JONS June 2015 Vol 6 No 3 by The Oncology Nurse

June 2015 • Vol 6, NO 3

Cancer Support Services Outside of Clinical Settings: An Evaluation of LIVESTRONG Foundation’s Cancer Navigation Program Katherine Treiman, PhD, MPH; Carla Bann, PhD; Linda Squiers, PhD; Bree Hemingway, MPH; Sarah R. Arvey, PhD; Emily Eargle, MSSW; Ruth Rechis, PhD

Impact of Psychosocial Distress on Cancer Care An Interview with Diane Robinson, PhD Patients’ Experience with Cancer Care: Impact of the National Cancer Institute Community Cancer Centers Program Lauren McCormack, PhD; Katherine Treiman, PhD, MPH; Carla Bann, PhD; Shelton Jones, MS; Irene Prabhu Das, PhD; Julia Rowland, PhD; Neeraj Arora, PhD; Steven Clauser, PhD

How 7 Nurses Maximize Their AONN+ Membership—This Is Your Invitation to Join Our QOPI Committee Pamela Goetz, BA

Physical and Functional Impairments and Physical Therapy Utilization in Cancer Survivors of Puerto Rican Descent Ann Marie Flores, PT, PhD, CLT; Jason Nelson, MPH; Dinorah Martinez Tyson, PhD; Rebecca Stephenson, PT, DPT, MS, WCS; Katherine L. Tucker, PhD

Navigating Patients Across the Continuum of Cancer Caretm www.AONNonline.org

www.JONS-online.com

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BREASTCANCER.ORG

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

University Distinguished Service Associate Professor of Breast Cancer, Depts of Surgery and Oncology, Administrative Director, the Johns Hopkins Breast Center, Director, Cancer Survivorship Programs at the Sidney Kimmel Cancer Center at Johns Hopkins, Associate Professor, JHU School of Medicine, Depts of Surgery, Oncology & Gynecology and Obstetrics, Associate Professor, JHU School of Nursing, Baltimore, MD e-mail: shockli@jhmi.edu

Section Editors

Breast Cancer Sharon S. Gentry, RN, MSN, AOCN, CBCN Breast Nurse Navigator Novant Health: Derrick L. Davis Cancer Center Winston-Salem, NC

PATIENT-CENTERED CARE Mandi Pratt-Chapman Director GW Cancer Institute George Washington University Washington, DC

Cancer rehabilitation & survivorship Julie K. Silver, MD Associate Professor Harvard Medical School Department of Physical Medicine and Rehabilitation Boston, MA

Marcy Poletti, RN, MSN Nursing Operations Supervisor Wake Forest University Baptist Medical Center Winston-Salem, NC

Genetic Counseling Cristi Radford, MS, CGC Licensed Genetic Counselor Gene Mavens, LLC Sarasota, FL B:12.25”

S:10”

T:10.875”

HEALTH DISPARITIES Linda Fleisher, PhD, MPH Assistant Vice President Office of Health Communications & Health Disparities, Assistant Professor, Cancer Prevention & Control, Fox Chase Cancer Center, Cheltenham, PA HEALTH PROMOTION AND OUTREACH Iyaad Majed Hasan, CNP Director and Nurse Practitioner Survivorship Clinic and Program Cleveland Clinic, Taussig Cancer Center Cleveland, OH

Penny Widmaier, RN, MSN Oncology Nurse Navigator Botsford Cancer Center Farmington Hills, MI

PROSTATE CANCER Frank delaRama, RN, MS, AOCNS Clinical Nurse Specialist, Oncology/ Genomics Cancer Care Clinic Palo Alto Medical Foundation Palo Alto, CA THORAcIC ONCOLOGY Pamela Matten, RN, BSN, OCN St. Joseph Hospital Orange, CA

Quality, Outcomes, and Performance Improvement Committee Co-Chairs Elaine Sein, RN, BSN, OCN, CBCN Retired Senior Project Manager Fox Chase Cancer Center Partners Philadelphia, PA

Danelle Johnston, RN, MSN, OCN, CBCN Manager, Breast Services Memorial Hospital University of Colorado Health Colorado Springs, CO

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.

JONS-online.com • Journal of Oncology Navigation & Survivorship

PUBLISHING STAFF

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Table of ConTents LETTERS FROM LILLIE

6 Measuring the Impact of Our Navigation Programs Lillie D. Shockney, RN, BS, MAS SURVIVORSHIP NAVIGATION SERVICES

8 Cancer Support Services Outside of Clinical Settings: An Evaluation of LIVESTRONG Foundation’s Cancer Navigation Program

Katherine Treiman, PhD, MPH; Carla Bann, PhD; Linda Squiers, PhD; Bree Hemingway, MPH; Sarah R. Arvey, PhD; Emily Eargle, MSSW; Ruth Rechis, PhD

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PERSPECTIVES ON CANCER CARE

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18 Impact of Psychosocial Distress on Cancer Care An Interview with Diane Robinson, PhD

NCCCP PATIENT NAVIGATION PROGRAM

24 Patients’ Experience with Cancer Care: Impact of the National Cancer Institute Community Cancer Centers Program Lauren McCormack, PhD; Katherine Treiman, PhD, MPH; Carla Bann, PhD; Shelton Jones, MS; Irene Prabhu Das, PhD; Julia Rowland, PhD; Neeraj Arora, PhD; Steven Clauser, PhD QUALITY, OUTCOMES, AND PERFORMANCE IMPROVEMENT (QOPI) COMMITTEE

36 How 7 Nurses Maximize Their AONN+ Membership—This Is Your Invitation to Join Our QOPI Committee Pamela Goetz, BA

40 A Coincidence Turns into a Career

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June 2015 • Vol 6, NO 3

46 Physical and Functional Impairments and Physical Therapy Utilization in Cancer Survivors of Puerto Rican Descent Ann Marie Flores, PT, PhD, CLT; Jason Nelson, MPH; Dinorah Martinez Tyson, PhD; Rebecca Stephenson, PT, DPT, MS, WCS; Katherine L. Tucker, PhD NURSE NAVIGATION

56 Metrics for Successful Nurse Navigation 58 Nuts and Bolts of Survivorship Care Plans CLINICAL TRIAL TRACKER

60 Clinical Trials Under Way in Renal-Cell Carcinoma Online Exclusive: ONS Meeting Coverage Artwork from the Lilly Oncology On Canvas: Expressions of a Cancer Journey Art Competition and Exhibition (www.lillyoncologyoncanvas.com). ©Eli Lilly and Company. All Rights Reserved. Used with Permission. The cover art and narrative appear on page 20. Journal of Oncology Navigation & Survivorship, ISSN 2166-0999 (print); ISSN 2166-0980 (online), is published 6 times a year by Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright © 2015 by Green Hill Healthcare Communications, LLC. All rights reserved. Journal of Oncology Navigation & Survivorship logo is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America. EDITORIAL CORRESPONDENCE should be addressed to EDITORIAL DEPARTMENT, Journal of Oncology Navigation & Survivorship (JONS), 1249 South River Road, Suite 202A, Cranbury, NJ 08512. E-mail: dbuffery@the-lynx-group.com. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $50.00; institutions, $90.00; single issues, $5.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. The ideas and opinions expressed in JONS do not necessarily reflect those of the editorial board, the editorial director, or the publisher. Publication of an advertisement or other product mentioned 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.

4 June 2015 • Vol 6 • No 3 • JONS-online.com

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LETTERS FROM LILLIE

Measuring the Impact of Our Navigation Programs Hello everyone. It is my pleasure to introduce you to the newest issue of the Journal of Oncology Navigation & Survivorship. It is packed with new knowledge and information that I am very confident will aid you in your personal and collective roles as navigators. You will find an in-depth article that focuses on “Patients’ Experience with Cancer Care: Impact of the National Cancer Institute Community Cancer Centers Program.” If there were ever any doubts about the value of navigation programs and their impact on the patient experience, this article solves that mystery! You are all familiar, to some degree, with the LIVESTRONG Foundation, but you may not be intricately knowledgeable about the work they have invested in their support of patients with cancer for survivorship care at the community level. Well, now you will! There is a great article waiting for you inside about the evaluation of the LIVESTRONG Foundation’s Cancer Navigation Program. I predict you will likely want to share this information with other colleagues on your oncology support team. You will also learn about the physical rehabilitation needs of patients with cancer, with a special focus on a specific culture and population—survivors of Puerto Rican descent. (Remember, our job as navigators is to address the needs of our patients by being culturally competent.) I predict that after you read the welcome invitation from the Quality, Outcomes, and Performance Improvement (QOPI) Committee and what they have been working on on your behalf, several of you will want to step up to the plate and join the QOPI Committee! Find out how you can make a difference personally and professionally. And keep in mind that contributing to such efforts also enhances your CV. Read about one of our nurse navigators’ personal journey, which brought her to the (happy) place she is today— working as a nurse navigator! She shares her personal story, which will also enlighten you about the work of our QOPI Committee, of which she is a member. Not all the articles published in this peer-reviewed journal are about evidence-based research. As you can see from the article that focuses on one of our committees, as well as the stories about navigators’ personal careers, we like to provide you with a variety of perspectives. That brings me to the “Perspectives on Cancer Care” section, where, in this issue, we talk about the impact that psychosocial distress can have on cancer care. Read the interview to learn more about a topic that has historically gone unaddressed, and is now a standard required by the Commission on Cancer (CoC). Psychosocial issues have become a priority that we must measure and intervene in. Recently, the Oncology Nursing Society held its 2015 congress. Highlights from that conference are provided in this issue, and as an online exclusive at www.JONS-online.com. They specifically relate to how patient navigation got its start with lay navigators and community outreach case workers in Harlem, New York. You will also find highlights associated with the status of survivorship care plans (SCPs), which are also a CoC standard. Learn about some of the various models being used. Something I would like you all to consider regarding SCPs is the opportunity to formally measure the impact (perceived benefit) patients say SCPs have on their ability to engage in self-management, make lifestyle changes to reduce the risk for recurrence, and to be satisfied overall with having a treatment summary and a sense of direction for future monitoring and screening. Although it sounds conceptually logical, we still lack regional and national evidence-based research validating that we are making a difference in the long-term clinical and emotional outcomes of our cancer survivors today. So get your reading glasses on, and turn the page! With kind regards,

Lillie D. Shockney, RN, BS, MAS Editor-in-Chief 6 June 2015 • Vol 6 • No 3 • JONS-online.com

MPDL3280A (an engineered anti-PDL1 antibody)

CURRENTLY ENROLLING

Clinical trials in various tumor types for MPDL3280A (an engineered anti-PDL1 antibody) Trials for MPDL3280A,* an investigational anti-PDL1 antibody, are currently recruiting patients in various tumor types: • Bladder • Kidney • Melanoma — NCT02302807

• Colorectal — NCT02291289

• Hematologic malignancies — NCT02220842

— NCT01656642

— NCT01984242

• Lung

• Solid tumors

— NCT02366143 — NCT02367781 — NCT02367794 — NCT02013219

— NCT02323191 — NCT02304393 — NCT01633970 — NCT02174172 — NCT01375842

For more information about the MPDL3280A clinical trial program Call: Genentech Trial Information Support Line: 1-888-662-6728 (US only) Visit: antiPDL1ClinicalTrials.com/hcp Email: global.rochegenentechtrials@roche.com

*Product under investigation has not been approved for use outside of the clinical trial setting. This information is presented only for the purpose of providing an overview of the clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

Survivorship Navigation services

Cancer Support Services Outside of Clinical Settings: An Evaluation of LIVESTRONG Foundation’s Cancer Navigation Program Katherine Treiman, PhD, MPH1; Carla Bann, PhD1; Linda Squiers, PhD1; Bree Hemingway, MPH2; Sarah R. Arvey, PhD2; Emily Eargle, MSSW2; Ruth Rechis, PhD2 1 RTI International, Research Triangle Park, NC; 2LIVESTRONG Foundation, Austin, TX Objectives: The objectives were to evaluate the LIVESTRONG Cancer Navigation Services program, which was developed to address cancer survivors’ psychosocial needs from diagnosis through posttreatment survivorship, and to discuss its implications for the provision of care for survivors occurring outside the clinical setting. Methods: We conducted a longitudinal study to track cancer survivors who received navigation services, surveying participants at intake and at 2 weeks and 6 weeks postintake. We examined changes in (1) the perceived impact of cancer-related concerns; (2) self-efficacy related to getting support and coping with emotional health; and (3) emotional distress, plus the impact of receiving counseling from an emotional support navigator. Results: The most common need among the cancer survivors was for emotional support, followed by insurance, financial, and employment concerns. The numbers and types of needs differed by age at diagnosis, stage in treatment, and other individual characteristics. As a whole, the study participants’ self-efficacy increased over time, and the impact of cancer- related concerns and emotional distress decreased. Survivors referred to an emotional support navigator had increased self-efficacy and reduced emotional distress and concerns about the impact of cancer. Overall, the participants reported high levels of satisfaction with navigation services, which were higher among survivors with more needs, who finished treatment <5 years ago (vs ≥5 years ago), and who had more interactions with a navigator. Conclusions: These findings highlight the importance of navigation services throughout the cancer journey and the value of the LIVESTRONG model, which augments community-based and clinic-based services. Because adequate psychosocial care is not available across many oncology care settings, services outside the clinical setting can help meet cancer survivors’ needs.

hen patients are faced with a cancer diagnosis, they often experience emotional distress and feelings of uncertainty. They must deal with complex medical information, make difficult and often life-altering decisions, and navigate a fragmented healthcare system. Patient navigation programs can help patients, as well as family members and other loved ones, throughout the cancer journey by providing tangible assistance and emotional support. A growing body of research finds that patient navigation services improve screening rates, time from screening to diagnosis, timeliness of care, and patient satisfaction with the navigation services; re-

8 June 2015 • Vol 6 • No 3 • JONS-online.com

duce patient distress; and improve other outcomes.1 Patient navigation services typically are based in clinical or hospital settings, and patients with cancer are referred to the navigation program by physicians or by other clinic-based staff.2,3 Initially, patient navigation focused on getting patients into treatment in a timely manner and supporting them in active treatment.1,4 Patient navigation services have not traditionally focused on cancer survivors who have completed active treatment, although there is growing recognition of the importance of continuing navigation support for patients at this stage.5 In fact, it was very recently that the oncology

Survivorship Navigation services

accrediting program of the American College of Surgeons—the Commission on Cancer—established standards for patient navigation services and psychosocial screening and care, which are to be implemented in 2015.6 Furthermore, although cancer clinics are increasingly following the 2003 National Comprehensive Cancer Network Distress Management Guidelines, studies indicate that many patients do not receive the coping resources and psychosocial support services they need.7,8 Recognizing that cancer survivors’ myriad needs were not being comprehensively met within the clinical setting, the LIVESTRONG Foundation created a navigation service program in 2004 to fill this gap. These services act as a community-based complementary system for clinical models of navigation, and for communities without existing local navigation and psychosocial screening and support. LIVESTRONG Cancer Navigation Services program (henceforth, LIVESTRONG Navigation) provides services independent of any clinic or hospital, and the program is designed to address the needs of patients with cancer and survivors across their cancer journey from diagnosis through posttreatment survivorship. Other nonprofit organizations, including the Cancer Support Community, the National Coalition for Cancer Survivorship, and the American Cancer Society, also provide support services to individuals affected by cancer, using different models.9-11 The purpose of this article is to describe the LIVE STRONG Navigation program, to present findings from an evaluation of its unique model of services, and to discuss the findings’ implications for the provision of care for cancer survivors that can occur outside the clinical setting. The goal of LIVESTRONG Navigation is to provide free, comprehensive, one-to-one support to all people affected by cancer, including those who currently have or who were ever diagnosed with cancer, caregivers, family, friends, and healthcare providers. This article focuses on navigation services for patients who have been diagnosed with cancer (ie, cancer survivors). The program provides services by phone, e-mail, or in-person (in the LIVESTRONG office in Austin, TX) in 6 main areas: (1) addressing insurance, financial, and employment concerns; (2) education and matching for clinical trials; (3) locating and accessing local resources; (4) educating on and providing financial discounts for fertility preservation services; (5) coping with emotional concerns through counseling and support groups; and (6) providing education about a cancer diagnosis and treatment decision-making. Soon after starting LIVESTRONG Navigation, the LIVESTRONG Foundation recognized that cancer survivors had considerable emotional support needs. To address

these needs, LIVESTRONG created the Emotional Support Navigation program. Specially trained emotional support navigators (ESNs) are licensed social workers who provide professional short-term counseling by telephone (and in person in the Austin office). ESNs help cancer survivors set goals, such as depression management, improving self-care, and improving communication with health professionals, family, and other loved ones. ESNs also help survivors to identify strategies to reach their goals (eg, for depression, strategies may include cognitive reframing, journaling, and mindfulness meditation). LIVESTRONG Navigation is able to provide this robust range of services for people affected by cancer because of the national partnership model that acts as the program’s underpinning. LIVESTRONG Navigation acts as the convener of organizations that partner to create a coordinated service delivery system that is intended to reduce service redundancy and create a seamless experience for survivors. Partner organizations and the type of support provided at the time of the study include: • Patient Advocate Foundation: insurance, debt management, and employment concerns • EmergingMed: clinical trials education and matching • NavigateCancer Foundation: understanding a diagnosis and making informed treatment decisions • Imerman Angels: connecting with peers who have had a similar cancer experience. The LIVESTRONG Foundation promotes navigation services via community outreach, community partnerships, and advertising through various media. Based on intake data of the navigation program with the LIVESTRONG Foundation, cancer survivors most frequently learn about LIVESTRONG from healthcare providers (34%), community partners (24%), word of mouth (15%), and the Internet (12%). During the first communication between a LIVE STRONG navigator and a survivor, the navigator conducts a distress screening using a stress thermometer and assesses the survivor’s needs. The navigator then connects the survivor to the appropriate LIVESTRONG services and resources (including the LIVESTRONG at the Y program, the LIVESTRONG Care Plan, the LIVESTRONG Guidebook, or the Living After Cancer Treatment brochure series) and to partner organizations as appropriate. LIVESTRONG also provides emotional support services, fertility assistance, and referrals to community resources and psychosocial support programs. LIVESTRONG navigators coordinate each survivor’s care, provide appropriate follow-up, ensure that the survivor’s needs are met, and identify future needs that may arise (Table 1).

JONS-online.com • Journal of Oncology Navigation & Survivorship

Survivorship Navigation services

Table 1 Overview of Survivors’ Needs and Services Provided Needs

Services provided

1. Emotional support

Referrals to local or telephone-based support groups Professional short-term counseling

2. Help with financial and insurance issues

Help with disability and insurance issues, such as appealing insurance denials Financial advising (eg, about credit, turning personal property into income) Information about federal and state benefits programs

3. Help with work-related issues

Information on and advising about talking with the employer, making decisions about working, disability insurance, retaining health insurance while not working, federal protection laws

4. Information about clinical trials and alternative treatments

Education and information about clinical trials Matching of patients with clinical trials

5. Help with posttreatment concerns

Development of a survivorship care plan Management of late side effects Treatment of emotional concerns Planning of ongoing medical care Referral to LIVESTRONG at the Y, a program to help posttreatment cancer survivors feel physically and emotionally stronger

6. Help understanding a cancer diagnosis and treatment

LIVESTRONG partners with the NavigateCancer Foundation to offer services by experienced cancer nurses Information about a cancer diagnosis and treatment options Goal setting for care Management of side effects Advice about second opinions

7. Fertility concerns and fertility preservation

Information about fertility risks and fertility preservation options Information about fertility centers Financial assistance for fertility preservation

8. Health and wellness

Information about healthy living during and after treatment, including diet and exercise, physical activity, and managing stress Referral to LIVESTRONG at the Y

9. Resources (eg, informational LIVESTRONG offers web-based and print materials, including the LIVESTRONG resources, guidebooks, Guidebook, fertility risk calculator, survivorship care plan, the LIVESTRONG Fertility tools) brochure, and the Living After Cancer Treatment brochure series

To determine the model’s impact, LIVESTRONG designed an evaluation study that focused on service delivery and survivor-reported outcomes.

Methods

Study Design

LIVESTRONG conducted a longitudinal study to track cancer survivors who received LIVESTRONG Navigation services. The study participants were surveyed at 3 time points—during intake (Survey 1 = T1); 2 weeks after intake (Survey 2 = T2); and 6 weeks after intake (Survey 3 = T3). The survivors completed the intake survey (Survey 1) using the mode by which they initially contacted LIVESTRONG (ie, in person, by telephone, or online); the remaining surveys (Surveys 2 and 3) were sent by mail or by e-mail.

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Enrollment

Cancer survivors who contacted LIVESTRONG Navigation between March 2011 and October 2012 and met the age eligibility criteria (aged ≥18 years) were invited to participate in the study. Of 1162 cancer survivors who participated in the navigation study, 761 completed the baseline survey and at least 1 follow-up survey; another 401 cancer survivors did not complete a follow-up survey and were therefore excluded from the analysis.

Data Collection Instruments

The intake form, which was created as a basic needs assessment tool, includes questions to gather demographic, contact, and minimal medical information, such as diagnosis and stage of treatment. Also, questions are included to help assess the patient’s emotional, practical, and

Survivorship Navigation services

Table 2 Outcome Measures Key outcome Satisfaction with LIVESTRONG Navigation

Survey item(s)

Response optionsa

For the following statements, please put an X to show the answer that best represents how true the following statements are for you:

Response options for each item: 1 = not at all to 5 = very much

I would contact LIVESTRONG in the future if I needed them.

