June 2012, Vol 3, No 3 by The Oncology Nurse

JUNE 2012

www.AONNonline.org

VOL 3, NO 3

SURVIVORSHIP RESEARCH Problems and Process in a Study Design—Lessons Learned

ORIGINAL RESEARCH Implementation of a TheoryBased, Nonclinical Patient Navigator Program to Address Barriers in an Urban Cancer Center Setting

WEB SITE REVIEW www.PatientAdvocate.org PAF – Patient Advocate Foundation: Solving insurance and healthcare access problems since 1996

NAVIGATING PATIENTS ACROSS THE CONTINUUM OF CANCER CARE

The median age of patients treated in the VISTAยง trial was 71 years (range: 48-91).

NOW APPROVED FOR SUBCUTANEOUS ADMINISTRATION*

Survival never gets old VELCADE® (bortezomib) delivered >13-month overall survival advantage in combination with MP† vs MP alone for previously untreated multiple myeloma (median 56.4 vs 43.1 months‡; 60.1-month median follow-up§)

VELCADE (bortezomib) Indication and Important Safety Information INDICATION

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CONTRAINDICATIONS

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ADVERSE REACTIONS WARNINGS, PRECAUTIONS AND DRUG INTERACTIONS ▼

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Living Proof

Brief Summary INDICATIONS: VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma. VELCADE is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy. CONTRAINDICATIONS: VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. VELCADE is contraindicated for intrathecal administration. WARNINGS AND PRECAUTIONS: VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. Complete blood counts (CBC) should be monitored frequently during treatment with VELCADE. Peripheral Neuropathy: VELCADE treatment causes a peripheral neuropathy that is predominantly sensory. However, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with pre-existing symptoms (numbness, pain or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy (including ≥ Grade 3) during treatment with VELCADE. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. In the Phase 3 relapsed multiple myeloma trial comparing VELCADE subcutaneous vs. intravenous the incidence of Grade ≥ 2 peripheral neuropathy events was 24% for subcutaneous and 41% for intravenous. Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group. Starting VELCADE subcutaneously may be considered for patients with pre-existing or at high risk of peripheral neuropathy. Patients experiencing new or worsening peripheral neuropathy during VELCADE therapy may benefit from a decrease in the dose and/or a less dose-intense schedule. In the single agent phase 3 relapsed multiple myeloma study of VELCADE vs. Dexamethasone following dose adjustments, improvement in or resolution of peripheral neuropathy was reported in 51% of patients with ≥ Grade 2 peripheral neuropathy in the relapsed multiple myeloma study. Improvement in or resolution of peripheral neuropathy was reported in 73% of patients who discontinued due to Grade 2 neuropathy or who had ≥ Grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Hypotension: The incidence of hypotension (postural, orthostatic, and hypotension NOS) was 13%. These events are observed throughout therapy. Caution should be used when treating patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated. Management of orthostatic/postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics. Cardiac Disorders: Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have been reported, including reports in patients with no risk factors for decreased left ventricular ejection fraction. Patients with risk factors for, or existing heart disease should be closely monitored. In the relapsed multiple myeloma study of VELCADE vs. dexamethasone, the incidence of any treatment-emergent cardiac disorder was 15% and 13% in the VELCADE and dexamethasone groups, respectively. The incidence of heart failure events (acute pulmonary edema, cardiac failure, congestive cardiac failure, cardiogenic shock, pulmonary edema) was similar in the VELCADE and dexamethasone groups, 5% and 4%, respectively. There have been isolated cases of QT-interval prolongation in clinical studies; causality has not been established. Pulmonary Disorders: There have been reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome (ARDS) in patients receiving VELCADE. Some of these events have been fatal. In a clinical trial, the first two patients given high-dose cytarabine (2 g/m2 per day) by continuous infusion with daunorubicin and VELCADE for relapsed acute myelogenous leukemia died of ARDS early in the course of therapy. There have been reports of pulmonary hypertension associated with VELCADE administration in the absence of left heart failure or significant pulmonary disease. In the event of new or worsening cardiopulmonary symptoms, a prompt comprehensive diagnostic evaluation should be conducted. Reversible Posterior Leukoencephalopathy Syndrome (RPLS): There have been reports of RPLS in patients receiving VELCADE. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. Brain imaging, preferably MRI (Magnetic Resonance Imaging), is used to confirm the diagnosis. In patients developing RPLS, discontinue VELCADE. The safety of reinitiating VELCADE therapy in patients previously experiencing RPLS is not known. Gastrointestinal Adverse Events: VELCADE treatment can cause nausea, diarrhea, constipation, and vomiting sometimes requiring use of antiemetic and antidiarrheal medications. Ileus can occur. Fluid and electrolyte replacement should be administered to prevent dehydration. Thrombocytopenia/Neutropenia: VELCADE is associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle. The cyclical pattern of platelet and neutrophil decreases and recovery remained consistent over the 8 cycles of twice weekly dosing, and there was no evidence of cumulative thrombocytopenia or neutropenia. The mean platelet count nadir measured was approximately 40% of baseline. The severity of thrombocytopenia was related to pretreatment platelet count. In the relapsed multiple myeloma study of VELCADE vs. dexamethasone, the incidence of significant bleeding events (≥Grade 3) was similar on both the VELCADE (4%) and dexamethasone (5%) arms. Platelet counts should be monitored prior to each dose of VELCADE. Patients experiencing thrombocytopenia may require change in the dose and schedule of VELCADE. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. The incidence of febrile neutropenia was <1%. Tumor Lysis Syndrome: Because VELCADE is a cytotoxic agent and can rapidly kill malignant cells, the complications of tumor lysis syndrome may occur. Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken. Hepatic Events: Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic events include increases in liver enzymes, hyperbilirubinemia, and hepatitis. Such changes may be reversible upon discontinuation of VELCADE. There is limited re-challenge information in these patients. Hepatic Impairment: Bortezomib is metabolized by liver enzymes. Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with VELCADE at reduced starting doses and closely monitored for toxicities. Use in Pregnancy: Pregnancy Category D. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE. Bortezomib administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post-implantation loss and a decreased number of live fetuses.

ADVERSE EVENT DATA: Safety data from phase 2 and 3 studies of single-agent VELCADE (bortezomib) 1.3 mg/m2/dose administered intravenously twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously treated multiple myeloma (N=1008, not including the phase 3, VELCADE plus DOXIL® [doxorubicin HCI liposome injection] study) and previously treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma. In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness); (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated); (39%), thrombocytopenia and appetite decreased (including anorexia); (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia (each 22%), dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness (excluding vertigo); (each 17%), pain in limb and abdominal pain (each 15%), bone pain (14%), back pain and hypotension (each 13%), herpes zoster, nasopharyngitis, upper respiratory tract infection, myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and anxiety (each 10%). Twenty percent (20%) of patients experienced at least 1 episode of ≥Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%). In the phase 3 VELCADE + melphalan and prednisone study in previously untreated multiple myeloma, the safety profile of VELCADE administered intravenously in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/prednisone. The most commonly reported adverse events in this study (VELCADE+melphalan/prednisone vs melphalan/prednisone) were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46% vs 17%), anemia (43% vs 55%), constipation (37% vs 16%), neuralgia (36% vs 1%), leukopenia (33% vs 30%), vomiting (33% vs 16%), pyrexia (29% vs 19%), fatigue (29% vs 26%), lymphopenia (24% vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% vs 13%), headache (14% vs 10%), pain in extremity (14% vs 9%), abdominal pain (14% vs 7%), paresthesia (13% vs 4%), herpes zoster (13% vs 4%), bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%), nasopharyngitis (11% vs 8%), bone pain (11% vs 10%), arthralgia (11% vs 15%) and pruritus (10% vs 5%). In the phase 3 VELCADE subcutaneous vs. intravenous study in relapsed multiple myeloma, safety data were similar between the two treatment groups. The most commonly reported adverse events in this study were peripheral neuropathy NEC (38% vs 53%), anemia (36% vs 35%), thrombocytopenia (35% vs 36%), neutropenia (29% vs 27%), diarrhea (24% vs 36%), neuralgia (24% vs 23%), leukopenia (20% vs 22%), pyrexia (19% vs 16%), nausea (18% vs 19%), asthenia (16% vs 19%), weight decreased (15% vs 3%), constipation (14% vs 15%), back pain (14% vs 11%), fatigue (12% vs 20%), vomiting (12% vs 16%), insomnia (12% vs 11%), herpes zoster (11% vs 9%), decreased appetite (10% vs 9%), hypertension (10% vs 4%), dyspnea (7% vs 12%), pain in extremities (5% vs 11%), abdominal pain and headache (each 3% vs 11%), abdominal pain upper (2% vs 11%). The incidence of serious adverse events was similar for the subcutaneous treatment group (36%) and the intravenous treatment group (35%). The most commonly reported SAEs were pneumonia (6%) and pyrexia (3%) in the subcutaneous treatment group and pneumonia (7%), diarrhea (4%), peripheral sensory neuropathy (3%) and renal failure (3%) in the intravenous treatment group. DRUG INTERACTIONS: Bortezomib is a substrate of cytochrome P450 enzyme 3A4, 2C19 and 1A2. Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the exposure of bortezomib by 35% in 12 patients. Therefore, patients should be closely monitored when given bortezomib in combination with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir). Co-administration of omeprazole, a strong inhibitor of CYP2C19, had no effect on the exposure of bortezomib in 17 patients. Co-administration of rifampin, a strong CYP3A4 inducer, is expected to decrease the exposure of bortezomib by at least 45%. Because the drug interaction study (n=6) was not designed to exert the maximum effect of rifampin on bortezomib PK, decreases greater than 45% may occur. Efficacy may be reduced when VELCADE is used in combination with strong CYP3A4 inducers; therefore, concomitant use of strong CYP3A4 inducers is not recommended in patients receiving VELCADE. St. John’s Wort (Hypericum perforatum) may decrease bortezomib exposure unpredictably and should be avoided. Co-administration of dexamethasone, a weak CYP3A4 inducer, had no effect on the exposure of bortezomib in 7 patients. Co-administration of melphalan-prednisone increased the exposure of bortezomib by 17% in 21 patients. However, this increase is unlikely to be clinically relevant. USE IN SPECIFIC POPULATIONS: Nursing Mothers: It is not known whether bortezomib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from VELCADE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: The safety and effectiveness of VELCADE in children has not been established. Geriatric Use: No overall differences in safety or effectiveness were observed between patients ≥age 65 and younger patients receiving VELCADE; but greater sensitivity of some older individuals cannot be ruled out. Patients with Renal Impairment: The pharmacokinetics of VELCADE are not influenced by the degree of renal impairment. Therefore, dosing adjustments of VELCADE are not necessary for patients with renal insufficiency. Since dialysis may reduce VELCADE concentrations, VELCADE should be administered after the dialysis procedure. For information concerning dosing of melphalan in patients with renal impairment, see manufacturer’s prescribing information. Patients with Hepatic Impairment: The exposure of bortezomib is increased in patients with moderate and severe hepatic impairment. Starting dose should be reduced in those patients. Patients with Diabetes: During clinical trials, hypoglycemia and hyperglycemia were reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetic medication. Please see full Prescribing Information for VELCADE at VELCADEHCP.com.

