Journal of Oncology Navigation & Survivorship by The Lynx Group

About cover art, page 10

NCI-MATCH: A Paradigm Shift in the Evolution of Personalized Medicine Trials. An Interview with Douglas R. Lowy, MD, of the National Cancer Institute Pg. 14 Oral Chemotherapy: Patient Education and Nursing Intervention Pg. 20

Learning Guide – Overview of Professional Roles and Responsibilities Pg. 28 Learning Guide – Overview of End-of-Life Care Pg. 32 Oncology Navigation Promotes Population Health Pg. 45 www.JONS-online.com New Look, Same Great Content

NAVIGATING PATIENTS ACROSS THE CONTINUUM OF CANCER CARETM www.AONNonline.org

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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

Photo by MSKCC

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

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

CANCER REHABILITATION & SURVIVORSHIP Julie K. Silver, MD Associate Professor Department of Physical Medicine and Rehabilitation Harvard Medical School Boston, MA

Marcy A. 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

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

HEALTH DISPARITIES Linda Fleisher, PhD, MPH Senior Scientist, The Center for Injury Research and Prevention Assistant Professor, Cancer Prevention & Control, Fox Chase Cancer Center Philadelphia, PA

PROSTATE CANCER Frank dela Rama, RN, MS, AOCNS Clinical Nurse Specialist, Oncology/Genomics Cancer Care Clinic Palo Alto Medical Foundation Palo Alto, CA

ONCODERMATOLOGY Kathryn Ciccolini, RN, BSN, OCN, DNC Clinical Nurse Department of Dermatology Memorial Sloan Kettering Cancer Center New York, NY

THORACIC ONCOLOGY Pamela Matten, RN, BSN, OCN St. Joseph Hospital Orange, CA

Evidence into Practice 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

EDITORIAL ADVISORY BOARD Al B. Benson III, MD, FACP, FASCO Northwestern University, Chicago, IL Darren Sigal, MD Scripps Clinic Medical Group, San Diego, CA

Samuel M. Silver, MD, PhD, MACP, FASCO Assistant Dean for Research; Professor, Internal Medicine/Hematology-Oncology, University of Michigan Medical School; Chair, Board of Directors, National Comprehensive Cancer Network

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TABLE OF CONTENTS LETTERS FROM LILLIE 12 Empowering Navigators: Navigation Credential Certification Exam Offered at the Annual Meeting Lillie D. Shockney, RN, BS, MAS

Travis Sullivan tjsullivan@the-lynx-group.com Editorial Director Kristin Siyahian ksiyahian@the-lynx-group.com Senior Copyeditor BJ Hansen Production Manager Marie RS Borrelli

INTERVIEW WITH THE INNOVATORS 14 NCI-MATCH: A Paradigm Shift in the Evolution of Personalized Medicine Trials. An Interview with Douglas R. Lowy, MD, of the National Cancer Institute ORAL CHEMOTHERAPY 20 Oral Chemotherapy: Patient Education and Nursing Intervention Cheryl Bellomo, MSN, RN, OCN LEARNING GUIDES 28 Overview of Professional Roles and Responsibilities Sharon Gentry, RN, MSN, CBCN, CBEC 32 Overview of End-of-Life Care Lillie D. Shockney, RN, BS, MAS

CLINICAL TRIALS TRACKER 34 Select Ongoing Trials Currently Enrolling Patients with Colorectal Cancer

Continued on page 10 ASSOCIATION & CONGRESS DIVISION President Abigail Adair Account Group Supervisor Karie Gubbins Account Supervisors Alex Charles Deanna Martinez Senior Account Executives Jeremy Shannon Meg Spencer Business Development Advisor Saher Almaita

8 July 2016 • Vol 7 • No 6 • JONS-online.com

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TABLE OF CONTENTS (Continued) ONCOLOGY NURSING SOCIETY 38 More Than One Way to Provide Survivorship Care 40 Get Going with Distress Screening! 41 Navigation Reports Can Be Incorporated into Epic AONN EAST COAST REGIONAL MEETING 45 Oncology Navigation Promotes Population Health

ABOUT THE COVER ART Beautiful Courage Watercolor by a Person Diagnosed with Cancer Cancer redefines everything. It changes how you spend your time, the definition of a “good day,” what you say to your loved ones, and what tomorrow really means. It shifts priorities, challenges livelihoods, and accentuates relationships. Cancer redefines the meaning of things. Things like hope, beauty, and courage. This painting speaks to what the word courage means to me now that I have gone through cancer and survived. To me, courage need not be loud, prideful, or brash. Courage can be quiet and resolve, silent determination and resilience of spirit. Courage can be both fragile and strong. Courage doesn’t cower, but keeps striving for the light, and in doing so, radiates its own. Courage allows hope. Hope begets life. Life carries on. Artwork from the Lilly Oncology On Canvas: Expressions of a Cancer Journey Art Competition and Exhibition (www.lillyoncologyoncanvas.com). Copyright © Eli Lilly and Company. All Rights Reserved. Used with Permission.

Journal of Oncology Navigation & Survivorship (JONS) ISSN 2166-0999 (print); ISSN 2166-0980 (online), is published 11 times a year by Green Hill Healthcare Communications, LLC, 1249 South River Rd, Suite 202A, Cranbury, NJ 08512. Copyright © 2016 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. The ideas and opinions expressed in Journal of Oncology Navigation & Survivorship do not necessarily reflect those of the Editorial Board, the Editors, or the Publisher. Publication of an advertisement or other product mentioned in Journal of Oncology Navigation & Survivorship should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the Editors nor the Publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication. EDITORIAL CORRESPONDENCE should be addressed to EDITORIAL DIRECTOR, Journal of Oncology Navigation & Survivorship (JONS), 1249 South River Rd, Suite 202A, Cranbury, NJ 08512. E-mail: ksiyahian@the-lynx-group. com. Phone: 732-656-7935. 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 Rd, Suite 202A, Cranbury, NJ 08512 POSTMASTER: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Journal of Oncology Navigation & Survivorship, 1249 South River Rd, Suite 202A, Cranbury, NJ 08512. Fax: 732-6567938. 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. BPA Membership Applied for May 2015

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.

LETTERS FROM LILLIE

Empowering Navigators: Navigation Credential Certification Exam Offered at the Annual Meeting Dear Navigators, Welcome to this issue of Journal of Oncology Navigation & Survivorship (JONS), the official publication of the Academy of Oncology Nurse & Patient Navigators. Navigating patients is much more than planning the logistics of appointments and transportation for our patients; it is an imperative service that engages and empowers patients throughout the cancer care continuum. From community outreach to education and survivorship, navigation can successfully impact the course of treatment for patients today. We intend to provide our readership with the information that will empower navigators to execute their jobs at the highest level possible. To achieve this goal, we are working on providing 2 types of credentials for navigators; one for lay navigators, the other for nurse navigators. Our task force is creating a series of learning guides to prepare those interested in obtaining the credential. In this issue, we offer 2 guides: “Overview of Professional Roles and Responsibilities” by Sharon Gentry (page 28), and “Overview of End of Life” written by me (page 32). The first credential test will be offered this November at our annual meeting in Las Vegas. If you haven’t already registered, please Navigation is an imperative visit www.etouches.com/aonnvegas. In our effort to bring you important information from the onservice that engages and cology community at large, you will read in the Interview with the Innovators segment our exchange with Douglas R. Lowy, MD, empowers patients of the National Cancer Institute. We had the pleasure of speaking throughout the cancer with Dr Lowy about the NCI-MATCH trial and how Vice President Biden’s Moonshot program will help expand work in this care continuum. critical area of cancer research (page 14). As always, we bring you the latest in navigation research. We are pleased to feature an article by Cheryl Bellomo entitled “Oral Chemotherapy: Patient Education and Nursing Intervention” (page 20). On behalf of the entire editorial board, thank you for being part of our JONS reading community. Sincerely,

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

INTERVIEW WITH THE INNOVATORS

NCI-MATCH: A Paradigm Shift in the Evolution of Personalized Medicine Trials

An Interview with Douglas R. Lowy, MD, of the National Cancer Institute

recision medicine has become a high-profile term with equally as high expectations. With the president’s announcement last year of a Precision Medicine Initiative (PMI) and his more recent calling for a “moonshot” to cure cancer headed by Vice President Biden, the march toDouglas R. Lowy, ward personalizing care continues to MD gain momentum. In the PMI budget, $70 million will go to the National Cancer Institute (NCI) to scale up efforts in identifying genomic drivers in cancer and then applying that knowledge to the development of more effective approaches to cancer treatment. The NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) clinical trial supports the objectives of PMI as it accelerates the design and testing of tailored treatments for cancer by expanding genetically based clinical cancer trials, explores fun-

damental aspects of cancer biology, and establishes a national “cancer knowledge network” that will generate and share new knowledge to fuel scientific discovery and guide treatment decisions. NCI-MATCH analyzes patients’ tumors to determine whether they contain actionable genetic mutations for which a targeted drug exists. The primary end point for NCI-MATCH is the objective response rate, defined as the percentage of patients whose tumors have a complete or partial response to treatment. The trial opened for enrollment in August 2015 with 10 arms, with an additional arm scheduled to open this year. It is anticipated that more than 20 treatments will ultimately be tested, each in a different arm of the trial. NCIMATCH is flexible in that it can add or eliminate treatments over time. In an effort to learn more about NCI-MATCH, we asked the Acting Director, Douglas R. Lowy, MD, to speak with us. What follows is our exchange.

JONS Thank you for speaking with us, Dr Lowy. To begin, can you please provide your definition of precision medicine. Dr Lowy I believe most people think of precision medicine as being focused primarily or exclusively on cancer treatment. Further, there is the belief that precision medicine takes advantage of the deep molecular understanding that we have of cancer and how this understanding helps us to distinguish one cancer from another. If we can deliver tailored treatment under the best of circumstances based on the particular molecular abnormalities that are in the cancer, we might be able to achieve the goals of precision medicine.

My view of precision medicine is broader, because I feel that it should also be thought of as equally applicable to cancer prevention and screening. I like to define pre-

Dr Lowy is Acting Director of the National Cancer Institute.

The NCI-MATCH trial analyzes patients’ tumors to determine whether they contain actionable genetic mutations for which a targeted drug exists. cision medicine as a molecular characterization and understanding of the pathology of cancer and then using that information for intervention. Intervention can

INTERVIEW WITH THE INNOVATORS

occur with prevention, screening, or treatment. Let me give you an example. In primary prevention, HPV [human papillomavirus] vaccination is something that you would administer to try to take care of HPVassociated cancers. This is a population-wide approach. Conversely, colorectal cancer screening based on molecular abnormalities or cervical cancer screening based on detecting HPV is just as much precision medicine as the treatment aspect. I believe precision medicine should be understood in a much broader context than just in the important area of cancer treatment. JONS We are curious about the goals of the PMI and the funding the NCI will receive from that initiative. Dr Lowy First, we just received funding for the oncology portion of the PMI with this year’s budget. Although we already have a certain amount up and running, it is not as fully developed as it will be now that we actually have the funding. The president’s PMI in oncology really has several components. It’s focused on cancer treatment, and the long-term goals are to improve the outcome for patients based on a clearer and more detailed understanding of the molecular abnormalities in cancer and to improve our ability to treat those cancers with either single-agent or combination treatment. The key part from a clinical trials perspective is the NCI-MATCH trial. NCI-MATCH is a major paradigm shift as it is really the first trial where entry is based on your molecular abnormality rather than the site of origin of your tumor. We currently have the adult NCI-MATCH trial that started back in August, and we are looking forward to initiating a pediatric version of the NCI-MATCH trial by the end of this year. There are suggested forms of new preclinical models in the proposal, such as patient-derived xenographs, and for using more recent technology for developing cultured tumor material, such as organoids. We are developing these types of models and will support their development by other groups. The goal is to have these panels of new models available to the research community for designing studies that focus on 2 major areas. The first is for understanding primary and secondary resistance; that is, resistance to drugs and how to overcome that resistance. The second is to try to gain some understanding of how to optimize combination treatment with targeted agents as well as incorporating immunotherapy. This will be a long-term goal to try to get closer to predictive oncology—that based on the molecular abnormalities in a tumor, we will be able to be more effi-

cient and more effective in giving the right treatment to the right patient. JONS NCI-MATCH considers genetic mutations as opposed to tissue of origin. Can you give us an example? Dr Lowy Let’s take mutant EGFR [epidermal growth factor receptor] as an example. A mutant EGFR can occur in a range of tumors. There is an FDA-approved product to treat lung adenocarcinoma. So, we have a patient who has a mutant EGFR, but this patient has, say, liver cancer. If you have a mutant EGFR in liver cancer, EGFR inhibitors are not approved for liver cancer, but you would then be eligible for an EGFR inhibitor given the molecular abnormality.

