient to complete and share with her oncology team as a communication piece when coming to her next appointments.

Comfort and Support Kit: Also for patients taking Sprycel, they can receive a very nice small travel-size mesh bag containing various products for skin care that are helpful during treatment. The items are all travel-size so they can easily fit into a pocket or purse. There is also Aveeno oatmeal bath salts for times when skin is particularly irritated and/or itchy.

My Treatment Journal: This journal, which provides personal patient stories as well as places for a patient to record their treatment team, appointment schedule, side effects checklist, and other useful information, including journaling, is specific for patients with advanced melanoma. (The drug referenced in the journal is Yervoy.) g

GET YOUR NURSE NAVIGATION PROGRAM 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.

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DECEMBER 2013 • VOLUME 4, ISSUE 6

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

QUALITY, OUTCOMES, AND PERFORMANCE IMPROVEMENT (QOPI) COMMITTEE

Sharon Gentry, RN, MSN, AOCN, CBCN

Breast Nurse Navigator Novant Health Derrick L. Davis Cancer Center Co-Chair of Fourth Annual Academy of Oncology Nurse & Patient Navigators Conference Leadership Council of Academy of Oncology Nurse & Patient Navigator

I

have traveled the road to nurse navigation via roles of a CNA, staff nurse, patient educator, clinical trial site coordinator, clinical manager, and case manager at the same hospital I have maintained employment with for 33 years. Each nursing position has applied purpose, value, and clinical measure to the patient-centered focus of nurse navigation. The positive experience on the oncology 4 bed wards during nursing school and as a new staff nurse working “swing shifts” between second and third time tracts set the foundation for time management, problem solving, and critical thinking. As an older oncology nurse, the admixture of chemotherapy in the medication room…before chemo hoods or the vertical-laminar-airflow-hood…was the norm. The BSN degree opened doors that allowed me to serve on such committees as the Cancer Center Cancer Education Committee, Nursing Education Quality Management Committee, and the Nursing Education Finance Committee. The standards for safe administration of chemotherapy were established for our healthcare facility through these committees. Those formative years developed collaborative practice traits, an interest in the professional scope of practice using legal and professional guidelines, and communication proficiencies.

Strong leadership from our oncology administration introduced the Oncology Nursing Society (ONS) for standard resources and that involvement led to the participation in the founding of our local chapter, Piedmont Triad ONS. I was the first OCN and AOCN nurse for our institution and have championed the cause since 1988.

At the same time, my role change to Oncology Patient Educator allowed interaction with all oncology patients and their individualized education needs. This opportunity allowed teamwork with the cancer unit to develop patient-specific education and teaching sheets. This involved the Joint Practice Committee for nurses, doctors, and other healthcare team members to look at care practices. Leading 2 groups, 1 for patients and 1 for caregivers, as part of the educator role, allowed me to witness the care from the eyes of the nurse, patient, and caregiver.

This was truly the start of patient-centered care, advocacy, and response to patient and caregiver needs.

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The journey with breast care began the national P1 study or the Breast Cancer Prevention Trial. As site coordinator and data manager, the concept of prevention became a reality for someone who had always supported the treatment continuum of care. The foundation for patient navigation was developed as healthcare reimbursement changed and an oncology case manager was requested for the inpatient unit. The ideas of using community resources, being a good steward of the healthcare dollars, and practicing care in a safe and efficient way for the patients and caregivers was a constant in this role.

While obtaining an MSN in education, the advanced nursing project relating to end-of-life care-setting choices led to the idea of separating palliative care and hospice care from acute care. This actually stemmed from case management and the dilemma nurse case managers faced when a physician gave the patient and caregiver permission to stay in an acute care bed for palliative care when the utilization review criteria defined the patient as needing subacute care. Our community had a strong hospice program as well as a hospice inpatient facility that would allow follow-up bereavement care to caregivers. After successful implementation of this program, a challenge to navigate the breast care for our institution was presented when our breast patients were uncomfortable with “not receiving the same care other ladies in the neighborhood got at our facilities.”

Nurse navigation has been a perfect combination of patient education, joint practice, proactive care, and case management from prevention/detection through palliative and hospice care. Initial education through the National Consortium of Breast Centers, EduCare’s Breast Health Training, involvement in the Piedmont Triad Susan G Komen affiliate (now NW Komen of the Triad), and feedback from patient surveys led to the basis of the breast nurse navigation program as it exists today. Within 2 years, changes in the breast process had streamlined care and changed the way the community survivors interacted with newly diagnosed patients. The community acknowledged the difference patient-centered–directed care made in the patients’ lives by awarding me the local Komen Volunteer of the Year award in 2002 and Cancer Services

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QUALITY, OUTCOMES, AND PERFORMANCE IMPROVEMENT (QOPI) COMMITTEE

Inc. Patient Advocate of the Year award in 2003. At the institution level, exploring the local increase in prophylactic mastectomies from the patient point of view was a result of this role. The breast navigators heard very different reasons from the patient that were being cited by healthcare professionals at patient conferences. The voice of the patient was gathered and shared with institution members. This was shared as an original research abstract titled “Influencing Factors for a Contralateral Prophylactic Mastectomy” at the Academy of Oncology Nurse & Patient Navigators (AONN+) conference in 2011. In 2012, a process abstract “Evaluation Why Some High-Risk Patients Do Not Use Genetic Consultation Services” was shared. The patient-centered concept of this role is invaluable to the community and healthcare institution as they meet the needs of the patients. National recognition was bestowed in 2012 as peers nominated me for one of the 2012 HealthLeaders honorees and I was recognized as someone who changes healthcare for the better.

It is rewarding when a collaborative, critical analysis of the challenge reveals a method to overcome the barrier.

With the help of Pfizer, local and state nurse navigators started meeting in 2005 and the NC Oncology Navigation Nursing Association was founded in April 2008.

Pfizer Oncology’s recognition of the development and growth of our navigation program has allowed me the opportunity to speak about navigation and hear about other program in travels across the United States. It has been heartwarming to hear the successes on behalf of the patients as navigation process models have been applied to individual cultures and communities. It is challenging to hear of the barriers navigators face in their community and healthcare institutions. It is rewarding when a collaborative, critical analysis of the challenge reveals a method to overcome the barrier.

The ONS has been a mainstay in this role as the patient education, breast care, and nurse navigation special intrest groups have provided education and resources to grow and develop the role. As a member of the Oncology Nursing Certification Breast Care Task Force and Oncology Nursing Certification Test Development Breast Committee, the education in developing and maintaining a certification examination has been an invaluable

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experience. Participation on the Oncology Nursing Certification Breast Care examination team as an item writer and committee chair of the group has set a firm belief that all breast nurse navigators need Certified Breast Care Nurse (CBCN) as part of their basic education and training. All nurse navigators need the basic genetic and clinical trial course to direct patients to best care along with the site-specific cancer course that they navigate.

The opportunity to be a part of the AONN+ Leadership Council since its inception and experiencing the co-chair position for the Third and Fourth Annual Navigation and Survivorship conferences has allowed me to witness the development and history of this new role, explore the philosophy of this care, and support ongoing education and professional development of navigation.

This experience has allowed growth in expertise on breast cancer navigation, overall patient navigation, literary expertise, and the ability to serve as a mentor for new navigators joining our profession. The website blog featuring expert commentary (AONN+ Community forum) has allowed interaction with all types of navigators across the United States. I have appreciated the stimulating conversations and comments readers have shared after reading the column. Being a part of the editorial board of The Oncology Nurse-APN/PA and the Journal of Oncology Navigation & Survivorship has brought to light different navigation ideas and concepts. Thank you for sharing your research and practice ideas. This experience has encouraged me to write and contribute articles for publication.