VELCADE, MILLENNIUM and are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners. Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright © 2012, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA

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TABLE OF CONTENTS

JUNE 2012 • VOL 3, NO 3

SURVIVORSHIP RESEARCH

EDITORIAL DIRECTOR

Kristin Siyahian kristin@greenhillhc.com MANAGING EDITOR

Jim Scelfo jim@greenhillhc.com

Problems and Process in a Study Design— Lessons Learned

EDITORIAL ASSISTANT

By Carol Guarnieri, RN, MSN, FNP-C, AOCNS; Patrice Welsh Benjamin, RN, MA, OCN; Melanie O’Hara, RN, MSN, OCN; Marlene Miller, RN, MSN, CORLN; Lindsay Thomas, RN, MSN, OCN; Maria Bautista, MS, ANP, CGRN; Sally Kazilek, RN, MSN, OCN; Melanie Brewer, DNSc, RN, FNP-BC

Jennifer Brandt SENIOR COPY EDITOR

Rosemary Hansen PRODUCTION MANAGER

Stephanie Laudien QUALITY CONTROL DIRECTOR

Barbara Marino

ORIGINAL RESEARCH

BUSINESS MANAGER

Blanche Marchitto

Implementation of a Theory-Based, Nonclinical Patient Navigator Program to Address Barriers in an Urban Cancer Center Setting By Linda Fleisher, PhD, MPH; Suzanne M. Miller, PhD; Danielle Crookes, MPH; Venk Kandadai, MPH; Kuang Yi Wen, PhD; Rachel E. Slamon, BS; Jeanne Chaivous, MSW

WEB SITE REVIEW

www.PatientAdvocate.org PAF – Patient Advocate Foundation: Solving insurance and healthcare access problems since 1996 By Lillie D. Shockney, RN, BS, MAS

ABOUT THE COVER Purgatory Oil by a Healthcare Professional Texas Artwork from the Lilly Oncology On Canvas: Expressions of a Cancer Journey Art Competition (www.LillyOncologyOnCanvas.com).

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CIRCULATION DEPARTMENT

circulation@greenhillhc.com Journal of Oncology Navigation & Survivorship, ISSN 21660999 (print); ISSN 2166-0980 (online), is published 6 times a year by Green Hill Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright ©2012 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 MANAGING EDITOR, Journal of Oncology Navigation & Survivorship (JONS), 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. E-mail: jim@greenhillhc.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, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. 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.

JOURNAL OF ONCOLOGY NAVIGATION & SURVIVORSHIP

LETTERS FROM LILLIE

Editor-in-Chief Lillie D. Shockney, RN, BS, MAS University Distinguished Service Associate Professor of Breast Cancer Depts of Surgery and Oncology Administrative Director, Johns Hopkins Breast Clinical Programs Administrative Director, Johns Hopkins Cancer Survivorship Programs Associate Professor, JHU School of Medicine, Depts of Surgery & Gynecology and Obstetrics Associate Professor, JHU School of Nursing

INSPIRE AWARENESS THROUGH INNOVATIVE IDEAS

shockli@jhmi.edu

Section Editors Breast Cancer Sharon Gentry, RN, MSN, AOCN, CBCN Breast Health Navigator Derrick L. Davis Forsyth Regional Cancer Center

Prostate Cancer Frank delaRama, RN, MS, AOCNS Clinical Nurse Specialist Oncology/Genomics Cancer Care Clinic Palo Alto Medical Foundation

Healthcare Disparities Linda Fleisher, PhD, MPH Assistant Vice President Office of Health Communications & Health Disparities Assistant Professor Cancer Prevention & 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

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

Dear Colleague,

he summer months are often a period of time when there is less happening in the “cancer awareness” arena. For this reason, I want to challenge everyone to get the creative juices flowing and think about some new and innovative ways to raise awareness and truly inspire consumers to take better care of themselves by getting the cancer screening tests they need. This might mean changing the way outreach is traditionally done. Is there a way to reach the right populations of people at risk other than setting up a booth at a health fair? Recently, I thought about this regarding colorectal cancer screenings. (Let’s face it, no one wants to walk over to a colorectal cancer education booth!) So rather than expecting people to come to us, I recommended that we go to them—beginning with our own Hopkins employees. Two wonderful willing people here got into costumes— a polyp costume (a modified tomato costume available online will do) and a policewoman’s uniform—and went into various departments as the “polyp police”!! Handcuffed together, the policewoman showed employees seated at their desk that she had “caught this one, but it had already gone bad” and recommended that they read the criteria for who needs colonoscopy screening done and call the (new) Hopkins employee scheduling number to get scheduled. It was fun, engaging, and caused lots of employees to talk about colon cancer!! And the polyp police will be making the rounds every month to a different department here to spread the word. We don’t want to do this just during national colorectal cancer awareness month, right? People sure need to be aware during months other than March. So write to us and let us know some of your innovative ideas you have already implemented that others, including me, can learn from. Also share with us new programs that you will be launching soon. I’m working next on breast cancer awareness and lung cancer awareness and have some hopefully clever ways to inspire people to get screening mammograms as well as give up the cancer sticks. Got any ideas yet? Let me know! g

Nurse Navigator Botsford Cancer Center

MISSION STATEMENT

The Journal of Oncology Navigation & Survivorship (JONS) promotes reliance on evidence-based practices 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.

JUNE 2012 • VOLUME 3, ISSUE 3

With best regards,

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

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The ONLY journal focused on patient navigation and survivorship care in oncology patients

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SURVIVORSHIP RESEARCH

Problems and Process in a Study Design— Lessons Learned By Carol Guarnieri, RN, MSN, FNP-C, AOCNS Oncology Nurse Practitioner, Scottsdale Healthcare, Scottsdale, Arizona

Patrice Welsh Benjamin, RN, MA, OCN Oncology Nurse Clinician, Scottsdale Healthcare, Scottsdale, Arizona

Melanie O’Hara, RN, MSN, OCN Cancer Care Coordinator, Scottsdale Healthcare, Scottsdale, Arizona

Marlene Miller, RN, MSN, CORLN Cancer Care Coordinator, Scottsdale Healthcare, Scottsdale, Arizona

Lindsay Thomas, RN, MSN, OCN Director of Oncology Services, Scottsdale Healthcare, Scottsdale, Arizona

Maria Bautista, MS, ANP, CGRN Radiation Oncology Nurse Practitioner, Scottsdale Healthcare, Scottsdale, Arizona

Sally Kazilek, RN, MSN, OCN Radiation Therapy Nurse, Banner Desert Medical Center, Mesa, Arizona

Melanie Brewer, DNSc, RN, FNP-BC Director of Nursing Research, Scottsdale Healthcare, Scottsdale, Arizona

Abstract: Healthcare professionals want to ensure that every patient receives quality care throughout the continuum of their cancer illness. In addition, many national organizations have challenged healthcare providers to provide comprehensive services to cancer survivors. Research indicates that long-term adverse outcomes for cancer survivors are more prevalent, serious, and persistent than previously known. As a result, survivorship care presents many new avenues for nursing research. In developing our survivorship program, an interdisciplinary team at our hospital developed an exploratory pilot research study to evaluate the impact of assessment, education, support, and guidance on patients’ quality of life and distress. The goal of the pilot study was to evaluate our interventions and make recommendations to expand our survivorship services to all cancer patients in our hospital system. We encountered several problems with implementing our study. This paper describes our research process and the problems we encountered with our study design and the revisions that were made in order to accrue patients and achieve our goals. A description of these challenges and the changes we made may assist others with their research endeavors.

t is estimated that nearly 12 million individuals in the United States are living with cancer.1 Cancer survivorship is defined as the experience of living with, through, and beyond cancer for both patients and the people in their lives who are impacted by the diagnosis. Survivorship encompasses the physical, psychological, emotional, social, spiritual, and economic aspects of life.2 Psychological distress, impaired organ function, sexual dysfunction, cosmetic changes, limitations in mobility, communication issues, and decreased cognition are among some of the problems faced by many cancer survivors. The eco-