Satisfaction score: the mean of the numeric responses for all satisfaction items

LIVESTRONG helped me address my concerns about cancer. I would recommend LIVESTRONG to someone who is affected by cancer. Cancer-related concerns

For each of the following statements, please put an X to show the answer that best represents the level to which you have had that feeling or experience IN THE PAST WEEK: Thoughts of cancer have negatively affected my relationships with others. Cancer concerns have negatively affected my ability to concentrate.

Self-efficacy related to getting support and coping with emotional health

Response options for each item: 1 = not at all to 5 = very much Cancer concerns score: the mean of the numeric responses for both concern questions

For each of the following tasks, please put an X to show the answer that best represents how confident you feel AT THE PRESENT TIME to complete each task:

Response options for each item: 1 = not at all confident to 5 = very confident

Get emotional support from friends, family, or community resources (such as listening or talking over my problems).

Self-efficacy score: the mean of the numeric responses for all selfefficacy items

Discuss openly with my doctor any personal problems that may be related to my cancer diagnosis. Do something to make myself feel better when I feel sad or down. Emotional distress

Overall, looking back on THE PAST WEEK, please circle the number on the thermometer that shows your level of distress on a scale from 1 (no distress) to 10 (extreme distress).

No distress

Extreme distress

1 2 3 4 5 6 7 8 9 10

Distress score: the numeric response on the distress scale

“Prefer not to respond” was a response option for each item. LIVESTRONG Navigation indicates LIVESTRONG Cancer Navigation Services.

financial needs. The form is used to determine appropriate LIVESTRONG resources and referrals to partner organizations, as well as to provide some data for evaluation. The intake form also assessed baseline levels for key outcomes, such as cancer-related concerns, emotional distress, and self-efficacy related to getting support for cancer-related needs. Surveys 2 and 3 also assessed these outcomes, as well as satisfaction with LIVESTRONG Navigation (Table 2). We included measures that are relevant to LIVESTRONG’s main areas of service; for example, the results from assessing cancer-related concerns before and after counseling inform these services.

Data Analysis We examined the outcomes by first computing descriptive statistics (means and standard deviations) of the outcome measures at each time point for all participants and for subgroups. We then fit a series of models to examine

the impact of LIVESTRONG Navigation on the participants’ outcomes. Two variables captured service delivery—(1) number of interactions with LIVESTRONG navigators, and (2) number of services provided. We conducted a linear regression model examining the relationship between LIVESTRONG Navigation services and participant-reported satisfaction with the services at the end of the study. Satisfaction was based on the T3 survey measures, but T2 scores were used for participants with missing satisfaction scores at T3. The model controlled for the number of service needs, sex, race, age at diagnosis, the number of interactions with an ESN, marital status, and the stage of treatment. Because of the large number of missing values for age at diagnosis, marital status, and stage of treatment, we included an unknown (ie, missing) category for each of these variables to allow for the inclusion of as many participants as possible in the analyses.

JONS-online.com • Journal of Oncology Navigation & Survivorship

Survivorship Navigation services

Table 3 D emographic Characteristics of Study Participants (N = 761) Demographic characteristics

Participants, N (%)

Sex (N = 752) Female Male

Demographic characteristics

Participants, N (%)

Age at diagnosis, yrs (N = 600) 508 (68)

0-14

76 (13)

244 (32)

15-17

7 (1)

Ethnicity/race (N = 728)

18-25

43 (7)

African American

60 (8)

26-39

155 (26)

American Indian, Alaska Native

4 (1)

40-49

142 (24)

Asian

16 (2)

50-64

150 (25)

White

564 (77)

27 (5)

≥65

Adolescent/young adult when diagnosedb (N = 698)

Hispanic/Latino

67 (9)

Native Hawaiian/Pacific Islander

5 (1)

Yes

220 (32)

Mixed race

6 (1)

478 (68)

Other

6 (1)

Age at diagnosis, yrs (N = 600)

Marital status (N = 592)

Mean

38.9

Single

150 (25)

Median

42.0

Married

306 (52)

Mode

5.0

Stage of treatment at intake (N = 505)

Domestic partnership

19 (3)

Separated

18 (3)

Currently in treatment

302 (60)

Divorced

89 (15)

Finished treatment <5 years ago

150 (30)

Widowed

10 (2)

Finished treatment ≥5 years ago

51 (10)

Receiving hospice or palliative care

2 (<1)

Lives in Texas (N = 759) Yes

154 (20)

605 (80)

Type of cancer (N = 761)

Location (N = 654) Metropolitan

572 (87)

Micropolitan

Breast

190 (25)

Digestive/gastrointestinal

104 (14)

Eye

2 (<1)

46 (7)

Genitourinary

94 (12)

Small town

28 (4)

Germ-cell

6 (1)

Rural

8 (1)

Gynecologic

49 (6)

Age at intake, yrs (N = 604)

Head and neck

47 (6)

18-25

30 (5)

26-39

156 (26)

Musculoskeletal

10 (1)

40-49

156 (26)

33 (4)

50-64

219 (36)

Neurologic, endocrine, neuroendocrine Respiratory/thoracic

40 (5)

Skin

16 (2)

≥65

43 (7)

Age at intake, yrs (N = 604)

Hematologic/blood

156 (21)

Mean

46.6

Unknown primary

4 (1)

Median

47.0

Other

10 (1)

Mode

52.0

NOTE: Some of the totals do not equal 100%, because of rounding. a Intake form asks “ethnicity,” with the responses as listed. b Aged 15-39 years at diagnosis. c Participants can identify 2 types of cancer.

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Survivorship Navigation services

Table 4 Services Needed and Received by Study Participants (N = 761) Services needed

Participants, N (%)

Total services needed (N = 755) 0

Services received

Participants, N (%)

Mode of accessing navigation service (N = 720) 24 (3)

Online

603 (84)

Not online (in-person or by phone)

117 (16)

1-4

310 (41)

5-10

253 (34)

11-15

98 (13)

Mean

5.8

16-20

42 (6)

Median

4.0

21-30

25 (3)

Mode

3.0

31-40

3 (<1)

Mean

7.0

Median

5.0

1-4

267 (36)

Mode

3.0

5-10

262 (36)

11-15

81 (11)

Type of need (N = 761)

Total interactions with navigation services (N = 761)

Total services needed (N = 735) 50 (7)

Emotional support

536 (70)

16-20

47 (6)

Finances and insurance

426 (56)

21-30

27 (4)

Alternative treatment

287 (38)

31-40

1 (<1)

Posttreatment care

233 (31)

Mean

7.0

Work concerns

143 (19)

Median

5.0

Diagnosis and treatment

125 (16)

Mode

3.0

Fertility

100 (13)

LIVESTRONG resources

94 (12)

We then examined changes over time from intake to 6-week follow-up in (1) perceived impact of cancer-Â related concerns, (2) self-efficacy related to getting support and coping with emotional health, and (3) emotional distress. Multilevel models were conducted to account for measurements repeated over time. In addition to examining the impact of services and interactions with navigators on outcomes, we also tested for an interaction between time and referral to the LIVEÂ STRONG ESN to determine whether survivors who received ESN support experienced greater or lesser improvements in outcomes over time than those who did not receive this service. Similar control variables were included

Type of service (N = 761) LIVESTRONG resources

553 (73)

Emotional support

488 (64)

Health and wellness

211 (28)

Posttreatment care

156 (21)

Finances and insurance

119 (16)

Diagnosis and treatment

110 (14)

Fertility counseling

72 (9)

Work concerns

56 (7)

in these models. We ran all models with and without participants who had missing values for age at diagnosis, marital status, and stage of treatment and found no differences.

Results Table 3 presents the characteristics of the study sample (N = 761). The majority of study participants were female (68%), white (77%), married (52%), and currently in treatment (60%). We found no significant differences between the study participants and those who were excluded from the analyses (who did not complete a follow-up survey) in terms of age at diagnosis, stage of treatment, or cancer type.

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Survivorship Navigation services

Table 5 Referrals to LIVESTRONG Partners (N = 761) Partners

Referrals, N (%)

Patient Advocate Foundationa

449 (59.0)

NavigateCancer Foundation

284 (37.3)

Imerman Angels

237 (31.1)

EmergingMed

170 (22.3)

National office and office in Austin, TX.

Figure 1 Self-Efficacy by Time and Stage of Treatment 5.0

Time 1

Time 2

Time 3

4.5

Mean score

4.0 3.5

3.69 3.72 3.35

3.71 3.69 3.33

3.58 3.66 3.18

3.39

3.25

2.94

3.0 2.5 2.0 1.5 1.0

Currently in treatment

All

Finished treatment <5 years ago

Finished treatment ≥5 years ago

Stage of treatment

ancer-Related Concerns by Time and Stage Figure 2 C of Treatment 5.0

Time 1

Time 2

Mean score

4.0 3.31

3.50 3.16

3.0

2.99

3.25 3.15

3.42 3.43 3.32 2.89 2.98 2.78

2.5 2.0 1.5 1.0

All

Currently in treatment

Finished treatment <5 years ago

Stage of treatment

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At intake, the navigators assess the participants’ needs and connect them with the appropriate services, resources, and partners. Table 4 shows the types and numbers of services that were needed and received by the participants (mean, 7.0 needs). Overall, the most frequently reported needs were emotional support (70%), followed by financial and insurance needs (56%). Emotional support was the most frequently reported need for all age-groups, for men and women, and across all stages of survivorship. However, among nonwhite participants, financial and insurance needs were greater than emotional support needs, and there were marked differences between white and nonwhite participants (71% of white participants had emotional needs vs 59% of nonwhite participants, P <.05; and 55% of white participants had financial and insurance needs vs 70% of nonwhites, P <.05). Participants with neurologic, endocrine, neuroendocrine, gynecologic, or digestive/gastrointestinal cancers had the most needs (mean, 8.0); those with genitourinary and other cancers (including skin, musculoskeletal, germ-cell, eye, and unknown) had the lowest number of needs (mean, 6.0 needs). Participants who were diagnosed with cancer as adolescents and young adults (aged 15-39 years) had a significantly higher number of needs (mean, 8.6) than those who were aged 40 to 59 at diagnosis (mean, 6.8), aged ≥60 years at diagnosis (mean, 6.8), and aged ≤14 years at diagnosis (mean, 7.6; P <.009). Participants who were currently in treatment were more likely to have financial and insurance needs (65%) compared with participants who had finished treatment (49% for those who had finished <5 years ago and 56% for those who had finished ≥5 years ago; P = .004).

Services Provided

Time 3

4.5

3.5

Participant Needs

Finished treatment ≥5 years ago

Overall, the participants interacted with LIVE STRONG Navigation an average of 5.8 times and were provided, on average, 7 different services (Table 4). The most common types of services were LIVESTRONG resources (73%), ESN (64%), health and wellness (28%), and posttreatment care (21%). The participants were also referred to partner organizations for specialized services (Table 5).

Outcomes Overall, the participants’ self-efficacy (related to getting support and coping with emotional health) increased over time, and the impact of cancer-related concerns and distress decreased over time (Figures 1, 2, and 3).

Survivorship Navigation services

Satisfaction with LIVESTRONG Navigation Services

Overall, participants were highly satisfied with LIVE STRONG Navigation. For the study participants as a whole, the mean satisfaction score was 4.22 (standard deviation, 1.06) of a maximum score of 5. Participants who were diagnosed at age 15 to 39 years were more satisfied (mean, 4.32) than participants who were diagnosed at age 40 to 59 (mean, 4.13; P = .05). Participants who finished their treatment <5 years ago were significantly more satisfied than those who finished their treatment ≥5 years ago (mean, 4.25 vs 4.17 for patients who are currently in treatment and 3.88 for those who finished treatment ≥5 years ago; P <.05). We also conducted regression analyses to understand predictors of satisfaction at T3. Controlling for other factors, the participants who had more interactions with

Figure 3 E motional Distress by Time and Stage of Treatment 10 Time 1

Time 2

Time 3

Mean score

Self-efficacy. The mean self-efficacy scores increased over time, from 3.35 at T1 to 3.69 at T2 and 3.72 at T3 (increases were significant for T1 vs T2 and T1 vs T3; P <.05; Figure 1). At all 3 time points, self-efficacy was lowest among the survivors who finished treatment ≥5 years ago, although the differences were significant only at T1 and T3. At all 3 time points, self-efficacy also was lowest among survivors who were diagnosed at age 0 to 14 years; however, the differences were significant only at T2. Those diagnosed at age 0 to 14 years had lower self-efficacy (mean, 3.39) than survivors who were diagnosed at age 40 to 59 years (mean, 3.71) or at age ≥60 years (mean, 3.85; P <.05). There were no significant differences in self-efficacy by sex or by race/ethnicity. Perceived impact of cancer-related concerns. Survivors’ mean cancer-related concerns scores decreased significantly over time, from a mean of 3.31 at T1 to 2.99 at T3 (P <.05; Figure 2). At all 3 time points, survivors diagnosed with cancer <5 years ago had the lowest cancer-related concerns scores; the differences were significant only at T1 and T3. Similarly, survivors who were diagnosed at age ≥60 years had lower cancer-related concerns scores than those diagnosed at a younger age (P <.001 at T1; P = .07 at T2; P <.05 at T3). Emotional distress. Overall, the mean distress scores significantly decreased over time, from T1 (mean, 6.27) to T2 (mean, 5.80) and to T3 (mean, 5.54; P <.05; Figure 3). In addition, the distress scores varied significantly by stage of treatment at T1 (P <.001) and T3 (P = .014). At both time points, the distress was lowest among the participants who were diagnosed <5 years ago. Males had significantly higher mean distress scores than females at all 3 data collection points (mean, 6.49 vs 5.82 at T1, P <.001; 6.01 vs 5.39 at T2, P <.005; and 5.81 vs 4.96 at T3, P <.001).

7 6

6.27

6.37 5.80

5.54

5.81 5.74

5.61 5.39 5.39

6.06 5.92 6.07

5 4 3 2 1

All

Currently in treatment

Finished treatment <5 years ago

Finished treatment ≥5 years ago

Stage of treatment

LIVESTRONG reported greater satisfaction (B = 0.013; standard error, 0.01; P = .013). In addition, participants who received support from an ESN reported greater satisfaction (B = 0.29; standard error, 0.10; P = .004). Impact of Emotional Support Navigator

The changes in self-efficacy over time varied significantly according to whether cancer survivors had an ESN (Wald 2[2] = 8.33; P = .016). Although they started out at T1 with poorer self-efficacy, participants who had an ESN experienced consistent increases in self-efficacy over time and at T3 had similar scores to the participants who did not have an ESN. We also found that having an ESN was associated with significant reductions in the impact of cancer-related concerns over time (Wald 2[2] = 13.40). Cancer survivors who had an ESN reported a greater impact of cancer-related concerns at T1 and T2, but this impact was reduced over time, and at T3, those who had an ESN reported similar levels of impact to those who did not have an ESN. Finally, there is a general trend of differences in distress over time based on receiving ESN services (Wald 2[2] = 5.60; P = .061). Participants who had an ESN reported lower distress at T1 and T3, but higher-stress at T2, than those who did not have an ESN, although their T2 values were lower than their T1 values, suggesting a reduction in distress over time.

Discussion LIVESTRONG Navigation has developed a model of patient navigation that addresses cancer survivors’

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Survivorship Navigation services

needs outside the clinical setting. The services encompass areas that are often not addressed within traditional oncology care settings, including employment, insurance, and financial issues; emotional counseling; and fertility preservation assistance. These findings augment the growing body of evidence about the benefits of patient navigation services, highlight the importance of navigation support for cancer survivors outside the clinical setting, and suggest that the partnership model used by LIVESTRONG is effective in meeting cancer survivors’ diverse needs. We assessed the impact of navigation services on outcomes of interest, specifically self-efficacy, perceived impact of cancer-related concerns, and distress of cancer survivors. As a whole, survivors’ self-efficacy increased over time, and cancer-related concerns and distress concerns each decreased over time. In addition, participants had an enormous need for emotional support; it was the most frequently reported need among the survivors as a whole and across all the subgroups examined, with the exception of nonwhites, for whom insurance and financial issues were the top concerns. Participants who had an ESN benefited from increased self-efficacy, specifically confidence in their ability to get emotional support, to talk with healthcare providers about personal problems related to their diagnosis, and to take action to make themselves feel better. These participants also had lower levels of distress and cancer concerns after receiving emotional support services. Because psychosocial care is not a standard service across oncology care settings, LIVESTRONG Navigation services can help to meet the needs for emotional support among cancer survivors. These findings showed that the participants who finished their cancer treatment more recently (<5 years ago) were more satisfied with LIVESTRONG Navigation and had greater self-efficacy than those who finished their cancer treatment ≥5 years ago. We also found differences in satisfaction with LIVESTRONG Navigation and self-efficacy by age at diagnosis. Participants who were diagnosed with cancer as adolescents or as young adults had the highest satisfaction levels. Participants who were diagnosed with cancer as a child had the lowest self-efficacy. LIVESTRONG Navigation has a special focus on adolescents and young adults; therefore, these findings suggest that efforts to meet the needs of young survivors have been effective. These findings have led LIVESTRONG to review the services it provides to support longer-term cancer survivors and pediatric cancer survivors, and to conduct additional research to understand their needs. Overall, the participants reported high levels of satisfac-

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tion with LIVESTRONG Navigation. Participants with more needs and who had a higher number of interactions with a navigator reported greater satisfaction, suggesting that multiple “touch points” are often needed to meet survivors’ varied needs, and for navigators to build a trusting and supportive relationship with survivors.

Limitations These results should be considered in light of the study’s limitations. Because the study did not involve a control group, we must consider the findings about impact on outcomes of interest to be suggestive. Another limitation is that some of the data collection instruments were developed primarily for programmatic rather than for evaluation purposes. For example, survivor needs and services delivered did not use the exact same categories, making it difficult to definitively say that the program delivered the service that was needed. Finally, we were unable to assess the impact of LIVE STRONG’s partners, because there was no way to isolate the impact of the partner organizations’ services over and above the services provided directly by LIVESTRONG. To address these limitations, LIVESTRONG plans to implement a new case management system that will facilitate the assessment of how partner organizations meet survivor needs, and whether unmet needs remain, and is developing follow-up surveys that are specific to the types of services provided. LIVESTRONG is also considering the viability of using an experimental design and a more refined approach to examine the level of services received (eg, beyond the number of interactions with a navigator) and the impact of various services. Conclusion Overall, the findings highlight the importance of patient navigation services at all points of a patient’s cancer journey and the value of the LIVESTRONG model, which augments community-based and clinic-based navigation services. LIVESTRONG is using these findings to guide further development and evaluation of its navigation services. Support services outside the clinical setting can help to meet the needs of cancer survivors and should be considered by clinical care providers to ensure the best outcomes for survivors. LIVESTRONG is positioned to partner with hospitals and physicians to provide psychosocial screening and care that meet the Commission on Cancer standards. g Author Disclosure Statement The authors have no conflicts of interest to report. This study was funded by the LIVESTRONG Foundation.

Survivorship Navigation services

For information about partnering with LIVESTRONG, contact: Emily Eargle, MSSW, Director, Navigation Services, LIVESTRONG Foundation, 2201 E. 6th St, Austin, TX 78702, phone: 512-279-8431, Emily.eargle@livestrong.org.

References

1. Paskett ED, Harrop JP, Wells KJ. Patient navigation: an update on the state of the science. CA Cancer J Clin. 2011;61:237-249. 2. Battaglia TA, Burhansstipanov L, Murrell SS, et al; for the Prevention and Early Detection Workgroup from the National Patient Navigation Leadership Summit. Assessing the impact of patient navigation: prevention and early detection metrics. Cancer. 2011;117(15 suppl):3553-3564. 3. Guadagnolo BA, Dohan D, Raich P. Metrics for evaluating patient navigation during cancer diagnosis and treatment: crafting a policy-relevant research agenda for patient navigation in cancer care. Cancer. 2011;117(15 suppl):3565-3574. 4. Wells KJ, Battaglia TA, Dudley DJ, et al; for the Patient Navigation Research Program. Patient navigation: state of the art or is it science?

Cancer. 2008;113:1999-2010. 5. Willis A, Pratt-Chapman M, Reed E, Hatcher E. Best practices in patient navigation and cancer survivorship: moving toward quality patient-centered care. J Oncol Navig Surviv. 2014;5(2):8-14. 6. Commission on Cancer; American College of Surgeons. Cancer program standards 2012: ensuring patient-centered care. Version 1.2.1. 2012. www. facs.org/cancer/coc/programstandards2012.pdf. Accessed April 30, 2015. 7. Allen JO, Zebrack B, Wittman D, et al. Expanding the NCCN guidelines for distress management: a model of barriers to the use of coping resources. J Community Support Oncol. 2014;12:271-277. 8. Carlson LE, Waller A, Mitchell AJ. Screening for distress and unmet needs in patients with cancer: review and recommendations. J Clin Oncol. 2012;30:1160-1177. 9. Esparza A. Patient navigation and the American Cancer Society. Semin Oncol Nurs. 2013;29:91-96. 10. Sharpe K, Perocchia RS, Wiatrek DE, Shaw B. Milestones in mission: the work of the American Cancer Society’s mission delivery. J Cancer Educ. 2013;28:4-8. 11. Printz C. Not at any cost: organizations help patients cope with costs of cancer care. Cancer. 2011;117:879-881.

Call for Papers Launched in 2010, the Journal of Oncology Navigation & Survivorship (JONS) is the nation’s first peer-reviewed clinical journal for oncology nurse navigators. JONS is the official publication of the Academy of Oncology Nurse & Patient Navigators (AONN+), and is distributed to all paying members of AONN+. The editors are looking for original research, review articles, case studies, and best practices or “how to” articles, with the goals of improving the care of patients with cancer, expanding the evidence-based nursing literature, and reinforcing clinical competencies.

