JONS December 2014 Vol 5 No 6

December 2014 • Vol 5, NO 6

Ringing in the New Year Lillie D. Shockney, RN, BS, MAS

The Effect of Navigator Intervention on the Continuity of Care Cheryl Bellomo, RN, BSN, OCN, CN-BN

Relationship-Based Care: Creating a Patient Navigation Program Krista Moore, RN, BSN, MS; Amy Rettig, MSN, MALM, RN, ACNS-BC, PMHNP-BC, CBCN

Providing Therapeutic Guidance for Breast Cancer Patients in the Molecular Era With the Breast Cancer Index Assay SM

An Interview With Stephen C. Malamud, MD, and Susan K. Boolbol, MD

Navigating Patients Across the Continuum of Cancer Caretm

© 2014 Green Hill Healthcare Communications, LLC

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© 2014 Genentech USA, Inc. All rights reserved. BIO0002445101 Printed in USA.

LETTERS FROM LILLIE

Editor-in-Chief

Lillie D. Shockney, RN, BS, MAS

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

TRIM:10.5"

Cancer Rehabilitation & Survivorship Julie K. Silver, MD

BLEED:11.5"

Happy New Year! As 2014 comes to a close and we march into 2015, it is only fitting to hope that you and your family have a happy and healthy new year.

This issue of the Journal of Oncology Navigation & Survivorship (JONS) provides new insights into several important and key issues that many of you and your managers have brought up: the infamous goal of how you can demonstrate through evidence-based research that navigation has a positive impact on cancer care. Well, this issue provides some answers to that chronically asked question.

You will read about a literature review that was conducted, abstracting from a series of published work the positive impact that navigating cancer patients has demonstrated on the continuity of care and satisfaction of patients during their experiences with cancer. There also is an interesting article that provides information about navigation through relationship-based care and a professional practice model. This might be something you want to explore more for you and your institution.

Also, we know the value of continuous learning and knowledge sharing among peers. Read about how one clinic developed a process to ensure that its nursing team was provided ongoing learning opportunities as well as the chance to share knowledge between its seasoned staff and newly hired nurses.

Finally, you will read the synopsis of interviews with oncology specialists that addresses the new and upcoming era of molecular medicine. We may finally be moving toward this type of biology to match treatments with specific genomes and prognostic factors of a tumor with the hope that we can move away from the traditional poison, slash-and-burn methods of treatment we have needed to utilize for centuries. Fifty years from now scientists will read about the treatments that were provided to cancer patients in 2014 and shake their head that we had to rely on some “primitive” methods. (I also hope that cancer will be listed by then where polio is now in medical books: in the chapter entitled “Cured Diseases.”)

I am confident you will agree with me that this issue provides great content that you can share with others at your workplace and consider applying some of these concepts and ideas yourselves.

SAFETY:10"

Ringing in the New Year

Section Editors

With kind regards,

Breast Cancer Sharon S. Gentry, RN, MSN, AOCN, CBCN

Breast Health Navigator Novant Health Derrick L. Davis Cancer Center

Assistant Professor Harvard Medical School

Genetic Counseling

Cristi Radford, MS, CGC Gene Mavens, LLC

Healthcare Disparities Linda Fleisher, PhD, MPH

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

Health Promotion and Outreach Iyaad Majed Hasan, DNP, CNP

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

Patient-Centered Care Mandi Pratt-Chapman, MA Director GW Cancer Institute

Marcy Poletti, RN, MSN

Nursing Operations Supervisor Wake Forest University Baptist Medical Center

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

Prostate Cancer Frank dela Rama, RN, MS, AOCNS

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

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

Quality, Outcomes, and Performance Improvement Committee Co-Chairs

Elaine Sein, RN, BSN, OCN, CBCN Danelle Johnston, RN, MSN, OCN, CBCN

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

Mission Statement

The Journal of Oncology Navi­ gation & Survivorship (JONS) promotes reliance on evidence-based prac­ tices in navigating patients with cancer and their caregivers through diagnosis, treatment, and survivorship. JONS also seeks to strengthen the role of nurse and patient navigators in cancer care by serving as a platform for these professionals to disseminate original research findings, exchange best practices, and find support for their growing community.