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nomic impact of a cancer diagnosis can be an additional burden to cancer survivors through increased out-of-pocket medical expenses, changes in employment status, and decreased access to affordable health insurance.3 In addition to the physical and psychological effects of the disease and its treatment, living with cancer presents substantial life challenges to survivors and their families. Long-term adverse outcomes for cancer survivors may cause distress and negatively impact quality of life (QOL). The National Comprehensive Cancer Network (NCCN) has challenged healthcare providers to

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SURVIVORSHIP RESEARCH

provide comprehensive services to cancer survivors and has provided evidence-based guidelines and tools to assist in improving outcomes and enhancing QOL.4 In the report from the Institute of Medicine, From Cancer Patient to Cancer Survivor: Lost in Transition, 10 recommendations were made to improve the QOL of cancer survivors. The first recommendation is that healthcare providers, patient advocates, and other stakeholders should work together to raise awareness of the needs of cancer survivors, establish cancer survivorship as a distinct phase of cancer care, and act to ensure the delivery of appropriate survivorship care.3 Since care for survivors is a key component of a quality cancer program, leaders at Scottsdale Healthcare (SHC) wanted to develop a cancer survivorship program in response to these recommendations. SHC is a large community-based hospital system located adjacent to the Phoenix metropolitan area. An interdisciplinary team from the Virginia G. Piper Cancer Center (VGPCC) at SHC developed an exploratory research study to evaluate the impact of assessment, education, support, and guidance on the QOL and distress in head and neck cancer and lung cancer patients who had completed a minimum of 4 weeks of radiation therapy. Evaluating the effects of this program on patient distress and QOL was needed to determine whether program modifications, revisions, and/or additional services were indicated in order to minimize distress and enhance QOL for all cancer survivors. After an evaluation of outcomes, modifications would be made as needed to improve implementation processes, identify gaps in available services, and estimate the financial resources and personnel necessary to expand and sustain a community-based survivorship program. The program would then be offered to all adult cancer survivors who contact the VGPCC for care.

REVIEW OF THE LITERATURE Distress Distress is defined by the NCCN as a multifactorial unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms, and its treatment. Distress extends along a continuum, ranging from normal feelings of vulnerability, sadness, and fear to problems that can become disabling, such as

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depression, anxiety, panic, social isolation, and existential and spiritual crisis.4 Psychological distress in patients with cancer can negatively impact their QOL. According to Vachon, approximately one-third of cancer survivors report distressing symptoms that may range from sadness to debilitating depression.5 According to the National Cancer Institute, 44% of cancer survivors report some anxiety, with 23% reporting significant anxiety.6 The most common fear among cancer survivors is the fear of recurrence, ranging from 5% to 89%, depending on the type of cancer diagnosis, stage of cancer, and other factors.7

The first recommendation is that healthcare providers, patient advocates, and other stakeholders should work together to raise awareness of the needs of cancer survivors, establish cancer survivorship as a distinct phase of cancer care, and act to ensure the delivery of appropriate survivorship care. Quality of Life QOL is defined by the conceptual framework based on research by Ferrell and colleagues and includes an individual’s perception of physical, psychological, social, and spiritual well-being.8 As the treatment of cancer has become more successful, the number of cancer survivors has risen. Long-term survival from cancer has brought QOL to the forefront as an issue in cancer survivorship. QOL is defined as an individual’s assessment of his or her own general well-being. A core concept of measuring QOL is obtaining self-assessment by the patient across multiple “domains,” or areas, of well-being. In order to assess QOL in cancer survivors, standardized, self-administered questionnaires are generally used. It is recommended that assessments be repeated at regular intervals over a period of time, focusing on function in physical, psychological, social, and spiritual domains.3 SURVIVORSHIP BY DISEASE SITE Head and Neck Cancer Head and neck cancers can have a profound

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SURVIVORSHIP RESEARCH

impact on a survivor’s QOL. The head and neck region is important for the functions of eating and speech. Head and neck cancer survivors often undergo a combination of surgery, chemotherapy, and radiation. The combination of cancer and its treatment can leave a significant alteration in this area cosmetically, functionally, and socially. The treatment results in a variety of long-term effects such as xerostomia, loss of taste, dental decay/loss, and tissue loss resulting in disfigurement.9 Patients with head and neck cancer experience a variety of psychological symptoms and disorders of anxiety and depression, possibly at rates greater than those seen in patients with other types of cancer.10

By identifying needs early on, we can better understand the survivor’s concerns, provide education, and make appropriate referrals. According to a review by Goldstein and colleagues, QOL in head and neck cancer patients worsens during and shortly after treatment and then gradually improves, approaching baseline levels 12 months after diagnosis.11 This is consistent with the time frame of our intervention. An awareness of the type of issues experienced by head and neck cancer patients is vital for accurate assessment and effective intervention. By identifying needs early on, we can better understand the survivor’s concerns, provide education, and make appropriate referrals. A review of the head and neck cancer studies by Pandey et al and Karnell et al identified that anxiety, depression, family distress, social distress, and impact on activities of daily living all resulted from a cancer diagnosis.12,13

Lung Cancer Lung cancer patients have been identified through multiple studies as having high levels of distress.14-16 Symptoms that increase distress that have repeatedly been identified for lung cancer patients include fatigue, pain, cough, dyspnea, sleep disruptions, decreased appetite, anxiety, depression, and problems with family relationships and physical and cognitive functioning. The 2 most reported symptoms are fatigue and pain.17,18 The lung cancer research clearly demonstrates the serious nature of distress and the

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impact on QOL. In their study of 333 patients in a multidisciplinary lung cancer clinic, Graves and colleagues utilized the distress tool and identified clinically significant distress in 61.6% of the patients.14 Sarna and colleagues describe serious disruptions in the psychological and social aspects of QOL in 217 women with non–small cell lung cancer who were between 6 months and 5 years out from diagnosis.18

CONCEPTUAL FRAMEWORK The conceptual framework used in this study was the QOL model for cancer survivors developed by Ferrell and Grant at the City of Hope (COH) Medical Center.19 QOL is defined as a multidimensional concept consisting of 4 domains that include physical, psychological, social, and spiritual well-being. The concept is based on the belief that each domain contributes to an individual’s perception of overall QOL.3 Results from the COH QOL questionnaire were going to provide the foundation for patient-directed goal setting focusing on the 4 domains of QOL. STUDY DESIGN Objective This study evaluated the impact of assessment, education, support, and guidance on QOL and distress in head and neck cancer and lung cancer patients who had completed a minimum of 4 weeks of radiation therapy at SHC. Method This study employed a nonexperimental, exploratory, descriptive design. The study was conducted in an outpatient radiation center in a large Southwestern community-based hospital. The sample for the study consisted of adult oncology patients with a lung cancer or head and neck cancer diagnosis receiving radiation therapy for at least 4 weeks. An anticipated enrollment in the study was 90 participants, based on the number of head and neck cancer and lung cancer patients treated at the hospital. Inclusion criteria included those older than 18 years, who were able to speak, read, write, and understand English, had a primary diagnosis of lung cancer or head and neck cancer, and were able to complete a minimum of 4 weeks of radiation therapy. Patients were identified by the nursing staff in radiation oncology. Patients who met the inclusion criteria were

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asked to consider participation in the study. If the patient agreed, he or she was enrolled into the study. The COH QOL for Cancer Survivors and NCCN Distress surveys with an attached cover letter were distributed by mail 1 month after the completion of radiation therapy. Patients were contacted by phone to schedule the first meeting with the case management team and to answer any questions concerning completion of the questionnaires. Each participant was assigned a survivorship advanced practice team. Program team members were master’s-prepared certified oncology nurses and/or master’s-prepared licensed medical social workers and were investigators in this study. After completion of the assessment tools described, participants met with a team member to review the results of the assessment tools and work together to define patient-specific goals. Survivors were to work with their primary team member to develop an action plan to help address their concerns and goals. Referrals to the appropriate services and providers would be initiated as needed. Additional didactic information addressing common issues facing cancer survivors was to be provided at each patient contact. Topics included maintaining personal health records, the medical treatment summary and follow-up plan, common physical and emotional concerns, and practical matters. Patients also received a LIVESTRONG™ Survivorship Notebook and other educational materials as determined by participant needs. Participant contact with a primary team member would occur on a monthly basis, and more or less frequently as indicated through ongoing assessment of patient needs. The additional contacts were conducted in person or via phone calls. In addition to individualized case management services, participants were offered personalized education, psychosocial support and referrals, and community education seminars. Collection of demographic information and QOL and Distress surveys were to be completed 1 month posttreatment, and they were to be repeated at 3 and 6 months after completion of radiation therapy. Surveys were to be either mailed to patients for completion or completed in person. Data collected in the study were to be reported in the aggregate without patient-identifying information to protect anonymity. The study was approved by the Institutional Review Board at SHC, where the investigators were employed.

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DATA ANALYSIS PLAN Data were to be entered using a double entry into a customized Excel spreadsheet. Discrepancies were to be checked and corrected. All data collected in this study were going to be documented using summary tables. Descriptive statistics were to be provided for each variable measured, by group and measurement period. Statistics were to include sample size, arithmetic mean, median, standard deviation, and minimum and maximum for continuous variables. Categorical variables were going to be summarized using frequencies and percentages. Geometric means were to be calculated for variables that are non-normally distributed. Statistical analyses were to be performed using SPSS version 16.0. The primary analysis was to compare Distress Thermometer and QOL scores at 6 months across groups. Preliminary analysis was to be conducted to assess the degree of intercorrelation among the domain scores on the QOL instrument and the single score on the Distress Thermometer.