Article areas of high interest include: • Patient education

• Facilitating treatment decision-making

• Continuity of care

• Long-term follow-up

•N avigation processes and outcomes measures

• Patient adherence

• Screening programs

• Tumor board processes

• Caring for the underserved

• Transitional processes into survivorship care

• Community outreach

• Working with a multidisciplinary oncology team

• Emotional support

• Survivorship

All articles are subject to the journal’s peer-review process, and acceptance is based on that review. Articles are edited for style and sense. All authors must sign a copyright transfer form.

Submit a Manuscript! www.JONS-online.com or by e-mail to: editorial@jons-online.com Articles should follow the author guidelines at www.JONS-online.com.

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Perspectives on cancer care

Impact of Psychosocial Distress on Cancer Care An Interview with Diane Robinson, PhD

Neuropsychologist, Program Director, Cancer Support Community, Integrative Medicine Department, University of Florida Health Cancer Center, Orlando Health The Journal of Oncology Nursing & Survivorship spoke with Diane Robinson, PhD, at the fifth annual Academy of Oncology Nurse & Patient Navigators (AONN+) conference, held at the Walt Disney World Dolphin Hotel in Orlando, FL, in October 2014. AONN+ drew in more than 500 attendees, and addressed the evolving challenges in program improvement, best practices for navigation, survivorship, and psychosocial care for patients with cancer, as well as personalized medicine.

Q: What are the most pressing issues facing patients with cancer in your program and in the community? Diane Robinson, PhD: Currently, there are a lot of pressing issues facing patients seeking cancer care in the central Florida community. If I had to choose one issue, I think it would be the financial burden on patients with cancer. There have been many positive changes with the Affordable Care Act (ACA); however, many patients now have lower monthly payments, but with higher deductibles. This means that there is immediate financial stress at the beginning of treatment. Some patients still do not have adequate insurance, especially the indigent population. When they arrive at the cancer center for care, they have to face the additional stress of figuring out how they are going to pay for their cancer treatment, or that centers do not accept the insurance they have. Q: What are the most pressing issues that oncology nurses and physicians who care for these patients face? Robinson: Many issues that the physicians and nurses are facing have existed for a long time, but are now being amplified. For example, compassion fatigue is something we have examined for many years, but the recent demands on our clinical teams that have come with the changes in healthcare and accreditation mean that compassion fatigue is increasing. There is more paperwork and less time available for face-to-face meetings with patients.

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In addition, with the electronic revolution and the need for instant gratification, patients often look for medical information online and can become misinformed. They then come in for a visit and they have a lot more questions than our clinicians are used to being asked. It is a more demanding environment and an ongoing struggle, because physicians and nurses have so many responsibilities. We are asking them to do more, and now patients are asking them to do more too. This creates a tremendous amount of stress.

Q: Can you discuss some of the barriers to care within your patient community? Robinson: One barrier to cancer care we often forget to consider is psychosocial distress. We have excellent physicians, nurses, and clinic teams, using cutting-edge medical technology; however, if patients are internally struggling with life situations and circumstances, they sometimes will not follow through with their treatment plan. This is why taking care of the patient as a whole, not just treating the cancer diagnosis, is the heart of our institutional purpose of “inspiring hope through extraordinary care.” Q: What is the most pressing need for patients with cancer and their caregivers? Robinson: The most pressing need for patients with cancer and their caregivers is simply more quality education about the entire cancer journey from finances to support systems and clinical options in their treatment plan. There is such a tremendous amount of information available that patients can become overwhelmed, confused, or misinformed by relying on less-than-accurate Internet claims. All of us—navigators, clinicians, and hospital administrators—need to present accurate and timely information to help our patients navigate their complex, evolving situation so that they can focus on healing. For me, this is why navigators are so crucial.

Perspectives on cancer care

Q: Does the oncology community provide adequate psychosocial support? Robinson: With the Commission on Cancer (CoC) new continuum of care standards, hospitals are being held more accountable now for the inadequate psychosocial support that has been evident in the oncology community in the past. Our Cancer Center has viewed psychosocial distress as a significant influence on overall patient wellness for some time. We decided to become one of the first hospitals in the nation to make psychosocial care an opt-out approach, not the usual opt-in. We operate by incorporating the international nonprofit Cancer Support Community within our walls to help overcome some of the past barriers. Some barriers that patients come across for seeking psychosocial support include finances and transportation logistics. We offer our programs at no cost, and patients can attend before or after their clinic visits. Often, if you ask patients why they do not seek psychosocial support, they will say they do not need it. However, studies show that psychosocial support can be a key component in helping patients navigate the cancer journey more effectively, so their anxiety can decrease and overall outcomes can increase. Interestingly, when patients come to some of our events, they often express to me that they never realized how much they needed help and support. Therefore, the battle hospitals will ultimately face after incorporating programs to combat psychosocial distress is helping patients accept that they need support. Q: How has the ACA affected the delivery of social support? Robinson: The ACA has not truly addressed the mental health issues facing patients with cancer. This is an area that we need to pay more attention to as a nation, and the Institute of Medicine has been stating this for years. Hopefully, as awareness of mental health issues in cancer patients develops, we will find more reimbursements for it in oncology practice. At the UF Health Cancer Center, Orlando Health, we have provided many different psychosocial support methods that are free of charge for our patients. The ACA has not been a factor in how we deliver our services. We are fortunate to have incredible support from Orlando Health, the Orlando Health Foundation, and our generous donors, including Women Playing For T.I.M.E., to ensure that we have everything that our patients need, at no charge to them. For patients to gain access to high-quality psychosocial care, hospitals need to get more innovative. We need to form relationships in the community with different char-

ities, and work to connect patients with those services. It is about being a good community partner, reaching out, and perhaps doing things differently from how they have been done in the past.

Q: What would you recommend for oncology institutions starting a navigation program? Robinson: Starting a navigation program can be intimidating, and it is especially overwhelming with the new healthcare standards from the CoC. We decided the best approach was to take it one small step at a time. We looked at the most demanding clinic areas, and where our highest volume of patients is and started there. The plan was to learn from these clinics and then take those lessons to the next clinic area. As healthcare is changing, incorporating new procedures becomes essential for a hospital to adapt, survive, and offer outstanding patient care. Q: Which topics do you discuss with your oncology team? Robinson: Being in charge of the delivery of the CoC standard 3.2 means that I spend a lot of time discussing the importance of paying attention to psychosocial distress in our patients and their families. However, there are interesting variations to this that involve discussing multidisciplinary and innovative approaches to caring for our patients. For example, one of our neuro-Â oncologists was working on helping recently diagnosed patients with stage IV glioblastoma navigate this very serious diagnosis. We discussed how we can best care for and support these patients through the process, particularly when end-of-life issues emerge more quickly. He had addressed this issue by forming an interesting partnership with one of our local hospices, Cornerstone Hospice, where their palliative care physicians were immediately scheduled to meet with the patients after diagnosis. After reviewing the clinic flow, further discussions with the hospice expanded their role into offering an advance directives class, using the Five Wishes for all our patients with cancer, as well as a bereavement group. Partnerships like this are an imporÂ tant part of how our organization can offer such comprehensive care. Q: What do you think navigation will look like in 2020 and beyond? Robinson: I hope that in 2020 navigation will be such a common role that we no longer need to analyze it, and that it will be incorporated into hospitals and become the new standard of care for all diagnoses. All patients will have someone who is supporting them through their

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Perspectives on cancer care

medical issues and connecting them with services in a natural, effortless way, instead of having to stop and reevaluate each step. Currently, many of our nurse navigators are encountering difficulties with working out how they function within their hospitals. My hope is that by 2020, it will be a beautiful, fluid process, and every patient will have a nurse navigator.

Q: What are some of the lessons you have learned? Robinson: I have learned that we can have an impact far beyond what we imagined. For example, a social worker had been running a program for our Cancer Support Community, and when she left I had to step back into a clinical role. I was able to see and experience again the impact support groups can have, and it reinvigorated me. That particular program is called “Cancer Transitions,” and it takes our patients through active

treatment to posttreatment care. The hospital becomes a source of comfort for many patients with cancer who need extensive surgery, chemotherapy, or radiation for months or even years. When the oncologist finally tells them they are finished with their treatments, it can be a very unsettling feeling and a time of high anxiety for some. I was helping such patients step through this difficult time with this wonderful program. When filling out the evaluations at the end of the program, one of the patients wrote that it was a life-changing experience, and I knew from my interactions with her that it truly had transformed her life. This lesson had an immeasurable impact on me, and reaffirmed all that I knew to be true. Now, I have patients volunteering their time to let other patients know they can get help and do not need to be afraid. It is a great experience for me to watch this unfold, and it is incredibly rewarding. g

ABOUT THE COVER ART My Journey with a Blood Disorder

Acrylic by a Person Diagnosed with Cancer Artwork from the Lilly Oncology On Canvas: Expressions of a Cancer Journey Art Competition www.LillyOncologyOnCanvas.com I was diagnosed with plasmacytoma in mid-August 2001. One moment I thought I had “hip problems,” the next I was told I had cancer. I decided from the beginning to take things in stride and not freak out. I always viewed the diagnosis as but a part of me and not the whole. It is how I deal with it. When I painted this picture, that was my mindset. There are the obvious red and white blood cells; there is the plasma; however, the disorder is the grey and the few black strokes. Three years after the initial diagnosis, it became multiple myeloma, and now it is smoldering myeloma. This is my journey with a blood disorder.

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INDICATION: VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma. CONTRAINDICATIONS: VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of VELCADE. WARNINGS AND PRECAUTIONS: 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 39% for intravenous. Grade ≥3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 15% 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 require a decrease in the dose and/or a less dose-intense schedule. In the VELCADE vs dexamethasone phase 3 relapsed multiple myeloma study, improvement in or resolution of peripheral neuropathy was reported in 48% of patients with ≥Grade 2 peripheral neuropathy following dose adjustment or interruption. 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 8%. 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 Toxicity: Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have occurred during VELCADE therapy, 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 treatmentrelated cardiac disorder was 8% and 5% in the VELCADE and dexamethasone groups, respectively. The incidence of adverse reactions suggestive of heart failure (acute pulmonary edema, pulmonary edema, cardiac failure, congestive cardiac failure, cardiogenic shock) was ≤1% for each individual reaction in the VELCADE group. In the dexamethasone group, the incidence was ≤1% for cardiac failure and congestive cardiac failure; there were no reported reactions of acute pulmonary edema, pulmonary edema, or cardiogenic shock. There have been isolated cases of QT-interval prolongation in clinical studies; causality has not been established. Pulmonary Toxicity: Acute Respiratory Distress Syndrome (ARDS) and acute diffuse infiltrative pulmonary disease of unknown etiology, such as pneumonitis, interstitial pneumonia, and lung infiltration have occurred 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, consider interrupting VELCADE until a prompt, comprehensive, diagnostic evaluation is conducted. Posterior Reversible Encephalopathy Syndrome (PRES): Posterior Reversible Encephalopathy Syndrome (PRES; formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS)) has occurred in patients receiving VELCADE. PRES 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 PRES, discontinue VELCADE. The safety of reinitiating VELCADE therapy in patients previously experiencing PRES is not known. Gastrointestinal Toxicity: 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. Interrupt VELCADE for severe symptoms. 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 remain consistent in the studies of multiple myeloma with no evidence of cumulative thrombocytopenia or neutropenia in the treatment regimens studied. Monitor complete blood counts (CBC) frequently during treatment with VELCADE. Measure platelet counts prior to each dose of VELCADE. Adjust dose/ schedule for thrombocytopenia. Gastrointestinal and intracerebral hemorrhage has occurred during thrombocytopenia in association with VELCADE. Support with transfusions and supportive care, according to published guidelines. In the single-agent, relapsed multiple myeloma study of VELCADE versus dexamethasone, the mean platelet count nadir measured was approximately 40% of baseline. The incidence of bleeding (≥Grade 3) was 2% in the VELCADE arm and was <1% in the dexamethasone arm. Tumor Lysis Syndrome: Tumor lysis syndrome has been reported with VELCADE therapy. Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. Monitor patients closely and take appropriate precautions. Hepatic Toxicity: Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic reactions include hepatitis, increases in liver enzymes, and hyperbilirubinemia. Interrupt VELCADE therapy to assess reversibility. There is limited re-challenge information in these patients. Embryo-fetal Risk: Pregnancy Category D. Women of reproductive 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 REACTIONS: 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 reactions (≥10%) in this study (VELCADE+melphalan and prednisone vs melphalan and prednisone) were thrombocytopenia (48% vs 42%), neutropenia (47% vs 42%), peripheral neuropathy (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia (34% vs <1%), anemia (32% vs 46%), leukopenia (32% vs 28%), vomiting (26% vs 12%), fatigue (25% vs 14%), lymphopenia (23% vs 15%), constipation (23% vs 4%), anorexia (19% vs 6%), asthenia (16% vs 7%), pyrexia (16% vs 6%), paresthesia (12% vs 1%), herpes zoster (11% vs 3%), rash (11% vs 2%), abdominal pain upper (10% vs 6%), and insomnia (10% vs 6%).

T:7”

Brief Summary (cont’d)

VEL214CDNY7256_FCS_March2015_JournalAD_BS_r13.indd 2

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. OVERDOSAGE: There is no known specific antidote for VELCADE overdosage. In humans, fatal outcomes following the administration of more than twice the recommended therapeutic dose have been reported, which were associated with the acute onset of symptomatic hypotension and thrombocytopenia. In the event of an overdosage, the patient’s vital signs should be monitored and appropriate supportive care given. PATIENT COUNSELING INFORMATION Advise patients to contact their physicians if they experience the following symptoms: Dehydration/Hypotension, such as dizziness, light-headedness or fainting spells, or muscle cramps. Cardiac: swelling of feet, ankles, or legs, or other heart-related problems. Respiratory: shortness of breath, cough, or other lung problems. Hepatic: jaundice or right upper abdominal pain. Dermal: rash, severe injection-site reactions, or skin pain. Discuss the option for antiviral prophylaxis for herpes virus infection. Peripheral Neuropathy and Nervous System, such as new or worsening tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in the arms or legs. Advise patients to contact their physicians if they experience symptoms possibly indicative of PRES or PML such as convulsion, persistent headache, reduced eyesight, blurred vision, confusion, lethargy, altered ability to think, or difficulty walking. Other: increase in blood pressure, bleeding, fever, constipation, or decreased appetite. In addition, counsel patients on the following: Pregnancy/Nursing: Advise patients to use effective contraceptive measures to prevent pregnancy during treatment with VELCADE. Instruct them to report pregnancy to their physicians immediately. Advise patients that they should not receive VELCADE while pregnant or breast-feeding. If a patient wishes to restart breast-feeding after treatment, she should be advised to discuss the appropriate timing with her physician. Concomitant Medications: Advise patients to speak with their physicians about any other medication they are currently taking. Diabetic Patients: Advise patients to check their blood sugar frequently if using an oral antidiabetic medication and to notify their physicians of any changes in blood sugar level. Ability to Drive or Operate Machinery or Impairment of Mental Ability: Advise patients not to drive or operate machinery if they experience fatigue, dizziness, syncope, or orthostatic/postural hypotension. Please see full Prescribing Information for VELCADE at VELCADE-hcp.com.

Takeda Oncology and are registered trademarks of Takeda Pharmaceutical Company Limited. Other trademarks are the property of their respective owners. Copyright © 2014, Millennium Pharmaceuticals, Inc. USO/BOR/15/0040 All rights reserved. Printed in the USA

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In the phase 3 study of VELCADE® (bortezomib) administered intravenously vs dexamethasone in relapsed multiple myeloma, the most commonly reported adverse reactions (>20%) were nausea (52% vs 9%), diarrhea (52% vs 11%), fatigue (39% vs 25%), peripheral neuropathies (35% vs 4%), thrombocytopenia (33% vs 3%), constipation (30% vs 8%), vomiting (29% vs 3%), and anorexia (21% vs 2%). The most commonly reported serious adverse reactions were diarrhea (3%), dehydration, herpes zoster, pyrexia, nausea, vomiting, dyspnea, and thrombocytopenia (2% each) in the VELCADE treatment group and pneumonia (4%), hyperglycemia (3%), pyrexia, and psychotic disorder (2% each) in the dexamethasone treatment group. 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 reactions (≥10%) in this study were peripheral neuropathy NEC (37% vs 50%), thrombocytopenia (30% vs 34%), neutropenia (23% vs 27%), neuralgia (23% vs 23%), anemia (19% vs 23%), diarrhea (19% vs 28%), leukopenia (18% vs 20%), nausea (16% vs 14%), pyrexia (12% vs 8%), vomiting (9% vs 11%), asthenia (7% vs 16%), and fatigue (7% vs 15%). The incidence of serious adverse reactions was similar for the subcutaneous treatment group (20%) and the intravenous treatment group (19%). The most commonly reported SARs were pneumonia and pyrexia (2% each) in the subcutaneous treatment group and pneumonia, diarrhea, and peripheral sensory neuropathy (3% each) in the intravenous treatment group. In a single-arm, open-label study of retreatment with intravenous VELCADE in relapsed multiple myeloma, the most common adverse drug reaction was thrombocytopenia, which occurred in 52% of patients (grade ≥3: 24%). Peripheral neuropathy was experienced by 28% of patients (grade ≥3: 6%). The incidence of serious adverse reactions was 12.3%; the most commonly reported serious adverse reactions were thrombocytopenia (3.8%), diarrhea (2.3%), and herpes zoster and pneumonia (1.5% each). 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. Monitor patients for signs of bortezomib toxicity and consider a bortezomib dose reduction if bortezomib must be given in combination with strong CYP3A4 inhibitors (eg, 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 melphalanprednisone 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

NCCCP patient navigation program

Patients’ Experience with Cancer Care: Impact of the National Cancer Institute Community Cancer Centers Program Lauren McCormack, PhD1; Katherine Treiman, PhD, MPH1; Carla Bann, PhD1; Shelton Jones, MS1; Irene Prabhu Das, PhD2; Julia Rowland, PhD2; Neeraj Arora, PhD2,3; Steven Clauser, PhD2,3 1 RTI International; 2National Cancer Institute; 3Patient-Centered Outcomes Research Institute This work was completed while Drs Arora and Clauser were employed at the National Cancer Institute. Background: The National Cancer Institute Community Cancer Centers Program (NCCCP) aimed to provide high-quality care in community cancer care settings and to identify what contributes to a successful patient experience. Objective: This study evaluated the impact of the 3-year NCCCP pilot program.

Lauren McCormack

Katherine Treiman

Methods: We conducted 2 cross-sectional surveys of patients with cancer (Wave 1, N = 2009 respondents; Wave 2, N = 1946 respondents) and patient focus groups. Survey respondents and focus group participants were aged 21 years or older. Surveys were fielded 18 months apart, with Wave 1 occurring early in the pilot program. We conducted focus groups in randomly selected sites. Data collection comprised mail, online, and telephone surveys, as well as in-person focus groups. Results: Respondents in Wave 2 were significantly more likely to be helped by a patient navigator (P <.001), have a cancer care team that was always well informed and up-to-date about their care (P = .026), and reported better access to care (P = .001). Patient navigation mediated the relationships between patient characteristics and patient–provider communication, access to care, and coordination of care. These outcomes correlated with patients’ higher overall rating of their cancer care experience. Conclusions: The findings show that patients’ overall rating of their cancer care experience was high and that they benefited from NCCCP programs and services, particularly patient navigation.

Carla Bann

he National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) was a 3-year pilot program designed to bring the latest scientific advances and the highest level of innovative cancer care to patients in their home communities. Launched in 2007, the NCCCP involved a public–private partnership with 10 individual hospitals and healthcare systems across the United States.1 The program comprised 6 components, including (1) reducing disparities in care, (2) enhancing clinical trials research, (3) increasing capacity to collect, store, and analyze biospecimens, (4) improving the use of health information technology, (5) emphasizing survivorship and palliative care, and (6) improving access to quality cancer care. Quality cancer care is complex and depends on good

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coordination and communication among providers.2 To improve the quality of cancer care, the NCCCP prioritized a multidisciplinary cancer care approach that involved developing multidisciplinary cancer care conferences and clinics and implementing patient navigation services to improve care coordination and ensure that all patients receive timely and appropriate care.3 NCI defines patient navigation as a service throughout the cancer care continuum designed to “ensure that individuals with suspicious cancer findings receive timely diagnosis and treatment.”4 Models of patient navigation vary, with most sites using a combination of nurses and other staff (eg, social workers) as navigators.4,5 Common elements include the navigator’s multifaceted role in facilitating processes of

NCCCP patient navigation program

care, assisting patients to overcome barriers, and providing information and support.6,7 NCI contracted with RTI International to conduct an independent evaluation of the NCCCP pilot program. For this study, we examined how the NCCCP might have affected patients’ perspectives regarding several outcomes, including access to care, coordination of care, communication with the cancer care team, and overall rating of care. We looked at the effect of patient navigation services on these outcomes. This article pre sents the findings from the patient survey and patient focus groups, which provided quantitative and qualitative perspectives about quality cancer care within the NCCCP centers.