NCI-MATCH is a major paradigm shift as it is really the first trial where entry is based on your molecular abnormality rather than the site of origin of your tumor. JONS What about mutations that aren’t necessarily included in the NCI-MATCH trial? KRAS, for example. Dr Lowy Unfortunately, we don’t have effective interventions for patients who have mutant KRAS in their tumors. The NCI actually has a separate initiative whose goal it is to develop effective interventions against cancers that have mutant KRAS. This is part of a research initiative at the Frederick National Laboratory for Cancer Research. And there are a number of extramural laboratories that are also doing cooperative research in this area. JONS Can you talk about your research goals regarding drug resistance? Dr Lowy A fair number of drugs have been approved as single-agent treatment for targeted intervention against a fairly wide range of cancers. But not infrequently with single-agent treatment, patients develop resistance, and the resistance has many different mechanisms depending on the cancer, depending on the drug that is being used as the inhibitor, etc. This is really a major stumbling block or barrier to long-term benefits for patients when we are using targeted treatment. There are at least 2 problems; the first is that you have an abnormality that suggests this particular intervention should work, but it doesn’t. That’s considered primary resistance. Secondary resistance occurs when the patient makes an initial response to the treatment but then develops resistance, and the tumor recurs. We need to understand both of these areas in greater detail;

INTERVIEW WITH THE INNOVATORS

we need to figure out how to prevent secondary resistance from occurring and how to deal with primary resistance so that we can provide better treatment for our patients. My own view is that we will eventually get to the point in cancer treatments where we currently are with HIV treatments—where multidrug treatment is given, virtually everyone responds to the treatment, and the risk of resistance is much less than with single-agent treatment. Although this is a good goal, the major difference is that cancer is far more complicated. When you’re talking about HIV, there are just a few genes in the virus, whereas when you’re talking about cancer, you’re talking about a very wide spectrum of all the different genes in the body. JONS There is research to suggest that stem cells could very possibly be responsible for resistance, mutation, and metastasis. Is this component considered in your work? Dr Lowy Cancer stem cells or cancer-initiating cells are a component when you are thinking about resistance and the issue of tumor heterogeneity. The term “cancer stem cells” implies that there are master cells and responder cells. What you really need to go after are those master cells, also called tumor-initiating cells or cancer stem cells. This becomes a very important issue when you are trying to get long-term benefits from a treatment because it takes into consideration that there is heterogeneity, and if your treatment is very effective at basically treating the cells that are more differentiated than the tumor-initiating cells, your treatment is not going to be that successful. JONS How does immunotherapy fit into the precision medicine story? Dr Lowy Precision medicine is based on molecular abnormalities in the tumor, and immunotherapy is based on a new understanding of the regulation of the immune system. These approaches have quite distinct origins. But, it turns out that the immune checkpoint inhibitors seem to be more effective in tumors that have more mutations, and, therefore, the mutations that people have are almost certainly going to play a role in the response to immunotherapy. There are other approaches that take advantage of immunology, for example, CAR [chimeric antigen receptor] therapy. It’s highly targeted,

INTERVIEW WITH THE INNOVATORS

because you’re basically targeting a cell surface receptor on the tumor but taking advantage of activating the immune system. Also within immunotherapies are therapeutic vaccines. We look forward to vaccines that will directly target the molecular abnormality in a tumor. Targeted therapies and immunotherapies certainly have distinct origins, but they really are coming together in very complementary ways. JONS The president is calling for a “moonshot” to cure cancer. Vice President Biden has said he’d like to double our rate of progress. In your opinion, what would be needed to make that goal attainable? Dr Lowy First of all, it is difficult to have a metric that demonstrates that you have doubled the rate of progress. What he is talking about is an aspirational goal, which is that whatever we’re doing now, to do it faster, better, and more efficiently. I think that is something that is very achievable. But it will require more cooperation, more public-private partnerships, and more data sharing. The vice president is very interested in all these ideas. In addition, the president’s budget is proposing a 13% increase for the NCI, and such an increase would make it possible for us to accelerate the momentum that we already have. We are planning to have a blue-ribbon panel that will look at the proposal of the vice president, evaluate its various scientific aspects, and make a recommendation to the National Cancer Advisory Board. That board will provide advice to the NCI on the highest priority areas, areas of the greatest opportunity for cancer research in the near future, and how we should invest that money, whether it is in basic research or in the most applied research. The vice president’s initiative really runs the gamut. It has support for basic research, support for understanding cancer pathogenesis, and support for preven-

tion, screening, and, of course, treatment. It also talks about trying to increase implementation of standard of care—doing more of what we already know works— to reduce the healthcare gaps that exist within cancer, whether it is talking about prevention, screening, or treatment. JONS Any thoughts about the challenges of cancer being a heterogenic disease? Dr Lowy This is both a blessing and a curse. It gives us more to do because when you deal with 1 kind of cancer, your research may not have direct implications for other types of cancer. But on the other hand, there are a lot of common themes between cancers.

Cancer heterogeneity is certainly a problem, but it is a tractable one. It really underscores how important ongoing and future research is. And what we’ve seen with the NCI-MATCH trial, for example, is that people who have similar molecular abnormalities in different kinds of cancers may respond to similar kinds of interventions. And when they don’t, we need to conduct further research to understand that. Cancer heterogeneity is certainly a problem, but it is a tractable one. It really underscores how important ongoing and future research is so that we can improve our understanding of the disease in hope of leading to better efforts at prevention and screening as well as better outcomes for patients who develop cancer. JONS Thank you, Dr Lowy, and best of luck to you in your endeavors with the NCI-MATCH trial. Dr Lowy Thank you. g

ORAL CHEMOTHERAPY

Oral Chemotherapy: Patient Education and Nursing Intervention Cheryl Bellomo, MSN, RN, OCN Intermountain – Southwest Cancer Center Cedar City Hospital, Cedar City, UT

Background: With the cancer treatment paradigm shifting from the use of infusion chemotherapy that is administered in a clinical setting by oncology nurses to the use of oral chemotherapy that is self-administered by patients in the home setting, adherence to therapy and symptom management become challenges in ensuring safe, quality care for cancer patients. At Cedar City Hospital, a gap existed in the education, continual nursing assessment, and follow-up regarding symptom management and adherence of patients receiving oral chemotherapy. A review of the literature demonstrated the effectiveness of the use of tailored nursing interventions in addition to patient education to improve symptom management and adherence for these patients. Objectives: To improve education and intervention by oncology nurse navigators (ONNs) to promote effective symptom management in patients receiving oral chemotherapy. Methods: To enhance the education of patients receiving oral chemotherapy agents, a patient-centered assessment and education protocol utilizing the Multinational Association of Supportive Care in Cancer (MASCC) Teaching Tool for Patients Receiving Oral Agents for Cancer (MOATT) was implemented by the ONN. Before the initiation of oral chemotherapy, patients met with the ONN for education. During the education session, the ONN provided information regarding oral chemotherapy using the 4 sections of MOATT. A tailored nurse follow-up telephone call protocol for the continual assessment of symptom management and adherence was implemented by the ONN. Patients receiving oral chemotherapy received a phone call weekly for the first month of initiating treatment, twice monthly for the second and third months, and then monthly for the course of their treatment. During the telephone conversations, using the Adherence Starts with Knowledge (ASK-12) tool, the ONN assessed barriers to or facilitators of the patient’s adherence and addressed symptoms and side effects. The patient’s responses were used to develop tailored adherence and symptom management strategies to meet the patient’s individual needs. Results: During the 3-month pilot project of the patient-centered assessment and education protocol and the tailored nurse follow-up telephone call protocol, 24 patients with various types of cancer initiated oral chemotherapy. All 24 cancer patients received patient-centered education, continual nursing assessment, and follow-up telephone calls to assess and promote symptom management and adherence. Based on the responses to structured questions and the ASK-12 tool, all patients reported that the education program, the individualized written information, and the follow-up telephone contact reinforced their knowledge and understanding of their oral chemotherapy as well as enhanced their comfort level in being able to manage and adhere to their treatment. Conclusion: The patient-centered assessment and education protocol and the tailored nurse follow-up telephone call protocol were effective in promoting symptom management and adherence during the pilot project and have become a standard of practice for oral chemotherapy patients at Cedar City Hospital. With competency as a patient advocate in providing patient education, the ONN played a valuable role in supporting this pilot project to improve nursing practice and the care of patients receiving oral chemotherapy agents.

ORAL CHEMOTHERAPY

he administration of chemotherapy drugs has shifted dramatically in the past 15 years from parenteral infusion to oral administration, with oral cancer therapies accounting for 10% of treatments in 2010 and rising to 25% of all cancer therapies in 2013.1 With the cancer treatment paradigm shifting from the use of infusion chemotherapy administered in controlled, supervised clinical settings to the use of oral chemotherapy self-administered by patients in the home setting, adherence to therapy and symptom management become challenges in ensuring safe, quality care for cancer patients. Oral chemotherapy agents offer many advantages to cancer patients, including greater flexibility and convenience, and less disruption of activities of daily living for the patient and family/caregiver. Along with the advantages, the increased use of oral chemotherapy agents introduces new challenges for oncologists, oncology nurses, and patients. With the cancer treatment paradigm shift, ensuring medication adherence—the right drug being administered in the right amount and at the right time in a controlled setting—is being taken out of the hands of the oncologist and is being placed on the cancer patient/family/caregiver. Factors that have frequently been associated with nonadherence to oral chemotherapy include patient-related factors (cognition, support, depression, and belief in value of therapy), treatment-related factors (side effects, complexity of treatment, drug interactions, and label warnings), and healthcare system–related factors (lack of physician availability, lack of financial resources/insurance coverage, delays in obtaining prescription/refills, and delay in follow-up care).2 With the shift in cancer treatment from infusion to oral chemotherapy, cancer patients have less contact with nurses and fewer opportunities for education on treatment and symptom management, so patients face the increased responsibility of maintaining their own healthcare. In the practice at Intermountain – Southwest Cancer Center of Cedar City Hospital, cancer patients prescribed parenteral infusion and/or oral chemotherapy received written and verbal education on the oral chemotherapy agent from the oncology nurse navigator (ONN). Whereas patients receiving parenteral infusion chemotherapy were assessed by the oncology nurses at the time of their treatment, a gap existed in the practice for the continual nursing assessment and follow-up of patients receiving oral chemotherapy regarding symptom management and adherence. The ONN posed the research question: in adult cancer patients receiving oral chemotherapy agents, are tailored nurse coaching interventions in addition to patient education more effective than standard chemotherapy education alone in improv-

ing symptom management and patient adherence? For the pilot project, the ONN recommended the implementation of a comprehensive patient-centered assessment and education protocol to enhance the education of patients/families/caregivers on oral chemotherapy agents. The ONN also recommended the implementation of a tailored nurse-initiated follow-up telephone call protocol for the continual assessment of symptom management and adherence.

Objectives With the increasing use of oral chemotherapy agents in cancer treatment, patient adherence is critical to successful treatment outcomes. ONNs need to take a lead role in improving nursing practice and in caring for patients receiving oral chemotherapy agents by identifying barriers and implementing strategies to assure adherence, and, therefore, improve clinical outcomes. Patient-relat-

Along with the advantages, the increased use of oral agents introduces new challenges for oncologists, oncology nurses, and patients. ed barriers, such as educational barriers and lack of understanding of the importance of the medication, how to take the medication, and potential side effects and management of side effects, can lead to nonadherence.2 Disease/treatment factors such as complex treatment regimen, side effects, comorbidities, and concomitant medications are associated with nonadherence to oral chemotherapy by cancer patients.3 Oral chemotherapy patient education should include an assessment of comorbidities, concurrent medications, and education on drug/food interactions. Spoelstra and colleagues conducted an exploratory study of 30 adults receiving oral chemotherapy to evaluate the prevalence, severity, and attribution of symptoms, as well as the interference with management of comorbidities.3 Their findings indicated that patients with a greater number of comorbidities were more likely to include comorbidities in symptom attribution and reported interference from the oral chemotherapy agents in managing comorbid conditions.3 Cancer patients receiving oral chemotherapy need education on the agents, side effects, and symptom management and assessment to reduce the risk of nonadherence, and to ensure safety. Patient education and tools to enhance adherence and reduce drug interactions and Continued on page 24

Drug

Disease

Treatment Plan

•

in this information.

Include family member or other healthcare provider

Patient Characteristics

•

(pills/tablets) for cancer

adherence to treatment with oral agents

The following are aspects that impact the

This teaching tool has been prepared to assist health care providers in the assessment and education of patients receiving oral agents as treatment for their cancer. The goal is to ensure that patients know and understand their treatment and the importance of taking the pills/tablets that are prescribed.