In addition to individualized case management services, participants were offered personalized education, psychosocial support and referrals, and community education seminars. LESSONS LEARNED Participant Recruitment A major problem encountered was that our patient accrual was very slow. Patients chose not to participate for a variety of reasons. Our refusal rate was over 60%. Even for the patients who consented, not 1 patient was able to complete the study requirements. We chose this population of lung and head and neck cancer patients because we thought that these patients could benefit from extra assistance and education. However, our patients stated they did not have the energy to complete the forms or attend the meetings. Both were too burdensome and taxing. In our initial study, we also attempted to study a patient population with whom we did not have an established professional relationship. In the redesign, we chose patients according to our subspecialties

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area. This allowed the advanced practice nurse (APN) to develop a rapport with the patient before inviting him/her to participate in the study. We felt that developing a trusting relationship prior to an invitation to participate in the study also enhanced our recruitment process.

Developing a trusting relationship prior to an invitation to participate in the study also enhanced our recruitment process. Need for Study Revision The study has since been through several revisions. Through this process we have learned several lessons. First, the burden of a new diagnosis and treatment for severely ill patients, along with the burden of completing study questionnaires, was overwhelming. We needed to simplify the study. To facilitate recruitment, we broadened the study to include all newly diagnosed patients. All patients who agree to participate are given the NCCN Distress tool and the COH QOL tool. Upon completion of the questionnaires, the APN meets with the patient and significant other(s) to identify areas of concern and establish goals. The APN continues to meet with the patient as necessary. After 3 months of interventions, the patient is given an evaluation form to complete, assessing whether the APN’s interventions and education were helpful. Implementing this simple and less- complicated design, we are continuing to recruit and maintain patients. CONCLUSION Cancer survivorship care represents a major area of research opportunities. In developing a survivorship program that encompasses the needs of our patients, this was our first attempt to conduct a research study. We learned that a simplified research design and less strict recruitment criteria were beneficial. With our current simplified design, we are recruiting and maintaining patients. One of our most important lessons was that research happens by persevering through obstacles and multiple revisions. Most importantly, through our persistent efforts, our goal remains

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to assist our patients in meeting their needs by providing individualized care to help minimize distress and improve their QOL. g

REFERENCES

1. American Cancer Society. Learn about cancer. www.cancer. org/Cancer/news/News/numberofuscancersurvivorsgrowing. Accessed January 5, 2012. 2. Clark EJ, Stovall EL, Leigh L, et al. Imperatives for quality cancer care: access, advocacy, action, and accountability. In: Scherr SL, ed. Self-Advocacy: A Cancer Survivor’s Handbook. Silver Spring, MD: National Coalition for Cancer Survivorship; 1996. 3. Hewitt M, Greenfield S, Stovall, E, eds. From Cancer Patient to Cancer Survivor: Lost in Transition. Washington, DC: The National Academies Press; 2005. 4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Distress Management. http://nccn.org/professionals/physician_gls/PDF/distress.pdf. Accessed January 7, 2012. 5. Vachon M. Psychosocial distress and coping after cancer treatment. Cancer Nurs. 2006;29(2 suppl):26-31. 6. National Cancer Institute. Anxiety disorder PDQ. www.cancer.gov/cancertopics/pdq/supportivecare/anxiety/healthprofes sional. 2008. Accessed February 5, 2009. 7. Alfano CM, Rowland JH. Recovery issues in cancer survivorship: a new challenge for supportive care. Cancer J. 2006;12:432-443. 8. Ferrell BR, Grant M, Dow KH. Quality of life model applied to cancer survivors. http://prc.coh.org/pdf/cancer_survivor_ QOL.pdf. 2004. Accessed February 5, 2009. 9. Rogers SN, Ahad SA, Murphy AP. A structured review and theme analysis of papers published on ‘quality of life’ in head and neck cancer: 2000-2005. Oral Oncol. 2007;43:843-868. 10. Haman KL. Psychologic distress and head and neck cancer: part 1—review of the literature. J Support Oncol. 2008;6:155163. 11. Goldstein DP, Hynds Karnell L, Christensen AJ, et al. Health-related quality of life profiles based on survivorship status for head and neck cancer patients. Head Neck. 2007;29: 221-229. 12. Pandey M, Devi N, Thomas B, et al. Distress overlaps with anxiety and depression in patients with head and neck cancer. Psychooncology. 2007;16:582-586. 13. Karnell L, Christensen AJ, Rosenthal EL, et al. Influence of social support on health-related quality of life outcomes in head and neck cancer survivors. Head Neck. 2007;29:143-146. 14. Graves KD, Arnold SM, Love CL, et al. Distress screening in a multidisciplinary lung cancer clinic: prevalence and predictors of clinically significant distress. Lung Cancer. 2007;55:215224. 15. Logue AE, Gawiak CT, Houlihan N, et al. Development of a non-small cell lung cancer (NSCLC) survivorship program: baseline clinical characteristics and quality of life (QOL): PD53-8. J Thoracic Oncol. 2007;2:S481. 16. Zabora J, BrintzenhofeSzoc K, Curbow B, et al. The prevalence of psychological distress by cancer site. Psychooncology. 2001;10:19-28. 17. Cooley ME, Short TH, Moriarty HJ. Symptom prevalence, distress, and change over time in adults receiving treatment for lung cancer. Psychooncology. 2003;12:694-708. 18. Sarna L, Brown JK, Cooley ME, et al. Quality of life and meaning of illness of women with lung cancer. Oncol Nurs Forum. 2005;32:E9-E19. 19. Ferrell BR, Grant M. Quality of life Patient/Cancer Survivor version. http://prc.coh.org/QOL-CS.pdf. Accessed February 12, 2009.

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Jeanne Chaivous, MSW Temple University, Philadelphia, Pennsylvania

Abstract: Cancer patients face a myriad of psychosocial and practical issues. Especially challenging is the time from an initial diagnosis to the onset of treatment, and patient navigation services are important to guide patients, especially underserved populations, through this maze of uncertainty. Here we report on the Pennsylvania Patient Navigator Demonstration Project (PaPND) designed to evaluate the acceptability, feasibility, and impact of a culturally and linguistically appropriate nonclinical navigator program. The development of the project, based on behavioral theory and community-based participatory research principles, is described. Forty-four cancer patients from diverse backgrounds participated in the study, which included a baseline assessment, navigation services, and a 4-week and 12-week follow-up assessment. On average, participants experienced 1.8 barriers, with transportation and insurance issues the most common barriers. The majority (56%) of the barriers required more than an hour of the navigator’s time to address, with insurance, transportation, and caregiver/support issues requiring the most time. Overall, patients were fairly satisfied with the navigation services. After patient navigation, the findings showed improvement in patients’ worry, their understanding of their disease, and their beliefs in the importance of treatment, as well as their own self-efficacy in managing cancer-related issues. Results also suggest issues that need to be addressed include providing and connecting cancer patients to appropriate information to improve their understanding of their diagnosis and their recommended treatments and areas in which the integration of nonclinical and clinical navigation is essential. In addition, more attention to the assessment of psychosocial issues, such as the patients’ emotional worries, and more comprehensive training in these areas would enhance navigation programs.

ancer patients from all backgrounds face a myriad of psychosocial and practical issues that impact their cancer diagnosis, treatment, and survivorship experience.1-3 The time from an initial diagnosis to the onset of treatment can be overwhelming for patients as they need to manage multiple providers and healthcare systems, understand their insurance coverage and the specifics of their diagnosis and treatment options, as well as deal with the emotional challenges of facing an often unexpected diagnosis. Patient navigation programs and strategies have emerged as an important approach to addressing the range of psychosocial issues; access to care; and utilization of cancer screening, diagnostic, and treatment services.4 The role of patient navigation in cancer screening and care was initiated in the Harlem Cancer Education and Demonstration Project in the early 1990s,

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when patient navigation served as a means to improve timely movement along the cancer care continuum in medically underserved populations.5 Since that time, federally funded research has been implemented to evaluate the impact of patient navigation services, various government and voluntary agencies have developed patient navigation models and services, professional associations have emerged, and the evidence base supporting the positive effects of patient navigation has grown.6 Within the emerging field of patient navigation,4 numerous models and approaches have been described, including clinical (often nurse navigators) and nonclinical (other health professionals and/or community health workers) navigation and mixed models that include both approaches.7-9 Often these different models are implemented based on where along the cancer

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continuum the patient navigation services are focused. Although current randomized control trials are expected to provide more definitive conclusions about impact and cost-effectiveness of patient navigation, there are lessons to be learned from ongoing program evaluations and demonstration projects focused on establishing and implementing patient navigation in realworld settings.10,11 Toward that end, we conducted a demonstration project, called the Pennsylvania Patient Navigator Demonstration Project (PaPND) funded by the Pennsylvania Department of Health. The aims of the PaPND were to evaluate the acceptability, feasibility, and impact of a culturally and linguistically appropriate navigator program relying on a nonclinical patient navigation model. Specifically, the role of the nonclinical navigators was to address psychosocial and access barriers for patients during the period between diagnosis and initiation of treatment. The program was guided by the Cognitive-Social Health Information Processing (C-SHIP) theoretical framework,2,3 which focuses on the cognitive and emotional factors as well as the practical skills that impact health behaviors. Our goal was to infuse these concepts into the navigator training and baseline assessment and evaluate the impact of navigation on these factors. Our previous experience in service-related research12 supported our approach to the design and implementation of the program using community-based participatory research (CBPR)13,14 concepts by involving the sites in the grant application and project development process, funding a dedicated onsite navigator, jointly supervising the navigator, and participating in the evaluation. Navigation services were offered to all patients who had just been diagnosed with breast, cervical, prostate, colorectal, or lung cancer and were provided in both English and Spanish. The evaluation included data on barriers faced by participants, navigatorâ&#x20AC;&#x2122;s time to address the barriers, impact on psychosocial needs, and satisfaction with the navigation services.