Figure 1 Locations of Participating NCCCP Sites WA OR

•Billings

ID NV

WY Sioux Falls• NE CO

KS OK

NM TX

Orange

•

MI IL IN • OH

Indianapolisa

KY TN

MO AR LA

NY PA

NH MA

•Hartford, CT

•• Newark, DE

WV VA

Towson, MDa

•Spartanburg

AL GA SC MS Savannah•

• Baton Rouge

Methods HI To examine if and how patients’ experiences a In the 2 hospital systems with multiple sites (Indianapolis, IN; Towson, changed as the NCCCP pilot program developed MD), we conducted the survey in the lead site. and became more established at the cancer centers, Source: Clauser SB, et al. Implement Sci. 2009;4:63. we conducted a cross-sectional patient survey at 2 time points, with each administration involving a systematic probability sample of 475 patients from each different sample of patients—the Wave 1 survey early in cancer center per wave, which supported multiple subthe pilot program (from February to July 2009) and the group estimates within each cancer center and sufficient Wave 2 survey approximately 18 months later (from Jansize to detect center-level differences of 10% for 2-tailed uary to April 2011). The multimode survey (mail, online, tests for proportions as small as 0.15 versus 0.25, with an telephone) was available in English and in Spanish. Bealpha level of 5%. The conventional power of 80% was cause few respondents used the telephone version in the used, while assuming a combined patient eligibility reWave 1 survey, it was not included for the Wave 2 survey. sponse rate of approximately 52%. To explore access, coordination, and other aspects of The response rate was 51.8% for the Wave 1 survey and care, and to provide additional context, we also conduct48.9% for the Wave 2 survey, based on American Associaed patient focus groups midway between the 2 surveys tion for Public Opinion Research Rule #4,9 which counts (between May and September 2010). Focus groups adpartial responses as responses and assumes ineligibility dressing coordination of care (N = 46) and access to care among the “no contacts” at a similar rate as those surveyed. (N = 40) were each held in 5 NCCCP sites randomly We conducted a nonresponse bias assessment comparselected from the 10 study sites. To be eligible for the ing patient sampling rates by specific domains—includcoordination-of-care groups, patients either were receiving cancer type, race/ethnicity, cancer stage, and sex— ing care at the cancer center or had completed care versus the proportion of respondents obtained from within the past 3 months. For the access-to-care groups, among all respondents in these respective domains. We patients had to have been screened in the past 18 found significant deviations in several domains, and, to months and had follow-up testing at the cancer center. reduce the bias, we computed nonresponse-adjusted samWe conducted the survey in each of the 10 NCCCP ple weights using the following predictors: cancer disease cancer centers, which are located across the United site, cancer stage, treatment type, race/ethnicity, and States (Figure 1).1 To be eligible to participate in the survey, patients had to be aged 21 years or older and to age-group. The sample-design weights were adjusted uphave experienced one or more cancer outpatient visits ward by calculating the weight adjustments in the Statissince the beginning of the data collection period. tical Analysis System (SAS) using RTI’s generalized exFor the Wave 1 survey, a total of 11,828 patients with ponential model developed by Folsom and Singh.10 cancer met the study eligibility criteria; for the Wave 2 Patient Survey Measures survey, a total of 14,174 patients with cancer met the The patient survey instrument included the following criteria. We used the “no personal identification disoutcomes and other measures: closed” sampling approach8 in both waves to select a

JONS-online.com • Journal of Oncology Navigation & Survivorship

NCCCP patient navigation program

Table 1 Demographic Characteristics and Outcomes of Study Participants in the NCCCP Evaluation, by Wave Wave 1 (N = 2009), N (%)a

Wave 2 (N = 1946), N (%)a

Site 1

181 (11)

141 (8)

Site 2

205 (19)

190 (15)

Site 3

228 (11)

176 (14)

Site 4

143 (6)

127 (6)

Site 5

190 (14)

214 (14)

Site 6

168 (5)

148 (6)

Characteristic

P value

Sociodemographic characteristics Site <.001

Site 7

220 (6)

262 (9)

Site 8

210 (11)

217 (10)

Site 9

211 (4)

195 (9)

Site 10

253 (11)

276 (10)

63 ± 0

62 ± 0

.485

285 (17)

284 (20)

.023

1681 (83)

1628 (80)

Less than high school

195 (10)

135 (7)

High school graduate/GED

552 (28)

573 (29)

Some college

569 (28)

554 (29)

651 (35)

639 (34)

<$40,000

639 (36)

596 (36)

$40,000-$79,999

540 (31)

526 (31)

505 (32)

514 (32)

93 (5)

66 (3)

Medicaid/state-sponsored

196 (9)

205 (12)

Medicare

811 (39)

770 (37)

Private only

831 (43)

834 (44)

78 (4)

71 (4)

Breast

718 (31)

745 (36)

<.001

Colorectal

188 (10)

178 (9)

.345

Lung

189 (10)

171 (8)

.094

325 (17)

265 (16)

.299

Surgery

1267 (67)

1307 (69)

.346

Chemotherapy

827 (41)

876 (44)

.079

Radiation

1056 (48)

996 (51)

.049

Age, mean (SE), yrs Race/ethnicity Nonwhite White Education

College graduate Income

≥$80,000 Insurance No insurance/missing

Other Cancer type

Prostate Cancer treatment

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.095

.985

.060

NCCCP patient navigation program

Wave 1 (N = 2009), N (%)a

Wave 2 (N = 1946), N (%)a

P value

1185 (60)

1212 (63)

.056

Helped by patient navigator

485 (22)

588 (30)

<.001

Cancer care team always well informed and up-to-date about patient’s care

1443 (76)

1440 (80)

.026

Cancer care team always works together

Characteristic Sociodemographic characteristics Received all cancer care at the cancer center Outcomes

1448 (80)

1429 (81)

.423

Communication scale, mean (SE)

61 ± 1

63 ± 1

.324

Access to care scale, mean (SE)

70 ± 1

74 ± 1

.001

Overall rating of care experience, mean (SE)

90 ± 0

89 ± 0

.581

Weighted. GED indicates General Educational Development (certification); NCCCP, National Cancer Institute Community Cancer Centers Program; SE, statistical error.

Access to care. This scale is based on 3 questions: “In the last 12 months, how often…(1) did the people on your cancer care team help you get the medical appointments you needed? (2) were you able to get an appointment as soon as you wanted at the cancer center? and (3) were you able to get the tests and other procedures you needed done without delay?” These items used a 5-point response scale: never, rarely, sometimes, usually, always. Given the skewness of the items, we computed scale scores based on the number of items for which respondents answered “always” (vs “usually” to “never”). The Cronbach alpha for the scale was 0.61 in Wave 1 and 0.71 in Wave 2. Coordination of care. Respondents reported how often their cancer care team (1) seemed to be well informed and up-to-date about their care, and (2) seemed to work together to help them get the care they needed. These items used a 5-point response scale: never to always. Communication with the cancer care team. This scale is based on 5 questions that asked, “During the past 12 months,…(1) how well did members of the cancer care team explain plans for treatment” (5-point scale: poor, fair, good, very good, excellent); how often did members of the cancer care team (2) pay enough attention to your feelings and emotions?, (3) talk in terms you could understand?, (4) check to be sure you understood everything?, and (5) encourage you to ask questions?” (5-point scale: never to always). The scale score is based on the number of items for which respondents answered “always” or “excellent.” The Cronbach alpha was 0.85 in Wave 1 and 0.86 in Wave 2. Patient navigation. Respondents reported whether or not they received assistance from a patient navigator in the past 12 months.

Overall rating of care. Respondents rated the care they received at their cancer center in the past 12 months using a scale from 1 (worst possible care) to 10 (best possible care).

Analyses We conducted the following analyses to address the evaluation questions. First, to assess how patients’ experiences changed over time, we compared outcomes between the Wave 1 and Wave 2 surveys, using chi-square tests for categorical items (eg, NCCCP site) and t-tests for continuous items (eg, age). Because the 2 coordination-of-care items (ie, cancer care team was well informed and up-todate about patient’s care, and cancer care team works together) were strongly negatively skewed, we dichotomized these items into responses of “always” versus all other responses. Second, to examine what sociodemographic characteristics and other factors were associated with patients’ experiences, we conducted logistic regression analyses to identify predictors of help from a navigator and coordination of care. Third, to examine to what extent patients’ experiences with access to care, coordination of care, and communication accounted for their overall rating of care, we conducted linear regression models of scale scores for communication and access to care and overall rating of the care experience. Each model incorporated the survey weights and included site, survey wave, age, race/ethnicity, education, insurance, cancer type, cancer treatment, and received all cancer care at the NCCCP center. All models included help from a navigator, except for the model with this variable as an outcome. Finally, we conducted a path analysis to examine the role of help from a navigator as a possible mediator of patient outcomes.

JONS-online.com • Journal of Oncology Navigation & Survivorship

NCCCP patient navigation program

Table 2 L ogistic Regression Models of “Helped by Patient Navigator” and Coordination of Care for the NCCCP Pilot Evaluation

Variable

Helped by Patient Navigator Adjusted OR (95% CI) N (%)a

Cancer Care Team Always Cancer Care Team Always Well Informed and Up-to-Date Works Together About Patient’s Care Adjusted OR Adjusted OR (95% CI) (95% CI) N (%)a N (%)a

Wave Wave 1

485 (22)

1 [Reference]

Wave 2

588 (30)

1.40 (1.18, 1.66)

—

Nonwhite White

Age

1443 (76)

1 [Reference]

1448 (80)

1 [Reference]

1440 (80)

1.11 (0.92, 1.34)

1429 (81)

1.01 (0.83, 1.24)

0.99 (0.98, 1.00)

—

1.01 (1.00, 1.02)

—

1.00 (0.99, 1.01)

214 (36)

1.72 (1.34, 2.21)b

433 (80)

0.91 (0.67, 1.22)

427 (81)

0.70 (0.52, 0.96)d

846 (24)

1 [Reference]

2404 (77)

1 [Reference]

2409 (81)

1 [Reference]

b c

Race/ethnicity

Education Less than high school

110 (34)

1 [Reference]

258 (81)

1 [Reference]

260 (85)

1 [Reference]

High school graduate/GED

321 (28)

0.68 (0.48, 0.96)d

853 (81)

1.23 (0.80, 1.89)

875 (85)

1.16 (0.73, 1.85)

Some college

326 (28)

0.69 (0.49, 0.99)d

800 (77)

1.03 (0.67, 1.57)

812 (81)

0.91 (0.57, 1.46)

College graduate

302 (22)

0.53 (0.37, 0.75)

915 (75)

0.94 (0.62, 1.45)

876 (76)

0.65 (0.41, 1.03)

No insurance/missing

48 (30)

1.25 (0.79, 1.99)

107 (80)

1.43 (0.75, 2.72)

109 (84)

1.24 (0.64, 2.39)

Medicaid/statesponsored

135 (34)

1.35 (1.00, 1.81)

312 (82)

1.13 (0.80, 1.60)

317 (84)

1.19 (0.81, 1.75)

Medicare

388 (24)

1.22 (0.95, 1.56)

1164 (81)

1.07 (0.82, 1.40)

1136 (81)

1.03 (0.78, 1.37)

Private only

463 (26)

1 [Reference]

1191 (75)

1 [Reference]

1207 (79)

1 [Reference]

Other

39 (29)

1.09 (0.66, 1.79)

109 (81)

1.41 (0.81, 2.45)

108 (82)

1.06 (0.60, 1.88)

496 (31)

1.45 (1.17, 1.79)c

1106 (78)

0.97 (0.77, 1.23)

1127 (82)

1.09 (0.85, 1.40)

Insurance d

Cancer type Breast Colorectal

94 (26)

0.94 (0.69, 1.27)

275 (79)

1.03 (0.73, 1.47)

279 (82)

1.11 (0.76, 1.62)

Lung

108 (29)

1.20 (0.89, 1.63)

264 (79)

0.82 (0.58, 1.17)

256 (80)

0.77 (0.53, 1.10)

Prostate

98 (18)

1.10 (0.81, 1.50)

427 (80)

1.11 (0.81, 1.52)

402 (79)

0.98 (0.71, 1.35)

Surgery

722 (27)

1.18 (0.96, 1.44)

1856 (77)

0.93 (0.74, 1.16)

1853 (80)

0.86 (0.68, 1.09)

Chemotherapy Radiation

Cancer treatment 623 (36)

1.99 (1.65, 2.39)

1311 (78)

0.91 (0.74, 1.13)

1343 (82)

0.96 (0.76, 1.20)

641 (31)

1.19 (0.99, 1.44)

1580 (80)

1.16 (0.94, 1.42)

1593 (83)

1.19 (0.96, 1.48)

Yes

739 (29)

1.36 (1.13, 1.63)c

1867 (81)

1.62 (1.34, 1.96)b

1873 (84)

1.92 (1.56, 2.35)b

296 (22)

1 [Reference]

904 (72)

1 [Reference]

894 (75)

1 [Reference]

Yes

—

890 (84)

1.68 (1.34, 2.11)b

920 (86)

1.58 (1.23, 2.02)b

—

1960 (76)

1 [Reference]

1921 (79)

1 [Reference]

Received all cancer care at the cancer center

Helped by patient navigator

NOTE: Model also controls for site. a Weighted. b P ≤.001. c P ≤.01. d P ≤.05. CI indicates confidence interval; GED, General Educational Development (certification); NCCCP, National Cancer Institute Community Cancer Centers Program; OR, odds ratio.

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All analyses were conducted using SAS version 9.3, except for the path analysis, which was conducted using Mplus version 6.12. The results show the number of patients and the weighted percentage estimates that account for survey design and differential nonresponse.

Results

Patient Survey Findings

The Wave 2 survey included significantly higher percentages of nonwhite respondents (20% vs 17%), respondents who had breast cancer (36% vs 31%), and respondents who received radiation treatment (51% vs 48%) than the Wave 1 survey (Table 1). Participation also varied significantly across the 2 waves by site, perhaps because of fluctuations in enrollment over time (P <.001). We found no significant differences at P <.05 for age; education; income; insurance; colorectal, lung, or prostate cancer diagnosis; surgery or chemotherapy treatment; or whether the patient received all cancer care at an NCCCP center. In the bivariate analyses of outcomes, Wave 2 survey respondents were significantly more likely to be helped by a navigator (30% vs 22%; P <.001) and have a cancer care team that was always well informed and up-to-date about their care (80% vs 76%; P = .026). Wave 2 respondents also rated their access to care significantly higher (mean [statistical error] = 74 [1] vs 70 [1]; P = .001). However, respondents’ overall rating of their care experience was not significantly different over time. The lack of change on this measure may be due to a ceiling effect, as respondents’ overall rating of their care was very high at baseline. In the logistic regression models, after controlling for other factors, the adjusted odds ratio (OR) of respondents who reported receiving help from a navigator significantly increased from the Wave 1 to the Wave 2 survey: OR = 1.40 (95% confidence interval [CI], 1.181.66); P <.001 (Table 2). Respondents who were nonwhite, who were on Medicaid (vs private insurance), who had breast cancer, who received chemotherapy, and who received all care at the NCCCP center were also significantly more likely to receive navigation assistance. Older respondents and those with higher education (high school graduate/some college) were significantly less likely to receive navigation assistance. Respondents who received help from a navigator reported better coordination of care (Table 2). These respondents were significantly more likely to indicate their cancer care team was always well informed and up-to-date about their care (OR = 1.68 [95% CI, 1.34-2.11]; P <.001) and that their cancer care team always works together (OR = 1.58 [95% CI, 1.23-2.02]; P <.001). Receiving all

cancer care at the NCCCP site was also positively associated with coordination of care—specifically, the cancer care team was always well informed and up-to-date about their care (OR = 1.62 [95% CI, 1.34-1.96]; P <.001) and the cancer care team always works together (OR = 1.92 [95% CI, 1.56-2.35]; P <.001). Greater age was associated with higher odds of reporting that their cancer care team is always well informed and up-to-date about their care. Nonwhite respondents were less likely to report that their cancer care team always works together. Consistent with the coordination-of-care findings, respondents who received navigation assistance reported better communication with their cancer care team and better access to care. Also, their overall rating of their care experience was higher, controlling for other factors (P <.001; Table 3). Similarly, respondents receiving all of their care at the NCCCP center had more positive responses for communication, access to care, and their overall rating of their care experience (P <.001). Respondents with lung cancer reported significantly lower communication scores. Access-to-care scores increased over time (Cohen’s d = 0.10). Respondents who were college graduates reported less access to care than respondents with less than a high school education. Age was positively related to ratings of the care experience, with older respondents reporting higher ratings of their care experience. In addition, respondents who were high school graduates rated their care experiences higher than those with less than a high school education. Finally, we explored the role of a patient navigator as a mediator between (1) patient demographic and cancer- related characteristics and (2) patient outcomes, controlling for site. The hypothesized model fit well (Comparative Fit Index = 0.96, Tucker-Lewis Index = 0.94, Root Mean Square Error of Approximation = 0.02; Figure 2). Having a navigator was associated with higher communication and access-to-care scores and better coordination of care, which, in turn, were associated with higher overall ratings of the care experience. In addition, having a navigator was directly associated with higher overall ratings of care. Focus Group Findings

The focus group findings add contextual insight regarding the important role patient navigators played in enhancing the patient experience in terms of access, coordination, and communication. Focus group participants reported a wide range of assistance from the navigators, including organizing follow-up testing after screening, providing information and answering questions, helping them understand their diagnosis and the treatment plan, offering emotional support, linking them

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Table 3 L inear Regression Models of Communication, Access to Care, and Overall Rating of Care Experience for the NCCCP Pilot Evaluation

Variable Wave

Communication Adjusted Coefficient mean (SE) (SE)

Access to Care Adjusted Coefficient mean (SE) (SE)

Overall Rating of Care Experience Adjusted Coefficient mean (SE) (SE)

Wave 1

62.83 (1.08)

1 [Reference]

70.30 (0.83)

1 [Reference]

89.68 (0.42)

1 [Reference]

Wave 2 Age

60.94 (1.04)

–1.13 (1.40)

73.82 (0.85)

2.49 (1.28)

88.96 (0.40)

–1.18 (0.65)

—

–0.05 (0.08)

—

0.02 (0.07)

—

0.10 (0.03)b

59.68 (2.21)

–2.13 (2.21)

73.16 (1.71)

–0.33 (2.05)

87.70 (0.99)

–2.05 (1.14)

62.23 (0.80)

1 [Reference]

72.05 (0.66)

1 [Reference]

89.61 (0.30)

1 [Reference]

Less than high school

60.57 (3.29)

1 [Reference]

77.09 (2.46)

1 [Reference]

89.26 (1.42)

1 [Reference]

High school graduate/ GED

63.78 (1.47)

3.67 (3.12)

73.64 (1.23)

0.26 (2.71)

90.42 (0.57)

3.19 (1.65)a

Some college

62.32 (1.37)

1.22 (3.16)

73.01 (1.04)

–2.71 (2.73)

89.29 (0.49)

1.26 (1.65)

60.16 (1.32)

0.07 (3.19)

69.72 (1.07)

–5.92 (2.79)a

88.48 (0.54)

–0.00 (1.75)

No insurance/missing

63.17 (4.75)

1.55 (4.53)

71.90 (3.81)

1.33 (3.89)

84.86 (2.91)

–3.92 (3.27)

Medicaid/statesponsored

60.86 (2.58)

0.48 (2.62)

72.85 (2.00)

0.65 (2.40)

88.32 (1.32)

0.19 (1.43)

Medicare

63.67 (1.52)

2.45 (2.02)

72.86 (1.21)

1.03 (1.82)

89.72 (0.53)

0.75 (0.87)

Private only

60.24 (1.28)

1 [Reference]

71.58 (1.01)

1 [Reference]

89.30 (0.48)

1 [Reference]

66.04 (3.89)

4.67 (3.68)

73.85 (2.86)

2.91 (3.24)

90.91 (1.37)

2.51 (1.60)

Breast

61.71 (1.41)

0.34 (1.75)

70.57 (1.13)

–2.95 (1.61)

89.77 (0.50)

0.56 (0.79)

Colorectal

61.17 (2.64)

–0.29 (2.51)

70.95 (2.15)

–1.80 (2.20)

89.26 (1.14)

–0.17 (1.25)

Lung

56.93 (2.58)

–5.87 (2.53)

70.50 (2.18)

–3.86 (2.40)

91.97 (0.85)

1.10 (0.97)

61.75 (2.17)

–0.13 (2.29)

69.52 (1.85)

–2.39 (2.18)

88.21 (0.93)

–0.96 (1.18)

Surgery

61.54 (0.91)

–1.08 (1.68)

72.56 (0.72)

–0.14 (1.46)

89.62 (0.32)

1.01 (0.84)

Chemotherapy

63.14 (1.19)

2.03 (1.56)

73.09 (0.95)

2.28 (1.46)

89.26 (0.45)

0.82 (0.73)

63.65 (1.07)

2.90 (1.52)

71.17 (0.88)

–1.05 (1.39)

89.68 (0.38)

1.38 (0.73)

65.93 (0.93)

11.21 (1.51)c

73.30 (0.76)

8.19 (1.41)c

90.49 (0.32)

5.84 (0.76)c

54.82 (1.30)

1 [Reference]

70.40 (1.03)

1 [Reference]

87.25 (0.57)

1 [Reference]

Yes

69.95 (1.41)

11.16 (1.57)c

74.29 (1.07)

7.73 (1.38)c

90.51 (0.51)

4.47 (0.66)c

58.69 (0.90)

1 [Reference]

71.42 (0.72)

1 [Reference]

88.81 (0.34)

1 [Reference]

Race/ethnicity Nonwhite White Education

College graduate Insurance

Other Cancer type

Prostate Cancer treatment

Radiation Received all cancer care at the cancer center Yes No Helped by patient navigator

NOTE: Model also controls for site. a P ≤.05. b P ≤.01. c P ≤.001. GED indicates General Educational Development (certification); NCCCP, National Cancer Institute Community Cancer Centers Program; SE, statistical error.