(MOATT)©

RECEIVING ORAL AGENTS FOR CANCER

MASCC TEACHING TOOL FOR PATIENTS

* Recommended information to assess is noted in italics

Special Considerations when assessing patients receiving oral agents for cancer: When teaching the patient, you may need to adapt your teaching to accommodate special considerations such as, age, feeding tube, vision problems/color blindness, dietary issues, mental problems (dementia, depression, cognitive impairments).

9) Have you had any problems with your insurance that has interfered with obtaining your medications?

* Delays in obtaining the pills may affect when the oral drugs are started

7) Are you experiencing any symptoms that would affect your ability to keep down the pills, for example nausea or vomiting? 8) How will you fill your prescription?

* Find out if there were any problems, for example, taking the medications or any adverse drug effects.

3) Are you able to swallow pills or tablets? If no, explain. 4) Are you able to read the drug label/information? 5) Are you able to open your other medicine bottles or packages? 6) Have you taken other pills for your cancer?

* If you have a list of medicines, go over the list with the patient. * If you do not have a list, ask the patient what medicines he/she is taking, (both prescription and non-prescription), herbs, complementary, or other treatments.

2) What other medications or pills do you take by mouth?

* Verify that the patient knows that these oral agents are for cancer and are taken by mouth for their cancer.

1) What have you been told about this treatment plan with oral medications?

KEY ASSESSMENT QUESTIONS

Figure 1 MASCC Teaching Tool for Patients Receiving Oral Agents for Cancer (MOATT)

PATIENT EDUCATION

13) Plan ahead for travel, refills and weekends.

12) Let us know if you have a problem with paying for or getting your pills.

11) Carry with you a list of medicines that you are taking, including your cancer pills/tablets.

* The patient may be asked to bring unused pills/tablets back to the next visit.

10) Ask your nurse or pharmacist what you should do with any pills/tablets you have not taken or are out-dated.

9) If you accidentally take too many pills or if someone else takes your pills/tablets, contact your Doctor or nurse immediately.

8) Make sure you have directions about what to do if you miss a dose

* Give the patient some ideas, such as timer, clock or calendar.

7) Have a system to make sure you take your pills/tablets correctly.

6) Store your pills/tablets away from heat, sunlight, or moisture as it may degrade the pills/tablets, potentially making them less effective.

5) Do not crush, chew, cut or disrupt your pills/tablets unless directed otherwise

4) Wash your hands before and after handling the pills/tablets.

3) Keep the pills/tablets in the original container, unless otherwise directed. It could be dangerous to mix with other pills.

2) Keep the pills/tablets away from children and pets and in a childproof container.

1) Inform any other doctors, dentists or healthcare providers that you are taking pills/tablets for your cancer.

Discuss the following items with the patient and/or caretaker.

Generic Education for All Oral Drugs

ORAL CHEMOTHERAPY

Appendices

APPendix 1 | MOATT© brochure

__________________________________________ __________________________________________

* Give names and phone numbers here

When and whom to call with questions

Are there any drug and food interactions? __________________________________________ __________________________________________

Are there any precautions? __________________________________________ __________________________________________ __________________________________________

__________________________________________ __________________________________________ __________________________________________ __________________________________________

* Include lab evaluations or any medical tests that will be used for drug monitoring.

What are potential side effects and management of them?

__________________________________________ __________________________________________

* Be specific, for example, away from heat (not in the kitchen), humidity (not in the bathroom), sun (not on the window sill)

Where the drug should be stored

For how long? __________________________________________

How many times a day? ___________________________________

How many different pills? __________________________________

Dose and schedule

What the drug looks like __________________________________________

Drug name (generic and trade) __________________________________________

DRUG-SPECIFIC INFORMATION

For problems, contact ______________________________________ ______________________________________ ______________________________________ ______________________________________ ______________________________________

______________________________________

Your next appointment is?

Do you have any other questions?

When should you call the Doctor or Nurse?

Where do you plan to keep it?

Does it matter if you take this pill/tablet with food or not?

When will you take your cancer pill(s)/tablet(s)?

What is/are the name(s) of your cancer pill(s)/tablet(s)?

You have received a lot of information today. Let� s review key points.

Have the patient and/or caregiver answer the following questions to ensure that they understand what information you have given them.

EVALUATE

Figure 1 MASCC Teaching Tool for Patients Receiving Oral Agents for Cancer (MOATT) Continued

* Give names and phone numbers here

Are there any precautions? Are there any drug and food interactions? When and whom to call with questions

* Include lab evaluations or any medical tests that will be used for drug monitoring.

What are potential side effects and management of them?

* Be specific, for example, away from heat (not in the kitchen), humidity (not in the bathroom), sun (not on the window sill)

Drug name (generic and trade) What the drug looks like Dose and schedule. How many different pills? How many times a day? For how long? Where to store the drug

Whichever tool is used to educate the patient, include the following drug-specific information. You can complete the form provided below and give it to the patients using reference material you have on the specific pills/tablets.

References • Product package insert or prescribing information • http://www.cancerbackup.org.uk/Treatments/Ch emotherapy/Individualdrugs • Micromedix • AHFS Drug Info. • http://www.cancersource.com/LibraryAndResou rces/DrugGuide/ • http://www.naturaldatabase.com Add website addresses, email links, internet sites

Refer to drug specific information to educate the patient on his/her pills/tablets

The following information relates to topics and references for the specific treatment that the patient is receiving.

Drug-Specific Education �

ORAL CHEMOTHERAPY

Appendices

ORAL CHEMOTHERAPY

adverse effects are vital to the plan of care for patients receiving oral cancer therapies and to the success of oral chemotherapy treatment. Patient education is the cornerstone of oral chemotherapy and should be systematically implemented for every patient who initiates this type of therapy. As educators, ONNs need to be proactive in providing information on the purpose of the oral chemotherapy, the dose and schedule on which to take the medication, side effects and symptom management, and safety. Tailored patient chemotherapy education using strategies of prioritization of information, sensory needs, illustrations to reinforce messages, simple language, and teach-back has the potential to enhance patient safety, promote adherence, and enhance quality of life.4 Patient education should be thorough and include information on how, when, and whom to call for healthcare support; management and prevention of side effects;

Patient education is the cornerstone of oral chemotherapy and should be systematically implemented for every patient who initiates this type of therapy. importance of and tools for adherence; and safety issues.5 Oral chemotherapy agents are considered hazardous drugs by the Occupational Safety & Health Administration and require special storage, handling, administration, and disposal to minimize short- and long-term effects to patients and caregivers. Thus, it is essential to incorporate information about safe handling and disposal of oral chemotherapy agents as well as expanded information about adherence and potential side effects.6 In 2009, the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) published standards for the safe use of infusion chemotherapy.7 In 2013, with the increasing use of oral chemotherapy and targeted agents in the treatment of cancer, ASCO and ONS expanded the chemotherapy administration safety standards to include oral agents.7 The newly developed standards address the importance of patient and family education (materials appropriate for the patientâ&#x20AC;&#x2122;s reading/literacy level and documentation of education reflecting understanding) regarding administration schedules, expectation procedures, disposal of unused oral medication, and aspects of continuity of care.7 The 2013 ASCO/ ONS chemotherapy administration guidelines strength-

en the evidence-based recommendations on prescribing patient education and ongoing monitoring for patients receiving oral chemotherapy by incorporating monitoring in the treatment plan, assessing for adherence to the regimen, and assessing for toxicity at each visit.8 An example of a tailored intervention tool for patient education, developed by the Multinational Association of Supportive Care in Cancer (MASCC), is the MASCC Teaching Tool for Patients Receiving Oral Agents for Cancer (MOATT) (Figure 1). MOATT is a resource to assist healthcare providers to assess and teach patients about oral chemotherapy treatment by addressing key assessment questions, generic education discussion points, drug-specific education, and evaluation questions to help ensure that patients and caregivers understand the information provided.9 Nursing interventions such as MOATT that incorporate patient education, assessment of barriers to and facilitators of adherence, early symptom identification and management, and reminder prompts can promote adherence and improve outcomes.9 The results from a cross-sectional study of Australian oncology nurses conducted by Johnson and Adler indicated a desire to improve oral chemotherapy education and supportive care for patients using formal education, including MOATT and additional interventions of follow-up calls, and implementing the use of patient calendars/diaries.10 One key element to improve medication adherence is to provide close follow-up contact and support (affective strategy) for adherence.11 Consistent follow-up and enhanced communication between patients and healthcare providers create opportunities for patients to ask questions and relay concerns related to their medications and disease process, reinforce education, serve as reminders for medication administration, and facilitate motivational coaching, all of which serve to improve medication adherence.2 Using nurse coaching interventions to promote adherence helps patients manage symptoms and ensures that medications are taken safely.2 Cancer patients on oral chemotherapy and targeted agents tend to undergo long-term treatment, and the concepts of consistent follow-up, symptom management, and adherence are important for successful treatment outcomes.2 A 2-stage study of mixed-method approach and use of descriptive statistics by Griffiths and Pascoe evaluated a nursing-led education program promoting patient knowledge by utilizing MOATT and a posteducation follow-up call to facilitate adherence and promote safety and well-being.12 In this study, all participants reported that the provision of tailored information enhanced their knowledge about their oral chemotherapy treatment and

ORAL CHEMOTHERAPY

that with the follow-up phone call in conjunction with the education, they felt well prepared, more confident, and less distressed about their treatment.12 Schneider and colleagues conducted a randomized trial of 45 patients on oral chemotherapy; the control group received standard chemotherapy education, and the intervention group received standard chemotherapy education plus a tailored nurse-led phone call weekly for the first month and then twice a month for 6 months until completion of treatment.13 Patient adherence rates were measured in both the control and the intervention groups at 2 and 4 months with higher adherence rates seen for the intervention group, suggesting that tailored coaching follow-up call intervention was beneficial in promoting adherence.13 A nonexperimental descriptive feasibility pilot study by Sommers and colleagues evaluated the feasibility of face-to-face patient education, a nurse-initiated follow-up telephone call, and the use of a medication diary to support the patient’s self-reported medication adherence and knowledge of oral chemotherapy for patients with gastrointestinal cancer.14 The analysis of the data revealed improved symptom management with the utilization of the nurse-initiated follow-up telephone call and a high self-reported adherence rate with completed medication diaries.14 A review of the literature demonstrated the effectiveness of tailored nurse coaching interventions in addition to patient education in improving symptom management and adherence for oral chemotherapy patients. The ONN implemented the development of a comprehensive patient-centered assessment and education protocol to enhance the education of patients/families/ caregivers about oral chemotherapy agents. The ONN also implemented a tailored nurse-initiated follow-up telephone call protocol for the continual assessment of symptom management and adherence.

Methods For the pilot project, the ONN recommended enhancing the education of cancer patients/families/caregivers about oral chemotherapy by initiating the usage of MOATT. MOATT provides a structured format to ensure that all key areas of patient assessment and teaching are addressed, but it also allows for patient-centered individualization of teaching and uses evidence-based tenets in patient education.12 Prior to the initiation of self-administration of oral chemotherapy, patients and their families/caregivers met with the ONN, who provided information and education regarding the oral chemotherapy using the 4 sections of MOATT. In the first section, the ONN used a series of questions to assess the patient’s knowledge of the treatment plan,

current medications, and ability to obtain and administer the oral chemotherapy. In the second section, the ONN provided the patient/family/caregiver general instructions applicable to all oral chemotherapy agents, such as storage, handling, and disposal, and identified a patient-preferred individual system for remembering to take the oral chemotherapy (calendars, medication diaries, cellular phone alarm) and actions to take for various situations such as a missed dose. In the third section, the ONN provided agent-specific information such as dose and schedule, side effects, symptom management, and potential interactions (drug and food) by reviewing the patient’s medication list. In the fourth section, the ONN evaluated the understanding of the patient/family/caregiver of the information provided through a series of questions listed on the tool for teach-back. The tool provided an outline for patients/ families/caregivers to ensure that assessment, symptom management, and strategies for adherence are addressed. The information gathered from the tool assessment and education was documented in the patient’s medical record and a copy of the completed tool provided to the patient as a reference.