METHODS Study Site This nonrandomized, longitudinal 3-year demonstration project was developed and conducted at Temple University Hospital in Philadelphia, Pennsylvania. At the time that this project was

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initially planned, there were few patient navigation programs and even fewer best practice training and implementation tools. Therefore, we developed a patient navigator training program and institution-specific implementation procedures and processes; we also designed and conducted a program evaluation. Temple University Health System (TUH) is an urban 514-bed tertiary medical center, which provides care to over 20,000 inpatients and 150,000 outpatients annually. The hospital serves a predominantly low-income population, and the patient population is 47% African American and 14% Hispanic. This site was chosen to address the needs of historically medically underserved populations. This study was approved by the Institutional Review Board at Fox Chase Cancer Center and Temple Medical System.

Specifically, the role of the nonclinical navigators was to address psychosocial and access barriers for patients during the period between diagnosis and initiation of treatment. Inclusion/Exclusion Criteria of Participants Eligible participants were at least 18 years of age, with a diagnosis of breast, cervical, colorectal, prostate, or lung cancer. Participants were ineligible for the study if they could not speak English or Spanish, were unable to give proper informed consent, or had already begun treatment for their cancer diagnosis. Participants were referred to the program by physicians, radiologists, and pathologists or were identified directly by the navigator as eligible for the program. Development of Program and Training Building on the emerging literature on patient navigation and CBPR principles, procedures and processes were developed in collaboration with the implementation-site investigator and key hospital staff. The key goals were to develop the navigator job description, determine the organizational reporting structure, install the navigation tracking software, study procedures and processes, and oversee ongoing project management. Fox Chase Cancer Center research staff focused most

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on the research study implementation while the community-based cancer center focused on case management of patient care and treatment. The integration of research and service was overseen by project managers at both sites through weekly contact to coordinate, review, and discuss the research study, implementation, research issues, and data collection. Management and administration of the patient navigation program also required considerable logistical coordination, involving numerous planning meetings, participation in various cancer program meetings to address potential concerns, and development of an implementation process that was congruent with hospital operations and policies. The team addressed program planning with collaborative and creative coordination, including the development of a customized contact-management software package (SugarCRM Enterprise), which provided a system to keep notes on each contact with participants and any follow-up with other entities (eg, insurance company, transportation, primary care, etc).

The navigator possessed a bachelor’s degree in social work, was bilingual (English/Spanish), and was from the community in which participants were recruited, giving her an intimate knowledge of the community’s population and resources. A comprehensive, 2-week navigation training, modeled on the National Cancer Institute’s (NCI) Cancer Information Service training and the Pfizer Patient Navigation in Cancer Care Toolkit, included face-to-face sessions with a staff trainer, self-directed learning modules, and 2 online sessions. Topics covered included basic cancer concepts, the cancer continuum, resources, and barriers to treatment. Training was also provided on key navigator skills such as assessment and problem identification, the navigator’s role and responsibilities, and communication skills. The CSHIP framework was integrated throughout the training to ensure that the patient navigator understood the importance of both cognitive and

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affective issues as well as how to address these issues when providing navigation services. The training also included a component on the value of research as well as Health Insurance Portability and Accountability Act (HIPAA) and Human Subjects Protection certification.

Navigator Qualification and Training The patient navigator was recruited and hired by TUH, with the assistance and consultation of Fox Chase Cancer Center. The navigator possessed a bachelor’s degree in social work, was bilingual (English/Spanish), and was from the community in which participants were recruited, giving her an intimate knowledge of the community’s population and resources. She had no previous experience with formalized patient navigation or behavioral research. Once hired, Fox Chase provided the navigator with in-depth training on patient navigation. The implementation site provided its own institutional orientation. Study Implementation Patients were identified by the registration list or by direct referral from providers. The patient navigator first contacted eligible individuals by phone to obtain provisional informed consent and then secured final, written informed consent and HIPAA authorization at the first faceto-face clinic appointment. In addition, the navigator administered a baseline psychosocial survey and identified barriers to obtaining treatment and care. Two follow-up telephone assessments were administered by study research assistants at 4- and 12-weeks after the baseline assessment to determine the impact of the navigator intervention. Self-reported patient satisfaction was included in both the 4 and 12-week assessments. All study measures and follow-up interviews were conducted in either English or Spanish, as appropriate. To track barriers and the services provided to each participant, the navigator used the tracking software. Data recorded in this log included participant demographics, participant eligibility, barriers experienced, services provided, and the time period to address the recorded barriers. A section was available to record more detailed narrative. Individuals who were in need of navigator services but did not want to participate in the study were provided with these services.

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(Physician, radiology, pathology)

Continues providing ongoing service

Navigator calls patient

Navigator follow-up

• Determines eligibility • Obtains verbal consent

Extracts information from chart 2 months

Research Assistant

p Navigator meets patient • Obtains written consent • Conducts baseline survey • Completes assessment using online management log

Telephone follow-up 4 weeks

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Navigator service

Patient referred to navigator

Study Measures and Analysis The baseline survey was used to provide the initial patient needs assessment as well as to collect data for the study evaluation. The baseline measures included demographics, health status, cancer diagnosis, and perceived barriers to care. The barriers were categorized using the C-SHIP framework into (1) practical barriers (ie, health insurance copays), (2) negative cognitions (eg, lack of understanding of treatment procedures), (3) negative expectancies and beliefs (eg, fatalism), and (4) affective barriers (eg, worry about diagnosis). These measures were assessed not only at baseline but also at 4 weeks and 12 weeks post initial consult. A face-valid 9-item questionnaire on patient satisfaction, designed by the study team, was administered at both the 4week and 12-week follow-up assessments. These questions evaluated participants’ satisfaction with the navigator services, such as receiving cancer-related information, assistance with insurance-related problems, and getting community services. Participants were asked to indicate their agreement with each statement on a 5-point scale (0 = “Not at all” to 4 = “Very much”), and then scores were summed for an overall satisfaction score. After the initial consult and completion of the baseline survey, the navigator provided navigation services and tracked specific barriers that were addressed in the case management software. The navigator contacted the patients as needed during the treatment process. The barriers were tracked across the array of barriers (eg, transportation, scheduling, insurance, physical/ emotional support, housing/living issues, caregiver support, referral issues, other systems issues, and other financial issues). A barrier was defined as an issue described by the participant and subsequently addressed by the patient navigator. The navigator also recorded the time required to address each barrier. Descriptive statistics were generated for all variables and barrier data. A 2-sided, nonparametric, Wilcoxon signed-rank test was used to ascertain the difference in satisfaction scores at 4 and 12 weeks. Significance was determined at the 0.05 level, and data analysis was done using SAS version 9.2.

Figure 1 Overall Study Design of the Pennsylvania Patient Navigator Demonstration Project

Figure 1 depicts the overall study design and implementation.

Telephone follow-up 12 weeks

RESULTS Background Characteristics Participants enrolled in the study (N = 44) provided written consent and completed the baseline assessment. Table 1 shows the baseline characteristics of the study population. All participants were followed up after 4 weeks, and about 80% were followed up after 12 weeks. The mean age of the enrolled participants was 56.7 years (SD = 11.7; median = 55). The majority were African American (64%), were women (82%), earned less than $15,000 annually (63%), were unemployed (91%), and had a high school education or less (80%). Breast and prostate cancers represented over 70% of the case load. Just under one-third of participants reported being Hispanic/Latino. Addressing Identified Barriers On average, participants experienced 1.8 barriers (SD = 1.1; min = 1; max = 4). Figure 2 describes the types of barriers addressed by the navigators.

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Figure 2 Frequency of the Different Types of Patient Barriers Recorded by the Patient Navigator 35

31 30

Frequency

25 20

10 5

0 Referral Issues

Other Caregiver/ Insurance TransporOther Scheduling Housing/ Physical tation Financial Support and Living System Situation Emotional Issues Systems Issues Challenges

Barrier Type

Transportation and insurance issues (practical barriers) were the most common, representing nearly 60% of all the barriers addressed. Support issues (physical, emotional, caregiver) represented nearly 20% of the barriers addressed. We also reviewed the time required to address these barriers and created 3 categories: 30 minutes or less; 30 to 60 minutes, and greater than an hour. The majority (56%) of the barriers required more than an hour of the navigator’s time to address, with insurance, transportation, and caregiver/support issues requiring the most time (Table 2).

The majority (56%) of the barriers required more than an hour of the navigator’s time to address, with insurance, transportation, and caregiver/support issues requiring the most time. Patient Satisfaction Satisfaction was assessed through telephone follow-ups, and satisfaction items addressed how the navigator helped with cancer-related information, provided help with insurance and various medical services, was culturally sensitive, and helped with family and other responsibilities.

Higher scores indicated higher levels of satisfaction. The highest-rated items included seeking cancer-related information, access to care and community services, and being culturally sensitive (Table 3). There was improvement, although not significant, in specific measures over time. The overall satisfaction score significantly increased from 4 weeks (2.7) to 12 weeks (3.5). Table 3 depicts the mean scores of each of the 9 satisfaction items.