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NCCCP patient navigation program

Figure 2 Path Analysis of Outcomes Among Patients Receiving Care at NCCCP Sites Wave 2 (vs 1) Age Nonwhite

0.07a -0.06b 0.08a 0.15a

Education (vs college grad) Less than high school High school graduate Some college

0.04 0.04c 0.13a

None

0.03

Medicaid

0.05b

Other

0.03 0.00

Breast Colorectal Lung Prostate Cancer treatment Surgery Chemotherapy Radiation

Access to care

0.10a

Helped by a patient navigator

Received all cancer care 0.07a at the cancer center Cancer type

0.34a

0.06a

Insurance (vs private)

Medicare

Communication

Overall rating of care experience 0.09a

Coordination of 0.14a care: care team is well-informed

0.10a -0.01 0.02 0.00

0.03

0.10a

Coordination of care: care team works together

0.23a

0.04b

0.16

0.04c

Model Fit Indices: CFI = 0.96, TLI = 0.94, RMSEA = 0.02. a P <.05. b P <.01. c P <.001. CFI indicates Comparative Fit Index; TLI, Tucker Lewis Index; RMSEA, Rout Mean Square Error of Approximation.

with resources in the hospital and the community, scheduling appointments, and accompanying them to appointments. Key focus group themes and examples with illustrative participant quotes are provided in Table 4.

Discussion Capturing patients’ perspectives about quality of care is critical when evaluating a pilot program like the NCCCP. Overall, the evaluation findings underscore that patients had a positive experience at the NCCCP centers and that they particularly valued patient navigation services. The benefits of patient navigation reported

in the literature include higher cancer screening rates and less time elapsed between abnormal screening findings and diagnosis.11-23 Navigation is particularly impor tant in the treatment phase, because this phase often involves complex, multimodal treatment and multiple specialists over an extended period. However, the findings are mixed as to whether patient navigation improves treatment adherence and evidence-based quality of care.20 Studies have found that navigation services typically increase patient satisfaction with care24-29 and that patients value support from navigators.30,31 Our study examined patient navigation in communi-

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NCCCP patient navigation program

Table 4 Key Focus Group Themes and Illustrative Quotes from the NCCCP Evaluation Patient navigation

Illustrative quote

Navigator serves as a central point of contact for patients and families and provides “the human touch.”

“It’s a shock when you are first diagnosed...you don’t know what to ask or where to go…she took me by the hand and coordinated everything.”

Navigators facilitate patients’ access to care by setting up clinical and support services appointments in a timely manner.

“She set up an appointment with the social workers, the financial counselor, and the dietician, and was there for all of those meetings. And then, if there was anything more that you needed, you could go to her for that.”

Navigation assistance is particularly valuable early in care when patients are in a state of shock, overwhelmed, and do not know how the systems work or what resources are available.

“I would have been so overwhelmed with the process if it hadn’t been for the nurse navigator. She just picked up everything and said, ‘This is what you’re doing. This is the reason why,’ and I felt very confident.”

After patients become more familiar with their treatment routines and how the cancer center works, they can be more independent and do not need as much navigation assistance.

“Once you get the pattern down, once you kind of find out where you’ve got to go and who you’ve got to see, you can do it. After the first four or five times, it’s kind of like, ‘I know the routine.’”

Coordination of care

Illustrative quote

Patients have mixed experiences with coordination of care. Some said various providers worked together as a team, communicating about their treatment plan, sharing information, and staying informed about what each was doing.

“I always felt that my oncologist, who was the bus driver for me, was in contact with all of my other doctors.”

Other patients felt that the burden was on them (or their families) to make sure all their providers had the information they needed.

“It seems sometimes that some of the people don’t have all the information…you have to bring it to them. You have to be your own advocate.”

Patients felt more frustration and anxiety about coordination issues early in their care; some participants were unsure who—if anybody—was in charge of their care.

“I needed someone to drive the bus, and nobody was doing it.” Other patients used the analogy of “needing a quarterback” on the care team.

Patients did not understand the roles of different providers.

“In the first three or four meetings that I had after I was notified by phone that I had cancer, they told me where I was going next but not why I was going there. And so there was a little bit of anxiety because I knew I was going to see this fellow, but I didn’t know exactly why or what his particular skill was.”

Once patients connected with a navigator and a doctor “took charge,” coordination improved.

“I found that everything was well coordinated; every doctor knew what the other doctor was doing.”

NCCCP indicates National Cancer Institute Community Cancer Centers Program.

ty cancer centers in diverse geographic locations, serving diverse patient populations, and focusing on the treatment phase of care. Most prior patient navigation studies were limited to a specific cancer type (particularly breast and colorectal) and were conducted at a single or geographically confined set of sites. Also, most studies focused on cancer screening, although more recent studies have included patients at different points along the care continuum.7,20,32 Donelan and colleagues33 examined patient navigation and patients’ perceptions about ease of access to care. However, we are unaware of any quantitative studies that have examined the link between patient navigation and patients’ perceptions about coordination of care or com-

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munication with their cancer care team, in a diverse set of sites and patient populations. When the NCCCP was launched, the approach for providing navigation services varied widely across the cancer centers.4,5 During the pilot program, the participating cancer centers established or strengthened navigation programs and shared strategies and approaches. Across the network, the sites shared best practices and collaborated to develop tools to facilitate patient navigation,4 possibly contributing to the success of the NCCCP navigation services. The proportion of patients receiving navigation services increased from 22% in the Wave 1 survey to 30% in the Wave 2 survey, and the patients helped by a navigator benefited in terms of their experi-

NCCCP patient navigation program

ences with access to care, coordination of care, and communication with their cancer care team. In interpreting the survey findings, note that the Wave 1 survey was not a true baseline, because some of the participating cancer centers had already initiated program development. However, the survey was conducted early in the pilot program. Nonwhite patients and patients receiving Medicaid were more likely to report patient navigation assistance. Patients with high school/some college were less likely to be assisted by a navigator. Together these findings suggest that the navigation services were successful in reaching underserved patients and furthering the NCCCP goal of addressing disparities in cancer care. Across the NCCCP sites, access to care improved from the Wave 1 survey to the Wave 2 survey, meaning that patients were more likely to get medical appointments as soon as they wanted and get tests and procedures without delay. The focus group data suggest that improvements in access to care could be tied directly to navigation services; navigators helped patients secure appointments and arranged transportation when needed. Access-to-care improvements might also be linked to effective coordination among the cancer care team, possibly due to multidisciplinary cancer care conferences (further study is warranted on the effect of multidisciplinary cancer care conferences on patients’ experiences with care coordination). From the patient perspective, effective care coordination involves assistance in navigating the complex healthcare system, sufficient and timely information about the care plan, and effective interactions among all those involved in the patient’s care.31 Patient-centered communication is integral to high-quality cancer care.34-38 Good communication between patients (and their family members and caregivers) and their cancer care team is critical throughout the cancer care continuum, beginning with communication that helps patients handle the emotional impact of a cancer diagnosis. Although patient-centered communication was not a direct goal of the NCCCP, it was tied to efforts to increase access to quality care and was central to navigation services. Although communication scores did not change significantly over time, patients generally reported positive communication experiences. Furthermore, patient navigation assistance mediated communication. This finding may reflect the role navigators play in providing informational and emotional support, as evidenced in the focus group findings. Overall, the NCCCP evaluation findings underscore that patients had a positive experience at the NCCCP sites and that they particularly valued patient navigation

services. This contributes to our understanding of the importance of patient navigation in achieving high-quality cancer care and enhancing the patient experience.16,39,40

Conclusion Given that the new cancer program accreditation standards of the American College of Surgeons Commission on Cancer focus on patient navigation as a key component of the continuum of care services,41 we are likely to see tremendous growth in patient navigation programs.42 As these programs grow, it will be impor tant to further assess the impact on treatment adherence and evidence-based quality of care, and to address common challenges, such as the lack of staff, administration, and physician support for patient navigation programs; difficulty finding qualified navigators42; and the need to develop measures to assess the impact of patient navigation.16,39,40,43 g Acknowledgments This project was funded by the National Institutes of Health, National Cancer Institute, under Contract No. GS-10F-0097L. We are grateful to the leaders and staff at the participating NCCCP centers who facilitated the data collection activities. The findings and conclusions presented in this article are those of the authors and do not necessarily represent the official position of the National Cancer Institute or the Patient-Centered Outcomes Research Institute. Author Disclosure Statement All authors reported no conflicts of interest. Corresponding Author: Katherine Treiman, PhD, MPH; RTI International, 203 Dale Drive, Rockville, MD 20850. E-mail: Ktreiman@rti.org.

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navigation in breast cancer: a systematic review. Cancer Nurs. 2010;33(2): 127-140. 8. Jones SM, McCormack LA, Johnson TP, et al. Sample design methodology for studying patients using registry data. Paper presented at: American Statistical Association, Proceedings of the Survey Research Methods Section; July 31-August 5, 2010; Vancouver, BC. Abstract 308148. www. amstat.org/meetings/JSM/2010/onlineprogram/AbstractDetails.cfm?abstractid= 308148. Accessed March 24, 2015. 9. American Association for Public Opinion Research. Standard Definitions: Final Disposition of Case Codes and Outcome Rates for Surveys. 7th ed. Ann Arbor, MI: American Association for Public Opinion Research; 2011. www.aapor.org/AAPORKentico/AAPOR_Main/media/MainSite Files/StandardDefinitions2011_1.pdf. Accessed March 24, 2015. 10. Folsom RE Jr, Singh AC. The generalized exponential model for sampling weight calibration for extreme values, nonresponse, and poststratification. Paper presented at: American Statistical Association Meeting, Proceedings of the Survey Research Methods Section; August 13-17, 2000; Indianapolis, IN. www.amstat.org/sections/srms/proceedings/papers/2000_ 099.pdf. Accessed March 24, 2015. 11. Battaglia TA, Bak SM, Heeren T, et al. Boston Patient Navigation Research Program: the impact of navigation on time to diagnostic resolution after abnormal cancer screening. Cancer Epidemiol Biomarkers Prev. 2012;21(10):1645-1654. 12. Byers T. Assessing the value of patient navigation for completing cancer screening. Cancer Epidemiol Biomarkers Prev. 2012;21(10):1618-1619. 13. Cantril C, Haylock PJ. Patient navigation in the oncology care setting. Semin Oncol Nurs. 2013;29(2):76-90. 14. Dudley DJ, Drake J, Quinlan J, et al. Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. Cancer Epidemiol Biomarkers Prev. 2012;21(10):1639-1644. 15. Freeman HP, Muth BJ, Kerner JF. Expanding access to cancer screening and clinical follow-up among medically underserved. Cancer Pract. 1995; 3(1):19-30. 16. Guadagnolo BA, Dohan D, Raich P. Metrics for evaluating patient navigation during cancer diagnosis and treatment: crafting a policy-relevant research agenda for patient navigation in cancer care. Cancer. 2011; 117(15 suppl):3565-3574. 17. Hoffman HJ, LaVerda NL, Young HA, et al. Patient navigation significantly reduces delays in breast cancer diagnosis in the District of Columbia. Cancer Epidemiol Biomarkers Prev. 2012;21(10):1655-1663. 18. Markossian TW, Darnell JS, Calhoun EA. Follow-up and timeliness after an abnormal cancer screening among underserved, urban women in a patient navigation program. Cancer Epidemiol Biomarkers Prev. 2012;21 (10):1691-1700. 19. Maxwell AE, Jo AM, Crespi CM, et al. Peer navigation improves diagnostic follow-up after breast cancer screening among Korean American women: results of a randomized trial. Cancer Causes Control. 2010;21(11):1931-1940. 20. Paskett ED, Harrop JP, Wells KJ. Patient navigation: an update on the state of the science. CA Cancer J Clin. 2011;61(4):237-249. 21. Paskett ED, Katz ML, Post DM, et al. The Ohio Patient Navigation Research Program (OPNRP): does the American Cancer Society patient navigation model improve time to resolution among patients with abnormal screening tests? Cancer Epidemiol Biomarkers Prev. 2012;21(10):1620-1628. 22. Raich PC, Whitley EM, Thorland W, et al; for the Denver Patient Navigation Research Program. Patient navigation improves cancer diagnostic resolution: an individually randomized clinical trial in an underserved population. Cancer Epidemiol Biomarkers Prev. 2012; 21(10):1629-1638. 23. Weber JJ, Mascarenhas DC, Bellin LS, et al. Patient navigation and the quality of breast cancer care: an analysis of the breast cancer care quality indicators. Ann Surg Oncol. 2012;19(10):3251-3256.

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24. Campbell C, Craig J, Eggert J, Bailey-Dorton C. Implementing and measuring the impact of patient navigation at a comprehensive community cancer center. Oncol Nurs Forum. 2010;37(1):61-68. 25. 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(1):114-124. 26. Fillion L, de Serres M, Cook S, et al. Professional patient navigation in head and neck cancer. Semin Oncol Nurs. 2009;25(3):212-221. 27. Fillon M. Can patient navigation help resolve gaps in cancer care? J Natl Cancer Inst. 2011;103(24):1815-1817. 28. Fiscella K, Whitley E, Hendren S, et al. Patient navigation for breast and colorectal cancer treatment: a randomized trial. Cancer Epidemiol Biomarkers Prev. 2012;21(10):1673-1681. 29. Guadagnolo BA, Cina K, Koop D, et al. A pre-post survey analysis of satisfaction with health care and medical mistrust after patient navigation for American Indian cancer patients. J Health Care Poor Underserved. 2011;22(4):1331-1343. 30. Carroll JK, Humiston SG, Meldrum SC, et al. Patients’ experiences with navigation for cancer care. Patient Educ Couns. 2010;80(2):241-247. 31. Walsh J, Young JM, Harrison JD, et al. What is important in cancer care coordination?: a qualitative investigation. Eur J Cancer Care (Engl). 2011;20(2):220-227. 32. Wells KJ, Battaglia TA, Dudley DJ, et al; Patient Navigation Research Program. Patient navigation: state of the art or is it science? Cancer. 2008; 113(8):1999-2010. 33. Donelan K, Mailhot JR, Dutwin D, et al. Patient perspectives of clinical care and patient navigation in follow-up of abnormal mammography. J Gen Intern Med. 2010;26(2):116-122. 34. Arora NK, Street RL Jr, Epstein RM, Butow PN. Facilitating patient- centered cancer communication: a road map. Patient Educ Couns. 2009;77(3):319-321. 35. Epstein RM, Street RL Jr. Patient-Centered Communication in Cancer Care: Promoting Healing and Reducing Suffering. NIH publication 07-6225. Bethesda, MD: National Cancer Institute; 2007. 36. Committee on Quality of Health Care in America; Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press; 2001. www.nap.edu/open book.php?record_id=10027&page=R2. Accessed March 25, 2015. 37. McCormack LA, Treiman K, Rupert D, et al. Measuring patient-centered communication in cancer care: a literature review and the development of a systematic approach. Soc Sci Med. 2011;72(7):1085-1095. 38. Street RL Jr, Makoul G, Arora NK, Epstein RM. How does communication heal?: pathways linking clinician-patient communication to health outcomes. Patient Educ Couns. 2009;74(3):295-301. 39. Fiscella K, Ransom S, Jean-Pierre P, et al. Patient-reported outcome measures suitable to assessment of patient navigation. Cancer. 2011;117(15 suppl):3603-3617. 40. Parker VA, Clark JA, Leyson J, et al. Patient navigation: development of a protocol for describing what navigators do. Health Serv Res. 2010;45(2): 514-531. 41. American College of Surgeons Commission on Cancer. Cancer Program Standards 2012 Version 1.2.1: Ensuring Patient-Centered Care. Chicago, IL: American College of Surgeons; 2012. www.facs.org/~/media/ files/quality%20programs/cancer/coc/programstandards2012.ashx. Accessed March 25, 2015. 42. Willis A, Pratt-Chapman M, Reed E, Hatcher E. Best practices in patient navigation and cancer survivorship: moving toward quality patient-centered care. J Oncol Navig Surviv. 2014;5(2):8-14. 43. Crane-Okada R. Evaluation and outcome measures in patient navigation. Semin Oncol Nurs. 2013;29(2):128-140.

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Quality, Outcomes, and Performance Improvement (QOPI) Committee

How 7 Nurses Maximize Their AONN+ Membership—This Is Your Invitation to Join Our QOPI Committee By Pamela Goetz, BA Oncology Survivorship Navigator, Johns Hopkins Medicine, Sibley Memorial Hospital, Washington, DC

even Academy of Oncology Nurse & Patient Navigators (AONN+) members want you to know about a membership benefit that you might have overlooked. Everyone knows about the newsletter, the conference, and webinars that come with a membership, but did you know that there is a committee whose business is to help you do quality improvement projects and other forms of research, regardless of your level of experience in these areas? Quality, Outcomes, and Performance Improvement (QOPI; not to be confused with ASCO’s QOPI) is a committee within AONN+ whose purpose is to connect members who have never done quality improvement projects with those who have done formal research projects, as well as those with any other level of experience in between. The QOPI Committee wants to be sure that all AONN+ members are aware of how the committee can support them as a navigator. Participating in the committee has been working for your colleagues, and it may help you, too. We have interviewed 7 committee members about why they decided to get involved with QOPI. The QOPI Committee consists of 38 members who work in a variety of settings and share some common professional goals. At the core of the committee is the aim to improve how each of us provides care to our patients, and quality improvement helps us do that by measuring what we are doing, and using this information to determine ways to make processes and programs better. From our conversations with committee members, a number of themes emerged relating to the benefits of being involved with QOPI. These include getting guidance in how to conduct quality improvement projects, how to write about quality improvement projects for presentations, learning about navigation best practices and evidence-based navigation, and how to prove your value as a navigator and justify your position on the healthcare team. Learning from others in the QOPI Committee about best practices in navigation was a common theme among the nurses interviewed.

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Sharing Best Practices Barb McHale, RN, BS, OCN, CBCN, is a nurse with many years of experience working with patients with cancer, who has held positions as a case manager and in the public health setting. She is now a nurse navigator at Samaritan Hospital Cancer Treatment Center in Troy, NY. McHale has long understood the importance of following evidence-based standards of care, and finding ways to measure outcomes. She has presented posters at the AONN+ conferences, winning first place in 2012 for a study looking at navigation and patient education for patients with head and neck cancers. She was invited to do a presentation at the advanced navigation track at the 2013 AONN+ conference in Memphis, TN.

“Research doesn’t require statistics, just a nursing practice. If you’re doing things, write it up!” In preparing for the talk, McHale received mentoring support from QOPI chairs Elaine Sein, RN, BSN, OCN, CBCN, who recently retired from Fox Chase Cancer Center, and Danelle Johnston, RN, MSN, OCN, CBCN, Manager of Breast Services at Memorial Hospital, University of Colorado Health. With their help, McHale refined her presentation, which described a project she undertook to improve patient access to rehabilitation services, using limited resources. As McHale said, “The committee advocates for evidence-based practices, and working with the QOPI committee has offered me the opportunity to learn about and share best practices, not just follow trends in navigation.”

Quality, Outcomes, and Performance Improvement (QOPI) Committee

Mentorship, Paying Forward Deb Christensen, RN, BSN, HNB-BC, navigates patients with hematologic and solid tumor cancers at the Intermountain Southwest Cancer Center in St. George, UT. She cares for patients from diagnosis through survivorship. She noted that the QOPI Committee is a place where seasoned nurses, who have already been published, can help others with getting published. Through mentorship, those new to research and quality improvement can glean skills from those with more experience; in turn, those mentored can use this knowledge to make their own contributions to the field of navigation. Christensen met with Elaine Sein for guidance with some research projects, and now views the

“My goal is to assist patients and the system as a whole.” committee as a resource that she can turn to for help in the future. Fortunately, Christensen’s institution supports her in doing research and in disseminating her results. To date, she has had 3 posters and an article published with the Journal of Oncology Navigation & Survivorship (JONS). One of her poster presentations was titled “Utilizing Metrics to Advance Navigation Services.”

Quality Improvement Tools Nurses often do not have a lot of time to find the tools to carry out quality improvement projects and to report on their outcomes. QOPI can help navigators get a jump-start on their projects by offering resources, including metrics, data collection tools, needs assessments, how to design and complete a quality improvement project, and information on writing abstracts, designing posters, and writing research articles. Marian E. Gilmore, RN, OCN, is a nurse navigator in a multispecialty clinic at Dana-Farber/Brigham and Women’s Cancer Center, in clinical affiliation with South Shore Hospital in South Weymouth, MA. Gilmore recognizes that the QOPI Committee has helped her and others in identifying metrics that are meaningful to navigation, such as documenting the num-

ber of patients seen, how to track phone calls, and triaging patients.

“Documentation is the starting point of quality improvement.” In addition to learning about metrics, Gilmore has seen rewards by attending the AONN+ conference, where there are opportunities to acquire great information, get help with program development, and learn about quality improvement, specifically in a surgical setting. Gilmore is willing to help others with surgical navigation and quality improvement, as this is the area she supports patients pre- and posttreatment.

Frances M. Johnson, MSN, RN, AOCN, ANPBC, CNS, is a Primary Care Triage Nurse at Michael E. DeBakey Veterans Affairs Medical Center in Houston, TX. She is also working on her dissertation, which focuses on the role of nurse practitioners in oncology navigation. Johnson has been motivated to be involved with QOPI to help with defining metrics, which will progress the field of nursing and navigation.

“Navigation and nursing processes can be measured to improve patient care.” Nikki Levinson-Lustgarten, RN, BSN, CBPN-IC, works as a breast care coordinator at Navy Medical in Jacksonville, FL, the fourth largest Navy hospital in the system, which is the equivalent of a community hospital. They have surgical capabilities, and use community resources for hematology oncology and radiation oncology. Levinson-Lustgarten’s interest in QOPI stems from her recognizing that it is important to do quality improvement activities relative to processes and data, which will be important in stating a case for hiring another navigator. Because of her work schedule, Levinson-Lustgarten has yet to call on the group to help her achieve her goals, but has a number of projects that she hopes to pursue with QOPI. In particular, she is interested in producing a patient satisfaction survey, and sees QOPI as a resource to get this accomplished. Levinson-Lustgarten will also look to the committee for guidance in creating a database for tracking her patients, who receive some of their care at Navy Medical,

JONS-online.com • Journal of Oncology Navigation & Survivorship

Quality, Outcomes, and Performance Improvement (QOPI) Committee

and the remainder of their care is delivered in the community, which presents a challenge for many navigators. We all have limited resources in our own institutions, and QOPI is here to supplement and fill any informational needs.