The ONN implemented the development of a comprehensive patient-centered assessment and education protocol to enhance the education of patients. For the pilot project, the ONN contacted oral chemotherapy patients via telephone weekly for the first month after initiating treatment, twice a month for the second and third months, and monthly thereafter for the course of their treatment. During the telephone conversations, using the Adherence Starts with Knowledge (ASK-12) tool, the ONN assessed barriers to or facilitators of the patient’s adherence and addressed symptoms and side effects (Figure 2). The patient’s responses were used to identify and implement tailored specific adherence strategies to meet the patient’s individual needs. The follow-up calls, patient responses, and interventions were documented in the patient’s electronic record. Subsequent follow-up telephone calls assisted in evaluating the implemented tailored interventions. Proactive education and follow-up are critical with home-based oral chemotherapy. ONNs can effectively reinforce patient education, review the patient’s medication schedule, monitor adherence, evaluate early side effects, and imContinued on page 27

ORAL CHEMOTHERAPY

Figure 2 Adherence Starts with Knowledge (ASK-12)

Taking Medicine—What Gets in the Way? Thinkabout all of the medicines you take. Markone answer for each item below. INCONVENIENCE/ FORGETFULNESS Lifestyles 1

I just forget to take my medicines some of the time.

I run out of my medicine because I don’t get refills on time.

Taking medicines more than once a day is inconvenient.

TREATMENT BELIEFS Attitudes and Beliefs 4

I feel confident that each one of my medicines will help me.

I know if I am reaching my health goals.

Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

Help From Others 6

I have someone I can call with questions about my medicines.

Talking With Healthcare Team 7

My doctor/nurse and I work together to make decisions.

BEHAVIOR Taking Medicines

In the last In the last In the last More than 3 months week month 3 months ago

Have You... 8

Taken a medicine more or less often than prescribed?

Skipped or stopped taking a medicine because you didn’t think it was working?

Skipped or stopped taking a medicine because it made you feel bad?

Skipped, stopped, not refilled, or taken less medicine because of the cost?

Not had medicine with you when it was time to take it?

Never

If you checked any answers in the darkblue boxes, talkwith your doctor or healthcare professional.

This material was developed by GlaxoSmithKline.

Using ASK-12SM A Ask your patients to complete ASK-12 on paper, over the telephone.

B Identify potential barriers by reviewing any answers in dark blue boxes.

Printed in USA.

HM2231R1

July 2008

C Discuss with your patient any potential barriers. • If several barriers are identified, ask the patient which one matters most to him or her. D Provide ASK resources (www.takingmeds.com) to address specific adherence barriers. • Consider any social support or services that

ORAL CHEMOTHERAPY

plement appropriate symptom management through telephone assessment and follow-up.

Results During the 3-month pilot project of the patient-centered assessment and education protocol and the tailored nurse follow-up telephone call protocol, 24 patients initiated oral chemotherapy. All 24 patients received patient-centered education, continual assessment, and follow-up telephone calls. Based on the responses to structured questions and the ASK-12 tool, all patients reported that the education program, the individualized written information, and the follow-up telephone contact with the ONN reinforced their knowledge and understanding of their oral chemotherapy as well as enhanced their comfort level in being able to manage and to adhere to their treatment. Nurse-led education and follow-up telephone calls helped patients to better understand the schedule and side effects associated with their medication. With a better understanding of their oral chemotherapy, patients felt more comfortable and confident to self-administer and adhere to their cancer treatment. As shown by the teach-back responses to MOATT during patient education sessions and the responses to the ASK-12 tool during the follow-up telephone calls, effective teaching and follow-up benefited cancer patients in the pilot project by improving side effect management, decreasing anxiety, promoting adherence, empowering patients to be included in their care, and improving quality of life. Limitations The limitation of the 3-month pilot project is the small number of cancer patients initiating oral chemotherapy participating in the study. Discussion Patient education and tools to enhance adherence and reduce drug interactions and adverse effects are vital to the plan of care for patients and to the success of oral chemotherapy treatment. With more cancer patients self-administering chemotherapy outside of the infusion center, a greater need exists to develop improved strategies for assessment, patient education, adverse effect management, and ongoing monitoring of care. ONNs are the advocates for patients undergoing oral chemotherapy. ONNs need to become informed about the ever-developing new oral chemotherapy agents, educate patients about oral chemotherapy agents, and develop tools to assist patients with adherence and the management of adverse effects to improve patient quality of life.

Conclusion Patients receiving oral chemotherapy need to receive patient education and regular assessment for symptom management and adherence from an oncology nurse. Cancer patients on oral chemotherapy need education on the agents, side effects, and symptom management to reduce the risk of nonadherence and to ensure safety. Literature on medication adherence, including oral chemotherapy, indicates that patients cope more effectively when they are educated about their diagnosis and treatment.2 Effective teaching and follow-up benefit cancer patients by improving side effect management, decreasing anxiety, promoting adherence, empowering patients to be included in their care, and improving quality of life.12 The shift to treating cancer using oral chemotherapy agents has created a new paradigm in cancer care, and ONNs need to take a lead role in improving nursing practice and in caring for patients receiving oral chemotherapy agents. g References

1. Moody M, Jackowski J. Are patients on oral chemotherapy in your practice setting safe? Clin J Oncol Nurs. 2010;14:339-346. 2. Given B, Spoelstra S, Grant M. The challenges of oral agents as antineoplastic treatments. Semin Oncol Nurs. 2011;27:93-103. 3. Spoelstra S, Given CW, Sikorskii A, et al. Treatment with oral anticancer agents: symptom severity and attribution, and interference with comorbidity management. Oncol Nurs Forum. 2015;42:80-88. 4. Rigdon A. Development of patient education for older adults receiving chemotherapy. Clin J Oncol Nurs. 2010;14:433-441. 5. Winkeljohn D. Adherence to oral cancer therapies: nursing interventions. Clin J Oncol Nurs. 2010;14:461-466. 6. Lester J. Safe handling and administration considerations of oral anticancer agents in the clinical and home setting. Clin J Oncol Nurs. 2012;16:E192-E197. 7. Neuss MN, Polovich M, McNiff K, et al. 2013 updated American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards including standards for the safe administration and management of oral chemotherapy. J Oncol Pract. 2013;9(suppl):5s-13s. 8. Esper P. Identifying strategies to optimize care with oral cancer therapy. Clin J Oncol Nurs. 2013;17:629-636. 9. Kav S, Schulmeister L, Nirenberg A, et al. Development of the MASCC teaching tool for patients receiving oral agents for cancer. Support Care Cancer. 2010;18:583-590. 10. Johnson C, Adler K. The role of the nurse in patient education and followup of people receiving oral anti-cancer treatment: an Australian survey. Australian J Cancer Nurs. 2014;15:4-12. 11. Schneider SM, Hess K, Gosselin T. Interventions to promote adherence with oral agents. Semin Oncol Nurs. 2011;27:133-141. 12. Griffiths T, Pascoe E. Evaluation of an education program to facilitate patient adherence, toxicity monitoring and promote safety and wellbeing in the self-administration of oral chemotherapy in the home setting: an Australian study. Australian J Cancer Nurs. 2014;15:30-38. 13. Schneider SM, Adams DB, Gosselin T. A tailored nurse coaching intervention for oral chemotherapy adherence. J Adv Pract Oncol. 2014;5:163-172. 14. Sommers RM, Miller K, Berry DL. Feasibility pilot on medication adherence with knowledge in ambulatory patients with gastrointestinal cancer. Oncology Nurs Forum. 2012;39:E373-E379.

LEARNING GUIDE

Overview of Professional Roles and Responsibilities Sharon Gentry, RN, MSN, CBCN, CBEC Breast Nurse Navigator Novant Health Derrick L. Davis Cancer Center Winston-Salem, NC

avigation is one strategy proposed as a solution to many of the problems of American healthcare: high costs, uneven quality, and too frequent disappointing patient outcomes. Our fragmented system is often characterized by communication failures and nonbeneficial or redundant healthcare tests and services. Nurse navigation is not a new idea to the nursing profession. Identification of barriers to care was a primary focus of patient navigation that Dr Freeman initiated in the 1990s to help explain delays in diagnosis as well as incomplete care.1 This same premise was the goal of nursing utilization review in the 1970s and remained a focus for utilization management, case management, and care coordination.2 Utilization management did start the communication process with the physician, and case management furthered communication as a team ally, provided education, and addressed

Our fragmented system is often characterized by communication failures and nonbeneficial or redundant healthcare tests and services. psychosocial distresses, financial concerns, and care coordination. Nurse navigation cultivated the bidimensional care concept—patient centered and health system oriented—as oncology care moved to an outpatient setting.3 This holistic navigation effort is integral to facilitate effective interprofessional collaboration and promote patient satisfaction and care quality, as well as the efficient use of healthcare resources to decrease costs across oncology patient populations and healthcare settings. The guiding principles of patient navigation are to ensure that quality, confidentiality, and professionalism are threaded throughout all aspects of care and programming.4 Inherent in the process is continuous quality care

for patients from screening through diagnosis and treatment, based on the following tenets: •C ulturally competent care • Confidentiality • Respect • Compassion •P atient safety A basic nursing skill is to assess, and then plan, implement, and evaluate. One must assess first. To become a skillful nurse navigator, it is advantageous to take the time to observe the care process of patients in a step-bystep timeline fashion and document what is observed. This simple exercise will allow the nurse navigator to identify ineffective processes, communication gaps, and the needs of an oncology program. Shockney has an example in her book, Becoming a Breast Cancer Nurse Navigator, with a template applicable to any navigation program, and describes the use of a linear flowchart as a prerequisite to navigate patients.5 This overview of the patient flow through the system of care can allow definition of the point at which navigation begins and the point at which navigation ends. This is a fundamental principle of navigation, as is “patient navigation should be defined with a clear scope of practice that distinguishes the role and responsibilities of the navigator from that of all other providers.”1 Blaseg points out that a clear scope of practice with stop and start points will prevent overlap of the roles of others.6 If this basic fundamental is ignored in haste to initiate a navigation program and tasks are assigned to ensure a sense of productivity and value with the role, 2 things can occur—the navigator can assume responsibility for the role of others, and any difficulties associated with an individual patient’s circumstances can be deferred to the navigator. This can create team difficulty and frustration to the navigator as a catchall for patient problems. Once role boundaries are defined, common responsibilities of a nurse navigator may include: • Providing education and support to the patient and family

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• Identifying special needs of the patient and delegating to appropriate support staff • Enhancing understanding of treatment options available • Facilitating patient care plan recommendations by physician • Connecting patient and family with community resources • Coordinating multidisciplinary care from time of diagnosis throughout treatment • Improving timeliness of appointments • Serving as a resource for the community on health issues, prevention, screening, treatment, and research Confusion can exist about the navigator role and responsibility. Nurse navigators commonly spend time doing clerical tasks such as faxing documents, waiting on the phone for precertification, and scheduling appointments for patients. This time is best spent with patients in education, psychosocial counseling, or facilitating multidisciplinary care. On the AONN website, the definition of navigators describes this distinction.7 Willis and colleagues published on a collaborative project with national stakeholders in navigation to create a role delineation framework.8 The final framework is composed of 12 functional area domains with differences between community health workers, patient navigators, and clinically licensed navigators described in each frame. The annual evaluation of the patient navigation process outcomes is the primary element in the American College of Surgeons Commission on Cancer (CoC) Standard 3.1 Patient Navigation Process that will influence modifications to the nurse navigator’s process of care. The patient navigation process, driven by a community needs assessment, is established to address healthcare disparities and barriers to care for patients. Resources to address identified barriers may be provided either on-site or by referral to community-based or national organizations. The intent of the standard is to identify and address a new barrier each year. However, programs are allowed to address the same barrier or disparity for more than 1 year if the cancer committee documents in their minutes that they have put forth significant activity over the year but that there is an ongoing need to continue to address that barrier. The cancer committee may decide to continue work to address the barrier until the issue is resolved, for a period not to exceed the 3 years between CoC program surveys. Professional goals for the nurse navigator are quantifiable targets the cancer committee wishes to achieve. The George Washington Cancer Institute Center for the Advancement of Cancer Survivorship, Navigation, and

Policy (caSNP) has an Online Academy course titled “Executive Training on Navigation and Survivorship” that teaches the basics of navigation and survivorship program development and implementation.9 They stress the importance of quantifiable targets using the acronym S.M.A.R.T. for the 5 steps of specific, measurable, action-oriented, realistic, and time-bound goals that set an actionable plan for results. The trainings on the website are self-paced and available free of charge. Espinosa and colleagues explain metrics that support and justify the nurse navigator position.10 They provide questions to pose as well as a table of outcome metrics. Sein’s webinar on the AONN site has an excellent section on creating a dashboard and being specific with goals.11