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Impact of the Navigator Interventions on Changes in Cognitive-Affective Measures Descriptive and exploratory analyses were conducted for the cognitive-affective measures that were evaluated through self-reported assessment at baseline, 4 weeks, and 12 weeks. The measures were assessed on a 5-point scale (1 = “Strongly disagree” to 5 = “Strongly agree”). These measures included cancer worry, knowledge about treatment, beliefs about following the treatment regimen, and ability to cope with self–management related issues. Table 4 shows the mean and standard deviation of the items that showed significant changes on the post navigation assessment. Higher scores reflect more positive self-perceptions, except for worry measures. Two of the knowledge-related measures showed significant improvement at 12 weeks. Reductions in worry about the cancer diagnosis, pain, life changes, and embarrassment were seen at 4 and 12 weeks. Expectancies and beliefs or values/goals measures also showed improvement. Patients reported higher scores on the importance of adhering to the treatment plan, following through with physician recommendations, and the importance of family support. In regard to self-regulatory skills, patients reported improvements in management of distress, ways to cope with financial related issues, remembering appointments, and managing other responsibilities. DISCUSSION The Pennsylvania Navigating Cancer Patients (PaPND) demonstration project evaluated the acceptability, feasibility, and impact of a culturally and linguistically appropriate patient navigator model in an urban hospital. Findings from this study contribute to the emerging literature base that investigates the use of navigation during the period from cancer diagnosis to treatment. The PaPND had a modest budget and focused prima-

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Table 1 Background Characteristics of Study Participants (N = 44) Age 55 years or younger

N (%) 22 (50)

Older than 55 years

22 (50)

Race American Indian/Alaskan Native Asian

1 (2.3) 1 (2.3)

African American

28 (63.6)

Pacific Islander Caucasian

0 (0) 14 (31.8)

Ethnicity Hispanic/Latino Nonâ&#x20AC;&#x201C;Hispanic/Latino Gender Male Female Marital status Single/Never married Single/Living with other Married Separated, divorced, or widow(er) Annual income Less than $15,000 $15,000 or more Education level High school or less College or more Employment Unemployed Employed Current smoker? Yes No Have some type of private or government insurance? Yes No Cancer diagnosis Breast Cervical Colorectal Lung Prostate

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14 (31.8) 30 (68.2) 8 (18.2) 36 (81.8) 15 (34.1) 2 (4.5) 9 (20.5) 18 (40.9) 28 (63.6) 16 (36.4) 35 (79.5) 9 (20.5) 40 (90.9) 4 (9.1) 16 (36.4) 28 (63.6) 38 (86.4) 6 (13.6) 23 (52.3) 3 (6.8) 6 (13.6) 3 (6.8) 9 (20.5)

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Table 2 Types of Patient Barriers Recorded and Time Required to Address These Barriers (79 barriers recorded) ≤30 Minutes n (%)

31-60 Minutes n (%)

>1 Hour n (%)

Total N (%)

Scheduling

1 (3.6)

1 (11.1)

1 (2.3)

3 (3.8)

Insurance

4 (15.4)

0 (0)

13 (29.6)

17 (21.5)

Transportation

10 (38.5)

4 (44.4)

17 (38.6)

31 (39.2)

1 (3.6)

0 (0)

2 (4.6)

3 (3.8)

0 (0)

1 (2.3)

1 (1.3)

Other financial issues

4 (15.4)

1 (11.1)

4 (9.1)

9 (11.4)

Physical and emotional challenges

3 (11.5)

2 (22.2)

0 (0)

5 (6.3)

Caregiver/Support systems

3 (11.5)

1 (11.1)

6 (13.6)

10 (12.7)

26 (32.9)

9 (11.4)

44 (55.7)

79 (100)

Barrier

Housing/Living situation Other system issues

Total

rily on the process of implementing a nonclinical patient navigator program and the impact on psychosocial issues among an underserved population. The findings support that the program was feasible and that patients were satisfied with the navigation services. Of note, the navigator role was continued by TUH after the project ended. A number of important features of this study should be noted. It is one of the few studies that were conducted in both English and Spanish, with bilingual navigation, bilingual research staff, and Spanish language study instruments. It also relied on CBPR principles and involved the implementation site in all stages of the project.

Impressively, as a result of the study, the hospital elected to make the patient navigator position a full-time, permanent position. We utilized a dynamic management structure by which the research institution managed the research protocol remotely and the study-site institution managed the day-to-day navigator responsibilities. Remote management made it more difficult for the research institution to assess the navigator’s fidelity to the recruitment protocol and to determine when booster research trainings were necessary. However, the study site was involved in a number of decision-making processes (management, budgeting, and administrative

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processes). Perhaps the major challenge was the integration of service and research, with hospital leadership having limited experience in research. Future projects might consider focusing on the value and skills of research using CBPR or other community-engaged approaches to ensure more integration between the research institution and the practice institution.15 The results of the evaluation indicate that the patient navigator addressed close to 2 barriers per patient. The primary barriers were practical concerns, such as transportation and insurance, and these barriers required considerable time to address. However, almost 1 in 5 barriers were in the psychosocial domain, and the follow-up results indicate significant improvement in stress-related thoughts and key psychosocial measures, including a reduction in cancer-related worry. Overall, the participants were satisfied with the services of the patient navigator, especially related to the barriers that were addressed. The program was well received by the implementation site as indicated by the active participation throughout the entire project. Impressively, as a result of the study, the hospital elected to make the patient navigator position a full-time, permanent position. Our study experienced limitations and challenges. First, the sample size was smaller than we had anticipated. Based on projected caseloads at the implementation site, we expected to recruit 20 participants per month during the 18-month implementation for a maximum caseload of 350 participants. Of 147 participants who met the study’s eligibility criteria, only 44 consented to

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Table 3 Mean (SD) Patient Satisfaction Scores of Navigator Services Provided ( (0 = "Not at all satisfied" to 4 = "Highly satisfied") Satisfaction Measure Items

4 Weeks

12 Weeks

Seeking cancer-related information

3.3 (1.3)

3.5 (1.2)

Getting medical services

3.1 (1.5)

3.6 (1.8)

Taking care of insurance-related problem

2.5 (1.9)

3.6 (1.8)

Scheduling recommended appointments

2.5 (1.8)

3.4 (1.3)

Getting community services

2.7 (1.8)

3.6 (1.3)

Being sensitive to cultural needs

2.8 (1.8)

3.7 (1.6)

Handling family needs at home

2.2 (1.9)

3.1 (1.3)

Answering any concerns

3.1 (1.6)

3.6 (1.7)

Dealing with other responsibilities

2.3 (1.9)

3.4 (1.8)

Overall mean across items

2.7 (1.7)

3.5 (1.6)

participate in the study. This low accrual rate might be attributed to patient skepticism regarding participation in research, the time required to complete the baseline assessment, and limited training of the navigator in the nature and value of research and the research process. More training in study recruitment might have been helpful since the patient navigator did not have previous experience in behavioral research. In scenarios in which there is limited or no experience in behavioral research, patient navigator training should include modules discussing the understanding of research, the value of conducting research, the role of research protocols, and the importance of accrual and program fidelity. Although patients were satisfied, and the navigator addressed some of the critical issues regarding access to care, the evaluation results suggest that issues need to be addressed, including providing and connecting cancer patients to appropriate information to improve their understanding of their diagnosis and recommended treatments and identifying where the integration of clinical navigation is essential. In addition, more attention to the assessment of psychosocial issues, such as the patientsâ&#x20AC;&#x2122; emotional worries, and more comprehensive training in these areas would enhance navigation programs. As patient navigation in cancer care becomes a standard component of patient-centered care, it is important to explore the various models of navigation and evaluate the adaptation of patient navigation functions across the cancer

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continuum. The large, NCI-funded Patient Navigation Research Program studies will undoubtedly fill existing empirical gaps on the impact, cost-effectiveness, and sustainability of navigator programs.11,16,17 In addition, there is a need to evaluate the feasibility of implementing patient navigation programs at the community level18-20 as this is still where much cancer care is delivered. This study and others will provide

As patient navigation in cancer care becomes a standard component of patient-centered care, it is important to explore the various models of navigation and evaluate the adaptation of patient navigation functions across the cancer continuum. valuable information to determine the resources, both in personnel and infrastructure, that are necessary to promote sustainability in the real-world, community setting.11 As patient navigation is emerging as a viable intervention to reduce patient, provider, and systems barriers,11 it is important to explore how to expand these programs to systematically assess and address the broad array of psychosocial issues that face patients along their journey from diagnosis to survivorship. g

JOURNAL OF ONCOLOGY NAVIGATION & SURVIVORSHIP

ORIGINAL RESEARCH

Table 4 Improvement of Cognitive-Affective Measures at 3 Assessment Points (1 = “Not at all” to 5 = “Extremely”) Baseline Mean (SD)

4 Weeks Mean (SD)

12 Weeks Mean (SD)

How well do you understand the treatment procedures that were recommended (eg, radiation, chemotherapy) and why it is recommended that you have them? (Knowledge)

3.63 (1.09)

3.82 (0.95)

3.97 (0.95)*

How well do you understand the side effects of your recommended cancer treatments? (Knowledge)

3.48 (1.17)

3.48 (1.02)

3.88 (1.19)*

How worried are you about your cancer diagnosis? (Worry)

3.75 (1.30)

2.93 (1.56)*

2.94 (1.64)*

How worried are you about having pain or discomfort from the cancer treatments? (Worry)

3.91 (1.20)

3.23 (1.57)*

3.27 (1.61)*

How worried are you about how your life will change as a result of your cancer diagnosis? (Worry)

3.59 (1.34)

2.70 (1.49)*

2.82 (1.49)*

How embarrassed are you about having cancer? (Worry)

2.41 (1.58)

1.75 (1.35)*

1.48 (1.00)*

How important is it to stick to the treatment plan (eg, come to all scheduled treatment appointments and not skip any appointments)? (Beliefs)

4.73 (0.50)

4.95 (0.21)*

4.97 (0.17)*

How important is it for you to follow through with all of your doctor’s recommendations? (Beliefs)

4.77 (0.42)

5.00 (0.00)*

4.94 (0.24)

How important is it to your family that you get your cancer treatment? (Beliefs)

4.80 (0.46)

4.95 (0.21)*

5.00 (0.00)*

How well do you have ways to manage any distress you may be experiencing about your cancer diagnosis or treatments? (Self-efficacy)

3.14 (1.09)

4.12 (1.03)*

4.12 (1.17)*

How well do you have ways to manage the cost of the cancer treatment appointments? (Self-efficacy)

3.00 (1.31)

4.07 (1.13)*

4.21 (1.11)*

How well do you have ways of getting referral letters you might need for insurance purposes? (Self-efficacy)

3.30 (1.39)

4.35 (0.98)*

4.39 (1.03)*

How well do you have ways to make sure you will remember your treatment and follow-up appointments? (Self-efficacy)

4.09 (1.01)

4.84 (0.43)*

4.70 (0.73)*

How well do you have ways to manage your other responsibilities, such as getting childcare or eldercare, or covering yourself at work, so that you can keep your medical appointments? (Self-efficacy)

3.50 (1.49)

4.45 (0.83)*

4.74 (0.54)*

Items

*Indicates a statistically different mean compared to baseline mean.