Navigation is a commitment to patient-focused care across the continuum. There will be roles for different levels of the healthcare field to contribute as the patient journeys through cancer care. The voice of the nurse navigator is critical in the care of the patients at cancer centers, since it is through their advocacy that the patient’s voice is heard. Navigation is a field in its infancy and evidence/research is needed to direct the best use of navigation in the care of patients. In order to take this concept forward, successful practices need to share their ideas through commentaries, journal articles, and presentations at the AONN+ Conference. The patient will always be the winner as “best” patient navigation care is shared among this profession. Listening to different healthcare systems describe how they deal with care for their communities and cultures will hopefully spark ideas of improved patient care in other parts of the country.

The key to all navigation, throughout the care continuum, is the focus on the patient. I look forward to hearing about the creative navigation care in your community. g

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SCIENTIFIC CONFERENCES 2013-2014:

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

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

FOURTH ANNUAL AONN+ CONFERENCE

Six Posters Take Top Honors at AONN+ Conference At the 4th Annual AONN+ Conference, more than 50 posters in 6 categories were presented for judging. Here are the winners in each poster category. For information on how to submit a poster for next year’s conference, visit www.AONNonline.org/conference.

CATEGORY I: Patient Education

in Ontario, Canada, that demonstrated the benefits of nurse navigation within the setting of a diagnostic assessment program.

Deanna Xistris, APRN, AOCN Stamford Hospital/Bennett Cancer Center In her poster, Deanna Xistris described a best practices protocol that is implemented at Stamford Hospital by nurses prior to the start of patient treatment. These prehabilitation interventions are designed to prepare patients physically and emotionally for upcoming treatments. The protocol was developed based on the identification of factors that had been observed to interfere with individual readiness for the start of therapy, the efficiency of bed/chair utilization, and responsiveness to patients’ and families’ needs.

CATEGORY III: Tracking Processes Across the Continuum of Care

Improving Patient Readiness for Initial Chemotherapy Using a Nurse-Based Prehabilitation Teaching Protocol

CATEGORY II: Psychological Support

Canada’s Diagnostic Assessment Programs: An Ontario Perspective

Carol Gunsch, RN, BScN, CON(c); Barbara-Anne Maier, RN, BScN, CON(c) Grand River Hospital Carol Gunsch and Barbara-Anne Maier completed a literature review on the history and rationale for the development of a diagnostic assessment program as well as the role of nurse navigators within the program. They presented quantitative and qualitative data of 10 metrics that were observed and collected over the course of 1 year

An Outcomes Management Process for Navigation

Sharon Bartelt, RN, MSN, MBA, OCN, CPHQ, CSSBB Gibbs Cancer Center & Research Center Sharon Bartelt’s objective for this poster was to develop a process for tracking outcomes metrics as they relate to disease-specific nurse navigators in a community cancer center setting. The MIDAS community case management module now has the ability to track metrics related to return on investment for each disease-specific nurse navigator in order to validate the nurse navigator role at Gibbs Cancer Center.

CATEGORY IV: Original Research

Oncology Nurse Navigator Competencies: Providing Direction to Improve Care Delivery

The ONS Nurse Navigator Project Team The ONS Nurse Navigator Project Team described the process of clearly defining the role of oncology nurse navigators using evidence-based research to develop a navigation framework that supports the oncology nurse navigator in his or her scope of professional practice. The team’s research identified 40 core competencies to define the role of an oncology nurse navigator.

GET INVOLVED: HAVE YOU EVER WANTED TO WRITE AN ARTICLE FOR JONS? We’re interested in articles about the everyday issues that affect nurses—everything from chemotherapy safe handling to supportive care for patients to challenging cases.

Contact: editorial@greenhillhc.com for information.

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CATEGORY V: Screening Programs for the Underserved

Trial of a Cervical/HPV Hispanic Screening

Robin Atkinson, RN, BSN, OCN, GYN, Oncology Nurse Navigator Novant Health, Derrick L. Davis Cancer Center In her poster, Robin Atkinson described a free community-based screening that was offered to women of Hispanic descent over the age of 30 years in an accessible community oncology gynecologic clinic setting during evening hours. During the course of the project, 38 women who were recruited by a Hispanic patient advocate enrolled, 34 attended the clinic, and in these women, 13 abnormal screenings were discovered.

CATEGORY VI: Community Outreach

Implementation of a Lung Computer Tomography Cancer Screening Program at Frederick Memorial Hospital

Margaret Siebeneichen, BA, BSN, RN; Paul Chomiak, MD; Mark Soberman, MD, MBA, FACS Frederick Memorial Hospital Margaret Siebeneichen described in her poster the creation of a process for screening high-risk patient populations using a low-dose computed tomography (CT). From December 2012 to June 2013, 64 patients qualified for the program and were screened; of these, 42% were identified with an indeterminate pulmonary nodule, 7% were identified with a finding worrisome for lung cancer, and 10% had other abnormal CT scan findings. The nurse navigator’s involvement decreased the time from inquiry to completed screen and also eliminated the performance of inappropriate screens.

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 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.

JONS-online.com

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FOURTH ANNUAL AONN+ CONFERENCE

Cancer Program Standards 2012 R 1.2 Navigation and Survivorship: What’s Happening in the Field?

By Lisa A. Raedler, PhD, RPh Memphis, TN—The keynote address of the Fourth Annual Conference of the Academy of Oncology Nurse & Patient Navigators (AONN+) was delivered by Linda W. Ferris, PhD. Dr Ferris is vice president, Oncology System Service Line, at Centura Health in Colorado and Kansas, as well as chair of the Commission on Cancer (CoC) Accreditation Committee.

The CoC is a consortium of more than 50 professional organizations that is dedicated to improving survival and quality of life for patients with cancer through standard-setting, prevention, research, education, and the monitoring of comprehensive quality care. The CoC Accreditation Committee is responsible for developing and interpreting standards for cancer programs. Accreditation is granted to facilities that voluntarily commit to provide optimal cancer diagnosis and treatment, and that comply with established CoC standards. To maintain accreditation, facilities with accredited cancer programs must undergo an on-site performance review every 3 years. The 1500 CoC-accredited cancer programs that exist in the United States represent 30% of all hospitals that provide care to more than 70% of newly diagnosed patients with cancer each year.1 During her engaging presentation at AONN+, Dr Ferris shared insights and suggestions regarding 2 important CoC accreditation standards that are being phased in for 2015: Patient Navigation Process (Standard 3.1) and Survivorship Care Plan (Standard 3.3).

PATIENT NAVIGATION PROCESS (STANDARD 3.1) Standard 3.1 states “A patient navigation process, driven by a community needs assessment, is established to address health care disparities and barriers to care for patients. Resources to address identified barriers may be provided either on-site or by referral to community-based or national organizations. The navigation process is evaluated, documented, and reported to the cancer committee annually. The patient navigation process is modified or enhanced each year to address additional barriers identified by the community needs assessment.”1 To comply with CoC Standard 3.1 in 2015, navigation programs will be asked to: • Conduct a community needs assessment at least once during the 3-year survey cycle.

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• Establish a patient navigation process that provides resources to overcome barriers to cancer care. Resources can be provided to patients with cancer on-site or through referral to community-based or national organizations.

• Evaluate your patient navigation process each year, documenting findings and reporting these findings to your cancer committee.

• Modify your patient navigation process to address newly identified barriers to care.

When conducting a needs assessment, Dr Ferris reminded the navigators to take advantage of the many resources that are already available to help define your community. Examples of local data sources include the marketing department of your hospital or cancer center, your cancer committee, and your cancer registrar. Registrar data are particularly helpful in learning more information about your cancer population’s age, race, income, education, insurance status, travel distance to facility, and time to first treatment. “Mine your data,” she reminded the audience. (As an aside, Dr Ferris predicted that the role of cancer registrars will evolve as technology advances to allow rapid data reporting and faster data mining.