JONS-online.com journal of Oncology Navigation & Survivorship

3

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com Senior Vice President, Sales & Marketing Philip Pawelko ppawelko@the-lynx-group.com Vice President/Director of Sales & Marketing Joe Chanley jchanley@the-lynx-group.com Group Director, Sales & Marketing John W. Hennessy jhennessy2@the-lynx-group.com Vice President/Group Publisher Russell Hennessy rhennessy@the-lynx-group.com Publisher Cristopher Pires cpires@the-lynx-group.com Director, Client Services Dave Dempsey ddempsey@the-lynx-group.com Editorial Director Anne M. Cooper, MA acooper@the-lynx-group.com Copyeditor Rosemary Hansen Senior Production Manager Lynn Hamilton

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Table of ConTents

December 2014 • Vol 5, NO 6

LETTERS FROM LILLIE

3 Ringing in the New Year

Lillie D. Shockney, RN, BS, MAS

QUALITY, OUTCOMES, AND PERFORMANCE IMPROVEMENT (QOPI) COMMITTEE

6

Barbara McHale, RN, BS, OCN, CBCN

BEST PRACTICES

10

Sunrise, Sunset: Swiftly Go the Years

Peggy Barton, RN, BSBA; Sue Mahoney-Stombaugh, CNP; and Bahu Shaikh, MD, FACP LITERATURE REVIEW

14 The Effect of Navigator Intervention on the Continuity of Care and Patient Satisfaction of Patients With Cancer

Cheryl Bellomo, RN, BSN, OCN, CN-BN

DEVELOPMENT OF A NAVIGATION MODEL

23 Relationship-Based Care: Creating a Patient Navigation Program Through a Professional Practice Model Krista Moore, RN, BSN, MS; Amy Rettig, MSN, MALM, RN, ACNS-BC, PMHNP-BC, CBCN INTERVIEW WITH THE INNOVATORS

31 Providing Therapeutic Guidance for Breast Cancer Patients in the Molecular Era With the Breast Cancer Index Assay SM

An Interview With Stephen C. Malamud, MD, and Susan K. Boolbol, MD

QUALITY CARE

40

What Constitutes Good Oncology Care?

Sheryl Riley, RN, OCN, CMCN

Senior Project Managers Alyson Bruni Jini Gopalaswamy Project Manager Deanna Martinez Project Coordinator Mike Kodada IT Manager Kashif Javaid Administrative Services Team Leader Rachael Baranoski Office Coordinator Robert Sorensen Green Hill Healthcare Communications, LLC 1249 South River Road - Ste 202A • Cranbury, NJ 08512 phone: 732-656-7935 • fax: 732-656-7938

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december 2014 • Volume 5, number 6

Journal of Oncology Navigation & Survivorship, ISSN 2166-0999 (print); ISSN 2166-0980 (online), is published 6 times a year by Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Telephone: 732.656.7935. Fax: 732.656.7938. Copy­right © 2014 by Green Hill Health­care Com­muni­cations, LLC. All rights reserved. Journal of Oncology Navigation & Survivorship logo is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America.

EDITORIAL CORRESPONDENCE should be ad­­dressed to EDITORIAL DEPARTMENT, Journal of Oncology Navigation & Survivorship (JONS), 1249 South River Road, Suite 202A, Cranbury, NJ 08512. E-mail: fevans@the-lynx-group.com. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $50.00; institutions, $90.00; single issues, $5.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPART­MENT, Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. The ideas and opinions expressed in JONS do not necessarily reflect those of the editorial board, the editorial director, or the publisher.

Publication of an advertisement or other product mentioned in JONS should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the editorial board nor the publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications. It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician. Please convey any errors to the editorial director.

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Quality, Outcomes, and Performance Improvement (QOPI) Committee

Barbara McHale, RN, BS, OCN, CBCN Nurse Navigator, Samaritan Hospital Cancer Treatment Center, St. Peter’s Health Partners, Troy, NY

M

y initial encounter with patients with cancer began at the end of my first year of nursing school. I was assigned to a medical–surgical floor, and was given a patient who had been newly diagnosed with advanced colorectal cancer. It was 1975, and our community-based hospital was in the process of creating an oncology service line with the help of a new group of medical oncologists.