JUNE 2012 • VOLUME 3, ISSUE 3

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ORIGINAL RESEARCH

CORRESPONDING AUTHOR Suzanne Miller, PhD Senior Member and Professor Director, Psychosocial and Biobehavioral Medicine Program Fox Chase Cancer Center Robert C. Young Pavilion 333 Cottman Ave. - 4th Floor Philadelphia, PA 19111 Tel: 215-728-4069 Fax: 215-214-1651 Email: Suzanne.MillerHalegoua@fccc.edu DISCLOSURE OF FUNDING This work was supported by a grant from the Pennsylvania Department of Health (SAP ACKNOWLEDGMENTS The authors want to acknowledge the efforts of each implementation site, especially project coordinators and patient navigators. In addition, we acknowledge the support of Fox Chase Cancer Center’s Behavioral Core Facility and the Office of Health Communications & Health Disparities. REFERENCES 1. Miller SM, Bowen DJ, Croyle RT, et al, eds. Handbook of Cancer Control and Behavioral Science: A Resource for Researchers, Practitioners, and Policy Makers. Washington, DC: American Psychological Association; 2009. 2. Miller SM, Diefenbach MA. C-ship: a cognitive-social health information processing approach to cancer. In: Krantz D, ed. Perspectives in Behavioral Medicine. Mahwah, NJ: Lawrence Erlbaum; 1998. 3. Miller SM, Shoda Y, Hurley K. Applying cognitive-social theory to health-protective behavior: breast self-examination in cancer screening. Psychol Bull. 1996;119:70-94. 4. Thompson FE, Midthune D, Subar AF, et al. Development and evaluation of a short instrument to estimate usual dietary intake of percentage energy from fat. J Am Diet Assoc. 2007;107:760-767.

5. Freeman HP, Muth BJ, Kerner JF. Expanding access to cancer screening and clinical follow-up among the medically underserved. Cancer Pract. 1995;3:19-30. 6. Esparza A, Calhoun E. Measuring the impact and potential of patient navigation: proposed common metrics and beyond. Cancer. 2011;117(suppl 15):3535-3536. 7. Burstein HJ Jr. What is a patient navigator, and should we have them in major cancer centers? J Natl Compr Canc Netw. 2009;7:905. 8. Dohan D, Schrag D. Using navigators to improve care of underserved patients: current practices and approaches. Cancer. 2005;104:848-855. 9. Wells KJ, Battaglia TA, Dudley DJ, et al. Patient navigation: state of the art or is it science? Cancer. 2008;113:1999-2010. 10. Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities. Centers for Medicare & Medicaid Services Web site. URL Published February 8, 2011. Accessed May 31, 2012. 11. Freund KM, Battaglia TA, Calhoun E, et al. National Cancer Institute Patient Navigation Research Program: methods, protocol, and measures. Cancer. 2008;113:3391-3399. 12. Fleisher L, Kornfeld J, Davis S, et al. The NCI’s Cancer Information Service’s Research Continuum Framework: integrating research into cancer education practice (1999-2004). J Cancer Educ. 2007;22(suppl 1):S41-S48. 13. Israel BA, Eng E, Schulz A, et al, eds. Methods in Community-Based Participatory Research for Health. San Francisco, CA: Jossey-Bass; 2005. 14. Minkler M, Wallerstein N, eds. Community-Based Participatory Research for Health. San Francisco, CA: JosseyBass; 2003. 15. Steinberg ML, Fremont A, Khan DC, et al. Lay patient navigator program implementation for equal access to cancer care and clinical trials: essential steps and initial challenges. Cancer. 2006;107:2669-2677. 16. Ferrante JM, Chen PH, Kim S. The effect of patient navigation on time to diagnosis, anxiety, and satisfaction in urban minority women with abnormal mammograms: a randomized controlled trial. J Urban Health. 2008;85:114-124. 17. Ramsey S, Whitley E, Mears VW, et al. Evaluating the costeffectiveness of cancer patient navigation programs: conceptual and practical issues. Cancer. 2009;115:5394-5403. 18. Freeman HP. Patient navigation: a community based strategy to reduce cancer disparities. J Urban Health. 2006;83:139-141. 19. Freeman HP. Patient navigation: a community centered approach to reducing cancer mortality. J Cancer Educ. 2006;21(suppl 1):S11-S14. 20. Nguyen TT, McPhee SJ, Bui-Tong N, et al. Communitybased participatory research increases cervical cancer screening among Vietnamese-Americans. J Health Care Poor Underserved. 2006;17(suppl 2):31-54.

Visit our user-friendly Web site www.AONNonline.org In addition to Web-only exclusives, news coverage, journal articles, contests, and polling questions, you’ll have the opportunity to participate in a number of activities offered!

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JOURNAL OF ONCOLOGY NAVIGATION & SURVIVORSHIP

Third Annual Navigation and Survivorship Conference PRELIMINARY AGENDA* Friday, September 14 12:45 – 1:00pm

1:00 – 2:00pm & 2:15 – 3:15pm

3:15 – 3:30pm 3:30 – 5:00pm

5:00 – 6:00pm 6:00 – 8:00pm

Welcome Conference Co-Chairs: Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS Pre-Conference Workshops Beginners Track • Core Principles of Navigation Nicole Messier, RN, BSN Pamela J. Vlahakis, RN, MSN, CBCN Members • Getting Excited about Research – Case Examples Linda Fleisher, PhD, MPH Elaine Sein, RN, BSN, OCN, CBCN • Panel Discussion: Building Optimal Community Outreach – Lay and Community Jean B. Sellers, RN, MSN (Moderator) Leah Leilani Beck, BS Jessica Denton, MSW • Implementing a Survivorship Program/Clinic Cynthia Waddington, RN, MSN, AOCN Break Administrators Track • Administering a Navigation Program Bonnie J. Miller, RN, BSN, OCN, FAAMA Elizabeth Whitley, PhD, RN Navigators Track • How Do Case Managers and Navigators Interface? Nancy Skinner, RN-BC, CCM FREE TIME Welcome Reception/Posters in the Exhibit Hall

Saturday, September 15 7:30 – 8:30am 8:30 – 8:45am 8:45 – 9:45am

9:45 – 10:00am 10:00 – 11:30am

Breakfast Symposium/Product Theater Welcome & Introductions Conference Co-Chairs General Session 1: Navigation Update: 2012 Current Regulations – Navigation & Survivorship Care Plan Linda Ferris, PhD Break Disease-Site–Specific Breakouts Stand-Alone Sessions • Breast Cancer Navigation Mary Rooney, RN, BSN, OCN • Thoracic Oncology Navigation Pamela Matten, RN, BSN, OCN • GI Cancer Navigation Coralyn Martinez, MSN, RN, OCN • Colorectal Cancer Navigation Maura Kadan, RN, MSN, OCN • GYN Cancer Navigation Robin A. Atkinson, RN, BSN, OCN

11:45 – 1:00pm 1:15 – 2:15pm 2:15 – 3:15pm

3:15 – 4:15pm

4:15 – 5:00pm

5:00 – 7:00pm 7:00pm

• Prostate Cancer Navigation Juli Aistars, RN, MS, APN, AOCN Rapid Fire Sessions with Panel • Head, Neck, & Neuro Navigation Heather Stern, RN, BSN, CNOR, OCN And • Hematology/Oncology Tina Scherer, RN, MSN, OCN Administrators Session • The Role of the Administrator Lisa Shalkowski, RN, BSN, MSM Lunch in the Exhibit Hall Advocacy Keynote TBD General Session 2: Best Practices in Survivorship Care Rehabilitation Julie Silver, MD General Session 3: Plenary Session Financial and Legal Issues for Our Cancer Patients David S. Landay, JD The Art of Exceptional Professional Performance – Making a Difference in Your Patients’ Lives Selinza Mitchell, RN Poster Award Reception in the Exhibit Hall Pamela Matten, RN, BSN, OCN Conclusion of Day – Networking FREE TIME

Sunday, September 16 7:30 – 8:30am 8:30 – 9:30am

Breakfast Symposium/Product Theater General Session 4: Navigation in the Age of Personalized Cancer Care Sharon Gentry, RN, MSN, AOCN, CBCN Lillie D. Shockney, RN, BS, MAS 9:30 – 10:30am General Session 5: Best Practices in Addressing Health Inequities Lauren Kelley, MSW, MPA Adrienne Lofton, RN, MSN 10:30 – 10:45am Break 10:45 – 12:15pm Practice Setting – Panel Discussion with Moderator • Office-Based Roxanne Parker, RN, MSN, CPN (Moderator) • Academic Bonnie J. Miller, RN, BSN, OCN, FAAMA • Community Hospital–Based Karyl Blaseg, RN, MSN, OCN 12:15 – 1:15pm Lunch in the Exhibit Hall 1:30 – 2:30pm Clinical Survivorship Guidance Mandi Pratt-Chapman, MA Katherine Sharpe, MTS 2:30 – 2:45pm Conclusion/Final Remarks Conference Co-Chairs *Preliminary agenda, subject to change.