She envisions a future in which cancer registrars support navigators in both identifying specific patients’ needs and developing targeted survivorship care plans.)

Navigators can also access state-specific cancer statistics from the American Cancer Society (ACS), the Susan Komen Foundation, and the National Cancer Institute, as well as state governments’ websites. (As an illustration, an internet search for “Pennsylvania cancer statistics” resulted in the state government’s “Cancer Statistics” web page, which allows one to download annual and 5-year cancer incidence and mortality statistics for the state since 2010.

These data are provided by county and municipality, and by age, sex, race, primary site, and cancer stage.) “Do not overcomplicate the needs assessment process. This is not a huge initiative. Keep it simple,” Dr Ferris advised.

The primary goal of your needs assessment is to identify barriers to cancer care in your local area. Dr Ferris noted the common barriers to care in communities throughout the United States: lack of insurance coverage, patient fear

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FOURTH ANNUAL AONN+ CONFERENCE

and/or anxiety, transportation access issues, distrust of Western medicine, poor communication, language barriers, and low health literacy. She recommended focusing on these issues when evaluating your community’s resources and gaps.

Dr Ferris reassured the meeting attendees that there is no “right” way to organize your patient navigation program.

“Design it your way,” she said. She advised the navigators to customize programs based on organizational structure, community needs, and resources available. She recommended collaborating with social workers, case managers, oncology nurses, physicians, community navigators, other hospital staff, and hospital volunteers, as well as local cancer organizations (ie, ACS, Cancer Support Community, LIVESTRONG Foundation), to design and implement a navigation program.

For navigators who wish to attend training programs, Dr Ferris noted that several effective options are available: • “Patient Navigation Fundamentals,” University of Colorado • “Patient Navigation: From Outreach to Survivorship,” George Washington Cancer Institute Center for the Advancement of Cancer Survivorship • “Patient Navigation Program,” Harold P. Freeman Patient Navigation Institute • “Patient Navigator Certificate,” Sonoma State University • “Breast Patient Navigator Certification Programs,” National Consortium of Breast Centers After outlining the specifics of CoC Standard 3.1, Dr Ferris shared her answers to frequently asked questions about this requirement: • How can the CoC expect small rural programs to hire a patient navigator to fulfill this standard? CoC does not require rural hospitals or cancer centers to hire a patient navigator if one is not on staff.

• Does the patient navigator need to be a nurse? No. CoC does not stipulate requirements for the staff tasked with designing and implementing patient navigation programs.

• My cancer program is being surveyed in 2014. What will the surveyor be assessing during the survey?

Throughout 2014, surveyors will engage cancer committee members and individuals involved with the navigation process in dialogue and answer your questions. Dr Ferris explained that surveyors will clarify Standard 3.1 requirements and listen to your feedback related to challenges and concerns. CoC is dedicated to evolving this standard (and others) to reflect the realities of the process involved, such that navigators’ input is critical.

JONS-online.com

Figure 1 S urvey Results on Navigation 54% of respondents are addressing the entire standard!

Of those not addressing the entire standard, help is needed in the following areas: Information about how to evaluate the patient navigation process

84%

Tools that could be used to conduct the needs assessments

80%

Additional information about what is required to 75% successfully implement Recommendations for organizations that could help your program

75%

Referring to the results of a recent survey of 690 navigation programs, Dr Ferris was pleased to report that 54% of these programs already address the entire Patient Navigation Program Standard (Figure 1). Survey results provided by Nina Miller of CoC; Stephanie Van Winkle of ACS; Nina Wendling of National Coalition for Cancer Survivorship; Chris Gayer and Vicki Kennedy of Cancer Support Community; and Ruth Rechis, Saray Arvey, Haley Gardiner, Gema Lane, Stephanie Nutt, and Kathryn Kelly of LIVESTRONG.

She advised the navigators to customize programs based on organizational structure, community needs, and resources available.

SURVIVORSHIP CARE PLAN (STANDARD 3.3) CoC Standard 3.3: Survivorship Care Plan is also required for CoC accreditation after 2015. This standard requires the cancer committee to develop and implement a process to disseminate a comprehensive care summary and follow-up plan to patients with cancer who are completing cancer treatment. The process must be monitored, evaluated, and presented at least annually to the cancer committee and documented in minutes.

To comply with CoC Standard 3.3 in 2015, cancer committees will be asked to: • Develop a process to disseminate a comprehensive care summary and follow-up plan to patients with cancer within 6 months of completing cancer treatment.

• Each year the process implemented, monitored, evaluated, and presented to the cancer committee.1 When asked to rationalize this standard, Dr Ferris recalled the 2005 Institute of Medicine (IOM) report, “From Cancer

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Figure 2 W hy the New Standard?

• The National Cancer Institute (NCI) describes cancer survivorship as covering “the physical, psychosocial, and economic issues of cancer, from diagnosis until the end of life. It focuses on the health and life of a person with cancer beyond the diagnosis and treatment phases.

•S urvivorship includes issues related to the ability to get healthcare (may be relieved with Obamacare) and follow-up treatment, late effects of treatment, second cancers, and quality of life.

• Family members, friends and caregivers are also part of the survivorship experience.” (ACS, 2012) National Cancer Institute. NCI Dictonary of Cancer Terms. http://www.cancer.gov/dictionary?cdrid=445089. Accessed November 23, 2012.

Patient to Cancer Survivor: Lost in Transition.”2 The transition of cancer survivors from oncology practices to primary care practitioners (PCPs) has been identified by IOM as a significant area of unmet need. Today, more than 13.7 million cancer survivors need specialized follow-up care that includes monitoring of late effects of cancer treatment, surveillance for secondary cancers, and initiatives that optimize their quality of life.

As context, Dr Ferris reminded the navigators that ACS literature defines cancer survivorship as including physical, psychological, and economic issues that start at the point of cancer diagnosis and continue until death. These survivorship issues are relevant to the patient, as well as his or her family, friends, and caregivers (Figure 2).

If you were the patient, what would you want to know? Put yourself in their shoes; what is the right thing to do for them?

CoC survey results related to Standard 3.3 indicate that more than half of the navigators queried are “somewhat” to “not at all” confident in their ability to implement its requirements by 2015. Dr Ferris observed that most of the survey respondents want more information about evaluating survivorship care plan processes, tools to develop comprehensive care plans and survivorship documents, and more information about specific requirements of Standard 3.3.

Uncertainty and a need for more concrete details about Standard 3.3 requirements were mirrored by the navigators participating at the AONN+ Conference. In the question-and-answer session following Dr Ferris’s address,

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attendees focused on patient targeting: Should all cancer patients receive survivorship plans? Can it be a subset? If so, which ones? Concerns about program staffing and the time needed for data collection and reporting prompted these queries.

Dr Ferris reassured AONN+ attendees that they are not alone in their concerns. Navigators throughout the country are feeling “real anxiety” about their ability to comply with this new standard. “You as the cancer committee should decide what makes the most sense [in terms of survivorship plan dissemination]. Each program will be different based on your local resources.” To illustrate, Dr Ferris noted that patients with metastatic cancer in her center do not receive survivorship plans.

In the context of treatment plan preparation, Dr Ferris suggested that navigators, “Make [the patient’s treatment plan] a living document, rather than doing it all at the end when patients have completed all cancer treatments. Collect and document the patient’s treatment experience after each phase—after radiation, after completion of chemotherapy, etc.” When asked who should deliver this information to the patient, Dr Ferris recommended that navigators collaborate with oncologists to communicate the goals and content of the treatment plan summary and the survivorship plan to their patients.