Nurse navigators commonly spend time doing clerical tasks such as faxing documents, waiting on the phone for precertification, and scheduling appointments. AONN has a Standardized Metrics Project Team that recognizes the challenge navigation programs have encountered as standardized national metrics to measure programmatic success have yet to be created. The team is working to develop standard metrics in the areas of patient experience, clinical outcomes, and return on investment using the AONN DOMAINS for certification, which contain a comprehensive list of all areas of navigator practice. More on this project will be published in the coming months. Skills such as advocacy, problem solving, time management, critical thinking, multitasking, collaboration, and communication were identified in the Oncology Nursing Society oncology nurse navigation role delineation study.12 AONN has identified additional skills of leadership and systems management. Leadership skills of the nurse navigator are expressed in several publications, and the role is depicted as one that often survives in a macromanaged environment—one that needs minimal supervision. Seek and Hogle stressed this skill as the navigator works through the complex healthcare system to coordinate optimal care.13 Blaseg describes this as a desired quality for a nurse navigator—one who can make decisions and work independently within the bounds of the role and demonstrate personal and professional accountability with a commitment to lifelong learning.6 According to Vargas and colleagues, they remain flexible to possibilities of care.14 Systems management is best

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described by Fillion and colleagues, who wrote that the workflow of nurse navigation is bidimensional in nature—patient centered and health system oriented.3 Doll and colleagues state that nurse navigators possess oversight of the comprehensive care needs, provide education and advocacy for the patient, link the patient to networks of professional and community resources, and act as a distinct, constant contact to enhance psychosocial care.15 Blaseg describes the nurse navigator’s knowledge of resources as comprehensive across the healthcare system, community, and population served.6 An example of this systemic overview is shown in the work by Christensen and Bellomo with the navigation process that demonstrated decrease in system time as well as a cost advantage to the healthcare system.16

2. V is a renal cancer patient who comes in for care, and his wife is always with him. V can neither speak nor comprehend English, but his wife can do so fluently. During the Palliative Care Clinic visit today to address V’s pain and increasing fatigue, the question of end-of-life care was raised by the patient. The wife motions for the interpreter not to answer the question and conveys in English to the interpreter and staff to not answer the question. V looks bewildered by the exchange. What is the best action for the navigator to take at this point? a. Ask the wife to leave the room. b. Tell the interpreter to ignore the question c. Address the wife’s discomfort with the question d. Question V if he is positive he wants to know

The role of the nurse navigator is depicted as one that often survives in a macromanaged environment—one that needs minimal supervision.

Answers 1, a One must assess the current care process to identify possible causes before planning and implementing change. 2, c V is the focus of the care visit, but this barrier imposed by the wife needs to be addressed so the question can be answered for the patient.

The Oncology Nursing Society17 further defines the nurse navigator professional role as one of lifelong learning and evidence-based practice and encourages contribution to the knowledge base of the profession. The nurse navigator is expected to contribute to program development, participate in ethical decision-making for patients, and collaborate with the cancer committee, administration, and healthcare team members. Nurse navigation professional roles and responsibilities questions cover the history of navigation, critical thinking, problem solving, ethics, leadership, multidisciplinary team building, patient tracking, and navigation tasks. It is the work that you do as a nurse navigator on a daily basis. The questions will range from basic knowledge to application. Try the questions below! 1. AONN Community Hospital noticed that the head and neck cancer patients experienced high hospital admission rates. The cancer committee chose to address this phenomenon with the hiring of a nurse navigator. What nursing process will best identify the problem in the care continuum? a. Assess b. Plan c. Implement d. Evaluate

References

1. Freeman H, Rodriguez RL. History and principles of patient navigation. Cancer. 2011;117:3539-3542. 2. Shockney L. Evolution of patient navigation. Clin J Oncol Nurs. 2010;14:405-407. 3. Fillion L, Cook S, Veillette A, et al. Professional navigation framework: elaboration and validation in a Canadian context. Oncol Nurs Forum. 2012;39:E58-E69. 4. Freeman HP. A model patient navigator program. Oncology Issues. 2004;19:44-46. 5. Shockney L. Becoming a Breast Cancer Nurse Navigator. 1st ed. Sudbury, MA: Jones and Bartlett Publishers; 2010. 6. Blaseg K. Getting Started as a Nurse Navigator. In: Blaseg K, Daugherty P, Gamblin K, eds. Oncology Nurse Navigation Delivering Patient-Centered Care Across the Continuum. Pittsburgh, PA: Oncology Nursing Society; 2014:20-42. 7. AONN website. FAQ. What is the difference between a nurse navigator and a patient navigator? www.aonnonline.org/about/faq. 8. Willis A, Reed E, Pratt-Chapman M, et al. Development of a framework for patient navigation: delineating roles across navigator types. Journal of Oncology Navigation & Survivorship. 2013;4(6):20-26. 9. George Washington Cancer Institute Online Academy. http://smhs. gwu.edu/gwci/education. 10. Espinosa AR, Gabel M, Vlahakis P. Patient navigation: defining metrics that support and justify the nurse navigator position. Journal of Oncology Navigation & Survivorship. 2012;3(5):16-20. 11. Sein E. What Is the Patient Navigator Role in Oncology Quality Metrics? www.aonnonline.org/education/interactive-learning/. Accessed June 12, 2016. 12. Brown CG, Cantril C, McMullen L, et al. Oncology nurse navigator role delineation study: an Oncology Nursing Society report. Clin J Oncol Nurs. 2012;16:581-585. 13. Seek A, Hogle W. Modeling a better way: navigating the healthcare system for patients with lung cancer. Clin J Oncol Nurs. 2007;11:81-85.

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14. Vargas RB, Ryan GW, Jackson CA, et al. Characteristics of the original patient navigation programs to reduce disparities in the diagnosis and treatment of breast cancer. Cancer. 2008;113:426-433. 15. Doll R, Barroetavena MC, Ellwood AL, et al. The cancer care navigator: toward a conceptual framework for a new role in oncology. Oncology Exchange. 2007;6(4):28-33. 16. Christensen D, Bellomo C. Using a nurse navigation pathway in the timely care of oncology patients. Journal of Oncology Navigation & Survivorship. 2014;5(3):13-18. 17. Oncology Nursing Society. Oncology Nurse Navigator Core Competencies. www.ons.org/sites/default/files/ONNCompetencies_rev.pdf.

Additional Reading Accreditation Committee Clarifications for Standards 3.1 Patient Navigation Process and 3.2 Psychosocial Distress Screening. www.facs.org/publications/newslet ters/coc-source/special-source/standard3132. American Nurses Association. Code of Ethics for Nurses with Interpretive Statements. www.nursingworld. org/MainMenuCategories/EthicsStandards/CodeofEth icsforNurses/Code-of-Ethics-For-Nurses.html. Braun K, Kagawa-Singer M, Holden A, et al. Cancer

patient navigator tasks across the cancer care continuum. J Health Care Poor Underserv. 2012;23:398-413. Case MA. Oncology nurse navigator. Clin J Oncol Nurs. 2011;15:33-40. Fiscella K, Ransom S, Jean-Pierre P, et al. Patientreported outcome measures suitable to assessment of patient navigation. Cancer. 2011;117:3603-3617. Gentry SS, Sellers JB. Navigation Considerations When Working With Patients. In: Blaseg K, Daugherty P, Gamblin K, eds. Oncology Nurse Navigation: Delivering Patient-Centered Care Across the Continuum. Pittsburgh, PA: Oncology Nursing Society; 2014:71-120. Johnston D. Current state of care transitions and cancer survivorship. Journal of Oncology Navigation & Survivorship. 2013;4(4):11-20. Mack NA, Shalkowski L. How to Start and Expand a Nurse Navigation Program. In: Blaseg K, Daugherty P, Gamblin K, eds. Oncology Nurse Navigation Delivering Patient-Centered Care Across the Continuum. Pittsburgh, PA: Oncology Nursing Society; 2014:43-70. g

LEARNING GUIDE

Overview of End-of-Life Care Lillie D. Shockney, RN, BS, MAS University Distinguished Service Professor of Breast Cancer Johns Hopkins University School of Medicine, Baltimore, MD Program Director and Cofounder, AONN

upporting advanced-stage cancer patients in preparation for end of life is perhaps the most daunting aspect of nurse navigation. Even though it is known by the treatment team that their patient will succumb at some point to the cancer and its treatment, there remains hesitancy to discuss end of life, especially end-of-life planning. The focus instead is on treating the disease. The patient, however, is more than his or her pathology. Oncology nurse navigators, as patients’ advocates, must serve as the voice for patients when they are not able to speak confidently on their own behalf. Rather than receiving treatment for treatment’s sake, the goals of treatment must be based on what each patient’s goals are, and not anyone else’s. Palliative care for symptom management, especially pain relief, should be offered to any patient dealing with serious side effects of their illness, whether the cancer is life-shortening or not. However, doctors commonly combine palliative care with a hospice discussion, which implies that palliative care is for the very end of life, which it should not be. Palliative care should be viewed as quality-of-life preservation or quality-of-life restoration and not be coupled with hospice services. Although always provided with hospice care, it should be initiated much sooner while the patient is still receiving treatment. In the United States, the length of time a patient receives hospice care is only 5 days. Approximately 21% of metastatic patients will die in an intensive care unit. This is primarily because of poor or inadequate communication between the patient and the treating oncologist. Physicians are hesitant to discuss end of life out of fear that the patient will interpret such a discussion as giving up on the patient. What may be worse, however, is the patient having false hope due to poor communication. A research study conducted on solid organ tumor patients with advanced disease demonstrated that when the doctor says “I am hopeful your tumor will respond to this next treatment,” the majority of patients agree to have the treatment because they interpreted the word “respond” as meaning “cure.” Physicians are not taught to ask patients to repeat back to them their understand-

ing of what was just said; nurses are, however. So making sure that the patient understands what to expect from the next line of therapy is critically important. Well-meaning family members can display enabling behavior with the oncologist by going behind the scenes and asking the doctor to “not give up on their mother” and to “please give her any other treatment that is available,” even though there hasn’t been a conversation between the patient and the doctor indicating that the patient wants to stop treatment. Again, the importance of the navigator serving as the patient advocate could not be more important than at this time. Patients also will hesitate to agree to enroll in hospice care due to fear of abandonment by their doctor and other oncology support staff, including their nurse navigator. This can easily be addressed, however, if the doctor asks the patient to allow him to continue to remain in touch with hospice staff and family members, thereby affirming that the patient is not being abandoned, although it will be hospice physicians and staff providing the lion’s share of the support and medical care. Having the patient’s nurse navigator remain in touch with the patient and the family may be one of the best ways to support a patient to embrace hospice care. Patients need to be navigated through phases of hope. The first phase is commonly the hope for a miracle cure. The second phase is hoping for a long life with quality of life, living in harmony with their disease. The third phase is acknowledging they will have a shortened life but still hoping for quality of life for the time that remains. And finally, hoping for a “good death.” The elements of a good death include: • Knowing she had purpose for living, and it was valued by at least 1 other person • Leaving a legacy that is not related to leaving financial wealth • Being pain free • Dying with dignity in an environment of their own choosing (most want to die at home with hospice care if asked) • Giving forgiveness and receiving forgiveness • Feeling confident she will be spoken of fondly after she is gone

LEARNING GUIDE

• Having legal and financial affairs in order • Leaving no financial debt for their loved ones to pay associated with their cancer and its treatment • Feeling a connection spiritually to a higher power (which for some comes closer to the actual end of life) To orchestrate a good death, which everyone deserves, takes time and cannot be accomplished in a week. It commonly takes several months. When a physician tells the patient and their loved ones that it is “time to get their affairs in order,” the physician documents it in the medical record; however, that doesn’t mean it will actually happen as no resources or instructions are provided to assist the patient with this important and daunting task. That can result in it never happening, which later can cause chaos for the family members left behind. As the patient advocate, the nurse navigator can help support the patient by providing resources for planning legally and financially for end of life; making sure, too, that the patient’s goals are the goals of treatment; speaking with the family to diminish the risk of the family wanting to keep the patient alive but without quality of life; and discussing with the treatment team the patient’s candid discussions with the navigator about wanting to end treatment sooner versus later. Statistically, those who enroll in hospice care at home sooner live longer and with better quality of life than those who continue treatment until too ill to be given anymore. End of life requires good planning, and those with advanced cancers deserve for such planning to be part of their cancer care. The nurse navigator can and should serve as the patient advocate to help ensure that the patient’s voice is heard; that effective communication is taking place between the patient, family, and treatment team; that palliative care is initiated early; and that steps are taken and barriers removed to help facilitate a good death for the patient. g

Check your knowledge! 1. Palliative care is primarily a. Symptom management to restore or preserve quality of life b. Provided when hospice care is initiated for the patient c. Given in the home setting d. Focused on pain control and not on other side effects or symptoms 2. The average number of days a patient receives hospice care in the United States is: a. 5 b. 10

c. 15 d. 30 3. If a patient is asked where they would prefer to die, the most common answer given is: a. In the hospital b. In a nursing home c. At home with hospice d. At a hospice facility 4. The primary reason patients do not want to enroll in hospice care is: a. Believing a miracle can still happen b. Fear of abandonment by their oncologist and treatment team c. Fear of death d. Fear of pain 5. The primary reason for patients not receiving the care they desire and need at the time of end of life is due to poor communication. a. True b. False

Answers 1, a; 2, a; 3, c; 4, b; 5, a. Resources de Graaf E, Zweers D, Valkenburg ACh, et al. Hospice assist at home: does the integration of hospice care in primary healthcare support patients to die in their preferred location – a retrospective cross-sectional evaluation study. Palliat Med. 2016;30:580-586. Gaertner J, Siemens W, Antes G, et al. Specialist palliative care services for adults with advanced, incurable illness in hospital, hospice, or community settings—protocol for a systematic review. Syst Rev. 2015;25:123. Hack TF, Chochinov HM, Hassard T, et al. Defining dignity in terminally ill cancer patients: a factor-analytic approach. Psychooncology. 2004;13:700-708. Hawthorn M. The importance of communication in sustaining hope at the end of life. Br J Nurs. 2015;24:702-705. Meier EA, Gallegos JV, Thomas LP, et al. Defining a good death (successful dying): literature review and a call for research and public dialogue. Am J Geriatr Psychiatry. 2016;24:261-271. Shockney L. Fulfilling Hope: Supporting the Needs of Patients with Advanced Cancers. Hauppauge, NY: Nova Science; 2014. Sullivan MD. Hope and hopelessness at the end of life. Am J Geriatr Psychiatry. 2003;11:393-405. Vehling S, Kamphausen A, Oechsle K, et al. The preference to discuss expected survival is associated with loss of meaning and purpose in terminally ill cancer patients. J Palliat Med. 2015;18:970-976.