Advancing the Navigation Role— Locally and at the National Level Most of the navigators interviewed stated that quality improvement is important to them for the purpose of advancing their navigation role at the local and national level. Whether to argue the case for keeping an existing navigator position or justifying the need for an additional navigator, data collection and quality improvement projects are seen as necessary by many navigators. Carrie Stricker, PhD, RN, is a nurse practitioner and Director of Clinical Programs at Abramson Survivorship Center at the University of Pennsylvania, and is an adjunct faculty member in nursing. She wanted to document value to garner administrative support for program activities, so she uses data collection and quality improvement projects to help achieve this goal. Dr Stricker said, “Nurses and others don’t have one place to go for research support, and there is no one answer or agreement on what data to collect.”

“There’s a lack of experience with doing quality improvement projects, needs assessments, and how to tie metrics to these efforts.” Most nurses have not learned how to do evaluation work in their formal training, learning on the job with a mentor; therefore, networking in a professional organization, and taking learning opportunities via webinars or through mentorship in a committee like QOPI, can help fill this gap. Dr Stricker sees the value of being involved with QOPI as having an impact in the field of navigation at the national level, and wants to contrib-

Join the QOPI Committee To learn more about the quality improvement projects conducted by the interviewed AONN+ members or other members, go to the JONS archive page, www.jons-online.com/issue-archive/, and search by author name. To learn more about getting involved with any of these avenues to QOPI, simply send an e-mail to

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ute to discussions with others on the committee and to take information back to her team. Furthermore, Dr Stricker noted that patients with cancer have choices on where to go for their treatment, and the level of professionalism that a navigator offers can help draw patients to cancer care centers. The new Commission on Cancer mandates, when translated into practice, require cancer centers to collect data to show what a cancer program has done, and how the program addressed an identified need and made a difference to patients.

Britta Newcomer, RN, BSN, OCN, has an administrative role at Catholic Health Initiatives in the National Oncology Service Line in Denver, CO, which covers 45 cancer care centers. As a clinical quality specialist, Newcomer oversees 10 to 12 navigators who provide navigation, outreach, and survivorship care. Newcomer’s interest in the QOPI Committee is in contributing to discussions about

“I want to influence the work that QOPI is doing to improve patient care. I am looking forward to more participation in the future.” navigation at the national level, as well as taking pertinent information back to her team. In particular, she felt that Elaine Sein’s presentation on standardizing navigation metrics was timely for her team. Newcomer is grateful to be a part of QOPI and all it has to offer her, as well as the navigators she works with directly. If any of these themes have struck a chord with you, do not hesitate to get involved with QOPI. There are many different ways that you can participate, whether you want to learn from the other committee members or the general AONN+ community, or if you want to share information with others. qopicommittee@aonnonline.org. By joining the QOPI Committee, you will have access to: • Bimonthly calls • Committee meetings • Regional meetings • Webinars • Blogs

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Quality, Outcomes, and Performance Improvement (QOPI) Committee

• AONN+ website • AONN+ newsletter and QOPI Corner column • A community forum • QOPI workgroups • Mentorship opportunities. The QOPI Committee works, because there is a dynamic relationship within the group. We give and take information in the name of supporting each other in measuring what we do, evaluating processes and patient experience, justifying our roles, and proving our worth. Our members are motivated by the goals of helping individual patients, improving cancer

center processes, and advancing healthcare on the national level. In 2015, AONN+ will roll out the nurse navigator certification, and the QOPI Committee is positioned to enhance the higher standard of professionalism for navigators that the organization continues to support. We hope to hear from you soon about how we can provide mentorship to you, or how your skills can be added to our pool of resources for others to access. By participating, you make AONN+ stronger, the navigation field more credible, and you become a more engaged and informed professional. g

A Coincidence Turns into a Career Penny Daugherty, RN, MS, OCN Oncology Nurse Navigator, Gynecologic Oncology, Northside Hospital Cancer Institute, Atlanta, GA

became a nurse almost by coincidence, even as I realize it was meant to be. I was at home with my third child who, at age 6 months, was nursing voraciously (he did everything voraciously) when a good friend called me. She was in the midst of a divorce and was looking for a way to support herself and her 2 children going forward. She told me she was applying to nursing school and suggested that I join her that day in applying.

My orientation was intense, filled with tough love and entirely ingrained in me the desire to be the best oncology nurse I could be. Keep in mind that this was the late 1970s, when extensive surgeries were being done, and every patient was a challenge to the primary nurse. I had enjoyed a lovely career as a Master’s prepared clinical psychologist before having my third child; having received a wonderful education at the University of

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Washington, I had every intention of being a stay-athome mom, not to mention my aversion to blood-splattered scenarios. Needless to say, I was not very motivated to embark on a new and strenuous education. But friendship prevailed. I did go to Edison College with my friend, and, strangely enough, ended up enrolling in nursing school. On the way home, I rationalized that I could always be a school nurse (having worked with mentally handicapped children in my first career), thus combining my background in psychology with nursing—no problem. From the first day in school, I was enthralled—anatomy, physiology, microbiology, and, most especially, pathophysiology were like gates to a whole new world, and studying became an obsession. My husband just handed over his precious drafting table, so all my books and papers were always available to me as he watched me engulf myself in my studies. As an aside, I was blessed with what I consider some of the finest instructors in nursing education, so their contribution was an enormous motivating factor. When I started my pediatric clinical rotation, the instructor bluntly informed me, after seeing me with 3 very ill children, that this was not for me, that I could never be

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Quality, Outcomes, and Performance Improvement (QOPI) Committee

therapeutic with children, and that I needed to redirect my focus. She was right. I was a tearful, emotional wreck when exposed to the manifestation of physical illness in children. Surgery was next, and after obsessing all night about what I would do with blood-splattered operations, I somehow ended up shoveling my way to the front of the surgical field (I who was previously so squeamish). All my knowledge of anatomy, physiology, and pathophysiology just leapt into life, and my love of surgery was born that first day, despite the scolding I got from the circulating nurse about being too close to that field. If anything, that just ignited the fizz of the drama of surgery.

The Northside Hospital Cancer Institute Navigation program has flourished and burgeoned into one of the largest navigation programs in the country, and I can truly say I love every moment of my job. I did my oncology rotation in a head and neck unit at Fort Myers Community Hospital (remember me, squeamish about blood and body fluids?), and between the incredible head nurse, Madeline Norsworthy, and all the incredibly welcoming staff nurses (and the feisty and very needy patients), I knew that this was where I belonged. Surgical oncology became a part of my life in that moment, and has since been my soul’s home as a nurse. After graduation, I went to the same head nurse and pleaded my case, and miraculously, she hired me—a new graduate. My orientation was intense, filled with tough love, and entirely ingrained in me the desire to be the best oncology nurse I could be. Keep in mind that this was the late 1970s, when extensive surgeries were being done, and every patient was a challenge to the primary nurse, from the endless tracheostomy care to the disfiguration, to the already unique personalities and needs of the patients with head and neck cancer. I loved every minute of it: at that period in oncology nursing, we, the primary nurses, did everything, from wound care to intravenous administration and tracheostomy care, and sometimes (yes, it happens) reinsertion. When my husband and I opted to move from Florida to Atlanta, at first I had trouble adapting to this huge, sprawling city, and through a series of coincidences (there’s that word again), I met Alice Kerber who offered me a position as a Community Clinical Oncology Program (CCOP) research nurse at Southern Regional Medical Center.

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They had just hired a new clinical nurse specialist, Marty Polovich, and she and I shared what we euphemistically referred to as our “office” for many years. Alice (as our manager), Marty, and I were teammates, in an effort to make our oncology program shine—and shine it did. We had the highest CCOP clinical trial accrual in the city, and we brought state-of-the-art treatment to many underserved patients in our service area. I developed a new love for research as I familiarized myself with diseases I had never heard of, and guided patients through their care and treatment. Alice, Marty, and I are still close friends, and those of us who have been oncology nurses for many years know what this very unique and special bond means. I heard a talk at an Oncology Nursing Society (ONS) Metro Atlanta Chapter meeting about ovarian cancer, and a little fire sparked in me that this might well be something I could embrace. Just a few short years later (another coincidence?), I was offered the position of Research Director of one of the biggest gynecology oncology practices in the country, and I “threw” myself into that opportunity, where I happily flourished (blessed by a super research team and amazing doctors) for 10 years. During that period, I was incredibly privileged to participate in the ONS Core Competencies for Clinical Trial Nurses. During that time, Mary Gullatte asked me to be a contributing author in the third edition of her book, Clinical Guide to Antineoplastic Therapy: A Chemotherapy Handbook. I blithely agreed, and then realized I had absolutely no experience writing. Mary patiently edited my piece numerous times, giving me the encouragement to feel that I could actually be a credible author. At the ONS Congress in 2009, Barb Sigler (the then ONS Director of Publications) asked me if I would consider writing a “little book” to be titled Case Studies in Navigation. Coincidently, I had just finished my piece in Mary’s book, so I was brash enough to agree. John Zaphyr, Lisa George, and the entire ONS publishing team were to be our shining beacons of support with this book going forward when Barb retired. Historically, our gynecology/oncology practice was sold in 2010. I had become intrigued by the new navigation initiative, and our GASCO (Georgia Society of Clinical Oncology) team, under the inspired guidance of Matthew P. Mumber, MD, of the Harbin Clinic in Rome, GA, had created the Cancer Patient Navigators of Georgia. I was so excited to be one of the founding members—having no idea what I was about to do with my life and career—but loving every moment of that highly inspired beginning. The concept of navigation seemed to be such an incorporation of every experience I had had up to that point in my life.

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Quality, Outcomes, and Performance Improvement (QOPI) Committee

When I was selected to present at the prestigious and incredibly well-attended AONN+ conference last year, I looked out at all my fellow navigators with an overwhelming feeling of kinship and admiration for each individual who embraces this new specialty within our specialty. The Northside Hospital Cancer Institute Navigation Program has flourished and burgeoned into one of the largest navigation programs in the country, and I can truly say I love every moment of my job. As for the little book I told Barb Sigler I would write? ONS had decided that much more was needed, and I asked our navigation coordinator, Kathleen Gamblin, to be a coeditor; then Karyl Blaseg, from the Billings Clinic in Montana, joined us as the third and lead editor of the first ONS published book on comprehensive nurse navigation, titled Oncology Nurse Navigation: Delivering Patient-Centered Care Across the Continuum.

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This year, ONS has approved the companion book, Case Studies on Nurse Navigation, which we hope to publish in 2016. Our editors for this new book will be Kathleen Gamblin from Northside Hospital in Atlanta, GA, Margaret (Peg) Rummel from the University of Pennsylvania, and me. When I was selected to present at the prestigious and incredibly well-attended Academy of Oncology Nurse & Patient Navigators (AONN+) conference last year, I looked out at all my fellow navigators with an overwhelming feeling of kinship and admiration for each individual who embraces this new specialty within our specialty. I am ever grateful that Lillie Shockney and Sharon Gentry had the confidence in me to let me speak at the elegant AONN+ conference. My patients are all beautiful, heroic women who are given devastating and horrifying diagnoses that shatter their lives, and my job is to guide them through this incredibly treacherous set of diseases, so their lives and their families’ lives are filled with the highest possible quality of life. I am blessed to work with my patients through the entire continuum of their care. As I look back on my journey, I can clearly say that there are, indeed, no coincidences, and every single experience I have had as a nurse has gently (and sometimes not so gently) guided me to this moment—the very best job I could ask for, and to bring my personal compendium of experience to be that guide for my precious patients. In the interest of full disclosure, I can truly say that I have been blessed with a husband who has created an ever safe haven for me to come home to, and his outrageous sense of humor has sustained me in situations too numerous to mention. From the day he let me have his very precious drafting table, I knew he “got it,” and we would be a great team. g

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I applied to be the gynecology/oncology nurse navigator as Northside Hospital began their affiliation as a Cancer Institute through the National Cancer Institute Community Cancer Centers Program (recently renamed as the National Cancer Institute Community Oncology Research Program), and when Patti Owen, Director of Oncology, told me I was hired, I could hardly sit in my chair across from her desk. I remember telling her that I was considering stepping over her desk and hugging her. Gracious, lovely lady that she is, she simply smiled.

october 1- 4,heroes 2015 Compassion suRvivoR EducatE LoVe EducatE LoVe Hyatt Regency atlanta • atlanta, georgia strength TRUST Kindness CaRE strength TRUSTKin heroes Compassion

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Innovations in Oncology Management

A newsletter series for oncology practice administrators, administrative staff, advanced practice clinicians, and oncology pharmacists. This series provides concise, up-to-date information on current issues that are impacting the business of oncology.

Topics include: Part 1: Navigating Payer Audits Part 2: Coordinating with Specialty Pharmacies Part 3: CMS Oncology Care Model Part 4: Navigating Legislative and Policy Directives TO VIEW THE SERIES ONLINE PLEASE LOG ON TO:

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Managing Physical Impairment

Physical and Functional Impairments and Physical Therapy Utilization in Cancer Survivors of Puerto Rican Descent Ann Marie Flores, PT, PhD, CLT1; Jason Nelson, MPH2; Dinorah Martinez Tyson, PhD3; Rebecca Stephenson, PT, DPT, MS, WCS4; Katherine L. Tucker, PhD5 1 Department of Physical Therapy, Rehabilitation and Movement Sciences, Center for Cancer Survivorship Studies, Northeastern University, Boston, MA; 2Biostatistics Research Center, Institute for Clinical Research and Health Policy Studies, Tufts University Medical Center, Boston, MA; 3Department of Community and Family Health, College of Public Health, University of South Florida, Tampa, FL; 4Women’s Health Physical Therapy Program, Rehabilitation Services, Brigham and Women’s Hospital, Boston, MA; 5Clinical Laboratory & Nutritional Sciences, Center for Population Health & Health Disparities, University of Massachusetts–Lowell, MA Objective: To describe physical and functional impairments after cancer, and whether physical therapy was utilized to address impairments among cancer survivors from the Boston Puerto Rican Health Study. Methods: Puerto Rican cancer survivors were surveyed about impairments—joint range-of-motion impairment, muscle weakness, pain, fatigue, skin numbness, abnormal posture, and signs and symptoms of lymphedema (localized edema, skin texture or color changes, or self-reported diagnosis of lymphedema)— and referral to physical therapy for impairments. Percentages of cancer survivors with impairments and physical therapy utilization were compared by income, adjusting for cancer treatment, comorbidity, and years since diagnosis. Results: Among 70 cancer survivors interviewed, 100% had health insurance (Massachusetts state law requirement). Mean age was 67 years, 81% were female, 38% had an income <$10,000, and a mean of 6.8 comorbid conditions (>50% report arthritis and hypertension) were noted. The most common cancers reported (in descending order) were breast, prostate, female reproductive, colorectal, and cancer of the head and neck; 21% were “other” types. None reported lung cancer. Eighty-five percent reported having at least 1 impairment, with an average of 2.9 impairments; 53% reported 3 or more impairments. In addition, 50% had ≥1 signs and symptoms of lymphedema, whereas 35% reported cancer-related swelling. Of those with swelling, 50% received treatment for it. Less than 20% received physical therapy for any impairment. Conclusions: This sample of Puerto Rican cancer survivors was largely female and nearly all had low income. They reported a high level of comorbid conditions and impairments. Despite state-required health insurance, few received physical therapy, suggesting underutilization of physical therapy for this patient group.

ore Americans are living with cancer-related or treatment-related impairments than at any time in US history.1 The population of cancer survivors is estimated at 14.5 million and is projected to approach 18 million by 2022.2,3 Pain, fatigue, and lymphedema are well-known impairments, but lymphedema research is largely performed on samples of breast cancer survivors rather than heterogeneous samples of survivors of other tumor types.4 Poorly controlled pain can lead to sustained contraction of nearby muscles, tissue degradation, psychological distress, disability, and poor quality of life.5,6 Moreover, pain may also contrib-

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ute to patterns of movement overuse, poor posture, and faulty biomechanics.7-9 More than 90% of cancer survivors report fatigue interfering with health-related quality of life, mood, and activities of daily living.10-14 Lymphedema can occur wherever the lymph system is damaged (eg, by surgical resection, chemotherapy, or radiation). Less obvious impairments, such as muscle weakness, skin numbness, joint range-of-motion impairment, and abnormal posture, may be disabling.1 All of these impairments are frequently observed among cancer survivors and fall within the scope of practice of rehabilitation

Managing Physical Impairment

clinical specialists, including, but not limited to, physical therapy.8,15-21 Most studies describing side effects or impairments have focused on breast cancer survivors who are non-Hispanic, white, middle income, and have health insurance.22 Minorities, the poor, and the medically underserved bear the greatest burden of cancer, especially in terms of mortality, access to healthcare, and the ability to withstand cancer treatment costs.21-28 Among Hispanics, Puerto Ricans have the second highest cancer mortality rate (Cubans have the highest rate).29,30 Hispanic cancer survivors also report significantly worse distress, depression, social support, and health-related quality of life than non-Hispanics.31 Socioeconomic status (SES), unequal access to treatment, race, and ethnicity are cited as contributing to disparities in the prevalence of cancer and its related mortality27-30,32-39 with SES, rather than race or ethnicity, as the strongest predictor of cancer death.29 Despite these mechanisms, little is known about whether impairments and their treatment are also differently experienced for low-income Hispanics.35,40-43 This is one of the first studies to examine the prevalence of impairments for cancer survivors of Puerto Rican descent, and whether physical therapy has been utilized to address these impairments.

Methods

Study Participants

We included cancer survivors originally enrolled in the Boston Puerto Rican Health Study (BPRHS). This long-term, prospective, population-based cohort study had recruited Puerto Rican adults (aged 45-75 years) residing in the greater Boston metropolitan area. As with the BPRHS, a requirement of inclusion in our study was that participants be able to speak and understand Spanish or English. This subset of self-reported cancer survivors from the BPRHS (n = 104) was eligible to participate in our study. BPRHS recruitment and survey methods are described online at www.uml.edu/Research/ CPHHD/About/default.aspx and elsewhere.44 After receiving institutional review board approval (Northeastern University), we obtained contact information for the BPRHS cancer survivors who were still alive by December 2012. Next, we attempted to reconnect with these survivors by sending them an introductory recruitment packet that included a letter of introduction, a copy of the consent form, and a self-addressed stamped envelope. After the introductory packet was mailed, research staff members followed up by telephone to determine willingness to participate in the study. Up to 15 such attempts were made for each prospective participant, with 2 tries being the most common. Once we

established a survivor’s willingness to participate, we scheduled an in-home, face-to-face interview to be conducted in Spanish or English. All of our interviewers were bilingual—fluent in both Spanish and English— and were trained on informed consent and study procedures. Informed consent was obtained at the home visit and took approximately 60 minutes. Survey Instrument

The survey and written materials had a readability level of no higher than the 8th grade and were designed to be culturally sensitive and relevant, as per methods described previously by other investigators.44-47 The survey included items on social demographics, medical history, impairments, and utilization of physical therapy to address the reported impairments. Diagrams of the human body were used to indicate regions affected by the cancer and its treatment, as well as the specific locations of impairments. Participant Characteristics

SES was measured as level of formal education achieved (<9 years, 9-11 years, high school/GED, vocational/technical, some college/junior college, college graduate or higher) and annual household income (<$10,000, $10,000 to <$20,000, $20,000 to <$30,000, $30,000 to <$50,000, and ≥$50,000). We approximated the 2011 US Census Bureau official poverty threshold to represent “low income” ($22,811 for a family of 4)48,49—our categories of <$10,000 and $10,000 to $20,000.48,49 The number of years since cancer diagnosis was calculated by taking the year of diagnosis and subtracting it from the interview date. Health insurance status was classified by carrier—MassHealth, Medicare, private insurance (eg, Partners HealthCare/Neighborhood Health Plan, Harvard Pilgrim HealthCare, Tufts Health Plan), other type of insurance (not specified), and no insurance reported—at the time of the initial BPRHS interview. We verified that this information was still correct for each participant in the present study of cancer survivors. Medical History/Comorbid Conditions

Body mass index was calculated as self-reported current weight divided by height squared, from the 2-year BPRHS follow-up interview. Participants were asked to respond by yes or no to a history of high blood pressure; myocardial infarction; heart disease (other than heart attack); diabetes; cerebrovascular accident; respiratory disease (emphysema, chronic bronchitis, asthma); depression; osteoarthritis; osteoporosis; liver or gallbladder disease; kidney disease; intestinal/ulcer disorder; conges-

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Managing Physical Impairment

Table 1 Demographics and Characteristics Participants, % (N = 70, unless otherwise noted)

Characteristics Age, yrs, mean (SD)

67.0 (7.5)

Years since cancer surgery, mean (SD)

12.5 (11.1)

Sex, female, N (%)

57 (81.4)

BMI, kg/m , mean (SD) 2

31.7 (5.8)

Household income, % <$10,000

38.6

$10,000-<$20,000

47.1

$20,000-<$30,000

5.7

$30,000-<$50,000

4.3

≥$50,000

2.8

Don’t know/missing

1.4

Education, % Less than 5th grade

27.1

5th to 9th grade

32.9

9th to 12th grade or GED

27.1

Some college or bachelor’s degree

8.6

Some graduate school

2.9

Don’t know/missing

1.4

Type of insurance, %

MassHealth

67.1

Medicare

44.3

Private (eg, Partners HealthCare/ Neighborhood Health Plan, Harvard Pilgrim Health Care, Tufts Health Plan) Other (not specified) None reported

7.1

17.1 4.3

BMI and insurance status measured at Boston Puerto Rican Health Study 2-year follow-up interview. BMI indicates body mass index.

tive heart failure; Parkinson’s disease; eye disease (cataract or glaucoma); anxiety; depression; seizure disorder; tuberculosis; hepatitis; HIV/AIDS; memory problems; and paralysis. The sum of these conditions represents the total number of comorbid conditions.50 Physical and Functional Impairments

Participants were asked to respond yes or no as to whether they had any of the following impairments in the affected area(s): difficulty moving, muscle weakness, pain, fatigue, skin numbness, and abnormal posture. The

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sum of an individual’s positive responses comprised the total number of impairments for that participant. For the cardinal signs of lymphedema, participants were asked to respond yes or no regarding the presence or absence of the following factors in the affected area, in terms of whether (1) swelling stayed the same or came and went; (2) hardening of the skin was exhibited (texture change indicative of tissue fibrosis); (3) darkening of the skin occurred; or (4) feelings of fullness or heaviness were experienced.51-53 Physical Therapy and Potential Barriers to Its Utilization

From the literature, we compiled a list of possible barriers to seeking healthcare services. We asked participants whether they utilized physical therapy for the impairments noted. Participants were asked if any of the following served as barriers to physical therapy care: cost of care; lack of insurance for >6 months; doctor did not recommend physical therapy; fear that a physical therapist will not speak Spanish; forgot to go to physical therapy; insurance does not cover physical therapy; fear of finding cancer; fear of making cancer spread; too busy to attend physical therapy; fear of prejudice or racism; fear of embarrassment; physical therapy costs too much; fear of discomfort or pain; need to take time off from work to attend physical therapy; clinic has inconvenient hours; transportation problems; inability to secure care for children or adult relatives in order to attend physical therapy; attending physical therapy is not supported by the family; and did not know where to go for physical therapy care.