September 14-16, 2012 CONFERENCE REGISTRATION Register online: www.regonline.com/aonn2012 *Early Bird Rate: $295 Phoenix, Arizona Conference Registration: $345 Arizona Grand Includes Membership through September 30, 2013. Includes Membership through September 30, 2013. *Early bird expires August 1, 2012.

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

TARGET AUDIENCE AONN’s Third Annual Conference is the only meeting that gives you access to decision-makers and key practitioners involved in oncology navigation and survivorship. If your company provides any of the following services/products for the oncology healthcare community, this is the meeting for you. This educational initiative is directed toward oncology nurse navigators, patient navigators, and social workers.

Lillie D. Shockney, RN, BS, MAS University Distinguished Associate Professor of Breast Cancer Adm Director, Johns Hopkins Clinical Breast Programs Adm Director, Johns Hopkins Cancer Survivorship Programs Depts of Surgery and Oncology Associate Professor, JHU School of Medicine, Depts of Surgery, Oncology and Gynecology Associate Professor, JHU School of Nursing Johns Hopkins Avon Foundation Breast Center Baltimore, MD

FACULTY* Juli Aistars, RN, MS, APN, AOCN

Roxanne Parker, RN, MSN, CPN

Robin A. Atkinson, RN, BSN, OCN

Mandi Pratt-Chapman, MA

Leah Leilani Beck, BS

Mary Rooney, RN, BSN, OCN

Karyl Blaseg, RN, MSN, OCN

Tina Scherer, RN, MSN, OCN

Jessica Denton, MSW

Elaine Sein, RN, BSN, OCN, CBCN

Linda Ferris, PhD

Jean B. Sellers, RN, MSN

Linda Fleisher, PhD, MPH

Lisa Shalkowski, RN, BSN, MSM

Maura Kadan, RN, MSN, OCN

Katherine Sharpe, MTS

Lauren Kelley, MSW, MPA

Julie Silver, MD

David S. Landay, JD Adrienne Lofton, RN, MSN Coralyn Martinez, MSN, RN, OCN

Nancy Skinner, RN-BC, CCM Heather Stern, RN, BSN, CNOR, OCN Pamela J. Vlahakis, RN, MSN, CBCN

• • • • •

Pharmaceutical/Biotech Genetic Laboratory Services Navigation Software Patient Advocacy Training

• • • • •

Patient Access Reimbursement Publishers Education Certification

CONTINUING EDUCATION INFORMATION Goal AONN’s Third Annual Navigation and Survivorship Conference will advance the role of navigation and survivorship in cancer care to ultimately improve the quality of patient care. Objectives • Discuss the evolution of the role of navigation in healthcare • Assess strategies for navigating diverse patient populations by cancer type and environmental factors • Define methods for providing patient support and guidance in the age of personalized cancer care • Evaluate best practices regarding survivorship and psychosocial care

CALL FOR ABSTRACTS This is an opportunity to share research, programs, and results with your colleagues. Submit your abstract via e-mail to Liz@aonnonline.org. Abstract Deadline: August 1, 2012

Pamela Matten, RN, BSN, OCN Cynthia Waddington, RN, MSN, AOCN Nicole Messier, RN, BSN Bonnie J. Miller, RN, BSN, OCN, FAAMA

Elizabeth Whitley, PhD, RN *For full information visit www.aonnonline.org

CONFERENCE OVERVIEW AONN’s Third Annual Conference will continue to advance the navigation profession by expanding the scope of educational sessions, networking opportunities, and poster presentations. In addition, this year’s conference will address the evolving challenges of program improvement, the role of personalized medicine, and implementing best practices in navigation, survivorship, and psychosocial care.

SPONSORS This activity is jointly sponsored by AONN Foundation for Learning, Inc., Center of Excellence Media, LLC, and Medical Learning Institute, Inc.

REGISTERED NURSE DESIGNATION Medical Learning Institute, Inc. Provider approved by the California Board of Registered Nursing, Provider Number 15106, for up to 12.25 contact hours.

SOCIAL WORK DESIGNATION This activity is pending approval from the National Association of Social Workers. Contact hours for this continuing social worker education activity have been submitted to the National Association of Social Workers.

WEB SITE REVIEW

www.PatientAdvocate.org PAF – PATIENT ADVOCATE FOUNDATION: Solving insurance and healthcare access problems since 1996 By Lillie D. Shockney, RN, BS, MAS

he Patient Advocate Foundation (PAF) states that their mission is to provide effective mediation and arbitration services to patients to remove obstacles to healthcare, including medical debt crisis, insurance access issues, and employment issues for patients with chronic, debilitating, and life-threatening illnesses. There are many services and programs offered to patients via PAF, and today we highlight one of particular pertinence to oncology nurse navigators: case management. PAF’s professional case managers and attorneys specialize in mediation, negotiation, and arbitration to advocate on behalf of patients facing specific issues with their insurer, employer, and/or creditor regarding access to care, insurance, job retention, and/or debt crisis matters relative to their diagnosis of life-threatening or debilitating disease. In addition to direct case management assistance, PAF provides the programs and partnerships listed below:

VIRGINIA CARES UNINSURED Program—read more for those of you in the state of Virginia Virginia Cares Uninsured Program (VCUP) is a collaborative effort between PAF and the Commonwealth of Virginia to provide dedicated case management services to individuals throughout the state of Virginia who are diagnosed with a chronic, life-threatening, and/or debilitating illness and who are experiencing access-to-healthcare issues. VCUP case managers provide assistance to Virginians requiring access to care, medications, and transportation for treatment, as well as issues involving insurance appeals, benefit exclusions, and copays. Case managers assist patients with applying for, expediting, and appealing Social Security

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Disability Insurance (SSDI), Supplemental Security Income (SSI), Long-Term Disability (LTD) and/or Short-Term Disability (STD). They negotiate funding and/or insurance coverage to access medical devices, surgical procedures, and medications. They also arbitrate with facilities to obtain medical discounts and/or write-offs for services. Case managers also mediate access to free or reduced medication, nutrition, housing, utilities, and free or reduced transportation and lodging for patients who must travel for treatment. They also address COBRA, Medicaid, Medicare, and HIPAA plan issues relating to a patient’s diagnosis.

PAF’s professional case managers and attorneys specialize in mediation, negotiation, and arbitration to advocate on behalf of patients facing specific issues with their insurer, employer, and/or creditor regarding access to care, insurance, job retention, and/or debt crisis matters relative to their diagnosis of life-threatening or debilitating disease. PAF/AMERICAN CANCER SOCIETY PARTNERSHIP PAF has partnered with the American Cancer Society to provide case management services to patients nationwide who have been diagnosed with cancer or are being screened for symptoms of cancer. PAF provides extended services to patients experiencing healthcare issues to include insurance, debt crisis, employment, and/or out-

JOURNAL OF ONCOLOGY NAVIGATION & SURVIVORSHIP

WEB SITE REVIEW

of-pocket expenses related to cancer diagnosis and treatment. The dedicated PAF case managers assist patients with insurance appeals, copays for chemotherapy treatment and medications, transportation to and from treatment, debt crisis in relation to the patient’s diagnosis, preauthorizations, enrollment and/or eligibility for state- and federal-funded programs (Medicare or Medicaid), billing/coding errors, and unpaid medical debt.

The dedicated PAF case managers assist patients nationwide with insurance appeals, preauthorizations, billing/coding errors, and assistance with unpaid medical debt to include co-pays for chemotherapy treatment and medications. PAF/LIVESTRONG PARTNERSHIP PAF has partnered with LIVESTRONG to provide direct case management services to patients nationwide who have been diagnosed with cancer or are in need of cancer screening. PAF provides extended services to patients experiencing healthcare issues to include insurance, debt crisis, employment, and/or out-of-pocket expenses related to cancer diagnosis and treatment. The dedicated PAF case managers assist patients nationwide with insurance appeals, preauthorizations, billing/coding errors, and assistance with unpaid medical debt to include copays for chemotherapy treatment and medications.

PAF assists the uninsured and underinsured with accessing care and debt crisis situations due to a patient’s diagnosis. Case managers are available to assist patients with eligibility for state- and federal-funded programs such as Medicare, Medicaid, and Social Security Disability Insurance.

SURVIVORSHIP OF CANCERS IN UNDERSERVED POPULATIONS PAF was awarded a grant by the Centers for Disease Control and Prevention for education and outreach to underserved populations. The diseases that fall under this grant are breast, cervical, ovarian, prostate, and colorectal cancers, along with melanoma (skin cancer). The dedicated PAF case managers assist patients nationwide with insurance appeals, preauthorizations, billing/coding errors, and assistance with unpaid medical debt to include co-pays for chemotherapy treatment and medications. PAF assists the uninsured and underinsured with accessing care and debt crisis situations due to a patient’s diagnosis. Case managers are available to assist patients with eligibility for state- and federal-funded programs such as Medicare, Medicaid, and Social Security Disability Insurance. g Please take the time to visit this website and see the wealth of information and resources available to you and your cancer patients or reach them at the following address or phone number: Patient Advocate Foundation help@patientadvocate.org 421 Butler Farm Road Hampton, VA 23666 Tel: 800-532-5274 Fax: 757-873-8999

JUNE 2012 • VOLUME 3, ISSUE 3

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