Dr Ferris reassured the AONN audience, “Many resources are available,” including the CoC Best Practices Repository (http://www.facs.org/cancer/coc/bestpractic es.html), CoC Standards Resource Repository, and the CoC Answers Forum. She explained that her hospital provides patients with cancer a “very simple” 2-page treatment summary for patients, and a 2-page follow-up plan for PCPs. “The information you provide must be clear to the patient and to their PCP; keep it simple for both parties….If you were the patient, what would you want to know? Put yourself in their shoes; what is the right thing to do for them?”

Dr Ferris has worked with electronic medical record (EMR) vendors to design and report relevant patient information in this user-friendly format. While many meeting attendees indicated that they have been underwhelmed with their current EMR vendors’ capabilities, several navigators noted success in collaborating with EMR vendors to prepare and report patients’ treatment plans. The topic of working with EMR vendors to facilitate compliance with Standard 3.3 was suggested as an area for AONN+ to address through webinars and at the next annual conference.

THE EVOLUTION OF SURVIVORSHIP SERVICES As 2015 approaches, and as effective strategies for meeting Standard 3.3 requirements materialize, Dr Ferris predicted

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exciting opportunities for entrepreneurial care providers. She expects PCPs, oncologists, and others to institute various types of cancer patient survivorship clinics in academic centers and community settings. Viable alternatives include tumor-specific survivor clinics run by oncology specialists, primary care clinics that manage care for all types of cancer survivors, and “hybrid” practice models that offer both oncology and primary care services.

When survivorship care models like these come to fruition, Dr Ferris also identified significant opportunities for researchers to evaluate outcomes and characterize best practices: Do patients and physicians associate tangible benefits with survivorship plans? Which survivorship care models ensure consumer-focused, evidence-based medicine for cancer survivors? Robust research initiatives to understand and document experiences of cancer survivors who participate in various care models will be critical.

“We know that survivors are not prepared for the persistence of or development of long-term toxicities. It will be key to collect data on these patients to better understand their needs.”

In this context, Dr Ferris cited a poignant article written by Fitzhugh Mullan, MD, regarding his personal cancer survivorship experience.3 In this publication, Dr Mullan describes 3 phases of survivorship: 1. Acute stage: This stage includes the time from diagnosis through the end of treatment when the focus is on the actual disease. Navigation and support services available through healthcare professionals and loved ones are especially important to help patients through this journey.

2. Extended survivorship: This begins when and if the patient responds to treatment. Patients and caregivers often feel positive, yet uncertain. Fear of recurrence is present. Recovery focuses on the physical, emotional, and psychological effects of treatment.

Emotions can be varied and extreme. Because medical services are typically not needed on a regular basis, patients and families often rely on community and peer networks for psychosocial support.

3. Permanent survivorship: In this phase, recovery is celebrated. At the same time, survivors must manage the long-term physical and psychological effects of their cancer. Survivors require continued care by PCPs and

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specialists who have knowledge about long-term (late) effects of their cancer, and their management. Navigators help to develop specific plans for patients’ ongoing healthcare needs.

Extensive resources are available to help navigators prepare Standard 3.3–compliant cancer treatment plan summaries and survivorship care plans. Dr Ferris suggested that navigators review document templates that are provided by the American Society of Clinical Oncology, Journey Forward, Memorial Sloan-Kettering Cancer Center, Prescription for Living Plan, LIVESTRONG, and the Minnesota Cancer Alliance.

“We know that survivors are not prepared for the persistence of or development of long-term toxicities.

It will be key to collect data on these patients to better understand their needs.”

Dr Ferris concluded her presentation with a touching quote from Dr Mullan’s 1985 article to illustrate the real value that navigators’ attention to survivorship offers to patients with cancer. “Whatever our wishes, the person who has come through a cancer experience is indelibly affected by it. The Humpty Dumpty idea of ‘as good as new’—a powerfully appealing notion for cancer patients— simply does not pertain. For better and for worse, physically and emotionally, the experience leaves an impression.

No matter how long we live, cancer patients are survivors—at once wary and relieved, bashful and proud.” Sharing of best practices to facilitate compliance with both of these new CoC standards (3.1 and 3.3) will remain a focus area for both the CoC and AONN+. g

REFERENCES

1. Commission on Cancer. Cancer program standards 2012: ensuring patient-centered care. Version 1.2. http://www.facs.org/cancer/coc/program standards2012.pdf. Accessed December 4, 2013.

2. Institute of Medicine. From cancer patient to cancer survivor: lost in transition. http://books.nap.edu/openbook.php?record_id=11468. Washington, DC: The National Academies Press; 2006.

3. Mullan F. Seasons of survival: reflections of a physician with cancer.

N Engl J Med. 1985;313:270-273.

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Development of a Framework for Patient Navigation: Delineating Roles Across Navigator Types Anne Willis, MA1; Elisabeth Reed, MPA1; Mandi Pratt-Chapman, MA1; Heather Kapp, MPH, LICSW1; Elizabeth Hatcher, RN, BSN1; Virginia Vaitones, MSW, OSW-C2; Stacy Collins, MSW3; Jennifer Bires, LICSW, OSW-C4; Etta-Cheri Washington5 1 George Washington University Cancer Institute; 2Association of Community Cancer Centers; 3National Association of Social Workers; 4Association of Oncology Social Work; 5Capital City Area Health Education Center Background: The profession of patient navigation is rapidly growing: community health workers (CHWs), patient navigators, and clinically licensed navigators (ie, nurse and social work navigators) play critical roles in the continuum of care.

As navigators become more integral to the healthcare system, their roles need to be more clearly defined. This project sought to develop a framework to describe the similarities and differences across navigator types with a focus on clarifying the unique roles and responsibilities of patient navigators.

Methods: Leveraging expertise from project partners representing each of the navigator types, the framework was developed in 3 phases: a literature and internet review, mapping of review findings to functional area domains in a draft comprehensive framework, and creation of a simplified framework that delineated the similarities and differences for each domain across the 3 navigator types.

Results: A consensus-based finalized framework was developed that includes 12 functional area domains and indicates areas of commonality and distinction among CHWs, patient navigators, and clinically licensed navigators.

Conclusions: With more clarity regarding the roles and responsibilities of patient navigators, the field of patient navigation can move toward greater standardization of the profession within the healthcare system. The Patient Navigation Framework: Navigator Function Across Domains will serve as a guide for developing patient navigation–specific competencies, which will become the basis for competency-based training and thus inform certification efforts.

S

everal new healthcare professional roles have emerged to help patients navigate around barriers to accessing care. Though they may fall under the umbrella term of “navigator,” confusion exists about their unique roles and responsibilities. Community health workers (CHWs), patient navigators, and clinically licensed navigators (ie, nurse and social work navigators) are 3 professional types that have overlapping yet distinct roles and responsibilities. For example, they all involve individual or patient education, but the types of information provided can vary. The term patient navigator is used here to encompass professionals who are sometimes referred to as lay navigators. Because the latter term implies that these navigators have not received training or education or are not professionals, the term is used throughout this discussion rather than the term. The purpose of this paper is to clarify the role of the patient navigator who straddles community and healthcare settings vis-à-vis community health workers or clinically licensed navigators operating predominantly within the healthcare system.

Establishing competencies is critical for creating consistency across a profession. CHWs have a defined set of

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competencies in several states,1 and the Oncology Nursing Society (ONS) recently launched a project to define nurse navigator competencies.2,3 The Association of Oncology Social Work (AOSW) is also in the process of developing social work navigator–specific competencies. Despite these advancements, there is a lack of clarification about the roles of patient navigators and how they differ from the other navigator types.4,5 Identification of core competencies specifically for patient navigators is therefore needed to develop a standard of practice for patient navigators that is distinguishable from other navigator types. Before competencies can be established, however, the roles and responsibilities need to be clearly defined.