Statistical Analysis

Participants were stratified by annual household income (<$10,000, ≥$10,000). We describe participant characteristics with frequencies and percentages for categorical variables and means and standard deviation (SD) for continuous measures. Differences by income strata were assessed with Mantel-Haenszel chi-square tests for ordinal variables, chisquare tests or Fisher exact test for categorical variables, and independent sample t-tests for continuous variables. The threshold for statistical significance of all analyses was determined using a 2-sided P value of .05. Analyses were performed using SAS version 9.3 (Cary, NC).

Results From the total of 104 men and women who reported having been diagnosed with cancer before entry into the BPRHS and not previously known to have died, we com-

Managing Physical Impairment

pleted 70 interviews resulting in a relatively high (67%) recruitment rate (57 women, 13 men). Of the 34 nonparticipants, 20 could not be reached by telephone, mailing, or home visits; 5 reported never having had cancer; 8 refused to participate; and 1 had died, as confirmed through a search of the National Death Index database.

Table 2 M edical Comorbidities, Cancer, and Treatment Received

Cancer Treatment, Demographics, and Comorbidity

Specific demographics and participant characteristics are shown in Table 1. On average, participants in our sample had survived their cancer for 12.5 years and had a mean age of approximately 67 years. Eighty-one percent were female, 87% had annual household incomes ≤$20,000 and 39% had incomes ≤$10,000, 60% had formal education below the 9th-grade level, and 100% had health insurance (required by Massachusetts state law). There were no statistical differences between income levels. As shown in Table 2, the average number of comorbidities was 7, and the most frequently reported conditions were arthritis (77%), hypertension (74%), and depression (63%). The most frequently reported types of cancer were breast (n = 26; 46% of women), prostate (n = 5; 46% of men), female reproductive (n = 12; 21% of women), colorectal (n = 8; 11% of total sample), and cancer of the head and neck (n = 2; 7.1% of total sample). The remainder reported having “other” (18.6%) types of cancer. Surprisingly, there were no reports of lung cancer, possibly due to low survival from this type of cancer. Nearly 90% of the participants report having had surgery to treat their cancer; 41% had radiation, whereas 30% had chemotherapy and 40% had longterm medication.

Comorbidities Arthritis

77.1

Hypertension

74.3

Other

74.3

Depression

62.9

Anxiety

60.0

Obesity

57.1

Diabetes mellitus

57.1

Respiratory disease (including tuberculosis)

47.1

Hepatitis A, B, C; liver; or gallbladder disease

32.9

Cardiovascular disease (stroke, myocardial infarction, other heart disease)

30.0

Kidney disease

18.6

HIV/AIDS Sum of above comorbidities, mean (SD)

8.6 6.8 (2.8)

Cancer type Breast (females only, n = 57)

45.6

Prostate (males only, n = 13)

46.2

Female reproductive cancer (females only, n = 57)

21.1

Colorectal

11.4

Head and neck

7.1

Lung

Other

18.6

Cancer treatment type Surgery

Impairments and Physical Therapy Utilization

In our sample, 85% of participants reported having at least 1 impairment. Among the 12 impairments included in our survey, the average number reported was 2.9 (SD, 2.3). More than half of our sample reported having had 3 or more impairments: 30% had 3 to 4 and 23% had >4 impairments (Table 3). The most prevalent impairments were pain (63%), skin numbness of the hands and feet (40%), fatigue (40%), muscle weakness (34%), movement of the affected area (34%), numbness not in the hands/feet (31.4%), abnormal gait (29%), edema of affected area (23%), and balance impairment (20%). Despite these reported impairments, only 27% reported that their doctor referred them to physical therapy and 18% reported having received physical therapy to treat any impairment. Of those with muscle weakness, 18% report having utilized

Participants, % (N = 70, unless otherwise noted)

Don’t know Radiation Don’t know

88.6 1.4 41.4 1.4

Long-term medication

40.0

Don’t know

10.0

Chemotherapy

30.0

Don’t know

2.9

Includes eye disease, stomach or intestinal disorder, osteoporosis, skin cancer, seizures/convulsions, or Parkinson’s disease.

physical therapy. Similarly, of those with pain or movement impairment, 17%, respectively, reported having had utilized physical therapy. There were no statistical differences by income.

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Managing Physical Impairment

Table 3 T ype of Impairment, Physical Therapy Referral, and Utilization Variable

All patients, % (N = 70, unless otherwise noted)

Physical and functional impairment Pain

62.9

Numbness (hands and feet)

40.0

Fatigue

40.0

Muscle weakness

34.3

Movement in area treated for cancer

34.3

Numbness (not hands and feet)

31.4

Problems with walking

28.6

Swelling

22.9

Balance

20.0

Problems with swallowing

8.6

Problems with keeping food/drink in mouth

5.7

Posture

4.3

Mean number of impairments (SD)

2.9 (2.3)

Impairment category 0

14.3

1-2

32.9

3-4

30.0

22.9

Received referral to physical therapy for impairment(s) Don’t know/missing Participants with at least 1 impairment (n = 60) receiving physical therapya Don’t know/missing

27.1 4.3 18.3 5.0

Percentage for received physical therapy is among participants reporting specific physical and functional impairment (n = 60).

Lymphedema Signs and Symptoms

Of the 23 (33%) participants who reported signs and symptoms of lymphedema (Table 4), the most commonly affected areas were the upper quarter (61%, including the face/head/neck) and lower quarter (39% in the mid-trunk to lower quarter, including the abdomen, pelvis, and genitals, and the middle and lower back, and buttocks), whereas 21% (not shown in Table 4) had more than one area involved. In all, 32% reported swelling only in the area(s) treated for cancer. The most frequently reported sign or symptom of lymphedema was skin darkening (27%; indicating hemosiderin staining), skin hardening

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(26%; indicating fibrosis), and the affected area feeling heavy or full (20%). In addition, 28.5% reported having at least 2 signs or symptoms of lymphedema. Of those with edema, 57% had received treatment for their swelling. There were no statistical differences by income. Barriers to Physical Therapy

Table 5 presents the most frequently reported barriers to receiving physical therapy. Nearly 30% of participants cited a lack of a recommendation from their doctor. Some other variables participants mentioned were insurance will not cover physical therapy (28%); do not know where to go for physical therapy (27%); clinic had inconvenient hours (25%); and lack of support from family and friends (22%). There was a tendency for those with very low income (<$10,000) to report these more frequently (27%-39% vs 20%-24%). Nine percent reported fear of discomfort or pain as a barrier to seeking physical therapy. Notable barriers usually seen for accessing and receiving care for cancer were not identified by this group—only 6% expressed concern that the provider may not speak Spanish or that it would be a problem to take time off from work. Fewer than 5% noted fear of prejudice, fear of recurrence or spreading of the disease, problems with transportation, or concern about care for children or adult dependents. However, Table 5 shows how this is different for those who report having received a referral to physical therapy (n = 20). These participants report barriers of fear of pain (30%) and speaking Spanish (20%). Lack of support from family and friends, fear of prejudice or racism, fear of spreading cancer, transportation, and cost were each reported by 15% of our participants. Forgetting to schedule physical therapy, the inability to take time off from work to attend physical therapy, and a fear of recurrence were each reported by 10%. A lack of coverage by insurance, not knowing where to go for physical therapy, feeling embarrassed, and the inability to arrange for care for children or adult relatives were each reported by 5% of our participants. Clinic hours, being too busy, and interference with spending time with family were not reported as barriers to physical therapy.

Discussion This study is the first to report on impairments and physical therapy utilization across tumor types in a Puerto Rican population. Whereas survivors of different tumor types may have unique side effects in terms of surgery, radiation, and chemotherapy, we can view physical and functional impairments as common across tumor types, with variation by frequency and severity. For example, postmastectomy pain is experienced exclusively by breast

Managing Physical Impairment

cancer survivors, but pain (including neuropathic pain) is clearly experienced by cancer survivors of all types. Recent evidence suggests that survivors of breast, colo rectal, lung, and prostate cancers who are also minorities (including Hispanics) are significantly undertreated for pain, compared with their white counterparts.54 In general, rehabilitation specialists (ie, physiatrists and physical, occupational, or speech therapists) can reduce pain and may help reduce time taken off from work or unemployment claims.1,55 We were encouraged to learn that 20% of our participants had received physical therapy for their pain. Similarly, cancer survivors for whom lymph nodes and/or lymphatic vasculature are removed (surgically) or otherwise damaged (eg, radiation tissue fibrosis involving lymphatic nodes and vasculature) are at risk for lymphedema, and it was encouraging that physical therapy was utilized at least among some of those with edema.56 Our sample is unique in 2 important ways. First, it is comprised mostly of those with low incomes. This likely contributed to the lack of significance for household income. Second, all our participants had health insurance—a requirement by Massachusetts state law. Recent research on healthcare disparities suggests that residence in neighborhoods of low SES is associated with lower survival among patients across survivors of breast, colorectal, lung, and prostate cancers.57 A cultural value among many Hispanic cultures is living in a multigenerational family setting. Hence, future research may need to take into account family size and roles, in order to fully appreciate the effects of household income.58-63 SES is a strong predictor of health disparities alongside race and ethnicity,57,58,64-67 whereas other studies point to a lack of health insurance as a key explanatory factor for cancer disparities.68-71 Like previous literature, pain and fatigue were frequently reported impairments.10,72,73 Poorly controlled pain is a critically important issue, because it contributes not only to psychological distress but also to disability and poor quality of life.5,6,74 Physical therapy can help reduce pain, and so it was encouraging to see that one-fifth of our participants received physical therapy for pain. Most cancer survivors are affected by fatigue, which in turn affects quality of life and increases levels of disability and healthcare utilization.10,12,75 In a longitudinal study of 252 breast cancer survivors, 31% reported fatigue by the end of cancer treatment but only 11% had fatigue 6 months posttreatment, declining to 6% by the end of the first posttreatment year.13 In contrast, 40% of our cancer survivors reported cancer-related fatigue well beyond the first year of treatment. The majority (85%) reported having had at least 1

Table 4 Lymphedema Signs and Symptoms Signs and symptoms

Participants, % (N = 70, unless otherwise noted)

Any cancer-related edema

32.9

Don’t know/missing

5.7

Lymphedema signs and symptoms in area treated for cancer Skin darkening

27.1

Don’t know/missing

4.3

Skin hardening

25.7

Don’t know/missing

4.3

Feelings of heaviness or fullness

20.0

Don’t know/missing

1.4

Edema (comes and goes or stays)

8.6

Don’t know/missing

2.9

Lymphedema signs and symptoms category 0

52.9

19.6

20.0

≥3

8.5

Among those with edema

(n = 23)

Edema location by body quarters Mid-trunk to lower quarter (including abdomen/ pelvis/genitalia, mid- & lower back, buttocks)

39.1

Upper quarter (including face/head/neck)

30.4

Mid-trunk and upper quarter (including chest/ breast, shoulder/arm, wrist/hand, upper back)

30.4

Lower quarter (including thigh, leg, ankle/foot)

21.7

Received physical therapy treatment for cancer-related edema

56.5

impairment, with 53% having reported 3 or more impairments, indicating a high persistent symptom burden across a heterogeneous cancer survivor cohort in support of previous literature.72 Nearly one-third of our participants reported signs and symptoms of lymphedema, adding to the already variable prevalences reported across all tumor types.76,77 Despite a high prevalence of impairments among our sample, less than one-third of our sample reported having been referred to physical therapy, despite physical therapy having been identified as an important method to reduce the impact of these impairments.1,56 Other impairments examined represent opportunities to include rehabilitation services in survivorship plan-

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Managing Physical Impairment

Table 5 Barriers to Physical Therapy Utilization Barrier to physical therapy utilization

Participants, % (N = 70, unless otherwise noted)

It costs too much Don’t know/missing No health insurance ≥6 months Don’t know/missing

12.9 1.4 10.0 2.9

Last visit to oncologist Today

In the past week

5.7

In the past month

14.3

In the past year

41.4

More than a year ago

34.3

Don’t know/missing Doctor has not recommended physical therapy Don’t know/missing Barriers reported after doctor recommended physical therapya

4.3 28.6 2.9 (n = 20)

I am afraid of discomfort or pain

I am afraid they do not speak Spanish

I do not have support from family or friends to get physical therapy

I am afraid of prejudice or racism

I am afraid it will make cancer spread

I have problems with transportation

It costs too much

I forgot to do it

I can’t afford to take time off work

I am afraid of finding cancer

My insurance won’t cover it

I do not know where to go for physical therapy

I am embarrassed

I can’t get care for children or adult relatives

The clinic hours are inconvenient

I put it off because I am too busy

Going to physical therapy makes it hard to spend time with my family

Only 20 participants had their doctor recommend physical therapy.

ning. As licensed professionals, physical therapists are also able to bill insurance companies for reimbursement. In a state where insurance is required and well-subsidized,

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barriers to physical therapy care posed by underinsurance or lack of insurance may be minimal and, perhaps, limited only by copayment, making physical therapy more affordable for those residing in Massachusetts. The number of impairments and comorbidities suggest that our participants may be at risk for long-term cancer-related disability. It is interesting to note that in our sample, muscle weakness, pain, and impaired movement had the highest percentages of those who had been referred to physical therapy, whereas the remainder did not. It is possible that other rehabilitation specialties, such as consultations with rehabilitation physicians (physia trists) and occupational and speech therapists, may have been recommended for some of the other impairments.

Limitations Because we only asked about referral to physical therapy and not to other therapies, a limitation of our study is that we may have underestimated rehabilitation services received by our sample participants. It is possible that healthcare providers referring patients for physical therapy need more education on impairments and the role of rehabilitation (including physical therapy) in survivorship planning. This supports recommendations by the Institute of Medicine on cancer survivorship planning and the issue of addressing impairments (such as those noted in our study), as recommended by the American Cancer Society.35,78 Impairments may be subtle, slow to evolve, and difficult for a referring provider to diagnose. For example, early stages of lymphedema may be subtle, making detection difficult even for healthcare providers having much experience with the condition, thereby possibly delaying treatment.76-80 Another possibility is that referring providers do not have adequate thresholds from which to gauge whether a recommendation for physical therapy is warranted.81 It is also possible that some cancer survivors believe that they just have to “live with” side effects or impairments and do not report them.82,83 Combined with previous research, our study suggests that an unmet need for cancer rehabilitation may exist. Other limitations include the reliance on self-reported outcomes by cancer survivors, which raises possible issues regarding memory recall and attribution by our participants. Verification of these self-reports (eg, medical chart review) would have been ideal but is unrealistic due to the many hospitals, community health centers, and outpatient practice settings visited by participants and a limited budget. Regardless, recent documentation requirements for Medicare patients include the use of outcome measures of function, such as the patient-reported outcome measures used in this study. Clinically

Managing Physical Impairment

speaking, the self-report of the patient is often the only qualifier that the healthcare provider has in order to make a referral to physical therapy. These self-reports are critical for rehabilitation specialists to gauge the extent of interference with function and are linked to Medicare reimbursement. It is possible that some participants may attribute noncancer-related impairments to their cancer experience. We did not collect baseline or pretreatment data to determine preexistence of impairments. It is possible that physical and functional impairments existed prior to the cancer diagnosis and that cancer treatment exacerbated these impairments. The high level of comorbidity may mean that it is difficult to differentiate whether signs or symptoms are related to cancer versus a comorbid or preexisting condition. Regardless, these impairments are present, no matter the source. Aging can also compound impairments.84,85 It may be that these impairments could be worse for those with advanced age and higher rates of comorbid conditions.86 Our study included participants with low income, and it is possible that our results could be partially explained by differences in other income-related social determinants, such as location of residence. Areas with higher versus lower healthcare spending have been shown to have higher rates of recommended and preferred healthcare as well as lower lung cancer mortality.87 However, all of our participants are long-term urban dwellers in the greater Boston area—an area of relatively high healthcare spending.88 Future research should include these comparisons by taking advantage of hierarchical statistical modeling. Whether levels of impairment and comorbidity differ between those with and without a history of cancer for those of Puerto Rican descent remains to be examined. In the current study, we examined only whether participants reported having (or not having) a particular impairment. However, we recognize that the severity (not number) of impairments or interference with function may be the more important factor in determining whether physical therapy is recommended. This study limited its health services utilization to physical therapy for a number of reasons. The Institute of Medicine, in its publications concerning cancer survivorship, suggests that rehabilitation services in general are underutilized by cancer survivors. However, whereas they recommend the use of rehabilitation services in general, physical therapy is particularly underrepresented in the cancer survivorship literature. As such, this gap merited a focus on physical therapy. In many states, patients can self-refer to a physical therapist for evaluation. This means that a physician’s referral is not required for

a physical therapy evaluation. However, if treatment were to continue, a physician referral is often required for insurance reimbursement. One model of survivorship care delivery involves the physiatrist to manage and lead the care of cancer survivors’ rehabilitation needs.1 Advanced practice oncology nurse practitioners are also in an excellent position to manage these survivorship care needs, as suggested by the Institute of Medicine.35 However, an important part of care management is knowing when to refer to specialists who are best prepared to address specialized cancer survivorship needs— such as those described here. Further, it is incumbent upon the provider to gain the training and expertise needed to manage cancer survivorship issues. For example, if the need involves impairments such as those noted in our study, inclusion of the physiatrist and related rehabilitation specialists such as physical therapists is warranted, as they are an important part of the medical team. This could take the form of a physician-led model of care, as is the case for traditional rehabilitation care, or one that is more shared among oncologists, physia trists, advanced practice nurses, and other rehabilitation specialists (nursing, physical, occupational, and speech therapies). These rehabilitation specialists bring to bear their training, expertise, and skills to address the multitude of rehabilitation needs of cancer survivors. Other providers included in the rehabilitation model include social workers, clinical psychologists specializing in rehabilitation, dietitians, and recreational therapists. This model has long been the standard of care in the management of other complicated patient populations. The Commission on Accreditation of Rehabilitation Facilities 2015 Medical Rehabilitation Program Descriptions describe the elements of comprehensive rehabilitation for a variety of patient populations such as stroke, traumatic brain injury, spinal cord injury, burns, amputation, and cancer rehabilitation.89 Some have proposed a “prospective surveillance” model for the management of cancer survivors.90 Although “prospective surveillance” may sound appealing to those not specializing in rehabilitation, the fact is that the rehabilitation model has been in existence for a long time. This model is already established in most hospital and healthcare systems, and the Commission on Accreditation of Rehabilitation Facilities accreditation means that the facility has met rigorous and comprehensive national standards for specialized rehabilitation patient care.91 Irrespective of the conceptual model of care—rehabilitation versus prospective surveillance—both require that patients have health insurance. Massachusetts state law requires health insurance as a requisite for state residence. With the newly enacted Affordable Care Act, it

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Managing Physical Impairment

may be that rehabilitation services may be easier to access but it is too early to tell at this time. Regardless, the availability of culturally and linguistically relevant rehabilitation health services may be limited.92 Once this barrier is overcome, the penetration of access to healthcare services will be mixed with improvement or limited improvement.93,94 Nevertheless, the quality of care may not be optimal, as has been shown to be the delivery of mental health services to racial and ethnic minorities.95 Further studies may wish to account for culturally and linguistically accessible, available, and quality rehabilitation services.

Conclusions Currently, there is little information on physical therapy to address impairments among minority cancer survivors. Our study suggests that the burden of impairments for low-income cancer survivors of Puerto Rican descent may be high and undertreated, regardless of insurance status and despite relatively few barriers to care. The low rate of physical therapy utilization we noted suggests a need for specialty rehabilitation services for cancer survivors. Our study supports increased education for healthcare providers on impairments that cancer survivors face. Persistent side effects may escalate into impairment spilling over into other aspects of life, including the ability to return to work,96 and may lead to physical disability12 with real and lasting implications for income earnings potential over one’s lifetime. Our results suggest that strategies to enhance opportunities for the access and utilization of rehabilitation services may reduce the burden of impairments experienced by low-income cancer survivors. g Acknowledgments This work was supported by an internal seed grant from Northeastern University, Boston, MA, and by National Institutes of Health grants from the National Institute on Aging P01 AG023394, and National Heart, Lung, and Blood Institute, P50 HL105185. We are grateful to Lindsay Mancini, MPH, who conducted the follow-up interviews for this study and Elisa Lopez Martinez who assisted with data entry. Author Disclosure Statement The authors have no conflicts of interest to report.