CLINICAL TRIALS TRACKER

Select Ongoing Trials Currently Enrolling Patients with Colorectal Cancer

he following are a selection of key clinical trials that are currently recruiting patients for inclusion in investigations of new therapies or new combinations of available therapies for patients with colorectal cancer. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their eligible patients to one of these clinical trials.

Xilonix in Patients with Advanced Colorectal Cancer This randomized, parallel-assignment, double-blind, phase 3 clinical trial evaluates whether Xilonix, a monoclonal antibody, can prolong life in patients with co lorectal carcinoma that is refractory to standard therapy. Men and women aged ≥18 years with pathologically confirmed metastatic or unresectable colorectal carcinoma and with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive Xilonix or placebo. The primary outcome measure is overall survival. The secondary outcome measures include change in lean body mass, quality of life, progression-free survival, and objective response rate. This study plans to enroll 600 patients at multiple locations across the United States. For more information, contact Michael Stecher, MD, at 512-386-2900. The NLM Identifier is NCT01767857.

Fruquintinib versus Best Supportive Care in Patients with Advanced Colorectal Cancer After Previous Chemotherapy This phase 3, randomized, parallel-assignment, double-blind clinical trial evaluates the efficacy and safety of fruquintinib in the treatment of patients with metastatic colorectal cancer that has progressed after second-line or higher standard chemotherapy. Men and women aged 18 to 75 years with an ECOG performance status of 0 or 1, and with at least 1 measurable lesion, may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive fruquintinib or placebo. The primary outcome measure is overall survival. The secondary outcome measures include progression-free

survival, objective response rate, disease control rate, and safety and tolerance. This study expects to enroll 400 patients at multiple locations in China. For more information, contact Ye Hua, MD, at yeh@hmplglobal. com; or Songhua Fan, MD, at songhuaf@hmplglobal. com. The NLM Identifier is NCT02314819.

Intraoperative Chemotherapy with 5-FU for Patients with Colorectal Cancer Receiving Curative Resection This phase 3, single-blind, parallel-assignment, randomized study is assessing the efficacy and safety of intraoperative chemotherapy with fluorouracil (5-FU) for patients with colorectal cancer receiving curative resection. Men and women aged 18 to 75 years with histologically confirmed adenocarcinoma of the colon and rectum and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will undergo surgery alone or surgery plus chemotherapy with 5-FU. The primary outcome measure is disease-free survival. The secondary outcome measures include disease-free survival and safety profiles. This study plans to enroll 1246 patients in China. For more information, contact Xiaojun Wu, MD, PhD, at wuxj@sysucc.org.cn. The NLM Identifier is NCT01465451.

Masitinib plus FOLFIRI versus Placebo plus FOLFIRI in the Second-Line Treatment of Patients with Metastatic Colorectal Cancer The purpose of this phase 3, single-group, open-label clinical trial is to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, fluorouracil, and folinic acid) versus placebo plus FOLFIRI in the second-line treatment of patients with colorectal cancer. Men and women aged ≥18 years with nonresectable metastatic colorectal cancer with a life expectancy of >3 months and an ECOG performance status ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will receive masitinib plus FOLFIRI or placebo plus FOLFIRI. The primary outcome measure is overall survival. The secondary outcome measures include survival rate, progression-free survival, time to disease progression, best response, quality of life, pharmacogenomics assessment, and safety profile. This study expects to enroll 550 pa-

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tients in Canada. For more information, contact Olena Vlasyuk, MD, at olena.vlasyuk@ab.science.com. The NLM Identifier is NCT02605044.

Perioperative FOLFIRI versus Adjuvant FOLFIRI in Resectable Advanced Colorectal Cancer After Oxaliplatin Therapy This phase 3, open-label, parallel-assignment, randomized clinical trial is comparing perioperative FOL FIRI and adjuvant FOLFIRI in patients with resectable advanced colorectal cancer who were previously exposed to oxaliplatin. Men and women aged 18 to 80 years with histologically confirmed colorectal adenocarcinoma and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive perioperative FOLFIRI or adjuvant FOLFIRI. The primary outcome measure is progression-free survival. The secondary outcome measures include overall survival, R0 resection rate, toxicity, and quality of life. This study expects to enroll 360 patients in China. For more information, contact Jian Xiao, MD, at xiao_ jian@139.com. The NLM Identifier is NCT02087475.

Pembrolizumab versus Chemotherapy in Microsatellite Instability-High or Mismatch Repair Deficient Stage IV Colorectal Cancer The purpose of this phase 3, randomized, open-label, parallel-assignment clinical trial is to determine whether pembrolizumab will prolong progression-free survival compared with standard chemotherapy in patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) stage IV colorectal cancer. Men and women aged ≥18 years with a locally confirmed dMMR or MSI-H stage IV colorectal carcinoma and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive pembrolizumab or standard chemotherapy. The primary outcome measure is progression-free survival. The secondary outcome measures include overall response rate and overall survival. This study expects to enroll 270 patients at multiple locations in the United States and abroad. For more information, call 888-5778839. The NLM Identifier is NCT02563002.

Capecitabine plus Bevacizumab versus Capecitabine plus Bevacizumab and Irinotecan as First-Line Therapy in Patients with Metastatic Colorectal Cancer This randomized, single-group assignment, open-la-

bel, phase 3 clinical trial is assessing the efficacy of capecitabine plus bevacizumab versus capecitabine plus bevacizumab plus irinotecan in patients with metastatic colorectal cancer. Men and women aged ≥18 years with stage IV colorectal cancer and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive capecitabine plus bevacizumab followed by capecitabine plus irinotecan and bevacizumab in case of disease progression, or capecitabine plus irinotecan and bevacizumab. The primary outcome measure is time of failure strategy. The secondary outcome measures include objective response rate, overall survival, quality of life, and progression-free survival. This study plans to enroll 516 patients in Germany. For more information, contact Volker Heinemann, MD, at volker. heinemann@med.uni-muenchen.de. The NLM Identifier is NCT01249638.

FOLFIRI plus Cetuximab Until Disease Progression versus FOLFIRI plus Cetuximab for 8 Cycles Followed by Cetuximab Alone Until Disease Progression in First-Line Treatment of Patients with RAS and BRAF Wild-Type Metastatic Colorectal Cancer This randomized, open-label, parallel-assignment, phase 3 clinical trial is investigating whether cetuximab alone (given until progression or cumulative toxicity) after 8 cycles of FOLFIRI plus cetuximab results in a noninferior progression-free survival when compared with continuous FOLFIRI plus cetuximab (given until progression or cumulative toxicity). Men and women aged ≥18 years with a histologically proven diagnosis of colorectal adenocarcinoma with RAS and BRAF wild-type disease and with an ECOG performance status of 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive FOLFIRI plus cetuximab until disease progression or FOLFIRI plus cetuximab for 8 cycles followed by cetuximab alone until disease progression. The primary outcome measures are progression-free survival and the incidence of grade 3/4 adverse events. The secondary outcome measures include response rate, early tumor shrinkage assessed by response rate at week 8, overall survival, cetuximab-related skin toxicity, safety profile, and quality of life. This study plans to enroll 600 patients in Italy. For more information, contact Armando Orlandi, MD, PhD, at armando. orlandi@edu.rm.unicatt.it. The NLM Identifier is NCT02484833.

CLINICAL TRIALS TRACKER

Oxaliplatin, Leucovorin Calcium, and Fluorouracil with or without Celecoxib in Patients with Stage III Colon Cancer Previously Treated with Surgery This phase 3, randomized, double-blind, parallelassignment clinical trial is evaluating the efficacy of oxaliplatin plus leucovorin calcium and fluorouracil with or without celecoxib in patients with stage III colon cancer that was previously treated with surgery. Men and women aged ≥18 years with a histologically documented adenocarcinoma of the colon and an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive FOLFOX plus placebo (12 treatments), FOLFOX plus celecoxib (12 treatments), FOLFOX plus placebo (6 treatments), or FOLFOX plus celecoxib (6 treatments). The primary outcome measure is disease-free survival, and the secondary outcome measure is overall survival. This study plans to enroll 2500 patients at multiple locations in the United States and abroad. For more information, contact Jeffrey A. Meyerhardt, MD, MPH, at 617-632-5136. The NLM Identifier is NCT01150045.

Regorafenib as Single Agent in Patients with Metastatic Colorectal Cancer with Any RAS or BRAF Mutation Previously Treated with FOLFOXIRI plus Bevacizumab This open-label, single-group assignment, phase 2 clinical trial is evaluating the efficacy of single-agent regorafenib in the second-line treatment of patients with metastatic colorectal cancer with any RAS or BRAF mutation who were previously treated with FOLFOXIRI plus bevacizumab in terms of progression-free survival at 6 months. Men and women aged ≥18 years with stage IV metastatic colorectal cancer with any RAS or BRAF mutation and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive regorafenib. The primary outcome measure is progression-free survival at 6 months. The secondary outcome measures include objective response rate, disease control rate, time to progression, and overall survival. This study expects to enroll 53 patients in Spain. For more information, contact Inmaculada Ruiz de Mena, PhD, at ttd@ttdgroup.org. The NLM Identifier is NCT02175654.

Colectomy in Patients with Asymptomatic and Unresectable Stage IV Colon Cancer This randomized, parallel-assignment, open-label, phase 3 clinical trial is assessing whether overall surviv-

al and quality of life are improved in patients with asymptomatic colon cancer and unresectable liver metastasis that has been treated with resection of the primary tumor followed by chemotherapy versus chemotherapy alone. Men and women aged 18 to 75 years with pathologically confirmed colon adenocarcinoma and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive colectomy followed by chemotherapy versus chemotherapy alone. The primary outcome measure is overall survival. The secondary outcome measures include quality of life, postoperative complications, progression-free survival, time to metastatic progression, and the rate of secondary curative resection. This study expects to enroll 278 patients in France. For more information, contact Mehdi Karoui, MD, PhD, at 331-42-17-56-51. The NLM Identifier is NCT02363049.

Regorafenib or Standard of Care After Adjuvant FOLFOX in Patients with Stage IIIC Colorectal Cancer The purpose of this randomized, open-label, parallel-assignment, phase 2 clinical trial is to determine whether the addition of regorafenib after the completion of FOLFOX improves treatment compared with standard of care (no further treatment). Men and women aged ≥18 years with stage IIIC colorectal cancer and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients are randomized to receive regorafenib or standard of care. The primary outcome measure is finding the starting dose of regorafenib and the number of patients completing all 6 cycles. The secondary outcome measures include overall survival, number of adverse events, and disease-free survival. This study plans to enroll 264 patients in Florida. For more information, contact Melissa Pope at 281-863-6544, or melissa.pope@mckesson.com. The NLM Identifier is NCT02425683.

Pembrolizumab plus Azacitidine in Patients with Chemorefractory Metastatic Colorectal Cancer This open-label, single-group assignment, phase 2 clinical trial is evaluating the antitumor activity, safety, and tolerability of pembrolizumab in combination with azacitidine in patients with chemorefractory metastatic colorectal cancer without any further standard treatment options. Men and women aged ≥18 years with metastatic colorectal cancer that has been previously treated with currently approved

CLINICAL TRIALS TRACKER

standard therapies and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive pembroliz umab and azacitidine. The primary outcome measure is objective response rate. This study expects to enroll 40 patients in Pennsylvania. For more information, contact Natalie Streeter at 412-235-1276, or streeternr@upmc.edu. The NLM Identifier is NCT02260440.