To clarify and develop consensus on the roles and responsibilities of patient navigators, the George Washington University (GW) Cancer Institute embarked on a collaborative project with national stakeholders in navigation. This paper describes an effort to create a role-delineation framework for patient navigation to guide the development of patient navigator–specific competencies.

Ultimately, the project findings can be used to standardize patient navigation practice through the development of competency-based training.

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METHODS To create the framework, we used a collaborative approach that included a steering committee composed of 18 individuals with navigation expertise. Participants included representatives from the Academy of Oncology Nurse & Patient Navigators (AONN+), Association of Community Cancer Centers (ACCC), National Association of Social Workers (NASW), AOSW, and ONS. Patient navigators and CHWs from MAC Inc. (Maintaining Active Citizens), City of Hope, Nueva Vida, Moffitt Cancer Center, Capital City Area Health Education Center, and the University of South Florida were also integral to the effort.

Framework development took place in 3 phases: a literature and internet review, mapping of content to functional area domains in a draft comprehensive framework, and creation of a simplified framework that delineated the similarities and differences for each functional area domain across the 3 navigator types. In phase 1, we conducted a literature review and online search to identify published and/or public patient navigation training curricula, CHW certification competencies, and journal articles on the roles, responsibilities, tasks, competencies and/or activities of the 3 navigator types.

In phase 2, we created a framework outline that included the 3 patient navigator types and functional area domains for each. The common domains across navigation types were mapped vertically while the differing roles, responsibilities, tasks, competencies, or activities of CHWs, patient navigators, and clinically licensed navigators were included to the right of each domain. Functional area domains were established based on domains found in the literature and internet review. One researcher mapped the information identified in phase 1 to the framework. For example, one of the competencies identified by Minnesota for CHWs is the ability to define their scope of practice.1 This was mapped to the framework by identifying the functional area domain (Professional Roles and Responsibilities) and entering the competency statement into the box for CHWs. When this draft comprehensive framework was complete, 3 additional researchers with patient navigation expertise reviewed the framework to attain consensus on the mapping process. The 4 researchers collaboratively reorganized the content by combining similar competencies, moving content to different domains, and collapsing several domains.

The steering committee met by teleconference to review the project and the draft comprehensive framework.

Participants discussed the goals and methodology and were asked to provide additional resources to add to the framework. Several new resources were recommended and incorporated into an updated framework that was e-mailed to the partners for final approval for this phase.

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In phase 3, the framework was refined to focus on the similarities and differences across navigator types. The focus was on the patient navigator’s unique role compared with the other navigator types because the others have already been defined or are being defined. Based on the draft comprehensive framework, the 4 researchers drafted definitions for each functional area domain to encompass the similarities across navigator types. These definitions were based on existing definitions when possible as well as group consensus. The researchers also created short, high-level summary statements that described the distinctive role of each navigator type. These summary statements were based on the information in the draft comprehensive framework as well as the researchers’ expert opinion.

This simplified framework was e-mailed to the steering committee and reviewed by teleconference. Participants were then assigned to 1 of the 3 subgroups, each of which included a CHW, 1 or 2 patient navigators, a nursing representative, and a social work representative. Facilitated by a GW Cancer Institute research team lead, the groups were assigned 4 functional area domains and met by teleconference to provide feedback on the similarities and differences presented in the simplified framework. Each team lead compiled the subgroup’s feedback and sent an updated version of the group’s selected functional area domains back to their subgroup for review and finalization.

Framework development took place in 3 phases: a literature and internet review, mapping of content to functional area domains in a draft comprehensive framework as well as the researchers’ expert opinion.

With the final feedback from each subgroup incorporated, a fifth researcher reviewed the framework for coherence and identified remaining gaps. An updated simplified framework was e-mailed to the whole group. Participants met by teleconference to review any further feedback or seek clarification. The revised framework was e-mailed again to the group, and participants were asked to provide additional edits or comments by e-mail. Consensus was reached through this final round of feedback.

RESULTS In phase 1, we identified 4 patient navigator training programs (GW Cancer Institute Patient Navigation Training,6 Patient Navigator Training Collaborative Level 17 and Level 28 Training, Patient Navigation Research Pro-

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Table Patient Navigation Framework: Navigator Function Across Domains

Domain Professional Roles and Responsibilities: The knowledge

Community (Community Health Worker) General knowledge base on health issues such as cancer, diabetes, obesity, heart disease, stroke, HIV/AIDS, and other chronic diseases.

base and skills needed to perform job-related duties and tasks, including understanding scope of practice, supporting evaluation efforts, and identifyActive documentation in client ing and exercising self-care strategies. record.

The following general skills are Conduct evaluation focused on required: community needs assessment Organizational skills and health behaviors.

Office skills Interpersonal skills Time management Problem solving Multitasking Critical thinking

Community Resources: Ongoing identification, coordination, and referral to resources such as individuals, organizations, and services in the community.

Patient Empowerment: Identifying problems and resources to help patients solve problems and be part of the decision-making process.11 An important facilitator of patient empowerment is development of good patient rapport.

Provide referral to evidencebased health promotion programs.

Provide assistance accessing health insurance.

Motivate individual and community to make positive changes in health behaviors.

Activate and empower individuals and communities to self-advocate and make healthy decisions.

Community/Healthcare Institution (Patient Navigator)

Healthcare Institution (Nurse Navigator/Social Work Navigator)

Knowledge of cancer screening, diagnosis, treatment, and survivorship and related physical, psychological, and social issues.

Knowledge and maintenance of knowledge (eg, license, certification, continuing education) of cancer clinical impacts on patient, caregivers, and families and ability to intervene (eg, symptom management, assessment of functional status and psychosocial health).

Active documentation of encounter with patient, barriers to care, and resources or referrals to resolve barriers, which may be noted in the client record and/or the medical record.

Active documentation in medical record.

Conduct evaluation focused on barriers to care, health disparities, and quality indicators.

Conduct evaluation focused on clinical outcomes and quality indicators.

Provide assistance with scheduling appointments and facilitate request and follow-up with specialist or supportive care based on clinical referral.

Focus on clinically oriented resources, such as referrals for second opinions, treatment or testing that may not be offered at the patient’s institution, as well as supportive or specialty referrals within or external to the institution (specific to nurse navigators).

Provide assistance accessing health insurance, copay programs, patient assistance programs, and financial assistance.

Assist patient with identifying administrative, structural, social, and practical issues to participate in decisionmaking and solutions.

Empower patients by ensuring they know all their options; identify their preferences and priorities, and assist them to access healthcare services and self-manage their health.

Provide assistance in identifying community resources to access psychosocial support throughout treatment (specific to social work navigators).

Assist patients in decisionmaking regarding diagnostic testing and treatment options (specific to nurse navigators).

Provide patients with strategies to cope with disease, treatment, and stress (specific to social work navigators).

Educate patients on their rights and preferences and ensure they are able to participate in the decsionmaking process throughout their care and into survivorship or end-of-life care.

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Table Patient Navigation Framework: Navigator Function Across Domains (Continued) Community (Community Health Worker)

Community/Healthcare Institution (Patient Navigator)

Communication: Ensuring appropriate communication with patient, healthcare and service providers, and community.

Facilitate communication with community about access and utilization of the healthcare system.

Assist patient and provider with communicating expectations, needs, and perspectives.

Barriers to Care/Health Disparities: Identifying and addressing barriers to care and reducing health disparities as defined by age, disability, education, ethnicity, gender, sexual identification, geographic location, income, or race in populations that often bear a greater burden of disease than the general population.12

Address barriers to accessing the healthcare system.