The patient was brought to a private room, and the staff did not know how to handle her. There was no direction on giving patients such as her the care that they needed and deserved. At that instant, I knew my heart and soul would be given toward caring for these patients. I asked to be assigned to all patients who had a diagnosis of cancer.

After graduating from nursing school with a registered nurse degree, I was fortunate to be offered a part-time job at a 31-bed inpatient medical–surgical oncology floor. I supplemented my income by working part time in a private agency caring for oncology patients at home, with the goal of working full time on an oncology floor. I became involved with the American Cancer Society (ACS) of Rensselaer County, NY, and volunteered at breast cancer screenings and clinics. At that time, realizing the potential to increase my knowledge in the field, I ran in the Rensselaer County ACS Miss Hope Pageant and won the title—it was in 1978, and I was 22 years old.

A key feature of the New York State ACS Pageant was that the winner had the opportunity to complete a 6-week internship at Roswell Park Cancer Institute in Buffalo, NY. I continued to the state level of the pageant, where I was asked to give a presentation on my experiences with oncology nursing and my desire for further professional development. Once this was completed, the next step was an interview conducted by medical directors from various centers and nursing professors from across the state. I remember I was so scared; I did not know if I could get through the presentation, let alone be interviewed by a panel.

Once I started talking about my passion for oncology nursing and the impact I had on patients, I relaxed. True to my nature, once I started talking, I could not stop. I won the New York State ACS Miss Hope Pageant and continued working as a volunteer representative of ACS at the state level, volunteering at their breast screening clinics

6

December 2014 • Volume 5, number 6

and assisting at community education presentations.

I continued to work in oncology inpatient and outpatient clinics, and enrolled in a bachelor of science program full time while working 80% of the time. My focus of study was premedicine, but I found the competitiveness of the program disheartening. I completed my degree, but decided to continue as an oncology nurse; my patients needed me, and I, in turn, needed them.

I married in 1983 and started to raise a family. I began to feel complete and wanted to progress in my oncology nursing career. Then, in one of life’s unexpected turns, my husband died in an accident, and I became a widow at 34 years old. I would never wish for anyone to lose a spouse, but the experience has led me to a bond with others who have had the same experience. I took every opportunity to grieve while caring for my young daughters, aged 3 and 4 years old, as well as myself.

The patient was brought to a private room, and the staff did not know how to handle her. There was no direction on giving patients such as her the care that they needed and deserved.

After remarrying in 1992, I moved to Old Forge, NY, and began offering free consulting for patients with cancer.

The nearest hospital was 70 minutes away from this community, and hospice was 80 minutes away. My desire to help patients with cancer spurred me to help the community develop a hospice volunteer program, and I started working for the hospice program per diem. There was also a need for a per diem registered nurse for Meals on Wheels.

In addition, Herkimer County approached me about working part time for public health in the Old Forge area and its surrounding communities.

In 2004, I moved with my family back to Saratoga County, NY, worked at Saratoga Hospital in an inpatient oncology unit, and renewed my oncology nursing certification. I learned of an opportunity to manage a women’s health center and to do breast cancer navigation at Samaritan

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Quality, Outcomes, and Performance Improvement (QOPI) Committee

Hospital in Troy, NY. Intrigued with the idea, I interviewed for this position and met Sabrina Mosseau, RN, BS, OCN, who had developed the role and would be my manager.

Although I wanted the position, my father was diagnosed at that time with metastatic renal cancer. Despite his illness, he encouraged me to continue with the interview process and accept the job if it was offered to me, knowing that in this position, I could help patients navigate through the fragmented healthcare system. My father died 2 weeks before my final interview, but I listened to his advice, and when I was offered the job, I accepted. I was later offered a full-time navigator position in the Cancer Treatment Center at Samaritan Hospital in 2009.

As I have settled into this position, I have realized that all of the experiences and “smaller” jobs along my journey have helped me to come full circle; these different roles and life events have helped to make me a well-rounded navigator. I am currently the only navigator at the cancer treatment center, and am grant-funded through philanthropists who believe in this role. I meet with patients with breast, colorectal, lung, and head and neck cancers, and at times I am asked to assist with patients with other cancer diagnoses at varying stages. I work with the entire cancer team to coordinate the care these patients need; coordinated care translates into better outcomes.