Gemcitabine plus Docetaxel in Patients with Relapsed or Refractory Metastatic Colorectal Adenocarcinoma This single-group assignment, open-label, phase 2 clinical trial is assessing the efficacy of gemcitabine plus docetaxel chemotherapy in patients with relapsed or refractory metastatic colorectal cancer with methylated CHFR and/or microsatellite instability phenotype. Men and women aged ≥18 years with a histologically or cytologically confirmed metastatic or unresectable adenocarcinoma of the colon or rectum and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive gemcitabine plus docetaxel. The primary outcome measure is response rate. The secondary outcome measures include progression-free survival, overall survival, CHFR methylation, global methylation, and quality of life. This study expects to enroll 40 patients in the United States and the Nether-

lands. For more information, contact Rosalind Walker, RN, at 410-955-9628, or rwalker3@jhmi.edu. The NLM Identifier is NCT01639131.

FOLFOX plus Bevacizumab versus FOLFOXIRI plus Bevacizumab as First-Line Treatment of Patients with Previously Untreated Metastatic Colorectal Cancer and ≥3 Circulating Tumoral Cells This phase 3, randomized, open-label, parallelassignment clinical trial is evaluating FOLFOX (folinic acid, fluorouracil, and oxaliplatin) plus bevacizumab versus FOLFOXIRI (folinic acid, fluorouracil, oxaliplatin, and irinotecan) plus bevacizumab as first-line treatment for patients with previously untreated metastatic colorectal cancer and ≥3 circulating tumoral cells. Men and women aged 18 to 70 years with histologically confirmed adenocarcinoma of the colon or rectum, an ECOG performance status of 0 or 1, and a life expectancy of at least 3 months may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive FOLFOX6 plus bevacizumab or FOLFOXIRI plus bevacizumab. The primary outcome measure is progression-free survival. Secondary outcome measures include overall survival, response rate, and adverse events. This study plans to enroll 350 patients in Spain. For more information, contact Inmaculada Ruiz de Mena, PhD, at ttd@ttdroup. org. The NLM Identifier is NCT01640405. g

ONCOLOGY NURSING SOCIETY

More Than One Way to Provide Survivorship Care

t the 2016 Oncology Nursing Society Annual Congress, nurses from different practice settings described the various ways in which they have developed and implemented survivorship care plans, which are expected to be needed for more than 18 million individuals within 10 years.

Outsourcing to the Community “Ours is a small private care setting, so resources for providing survivorship care are limited. We have to refer out, while hospital-based practices may have these resources within arm’s length,” said Amita Patel, MSN, NP-C, OCN, of Regional Cancer Care Associates LLC in central New Jersey. “We reached out to various health professionals in our community to provide counseling in their respective areas of expertise.”

Amita Patel, MSN, NP-C, OCN, and Shannon Woerner, MSN, ANP-BC, OCN

Coauthor Shannon Woerner, MSN, ANP-BC, OCN, added, “We probably treated hundreds of patients before we had a mechanism in place to capture patients in the adjuvant setting.” The aim of these oncology nurses was to increase awareness about survivorship and to develop outside resources that could enhance a comprehensive survivorship program. They now ensure that all patients receiving adjuvant treatment have survivorship visits after completing therapy; this follows the ASCO Survivorship Care Plan. They reached out to potential resources in the community by letter, and got a good response. The resource list currently includes dietitians, psychologists, and health maintenance and smoking cessa-

tion specialists. These potential referral sources are compiled and centralized into a computer folder for easy access during patient visits. Their list currently holds about 10 nutritionists, 15 mental health providers, and 7 pulmonologists (for smoking cessation). “As the practice is getting bigger, we are branching out, and we are trying to reach into new geographic locations to make connections,” Ms Woerner said. With greater attention to survivorship, their survivorship visits more than doubled between 2014 and 2015. Primary care physicians receive copies of the patients’ survivorship care plans, helping to transition them back to their main provider. The nurses also determined that the percentage of “satisfied” patients jumped by more than 10 points with a better survivorship plan in place. They are now looking for community resources for fertility and genetic counseling.

Managing a Survivorship Program “From Afar” A survivorship care plan was described “from a nurse coordinator perspective” by Amy Monroe, BSN, RN, CNOR, of Froedtert Hospital and the Medical College of Wisconsin, Milwaukee. The program was Amy Monroe, started almost 3 years ago within the BSN, RN, CNOR gynecologic oncology department for patients with stage 1a endometrial cancer and has since expanded. According to Ms Monroe, the process works— but is not ideal. This department was one of the first to develop an innovative model for providing survivorship care plans to patients. Early buy-in from providers was due to an advanced practice provider promoting the use of the survivorship care plans, but the plan was actually developed and is being implemented by Ms Monroe, a nurse coordinator. “There were no additional full-time employee resources available for this process, so the program needed to absorb the work with the current team,” she explained. She is not embedded within the clinic but has an office elsewhere in the hospital where she also serves as a new patient coordinator. “I come down to the clinic when the patient is being seen by the provider,” she said.

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The point of her poster, she said, was to show that “you can tap a person who is not actually in the clinic to be your survivorship coordinator.” New patients are captured by the nurse coordinator at the weekly tumor conference, and established patients are forwarded to Ms Monroe via the electronic health record (EHR). She keeps track of all patients in the EHR, fills out the survivorship care plans, and meets with each patient to explain the plan. She sees more than 50 patients a year after they complete chemotherapy, but preferably not on the first postop visit. “I found that when I saw them that early, there was too much going on,” she said. This role has its challenges, she acknowledged. The current process is not sustainable for meeting the survivorship needs of all eligible patients. She often wastes time waiting for patients and could benefit from having a scheduling template. She would prefer to meet patients first on another visit. And it is difficult to “figure out the denominator” for the required number of care plans per year to satisfy the Commission on Cancer, she said. While the process is at least reaching survivors with critical information, she added, “consideration should be given to the development of a survivorship clinic.”

Hospital-Based Nurse Navigator Helps Community Oncologists “The oncology nurse navigator is uniquely positioned to take the lead in care coordination of cancer survivors,” according to Claire Sutherby, BSN, RN, CMSRN, of Deaconess Claire Sutherby, Hospital in Newburgh, IN. BSN, RN, Deaconess’ Cancer Committee adCMSRN opted the ASCO Survivorship Care Plan templates and added a survivorship nurse navigator to its multidisciplinary treatment team, which also includes medical, radiation, gynecologic and urologic oncologists, a genetic counselor, a pharmacist, and support therapy clinicians, she said. The survivorship nurse navigator reviews and monitors individualized survivorship care plans with patients after they complete their primary treatment. The navigator also advises patients when to seek treatment for side effects or concerns, discusses sur-

veillance guidelines, navigates the patient through support therapies, and provides education on cancer prevention and screening. Ms Sutherby sees patients with malignancies other than breast, lung, and head and neck cancers, which have their own navigators. She is hospital-based, but coordinates care for patients of 5 oncologists who practice in multiple locations in the community without survivorship care systems.

The survivorship nurse navigator reviews and monitors individualized survivorship care plans with patients after they complete their primary treatment. “I use the ASCO template and add the recommended screening, information on side effects and so forth depending on their type of cancer,” she said. Ms Sutherby, who receives a list of patients from the cancer registry, enters them into her Outlook calendar, determines their anticipated date of treatment completion, and schedules the survivorship visits. She currently has about 300 patients eligible for survivorship care planning. “The development of the cancer survivorship program within the interprofessional care team will not only meet the objectives of the Institute of Medicine and Commission on Cancer but also improve the navigation of care for cancer survivors through the continuum of care,” she pointed out. g

Resources Patel A, Woerner S, Flocco T. Nurse practitioners develop a comprehensive survivorship program in the private practice setting. 2016 Oncology Nursing Society Annual Congress. Poster 9. Monroe A. Survivorship care plan delivery process from a nurse coordinator perspective. 2016 Oncology Nursing Society Annual Congress. Poster 11. Sutherby C, Wilson D. The survivorship journey: development and implementation of a survivorship care plan program. 2016 Oncology Nursing Society Annual Congress. Poster 58.

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Get Going with Distress Screening!

tudies reported at the 2016 Oncology Nursing Society Annual Congress indicate that distress screening is slowly gaining traction in practices, and patients are benefiting. Cancer centers are now required by the Commission on Cancer to routinely screen for psychosocial distress. Incorporating distress screening and assessment is considered vital to providing comprehensive quality cancer care. A “rapid cycle improvement” project increased distress screening by 16% over 8 months at Baylor Scott & White McClinton Cancer Center in Waco, TX. The study was led by Poppy Patterson, BBA. Ms Patterson and her team identified 363 patients who came for an initial consult but were not all screened for distress. They identified several issues that contributed to this lack of screening: a developing cancer center with rapid volume growth, rotating providers, and multiple clinic subspecialties, along with a knowledge deficit among some team members.

Studies reported at the ONS Annual Congress indicate that distress screening is slowly gaining traction in practices, and patients are benefiting. They initiated a multidisciplinary screening pilot during which they identified and implemented various approaches to improvement. These strategies included staff training, development of a reusable screening tool, delivery of the tool by a delegated person, and charting and reporting within the electronic medical record with follow-up by the supportive care team. The pilot resulted in a 16% increase in patients screened, translating into an 84% current distress screening rate, Ms Patterson reported. “When patients are not initially assessed, the supportive oncology team identifies the next opportunity for assessment, leading to near 100% capture,” she noted. The evolving process increased communication among physicians, clinic nurses, nurse navigators, the financial navigator, social worker, dietitians, and schedulers and has ensured that patients receive “the ongoing care needed to support holistic cancer care.”

Screening of Breast and Gynecologic Cancer Survivors Cynae Johnson, MSN, CRNP, OCN, of Johns Hopkins University School of Nursing, Baltimore, MD, led a gap analysis to identify whether the needs of breast cancer survivors Cynae Johnson, (BCS) and gynecologic cancer surviMSN, CRNP, vors (GCS) were being met at her OCN institution. She and her team interviewed patients after completion of their primary cancer treatment to determine the degree to which their healthcare provider had assessed and managed their distress. Approximately one-third of BCS are believed to demonstrate some signs of “distress,” whereas the incidence among GCS has not been established, said Ms Johnson, who is a survivorship nurse practitioner. Especially for GCS, little is known about sources of distress, and any conclusions have been extrapolated from studies in BCS, which is felt to be a similar cancer experience for women. The National Comprehensive Cancer Network (NCCN) has recommended the NCCN Distress Thermometer as the instrument of choice for measuring cancer patients’ distress. The researchers assessed its use in this setting. Information from Focus Groups and Distress Thermometer

Ms Johnson and her team sampled 19 BCS and GCS in focus groups, who were 63% Caucasian, 26% black, and 11% of other ethnicities. The researchers were especially interested in the experience of underserved patients. They found that BCS were more likely to report having been assessed for distress and/or having issues addressed (66.7%) than GCS (30%), but their assessment was not done with the NCCN Distress Thermometer (which was not standard at the time) and lacked an emotional component (ie, was based on physical concerns). BCS were also more likely to have been referred to a supportive service (44.4%) than were GCS (20%). “The breast group had nurse navigation and a monthly support group, and those services did improve distress in that group,” she pointed out. Patients reported, in interviews, that nurse navigators (33%) and support group services (66%) had improved

ONCOLOGY NURSING SOCIETY

their distress, but 90% of GCS said they relied Table Distress Reported by Breast and Gynecologic Cancer on self-navigation for supportive resources. Survivors On the NCCN Distress Thermometer, they Breast Cancer Gynecologic Cancer found the scores (0-4 scale) similar between Type of Problem Survivors (%) Survivors (%) the groups: 3.33 for the BCS and 3.00 for the Spiritual 0 0 GCS. The groups differed somewhat, however, on the types of problems they reported (Table). Practical 33 60 “The gynecologic cancer survivors reported Family 55 40 higher practical and physical problems comEmotional 67 60 pared to the breast cancer survivors,” Ms JohnPhysical 78 90 son noted. More than 78% of both groups rated the NCCN Distress Thermometer as easy to use. The instrument captured most sources of distress except and linking patients to referral services as needed. g hospital administrative issues, she noted. Resources As a result of the study, her department now offers Patterson P, King M, Pederson J. Process of improvemore support groups and is expanding its navigation ment in distress screening. 2016 Oncology Nursing Sociwork by training the nurses to assume these roles. “We ety Annual Congress. Poster 11. have to figure this out with limited resources. We can’t Johnson C, George M, Angarita A, et al. Exploring hire all the nurse navigators we want, so we are looking distress in breast and gynecologic cancer survivors. 2016 at creative ways,” she said. Oncology Nursing Society Annual Congress. Poster 223. They are also implementing formal distress screening

Navigation Reports Can Be Incorporated into Epic

nurse navigator at Vidant Medical Center in Greenville, NC, spearheaded the integration of navigation data into the electronic health record that greatly streamlined navigation reporting. At the 2016 Oncology Nursing Society Annual Congress, Judy B. Koutlas, RN, MS, OCN, Coordinator of the Nurse Navigator Cancer Services at Vidant, a tertiary care center, described how she incorporated navigation data and documentation into Epic electronic health record (EHR) software and generated reports from this tool. The effort has produced greater efficiency and timelier reporting. “Prior to 2013, the data we were collecting from our navigation team lacked uniformity. Navigators within our healthcare system had different reporting structures, and regional navigators were not linked to our Vidant Medical Center team,” she said.