Domain

Provide translation and communication of clinical information.

Provide counseling through one-on-one communication and serve as conduit between patient and providers to address emotional and psychosocial needs of patients (specific to social work navigators).

Focus on reduction of general health disparities.

Education, Prevention, and Health Provide general health promotion Promotion: Promoting healthy behav- at the individual and community

iors and lifestyle, including integrative and wellness approaches.

Healthcare Institution (Nurse Navigator/Social Work Navigator)

level, including physical activity, healthy eating habits, stress reduction, sunscreen use, tobacco cessation, and reduction of other risky behaviors to reduce risk of cancer and chronic disease.

Address structural, cultural, social, emotional, and administrative barriers to care.

Focus on reduction of cancer health disparities in medically underserved patients and timely access to care across the continuum.

Educate patients on practical concerns and next steps in treatment with regard to what to expect.

Identify the educational needs of patients to advocate on their behalf with the care team.

Inform patients of the importance and benefit of clinical trials and connect them with additional resources.

Address clinical and service delivery barriers to care.

Provision of services to at-risk populations, which may be defined by individual need, high acuity, or high volume at institutional level.

Assess educational needs of patient.

Identify the educational needs of patients to advocate on their behalf with the care team.

Inform patients of the importance and benefit of clinical trials and connect them with additional resources.

Provide clinical education about diagnosis, treatment, side effects, and posttreatment care (specific to nurse navigators).

Educate patients and caregivers on their biopsychosocial concerns regarding their diagnosis and treatment (specific to social work navigators).

Ethics and Professional Conduct:

Understanding scope of practice and professional boundaries, assuring confidentiality, and following legal requirements. Maintaining and adhering to the professional standards. Bringing accountability, responsibility, and trust to the individuals the profession services.

Abide by state-defined scope of practice.

Understand difference in scope of practice between licensed professionals and nonlicensed professionals.

Abide by the ethical principles in the profession’s scope of practice and code of conduct according to licensure.

Table continued on page 24 JONS-online.com

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Table continued from page 23

Table Patient Navigation Framework: Navigator Function Across Domains (Continued)

Domain Cultural Competency: Healthcare

services that recognize, respect, and respond to cultural and social differences within the context of beliefs, practices, behaviors, and needs of diverse community and/or population served.13

Community (Community Health Worker) Act as community/cultural liaison and mediator between community and healthcare system using culturally appropriate education materials.

Community/Healthcare Institution (Patient Navigator)

Healthcare Institution (Nurse Navigator/Social Work Navigator)

Provide navigation services in a culturally competent manner (eg, National Culturally and Linguistically Appropriate Services [CLAS] Standards in Health and Health Care).

Provide clinical care and education materials in culturally competent manner.

Educate providers to increase their understanding of community’s history, culture, and needs, as well as the cultural appropriateness of their approaches and educational materials.

Outreach: Providing healthcare education to individuals and communities that address health disparities.14,15

Work with the community to identify education needs and opportunities.

Care Coordination: A method of organizing patient care activities to facilitate the appropriate delivery of healthcare services.16

Provide case management, service coordination, and system navigation.

Educate on cancer-related topics Consult and counsel patients on their unique risks. to reduce fears and barriers related to cancer screening.

Effectively link patients referred from the community to resources that can improve care coordination and timeliness to treatment.

Identify the pathway in the continuum and document the next steps to ensure the patient’s optimal outcomes.

Assess and facilitate coordination of psychosocial and medical/clinical care along the care continuum.

Identify unmet needs and facilitate cancer care resources to eliminate barriers along the cancer continuum.

Psychosocial Support Services/ Assessment: Providing and/or

Identify resources in the community for emotional and social support.

Screen and assess for psychoAdminister distress screening and provide assistance with ad- social distress. ministrative, practical, or social Provide psychosocial support issues identified. services such as counseling (specific to social work navigators).

Advocacy: Advocating on behalf of

Speak up for individual and community needs.

Educate providers on individual preferences of care and needs.

connecting patients to resources for psychosocial support services.

patient within the community and healthcare system.

gram Training Curricula,9 Ho`okele i ke Ola (Navigating to Health) Patient Navigation Training,10 and Cancer Disparities Research Program11). We also reviewed 5 programs with published or publicly available information on CHW training objectives or curricula (Boston,17 Minnesota,1 New Mexico,18 New York,18 Ohio,19 and Texas20) as well as 5 journal articles referencing roles and responsibil-

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Assure patients’ needs and preferences are integrated into treatment and care delivery.

ities across navigator types.2,21-24 Project partners recommended inclusion of the AOSW/NASW/ONS joint statement on patient navigation,25 the AOSW scope of work,26 and the ACCC Cancer Program Guidelines on patient navigation services.27 In phase 2, the original draft comprehensive framework was developed with 23 functional area domains. These domains were then collapsed

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into 12 domains as the roles, responsibilities, tasks, competencies, and/or activities were moved and combined.

The finalized framework includes 12 functional area domains: professional roles and responsibilities, community resources, patient empowerment, communication, barriers to care/health disparities, education/prevention and health promotion, ethics and professional conduct, cultural competency, outreach, care coordination, psychosocial support services/assessment, and advocacy. Differences between CHWs, patient navigators, and clinically licensed navigators are described to the right of each domain.

For example, in the domain “Professional Roles and Responsibilities,” regardless of navigator type, one must have a knowledge base and the skills needed to perform job-related duties and tasks, including understanding one’s scope of practice, supporting evaluation efforts, and identifying and exercising self-care strategies. Critical skills include organizational skills, office skills, interpersonal skills, time management, problem-solving, multitasking, and critical thinking. While CHWs should have general knowledge on health issues such as cancer, diabetes, obesity, heart disease, stroke, HIV/AIDs, and other chronic diseases, the oncology patient navigator should have a knowledge of cancer screening guidelines, diagnostic processes, treatment options, survivorship issues, and related physical, psychological, and social issues that might arise for cancer patients. In contrast, a social worker or nurse navigator should have knowledge of cancer clinical impacts and the ability to intervene to manage symptoms and assess functional status or psychosocial health. CHWs should document their activities within a client record, while patient navigators may document patient encounters, barriers to care, and resources or referrals within a client or medical record. Clinically licensed navigators should provide active documentation in the medical record. Finally, CHWs should focus evaluation on the community’s needs and health behaviors.

Patient navigators should conduct evaluation based on barriers to care, health disparities, and quality indicators.

And the evaluation focus for clinically licensed navigators should be clinical outcomes and quality indicators.

The Table illustrates the finalized Patient Navigation Framework: Navigator Function Across Domains, inclusive of all 12 domains and comparisons across navigator types.

CONCLUSION This framework helps to fill a critical gap in the field of patient navigation. The goal of the framework is to begin to clarify similarities and differences across patient navigator types, with a focus on better defining the unique role of patient navigators in the continuum of care. Aligned

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with the success of CHWs in creating certification programs at the state level, this project is the first step in a concerted effort to move toward creating a set of common competencies for patient navigators that can be used to create training and certification programs and ensure consistency across the profession. Next steps include refining the framework based on feedback from a larger group of patient navigators, creating competency domains and statements based on functional area, and validating the competency statements with a larger group of patient navigators and their supervisors through a national survey. A free training program will be developed around these competencies. Standardization across the profession will facilitate research on the efficacy and value of patient navigators to continue to advance the field. g

The goal of the framework is to begin to clarify similarities and differences across patient navigator types, with a focus on better defining the unique role of patient navigators in the continuum of care...