References

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JONS-online.com • Journal of Oncology Navigation & Survivorship

Nurse Navigation

Metrics for Successful Nurse Navigation By Alice Goodman

he role of the nurse navigator in helping patients through the trajectory of their journey from diagnosis to treatment to survivorship has evolved, and in many settings, the nurse navigator has become a key component of a multidisciplinary approach to cancer care. Studies show improved outcomes in settings where nurse navigation is a part of care. Angelina Esparza, RN, BA, BSN, MPH, Director of Health Equity, American Cancer Society, discussed metrics for measuring quality care and the sustainability of nurse navigation at the 2015 Oncology Nursing Society (ONS) annual meeting. “Metrics can help us understand the role of nurse navigator and American Cancer Society lay navigator and how that plays out prospectively in the patient’s life,” Ms Esparza said. The effort to develop metrics was initiated at the 2010 National Patient Leadership Summit. This summit convened to develop a consensus and to propose a set of metrics and methodologies to effectively measure the impact of navigation on individuals and systems across the cancer continuum. These metrics were published in a supplement of Cancer. “ONS funded and participated in developing the metrics,” Ms Esparza explained, “so our roundtable discussions truly reflected the various thought processes we went through. The navigators brought a practical sense of what would work, and sometimes we had to adjust our recommendations accordingly.” The metrics address: • Eliminating health disparities • The prevention and early detection of cancer • The diagnosis and treatment of cancer • Survivorship and end-of-life care • Palliative care • Navigation, family, and caregiver partners • Patient-related outcomes • Cost-effectiveness. Once the metrics were developed, a feasibility study was conducted at the Sanford Cancer Center in Sioux Falls, SD, a large healthcare system that encompasses 43 hospitals. The feasibility study is currently assessing the possibility of success fully implementing nurse navigators, and Ms Esparza shared information from that process. The next step after the study is completed is to disseminate the metrics. Four tasks were proposed, including (1) characterizing in detail the specific nature of the activities of the navigators as they remedy barriers to the receipt of cancer care, (2) determining whether the presence of a navigator minimizes the percentage of patients with significant delays in receipt of necessary care, (3) providing a baseline assess-

56 June 2015 • Vol 6 • No 3 • JONS-online.com

ment of the care coordination activities provided through the patient navigation program, and (4) measuring patient satisfaction with care and their perceptions of the value of a navigator. “We had clear objectives about what we wanted to measure, but as we started to partner with staff we saw that some of this was not feasible. So, we had to scale back on some of the measures. We were worried about patient burden. Our ideas about timing were not feasible and posed burdens on the patients,” Ms Esparza explained. The selected measures and instruments used included barrier log, timeliness review utilizing the data abstraction tool, psychosocial and health (eg, the 7-Item Anxiety Scale, the 9-Item Patient Health Questionnaire, and the Functional Assessment), and a patient satisfaction survey. “We hoped to learn how to effectively measure care coordination and navigation impact on timeliness of care [diagnosis through treatment process], stage of diagnosis and presentation, patient education, continuity of care, and patient-related outcomes [psychosocial measures],” she continued. The patient-reported barriers to care were evenly divided among no barriers, fear and anxiety, and deficit in patient knowledge. A smaller percentage reported access to care, transportation, and financial barriers. “But even among those reporting no barriers, if you read the log, the navigator’s notes revealed some barriers that were not reported,” Ms Esparza said. “The idea of patient education is really important. It helps allay some of the anxiety and fear.” She emphasized the important contribution of the lay navigator provided by the American Cancer Society. Ms Esparza noticed that access to care was a big problem for patients who lived in rural areas. Having the lay navigator’s perspective was enlightening, and supports the importance of multidisciplinary teams and collaboration. “In many cases, it takes 3 navigators to get 1 patient through the cancer journey, addressing access to care, transportation, and financial barriers,” she said. Some of the lessons learned from the feasibility study include the importance of partnership with staff at all levels, the fact that the selection of measurement tools does not always reflect the reality of the particular environment, and that it takes time to formalize and refine the metrics process. Having a multidisciplinary team approach provides the biggest gain for patients and families. Systematic evaluation yields potential for quality improvement, and collaboration with nonprofit organizations and patient advocacy organizations can be fruitful. g

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University Distinguished Service Associate Professor of Breast Cancer Johns Hopkins University School of Medicine, Baltimore, MD

am very excited to announce our Conquering the Cancer Care Continuum series. these t publications will continue to address

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nquering the Cancer Ca ce our third Annua series. th re Continuum l newsletter highly rele ese publications wil l continue vant topics to first issue in focuses on oncology managem address manufacturin ent. the current goo g d pra ctic includes arti e (cGmP) and cles written oncology by a clinica pha nurse practit rmacist, an oncolo l lawyer. th ioner, and a regula gy tory ese perspe ctives, bas the faculty ed on ’s experience expertise and person , explore a al wide array sues related of regulation to this topic, includ isrted by TEVA e ons opini tion on whviewsyandhav . TEVA provi som for the app ing expre e ssed info ded the idea arerma from at drugs, the rov this article patients, scie has worked for oth -the authors and not necessarilyforthose pros and con al of novel of TEVA. counter (o available. ntific data are not usu er tC) supple s of over-theFur ally importanc ments, and there is con thermore, even wh e of carefu the firm l patient en tion in clin that certain ation through rese selecical trials. arc Fut the series wil h ure issues treatment- otC options dim inish related sym care, advanc l discuss access to qua in not know pto lity whether the ms, we do ment, the es in side effect manag will have se substan Lillie D. Sho imp an ces Care Act on act of the Afford eckn lism of the impact on the metab able RN, BS, MA ey, can opatient car cancer care, and ped S cer therap ministered iatric e. y being ad. Cli Patients ofte existing ot nical trials of new n assume C suppleme or can be pur that if a dru pensive cha nts are g or supple fied in the concerns abo sed over the counte ment current wo that few or none can so exr, rld of health vestigated be tions that ut safety, efficacy, or there should be no within a clin care. All age justicou dru of a new ica nts l tria inment or per ld negatively impact g-to-drug interacl sett Dru son that has cos g Application, a reg ing require the use cancer to ask al health. it is com their cancer treatts of ulatory com mon for pat plexity Despite the its own. ien used to dim oncology nurses wh lack of def ich otC dru ts with inish specifi otC drugs initive inf motherapy gs c and supple ormation they are rec side effects caused by can be to make rec ments, nur eiving. th the ses must be about cheommenda ere are also tions about patient sett prepared situations ing their use in recommenda . When nurses are The developm considerin the outtion, they ga and a Med ent and publication would be ical Accurac of wise to con specific y review. The this article has been sider the supported views and opin by TEV ions expresse A. TEVA prov © 2014 Gre d are from ided the the authors en Hill Hea and not nece idea for this article lthcare Com munications, ssarily thos e of TEVA. LLC

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Survivorship Care Models

Nuts and Bolts of Survivorship Care Plans By Phoebe Starr

dvances in cancer treatment have led to a growing number of survivors, with 14.5 million survivors in 2014 and a projection of 19 million survivors by 2124. Survivorship care planning is now considered a quality metric, and survivorship care plans are a component of accreditation by the Commission on Cancer (CoC). Originally, the CoC stipulated that survivorship plans must be phased in by 2015; however, that date has been pushed to 2019, because this has been difficult to accomplish. Although not strictly a survivorship care plan, the American Society of Clinical Oncology (ASCO)’s Quality Oncology Practice Initiative includes a summary of chemotherapy treatment and dissemination to patients and practitioners as core measures for certification, explained Erin Ferrell, APN, Tennessee Oncology, Nashville, at her “Survivorship Care: Implementing the Essentials” presentation at the 2015 Oncology Nursing Society annual meeting. According to Ms Ferrell, survivors have an array of needs that must be addressed, including physical issues, psychosocial issues, education, follow-up care, and management of long-term and late effects of treatment. “It is empowering for patients to have this information, and it helps allay their anxiety,” she said. Ms Ferrell also noted, “We need to get patients’ buy-in on adopting healthier behaviors and improving their quality of life. We need to provide survivor-specific resources and support, and we need to direct survivors to community resources.” Lifestyle behaviors impact survivorship, yet it can be difficult to get some survivors to adopt healthy or healthier behaviors. The cancer trajectory involves acute survivorship, transitional survivorship, extended survivorship, and permanent survivorship. In the transitional survivorship phase, patients need to be encouraged to define a “new normal.” They may still suffer from emotional, mental, and physical fatigue. Their intimate relationships may be stressed by their illness and treatment, and they may have shifting expectations. Nurses need to step in and help patients through these transitions so their expectations are realistic.

Models of Survivorship Care There are several models of survivorship care. Primary care is perhaps the most feasible setting, but it does not have resources for a separate survivorship clinic. Also, patients with cancer may be resistant to transitioning to a primary care provider, and may incorrectly perceive that

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oncology care involves taking care of their general health. However, a shared care model with the primary care provider and the oncologist is now being adopted by the Affordable Care Act, Ms Ferrell explained. This requires effective communication between these specialties. There will be a learning curve, because primary care providers prefer the shared care model, whereas oncologists generally prefer an oncology-based model. According to the Institute of Medicine, components of survivorship care include coordinating the prevention of recurrent cancers, new cancers, and other late effects; surveillance for cancer spread and recurrence, second cancers, and medical and psychosocial long-term and late effects; and intervention for the physical, psychological, social, and spiritual consequences of cancer.

Developing a Survivorship Program In 2015, every cancer survivor should have a comprehensive written survivorship care plan, Ms Ferrell emphasized. Part A includes diagnostic and treatment information, information about any genetic mutations, and documentation of who provided the treatments. Part B is the plan itself. Ms Ferrell cited ASCO’s website and LIVESTRONG Foundation’s website for survivorship care plan templates. City of Hope also has an excellent survivorship care plan template on its website. Part B, the written follow-up care plan, should incorporate evidence-based standards of care for the following categories: • Likely course of recovery and possible late or longterm effects • Need for any ongoing maintenance or adjuvant therapy • Recommended cancer screening and other periodic testing or examinations • Information on possible signs of recurrence and second malignancy • Specific recommendations for healthy behaviors • Referrals to specific follow-up care providers and/or support groups • A list of cancer-related resources and information. “I can’t emphasize enough how this empowers patients. And it may cut down on your phone time,” Ms Ferrell said. Not all practices can develop a full survivorship program. For practices that can find the resources for such a program, the specific survivor population needs to be defined. “Survivorship programs are expensive, and they are not money makers, but they provide patient satisfaction. Patients are healthcare consumers, and they can decide where they go for healthcare,” Ms Ferrell concluded. g

4-PART SERIES

BEST PRACTICES IN

PAT IE N T N AV IG AT ION HIGHLIGHTS

Contributing Faculty Margaret Rummel, RN, MHA, OCN, NE-BC Oncology Nurse Navigator Hematology/Head and Neck Services University of Pennsylvania Abramson Cancer Center Philadelphia, Pennsylvania

▶ Opportune timing for initial patient

interaction and/or community outreach

▶ Considerations in testing, patient readiness, and pre-education

Barbara Rogers, CRNP, MN, AOCN, ANP-BC Adult Hematology-Oncology Nurse Practitioner Fox Chase Cancer Center Philadelphia, Pennsylvania

▶ Counseling patients through the

implications of their disease and possible impact on life goals

▶ Exploring potential communication

barriers among the cancer care team throughout the treatment process

an affiliate of

www.AONNonline.org

GHHC413_BestPracticesAsize052015

clinical trial tracker

Clinical Trials Under Way for Patients with Renal-Cell Carcinoma The following clinical trials are currently recruiting patients with renal-cell carcinoma for inclusion in several investigations. Each trial description includes the NLM Identifier to use as reference with ClinicalTrials.gov.

Dalantercept with or without Axitinib

This phase 2, randomized, double-blind, 2-part study aims to evaluate the safety, tolerability, and recommended dose level of dalantercept in combination with axitinib in part 1, and compare progression-free survival (PFS) between the above combination therapy versus axitinib alone in part 2. Patients with clear-cell renal-cell carcinoma who are aged ≥18 years may enroll if they have experienced disease progression after ≤3 lines of therapy, and if other criteria are met. Patients will receive axitinib orally twice a day with an injection of dalantercept or placebo once every 3 weeks. The primary outcome of part 1 in the study is the number of patients with adverse events, and of part 2 is PFS. Part 2 has secondary outcome measures of overall survival (OS), time to tumor progression, objective response rate, duration of response, and disease control rate. Pharmacodynamic biomarker activities are also assessed. This study is expected to enroll 174 patients in many sites across the United States. For more information, contact the clinical trials manager at clinical trials041@acceleronpharma.com. The NLM Identifier is NCT01727336.

Entinostat with Aldesleukin

The objective of this phase 1/2 study is to determine the side effects and best dose of entinostat when given with aldesleukin to patients with metastatic or surgically unresectable renal-cell carcinoma. Patients aged ≥18 years may enroll if they have received ≤2 therapies, have an Eastern Cooperative Oncology Group (ECOG) performance score of 0, and if other criteria are met. Patients will receive oral entinostat once every 2 weeks starting 2 weeks before and throughout combination treatment with aldesleukin. High-dose intravenous aldesleukin is given every 8 hours on days 1 to 5 and 15 to 19. Courses repeat every 84 days in the absence of disease progression or unacceptable toxicity.

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Primary outcome measures include the recommended dose of entinostat when given in combination therapy and the overall response rate. Secondary outcomes include the incidence of toxicities in phases 1 and 2, and PFS and time to tumor progression in phase 2. Changes in level of specific T lymphocytes and tumor metabolisms are also assessed. This study is expected to enroll 54 patients in California, Maryland, New York, and Ohio. For more information, contact Roberto Pili, MD, at 716-845-3117 or roberto.pili@roswellpark.org. The NLM Identifier is NCT01038778.

AZD6094 (HMPL-504) for Papillary Renal-Cell Carcinoma

This phase 2, open-label trial examines the efficacy of AZD6094 (HMPL-504) in treatment-naïve or previously treated patients with papillary renal-cell carcinoma. Patients aged ≥18 years may enroll if they have an ECOG performance score of 0 or 1, adequate hematologic and liver functions, a glomerular filtration rate of ≥40 mL/min, and if other criteria are met. All patients will receive oral AZD6094 600 mg daily. The primary outcome measure is the antitumor activity of AZD6094 as defined by the percentage of patients with an incidence of complete or partial response that is confirmed ≥4 weeks later. The secondary measures include the PFS, safety and tolerability, and pharmacokinetics of the experimental drug. Changes in target lesion tumor size from baseline, duration of response, and OS are also assessed. All outcomes are assessed for ≤7 months. This trial is expected to enroll 75 patients in many locations throughout the United States. To locate a site, contact the Cancer Study Locator at 877-4004655 or astrazeneca@emergingmed.com. For more information, contact the AstraZeneca Clinical Study Information Center at 877-240-9479 or information.center@ astrazeneca.com. The NLM Identifier is NCT02127710.

Adjuvant Axitinib Therapy in High-Risk Patients

The purpose of this phase 3 trial is to determine whether adjuvant therapy with axitinib will prevent or delay the recurrence of renal-cell carcinoma in patients with high risk for the disease after surgery. Patients aged ≥18 years who have been treated with nephrectomy and

LATE BREAKING ABSTRACTS

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SUBMIT YOUR ABSTRACT BY JUNE 30, 2015 Submitting an abstract for AONN+â&#x20AC;&#x2122;s Sixth Annual Navigation and Survivorship Conference is an opportunity to share research, programs, and results with your navigation and survivorship care colleagues. This session will facilitate communication among the various professionals and programs to advance the knowledge of all of our members and those in attendance.

POSTERS WILL BE HIGHLIGHTED DURING A LUNCHEON ON SUNDAY, OCTOBER 4TH.

An exceptional submission from each category will receive the opportunity to present their research during the luncheon! Categories: Category I: Patient Education Category II: Psychological Support Category III: Quality, Outcomes, and Performance Improvement Category IV: Original Research on Navigation Programs Category V: Original Research on Survivorship Programs Category VI: Community Outreach and Screening Programs

SPACE IS LIMITED: To ensure that your accepted abstract/poster will be eligible for display at the conference please submit your abstract for review by June 30, 2015.

For additional information visit AONNonline.org/conference/call-for-abstracts

clinical trial tracker

have no evidence of macroscopic residual disease or metastatic disease may enroll if other criteria are met. Patients are randomized in a 1:1 ratio to receive a placebo or 5 mg of axitinib twice a day. The primary outcome is disease-free survival. Secondary outcomes include OS and the safety profile of both treatment arms. All outcomes are assessed for 5 years. This study is expected to enroll 592 patients in multiple locations throughout the United States. For more information, contact Rolf Linke, MD, at 650-954-0106 or rolf.linke@sfj-pharma.com, or Clinton White, PhD, at 925-963-8696 or clinton.white@sfj-pharma.com. The NLM Identifier is NCT01599754.

Pazopanib for Metastatic Non–ClearCell Renal-Cell Carcinoma

The objective of this phase 2, open-label, single-arm trial is to study how well pazopanib hydrochloride works in treating patients with metastatic non–clear-cell renal-cell carcinoma. Patients aged ≥18 years with an ECOG performance score of 0, 1, or 2 who have received ≤1 treatment other than pazopanib may enroll if other criteria are met. All patients will receive oral pazopanib hydrochloride daily for 28 days. The course will repeat every 28 days in the absence of disease progression or unacceptable toxicity. The primary objective is OS, defined as the percentage of patients who survive 12 months of treatment. Secondary outcome measures include tumor response rate, PFS, and adverse event rate, which are all assessed ≤2 years after treatment completion. This trial is expected to enroll 39 patients in Scottsdale, AZ, and Rochester, MN. For more information, contact the Clinical Trials Referral Office at 855-776-0015. The NLM Identifier is NCT01767636.

Autologous Dendritic-Cell Immunotherapy (AGS-003) plus Standard Treatment

This phase 3, open-label, randomized trial compares the OS benefit between patients who receive standard treatment plus AGS-003 and those who receive standard treatment alone; tumor collection will take place as part of this study. Patients aged ≥18 years with advanced renal-cell carcinoma may qualify for tumor collection if they are scheduled for cytoreductive or partial nephrectomy. Patients may receive treatment if they have been diagnosed within a year, have a Karnofsky performance status of ≥70, and a life expectancy of ≥6 months. All patients will receive standard treatment with sunitinib, and the experimental group will also receive AGS-003, an intradermal injection of an autologous dendritic-cell product.

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Primary outcome measures include OS, PFS, and tumor response. The number of emergent adverse events that require treatment is also assessed. This trial is expected to enroll 450 patients throughout many locations in the United States. For more information, contact the Adapt Study Team at 877-573-9235 or contact@adaptstudy.com. The NLM Identifier is NCT01582672.

Everolimus Efficacy Postsurgery

This phase 3, randomized, double-blind, parallel-group trial assesses the efficacy of everolimus in treating patients with renal-cell carcinoma who have received a partial or radical nephrectomy. Patients aged ≥18 years who had their first surgical resection within 84 days of study registration may enroll if other criteria are met. Patients are randomized to receive oral everolimus or placebo daily for 42 days, with the cycle repeating every 6 weeks. The treatment is given for up to 54 weeks in the absence of disease progression. The primary outcome measure is to compare recurrence-free survival between the 2 groups, and the secondary outcomes are to compare OS and toxicity between the 2 groups. This study is expected to enroll 1218 patients at sites throughout the United States. For more information, contact Gilbert Carrizales at 210-614-8808 or gcarrizales@swog.org, or Dana Sparks, MAT, at 210-614-8808 (extension 1004) or dsparks@swog.org. The NLM Identifier is NCT01120249.

Sunitinib versus Placebo

The objective of this phase 3, randomized, double-blind, parallel-group study is to compare the disease-free survival rate and safety of sunitinib versus placebo in patients who receive adjuvant treatment and who are at high risk for recurrent renal-cell carcinoma after surgery. Patients aged ≥18 years with high-risk renal-cell carcinoma, an ECOG performance score of 0 to 2, and who are treatment-naïve may enroll if other criteria are met. Patients are randomized to sunitinib malate 50 mg orally or placebo in a 4-weeks-on, 2-weeks-off regimen for a year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent. The primary outcome measure is the disease-free survival comparison between the 2 groups, assessed for a time frame of 36 months. Secondary outcome measures include OS, safety, tolerability, and patient-reported outcomes. This study is expected to enroll 720 patients at sites throughout the United States. For more information, contact the Pfizer CT.gov Call Center at 800-7181021. The NLM Identifier is NCT00375674. g

Conquer

the patient voice

FEBRUARY 2015 • VOL. 1 • NO. 1

INAUGURAL ISSUE

the patient voice

6 AN INFUSION OF HOPE

8 PATIENT STORIES

15 SURVIVORSHIP

17 FROM YOUR NURSE NAVIGATOR

CONQUER ™ magazine is the premier forum for patients with cancer featuring articles written by and for patients, survivors, nurse navigators, and other oncology team members initiated by the Academy of Oncology Nurse & Patient Navigators (AONN+).

24 GENETICS

38 FINANCIAL SUPPORT

46 PREVENTION

57 CANCER REHABILITATION

CALL FOR PAPERS 63

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