Within the Vidant Cancer Care Navigation Model are 6 disease-specific navigators, all oncology-certified nurses, who navigate patients across the continuum of care. At Vidant’s 6 regional hospitals, nurses and social workers may function as navigators. Judy B. Koutlas, Going Electronic RN, MS, OCN Before this project started, data collection was in paper form with a manual spreadsheet entry. This was time-consuming, cumbersome, and fraught with error, she said. In March 2014, one of the navigators developed a Google document on an iPad that allowed for real-time entry of data that could then be automatically tabulated and summarized. A setback occurred 1 year later when the center’s legal team saw the potential for privacy is-

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sues. The method was discontinued and the navigators returned, unhappily, to the paper format. But the team persevered in their effort to go digital, and a few months later their information system (IS) specialists had produced a navigator-specific encounter tool (document flow sheet) within the EHR. The navigators continued manual data collection as well, temporarily, to validate the accuracy of the new system. Today, all their data collection is done within, and reports are generated by, Epic.

The system has been considered a big success based on the data being more consistent and more accurate, and the reports being more timely. Demographic data are automatically extracted from the EHR by the IS team. This eliminates the time-consuming task of manually recording it. In addition to standard demographics, the patient identifiers include insurance status (a potential barrier to care). On the encounter-specific side, navigators enter chief complaint, diagnosis, location of visit, barriers/ needs, interventions/referrals, referral sources, home situation, and acuity scores. Navigators can add a narrative note if they wish. “It’s common that navigators are coordinating care, but that can mean a lot of different things for a disease-specific navigator. On the intervention form, with just a few clicks and in less than a minute, I can see where the navigator saw the patient, the home situation, and so forth,” Ms Koutlas said. They have recently updated the form to indicate the

amount of time spent with the patient in a particular encounter, and the complexity of that encounter.

Progress Report “There are still some barriers, and I am still working with IS,” she reported. “Building the form into the EHR was not difficult, but getting the reports out and have them accurately show all the data has been our biggest challenge.” Having the IS staff understand the “language” of navigation has been a bit of an issue, she added. The system has been considered a big success, however, based on the data being more consistent and more accurate, and the reports being more timely. The navigators have appreciated the improved efficiency and greater productivity, she said. Further refinements are in store. Ms Koutlas would like her system to have the ability to analyze specific data within the multidisciplinary teams across the whole healthcare system. Ideally, she could know, on a particular day, what each navigator at the various sites is dealing with. “We are not there yet,” she said. “But now I get reports by the 10th of the next month, which is much better than with manual collection, where we could be several months behind.” She sees opportunities for standardization of navigation data nationally among other Epic users, and research opportunities based on these data. “And we are all in tune with the fact that we need to show return on investment, to grow our programs and increase staff,” she added. This electronic system should be able to demonstrate outcome measures that will do that. Meanwhile, the navigators at Vidant Health, she said, “take pride in knowing that what they did is being captured. And by streamlining the data, they have more time to focus on their patients, which is what we are all about.” g

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Oncology Navigation Promotes Population Health

ncology nurse navigators can advance population health in a variety of ways and create value in the process, said Sharon Gentry, RN, MSN, CBCN, CBEC, a nurse navigator at Novant Health Derrick L. Davis Cancer Center. The drivers of population health are several. Pressure to increase revenue and decrease utilization is mounting, as is sustained pressure on operating and financial performance. In today’s market, payment mechanisms are emerging that focus on value, driving providers to take accountability for costs and quality. To survive, nurse navigators must look outside their own institutions. “We’ve got to look outside the walls,” Ms Gentry said, emphasizing building partnerships throughout the healthcare system. Population health is a mandate to promote health and prevent disease to create “an epidemic of health and wellness.” It is guided by the triple aim of improving population health and improving the individual patient’s experience while at the same time controlling the inflation of per capita costs. “Any time you interfere with 1 of these 3 sections, you can negatively or positively change another section,” she said. A campaign from the American Society of Clinical Oncology called Choosing Wisely can be used for guidance in the oncology setting, she said. Choosing Wisely provides metrics to improve population health. For example, one item on the Choosing Wisely list is to withhold PET, CT, and radionuclide bone scans in the staging of early breast cancer at low risk for metastasis because of a lack of evidence that such imaging increases survival. This recommendation accomplishes multiple aims (lowers cost and possibly improves individual patient experience). Early palliative care to control symptoms is another example. “If you get palliative care involved early, you decrease medical procedures,” said Ms Gentry. “You decrease psychological stress for the patient, but best yet, you decrease the caregiver burden.” Oncology has many roles in population health, including community assessment, setting benchmarks, and setting goals that are specific and measurable, actionoriented, and time-bound. “There’s need to navigate patients across the systems of care because they remain very disconnected,” she said.

“We know [patient navigation] requires coordination.” Population healthcare strategies depend on the patient population. Three distinct populations are the high-risk patients, rising-risk patients, and low-risk patients. High-risk patients are the 5% of paSharon Gentry, tients with complex diseases and comor- RN, MSN, CBCN, bidities who consume most of the healthCBEC care resources. These patients tend to have high-acuity tumors and may need help with coping. Patients with advanced disease also fall under this category. High-risk patients tend to require more one-on-one navigation. The key to managing the high-risk patient is to be proactive, said Ms Gentry.

In today’s market, payment mechanisms are emerging that focus on value, driving providers to take accountability for costs and quality. Rising-risk patients constitute 15% to 35% of the patient population. They tend to have a multitude of risk factors (ie, diabetes, obesity, heart disease) that need managing that, if left unaddressed, would propel them into the high-risk category. Again, being proactive to manage rising-risk patients can prevent hospitalizations and lower the acuity of their disease. This may mean calling in a diabetes educator when needed. Sixty percent to 80% will be low-risk patients in whom minor conditions are easily managed. It is in this group that your survivorship care plans become critical, said Ms Gentry. “You need to keep them healthy and make them healthier than they were before,” she said. Successful models in population health share 5 characteristics: • They are multidisciplinary, with each discipline having an opportunity to influence decisions about the patient’s care. Successful teams often include nurses and pharmacists with clinical and behavioral skills

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• They are data driven to identify avoidable cost opportunities across episodes of care. A gap analysis can pinpoint barriers to care delivery across the continuum and isolate them for targeted intervention • Successful models are resource efficient; employing diet, exercise, and smoking cessation counseling; preventive medications and vaccinations; among others • They are patient centered. Patient navigators know critical transition points to reduce the rate of emergency department visits and the rate of hospital admissions • They are longitudinal and therefore take advantage of clinical pathways and survivorship plans

Imperatives for Value An increase in the number of cancer survivors has translated into a growth in costs. These rising costs exacerbate concerns about value. Ms Gentry reviewed the 6 imperatives for driving value in cancer care. Ensure Adherence to Evidence-Based Guidelines

Patient navigation programs have had many successes in improving adherence to evidence-based guidelines. The weight of evidence from the Patient Navigation Research Program indicates that patient navigation can reduce the time from abnormal findings to diagnosis in breast, cervical, colorectal, and prostate cancers.

Patient navigation is designed to reduce health disparities by addressing specific barriers to obtaining timely, quality healthcare. In 2015, the new standard from the American College of Surgeons Commission on Cancer (CoC) established patient navigation programs in all CoC-accredited facilities. Navigation can increase clinical trial participation. When the University of Southern California Norris Comprehensive Cancer Center placed a navigator in the community, working with African American women, 86% of the women she engaged entered into a clinical trial; the other 14% did not qualify. By using navigators, Ms Gentry’s institution led the nation in enrollment in the phase 3 B40 clinical trial to examine the impact of neoadjuvant chemotherapy in

women who have undergone resection for relapsed breast cancer. “We also changed our process in 2013, and had a navigator sit down with a woman at diagnosis” to ensure that appropriate breast cancer patients are considered for neoadjuvant chemotherapy, she said. Gap analysis can identify bottlenecks in the healthcare continuum. A navigation team working with the Intermountain – Southwest Cancer Center identified a 7-day increase in the time for a medical oncology appointment. They developed a navigation pathway for newly diagnosed breast cancer patients, and the interval between the medical oncologist referral and treatment initiation was reduced by 10 days. “By the time the patient got to the medical oncologist, they had shaved off 24 minutes of that medical oncology visit,” she said. “This turned into more than $485,000 in 1 year.” Henrico Doctors’ Hospital used a gap analysis when it discovered that 240 women left their system in 1 year after receiving a breast cancer diagnosis. “They moved a nurse navigator to the front to be with the patient at the time of an abnormal finding,” Ms Gentry said. “ In 1 year, they took that number down to 28.” Reduce Unnecessary Emergency Department and Inpatient Admissions

Engaging patients in an oncology patient-centered medical home, which emphasizes coordination of care and avoidance of potential patient complications, can improve patient satisfaction while lowering costs. By empowering patients to report concerns before an emergency department or clinic visit is necessary, and using a nurse-based phone triage with symptom management algorithms, emergency department visits decreased by 50% despite an increase in patient volume. At Cleveland Clinic Lakewood, Medicare patients who received navigation services experienced a 30-day readmission rate that was 4% lower than that seen in patients who did not receive navigation services. Selfpay patients experienced similar results. Of the 1531 patients who worked with the patient navigator, only 3.16% were readmitted. With a salary of $35,000, and a combined savings of $156,000 in the first 6 months, the navigator paid for her salary in less than 2 months.

Focus on Services That Increase Quality

Patient navigation is designed to reduce health disparities by addressing specific barriers to obtaining timely, quality healthcare. With navigation, the continuity of care improves and patients report higher satisfaction. A one-time navigation for screening colonoscopy was estimated to be cost saving. The effects of patient navi-

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gation on mammography were to improve timely diagnostic resolution, decrease anxiety, and increase patient satisfaction among urban minority women with abnormal mammograms. In patients with head and neck cancers, navigators have been found to improve continuity of care while also leading to better body image and better emotional quality of life. Navigators have also been shown to decrease delays in chemotherapy and improve adherence to diagnostic services after an abnormality. Even in palliative care, navigators can address cancer rehabilitation needs. Enhance Patient-Provider Communication

Patient navigator programs help to facilitate direct contact between the navigator and the patientâ&#x20AC;&#x2122;s medical team, as well as full disclosure of relevant training, experience, credentials, and potential conflicts of interest to patients they serve. Hospitals in the Denver Health system employ navigators to help low-income Latinos access medical care. These navigators accompany patients on physician visits, remind them about upcoming appointments, and help patients explore options to pay for costly procedures. The no-show rate for screening colonoscopy declined from 57% to 17% after the health system hired navigators.

Engage Patients and Families in End-of-Life Planning

Many oncologists delay discussions with cancer patients about advance directives until chemotherapy options are exhausted. Navigators can help patients make

informed decisions concerning the use of hospice care for advanced illness and eliminate the use of ineffective chemotherapy in advanced stages of disease. An increase in hospice use by Latinos in eastern and central Massachusetts was the result of expanding outreach to the Latino community through navigator-led programs.

Navigators have also been shown to decrease delays in chemotherapy and improve adherence to diagnostic services after an abnormality. Advance Cost Goals

In a cost-benefit analysis conducted at Intermountain â&#x20AC;&#x201C; Southwest Cancer Center in Utah, medical oncologists experienced a 24-minute reduction in clinical visit time with a newly diagnosed breast cancer patient when the patient had received an educational visit with a nurse navigator, at a cost savings of $277,953 annually to the system. The educational intervention allowed the medical oncologist to see an additional clinic patient each day. The additional revenue of $207,360 plus the decrease in time had the potential to bring in $485,312 to the system annually. In 2011, Novant Health Derrick L. Davis Cancer Center published a report showing that the annual revenue captured from breast nurse navigation decreasing outmigration was $436,000. g