ACKNOWLEDGMENTS We would like to acknowledge all of the contributors to the project: Susan Bowman, RN, OCN, CBCN, MSW, Oncology Nursing Society; Margaret Darling, Nueva Vida; Leigh Ann Eagle, MAC Inc.; Lorena Gaytan, City of Hope; Linda Paige, Moffitt Cancer Center; Ana Quijada, Nueva Vida; Fedra Sánchez, Nueva Vida; Lillie Shockney, RN, BS, MAS, Academy of Oncology Nurse & Patient Navigators; David Trejo, City of Hope; Coni Williams, MS, University of South Florida. Partial support for this project was provided by the Avon Foundation for Women.

DISCLOSURES All authors report nothing to disclose.

CORRESPONDING AUTHOR Anne Willis, MA George Washington University Cancer Institute 2030 M Street, Suite 4069 Washington, DC 20036 REFERENCES

1. Minnesota Community Health Worker Outline. http://www.laguardia. cuny.edu/uploadedFiles/ACE/Programs/Career_Ladders_in_Allied_Health/ doc/MN-CHW-curriculum-outline-WILLAERT.pdf. Accessed May 15, 2013.

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2. Brown CG, Cantril C, McMullen L, et al. Oncology nurse navigator role delineation study: an Oncology Nursing Society Report. Clin J Oncol Nurs.

2012;16(6):581-585.

3. McMullen L, Banman TA, De Groot JM, et al. Oncology nurse navigator competencies: providing direction to improve care delivery. Poster presented at: 4th Annual Conference of the Academy of Oncology Nurse Navigators; November 15-17, 2013; Memphis, TN. 4. George Washington University Cancer Institute. National patient navigation collaborative inaugural meeting summary. 2011. http://smhs.gwu.edu/ gwci/sites/gwci/files/NPNCSummary2012.pdf. Accessed October 31, 2013.

5. Varner A, Murph P. Cancer patient navigation: where do we go from here.

Oncology Issues. 2010(May/June):50-53.

6. George Washington University Cancer Institute. Patient navigation training: from outreach to survivorship. Washington, DC; May 21-23, 2012.

7. Patient Navigator Training Collaborative. Level 1 course. http://patient navigatortraining.org/courses/level1/. Accessed May 15, 2013.

8. Patient Navigator Training Collaborative. Level 2 course. http://patient navigatortraining.org/courses/level2/. Accessed May 15, 2013.

9. Calhoun EA, Whitley EM, Esparza A, et al. A national patient navigator training program. Health Promot Pract. 2010;11(2):205-215.

10. Braun KL, Allison A, Tsark JU. Using community-based research methods to design cancer patient navigation training. Prog Community Health Partnersh. 2008;2(4):329-340.

11. Bone LR, Edington K, Rosenberg J, et al. Building a navigation system to reduce cancer disparities among urban black older adults. Prog Community Health Partnersh. 2013;7(2):209-218.

12. National Cancer Institute. Cancer health disparities fact sheet. Updated March 11, 2008. http://www.cancer.gov/cancertopics/factsheet/dispari ties/cancer-health-disparities. Accessed July 30, 2013.

13. The Office of Minority Health. What is cultural competency? Updated May 9, 2013. http://minorityhealth.hhs.gov/templates/browse.aspx?lvl=2& lvlID=11. Accessed July 30, 2013.

14. Johns Hopkins School of Nursing. Community outreach program. http://nursing.jhu.edu/excellence/community/outreach.html. Accessed July 30, 2013.

15. Community Tool Box. Section 6: Using Outreach to Increase Access. http://ctb.ku.edu/en/tablecontents/sub_section_main_1876.aspx. Accessed July 30, 2013.

16. Agency for Healthcare Research and Quality. Care Coordination Measures Atlas: Chapter 2: What is care coordination? 2011. http://www.ahrq.

gov/professionals/systems/long-term-care/resources/coordination/atlas/ chapter2.html. Accessed July 30, 2013.

17. Community Health Worker Initiative of Boston. Core competencies for community health workers. Published October 17, 2007. http://www. machw.org/documents/CHWInitiative10CHWCoreCompetencies 10.17.07.pdf. Accessed May 15, 2013.

18. Mayfield-Johnson S. Learning from community health worker certification and credentialing models: Texas, Ohio, Minnesota, Massachusetts, New Mexico and New York. 2011. http://www.michigan.gov/documents/ mdch/CHW_Certification_and_Credentialing_MICHW_8.24.111_ 376346_7.pdf. Accessed May 15, 2013.

19. State of Ohio Board of Nursing. Community health worker training program: program approval application. Updated February 12, 2009. http:// www.nursing.ohio.gov/PDFS/CHW/CHW%20PROG%20Packet.pdf. Accessed May 15, 2013.

20. Texas Department of State Health Services. CHW core competencies. http://www.dshs.state.tx.us/WorkArea/linkit.aspx?LinkIdentifier=id &ItemID=8589969406. Accessed May 15, 2013.

21. Gilbert JE, Green E, Lankshear S, et al. Nurses as patient navigators in cancer diagnosis: review, consultation and model design. Eur J Cancer Care.

2011;20(2):228-236.

22. Fillion L, Cook S, Veillette A-M, et al. Professional navigation framework: elaboration and validation in a Canadian context. Oncol Nurs Forum.

2012;39(1):E58-E69.

23. Natale-Pereira A, Enard KR, Nevarez L, Jones LA. The role of patient navigators in eliminating health disparities. Cancer. 2011;117(Suppl 15): 3541-3550.

24. Braun KL, Kagawa-Singer M, Holden AEC, et al. Cancer patient navigator tasks across the cancer care continuum. J Health Care Poor Underserved. 2012;23(1):398-413.

25. Association of Oncology Social Work, National Association of Social Workers and Oncology Nursing Society. Oncology nursing and social work professional associations release position on patient navigation. Published April 19, 2010. http://www.naswdc.org/pressroom/2010/041910.asp. Accessed June 20, 2013.

26. Association of Oncology Social Work. Scope of practice. 2011. http://www.aosw.org/html/prof-scope.php. Accessed July 30, 2013.

27. Association of Community Cancer Centers. ACCC’s cancer program guidelines: patient navigation services. Published 2009. http://www.accc cancer.org/education/pdf/PN2009/s4.pdf. Accessed June 20, 2013.

ABOUT THE COVER The Forest Watercolor by a Person Diagnosed with Cancer Artwork from the Lilly Oncology On Canvas: Expressions of a Cancer Journey Art Competition www.LillyOncologyOnCanvas.com

W

hen I was diagnosed with ovarian cancer, I was overwhelmed by the journey I faced. I had many questions and decisions to make to start my journey. At first, I was paralyzed by the forest of information and the fear of having cancer.

With the help of my medical team, family, and friends, I have been able to work through the information and make decisions that allow me to find my way through the forest. My journey continues to challenge me with new twists and turns.

During this journey, I discovered that I can have a fulfilling life with cancer that is serene and full of happiness.

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THE PATIENT’S VOICE

The Devil Is in the Details

By MMA

I

f I had to grade my oncology nurses, I would give them, as a group, an A+. They have saved my life, cleaned my privates, kept me company, rejoiced with me when I was discharged, and consoled me with every wave or trickle of bad news I have faced during my care.

Yet, the devil is in the details. There are some things they have not done, that I need them to do. I do not know enough about hospital administration and organization to know if these tasks fall to them, but the nurses are there in my room more often than anyone except my family—and I expect the nurses to do them.

cidents on the floor. While sometimes this problem is solved when I am told to use the bedside commode, it is still often the case that I just do not arrive. Why? I would estimate that 90% of the time it is because of 2 factors: one, I cannot get the chemo pole to wheel over the bump that leads to the bathroom, or, two, I cannot disconnect the cord from the wall and wrap it up in time to grab the chemo pole, navigate the door opening to the bathroom, get over that hump, and get to the toilet.

I consider that a nurse could easily accommodate the equipment in a way that would reduce these incidents.

Help with my toenails. Admittedly, my toenails have always resembled dinosaur claws rather than human nails.

Yet, since being told about a year ago I could not get a pedicure, they have deteriorated to thick, yellowish, nonmammalian entities. They hurt. I tell my nurse.

“Get a file,” she tells me. Well, I cannot. I do not know enough about pedicure procedures, I do not have the energy to do anything and I am in constant pain. Why can’t my nurse simply call someone to help me? Why do they always give me some unhelpful suggestion and then never mention it again? Perhaps I have not been proactive enough. Perhaps I need to bring this up with the doctor. Yet, justified or not, I blame the nurses for not helping me. My suggestion? Look at the feet of your patients and ask them if they need help with their toenails! Find a solution! Please!

Clean up after my vomiting/diarrhea episodes. Do you know what it is like to be vomiting, for hours on end, sometimes intermittently, sometimes in retching fits? Do you know how humiliating it is to not be able to control your bowel movements, and instead to dirty yourself time and time again? Do you know that most of the people who are caregivers for us are not trained in the medical field? Do you know that, as far as I know, it is not my caregiver’s job to do yours. Do not expect my caregiver to clean up my mess!

You need to do it! You are trained in the art of care. Please use that training. Come quickly! Help me! Please clean up!

I need you to do it!

Clean out the apparatus from my bathroom. Every time I want to take a shower at the hospital, I find myself confronted with chemo poles, bedside commodes, and other assorted paraphernalia stuffed in the bathroom, usually in the shower stall. Has no one noticed that maybe, just maybe, a patient cannot take a shower with all that junk dumped in the shower stall? Do you take a shower at your own house surrounded by heavy metal that you cannot move easily? Please make sure it is out of there before I need to take my shower. To me, when you do not, it suggests that no one really cares.

Place my chemo pole so I can easily access the restroom. In my case, bathroom functions dominate my hospital stays. I am given medicine to either make me urinate or make me have endless bowel movements. I find it embarrassing and humiliating. Worse yet, many times I do not make it to the restroom in time, instead having ac-

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DECEMBER 2013 • VOLUME 4, ISSUE 6

Make sure I have some way to wash my hands. Oftentimes, I use the bedside commode. I do my business, get up, and look around for a way to wash my hands. No one is in the room, I am too weak to walk to the bathroom, and apart from the toilet paper tucked on my chemo pole (if someone has remembered to put it there), there is no sign of anything to even clean my hands. So, I transfer back to my bed, aware that if I eat or sleep or anything else I run the risk of contaminating myself with excrement bacteria. All a nurse has to do is make sure I have wipe cloths, hand sanitizer, or some other way to keep myself clean.

It was hard to write this article. It seems sacrilegious to criticize the oncology nurses who have given me so much and cared for me through the course of this illness. However, all job performance can be improved. Nurses may not even be aware that, from a patient’s point of view, sometimes the devil is in the details. g MMA is undergoing treatment for cancer. She wishes to use her initials.

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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.

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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.

© Janssen Biotech, Inc. 2013

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ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

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

Nursing Mothers: ZYTIGA is not indicated for use in women. It is not known if abiraterone acetate is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from ZYTIGA, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Adrenocortical Insufficiency [see Warnings and Precautions].

• Hepatotoxicity [see Warnings and Precautions].

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

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

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

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

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

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

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

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

ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

4 Includes

1 Adverse

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

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

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

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

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

The median duration of treatment with ZYTIGA was 13.8 months.

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

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

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

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

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

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

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

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

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

THE PATIENT’S VOICE

COMMENTARY

A Nurse’s Voice

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

I

t has always been my opinion that nurses are often expected to be the healthcare professionals who “do everything.”

After much frustration with this over the years, I have come to understand that nurses are one group that will complete a task, do it right, and take ownership of the results. They will also report back to whomever assigned them the task and be willing to do more. In essence, nurses are often the catchall of the healthcare world. When a physician needs something, even if it is a phone number, the first assistant they look for is a nurse. When a patient needs something, they call their nurse. The result of this over the years is that nurses take on tasks that may be better served by non-nurses leaving insufficient time for nurses to complete tasks that require the training and experience of a nurse.

Unfortunately, patient care is affected when nurses become short on time, distracted, and exhausted.

One of my first staff nurse positions was in a hospital in Detroit working 12-hour shifts in the Medical Intensive Care Unit (ICU). This was a 6-bed unit and each patient, each shift, had 1 nurse. This never deviated. Every nurse cared for 1, and only 1, patient. I remember the satisfaction of knowing that each shift I was able to accomplish everything that my patient and their family needed, even trimming their nails. I never left work haunted by worries of missed medications, forgotten documentation, or patient neglect. This all changed somewhere in the mid-1990s. Someone in the organization targeted nursing hours to cut the budget. First, ICU nurses each maintained their 1 private patient but also assumed ½ care for a second patient; “shared” a patient with another nurse resulting in 2 nurses for every 3 patients rather than 3.

I always pitied that “shared” patient as they didn’t have an owner. Soon this worsened to 2 patients per nurse. Although I have not staffed in an ICU for more than 20 years, I understand from younger colleagues that the current ratio of nurses to patients is at least 1:2.5, sometimes as bad as 1 nurse for 4 patients. It is not possible to give the level of care and attention to each patient with this staffing plan. Generally the result of this is that the nurse’s time and attention land with the most unstable patient and soon nurses become fatigued and seek other positions.

Another direct result of budget cuts in healthcare has been the growing list of tasks that now fall to the nursing group that is already doing more with less. This can include cleaning, phlebotomy, secretarial duties, serving food, and super-

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DECEMBER 2013 • VOLUME 4, ISSUE 6

vising others. Nursing is generally one of the largest budget items in a healthcare institution and thus traditionally targeted when budget cuts are necessary. It is not uncommon for nurses to spend a great deal of their time away from their patients completing tasks that could be assigned to non-nurses. Nurses have also incorporated electronic medical records into their world; something that has proven quite challenging and time-consuming for older nurses. Understanding that the average age of employed nurses is 45 years, and the greatest group of employed nurses is above 50 years of age, this is not a generation that grew up with computers and electronic devices. Still, when asked to do such, nurses have taken on this task and have incorporated electronic documentation into their roles.

Nurses must find a way to provide care that is safe, efficient, compassionate, and respectful. We must never lose sight of our primary purpose—assisting others who are in need to reach their health and wellness goals, and to support those who are dying. Patients are all someone’s loved one; each patient has a family, community, and circle of friends who care for them. They are not a number, a diagnosis, or a biopsy. When they are sick their independence is compromised and nurses should be their champions throughout their journey. Nurses must speak when our patients cannot and stand by them when they are alone. It has been well documented that the greatest fear of one who is dying is to be alone. Nurses must learn to delegate tasks when appropriate allowing them to be with their patients. Nurses must also sometimes be able to say no. Nurses should listen to their patients allowing the patient to set the plan and goals, not the medical team. I recall a great television commercial that ran years ago in the Detroit area for a healthcare system. The commercial was the Chief Nursing Officer of a large, multi- center healthcare system speaking to the camera. She said that in healthcare you pick your doctor, you pick your hospital, but you are assigned your nurse; the one who you spend all day with. Her point was that in her system you would receive the best nursing care and if you didn’t, she wanted to hear from you. It pointed out some truths—patients do not pick their nurse, and nurses are the ones who actually take care of patients.

Let’s pay attention to the details of what our patients need and find ways to meet their needs when they cannot. g

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