In my navigator position, I use data, metrics, and evidence-based standards of care to show a return on investment and promote my role. I strive for evidence-based standards of care and ways to measure the outcomes I have achieved. Because of this desire for quality outcomes and processes of improvement, I joined the Quality, Outcomes, and Performance Improvement (QOPI) Committee of the Academy of Oncology Nurse Navigators (AONN) in March 2013. Through the mentoring and friendship of fellow navigators, such as Danelle Johnston, RN, MSN, OCN, CBCN, and Elaine Sein, RN, BSN, OCN, CBCN, I have been able to learn how to appropriately conduct research, publish abstracts, and network with many wonderful navigators.

After attending the AONN conference in 2011, I saw

there was a need for process improvements for patients with head and neck cancer. At the AONN 2012 conference the following year, I presented an abstract and poster, “The Role of Navigation and Patient Education in the Treatment of Patients with Complex Cancers: Our Experience with Head and Neck Cancer Patients,” based on the great process we have at our center. We received the first place award in the patient education category, an honor that further emphasized the need to share our research, data, and metrics.

Oncology is one of the most difficult and heart-wrenching nursing fields, but I receive so much in return from my patients and families.

The high point of my career was the opportunity to pre­ sent again the following year at the 2013 AONN conference in Memphis, TN, this time on the advanced navigation track. I was proud of the research I conducted on a rehabilitation program that was developed at the Samaritan Hospital Cancer Treatment Center and I knew other navigators could benefit from it.

Conclusion

In the years since 1975 when I encountered my first patient with cancer, my focus and love of nursing in oncology has never wavered. People ask me all the time, “Don’t you find it depressing?” Oncology is one of the most difficult and heart-wrenching nursing fields, but I receive so much in return from my patients and families.

I have always felt that if I could help direct and make their cancer journey easier in any way, then I could make a difference in their lives.

As the dawn of a new year is upon us, I am grateful for the opportunities I have had, the patients who I serve, and the wonderful colleagues I have worked and connected with. I continue to look forward to what the future holds. g

ABOUT THE COVER

Leap of Faith Mixed Media by a Person Diagnosed with Cancer Artwork from the Lilly Oncology On Canvas: Expressions of a Cancer Journey Art Competition www.LillyOncologyOnCanvas.com Those of us battling cancer are constantly seeking the cure—the right drug, treatment and path to take. Often the battle is long and painful. Drugs stop working, veins and organs weaken, and cracks appear in our resolve. But we make a leap of faith back into hopefulness and take pleasure in clear skies, blue waters and even golden rays of optimism. This painting, “Leap of Faith,” expresses both the hardness and the hopefulness of my cancer journey.

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December 2014 • Volume 5, number 6

AONNonline.org

3RD ANNUAL

s JO erie View NS s o t -o nli he nli ne ne a .co t m

A 5-part series The publishers of The Oncology Nurse-APN/PA, The Oncology Pharmacist, and Personalized Medicine in Oncology are proud to present our 3rd annual Conquering the Cancer Care Continuum series.

FIRST ISSUE IN A 5-PART SERIES THIRD ANNUAL

Conquering the Cancer Care Continuum Conquering Cancer Carthe i e Cont in SECoN

Good Manufacturing Practice Lillie D. Shockney, RN, BS, MAS

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

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

T SERIES IN A 5-PAR THIRD ISSUE NU AL TH IRD AN

uum g the n i r e u q n Co anceri Care CC o n t i n u uCmonquering th Cancer Care e ™

• Access to Quality Care • Advances in Side Effect Management • Impact of the Affordable Care Act in Cancer Care • Pediatric Patient Care

TO VIEW THE SERIES ONLINE PLEASE LOG ON TO:

www.JONS-online.com

FoURTH ISS UE IN A 5-P ART SERIE S TH IR D AN NU AL

Contin

Conquering t u u m Cancei r Carehe Co IN A 5-PA RT SERIES TH IR D A NNUAL Impact of the Affordab le Care Ac t in Cancer

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CCC JONS Next Issue A-SIZE_71114

Best Practices

Sunrise, Sunset: Swiftly Go the Years

Peggy Barton, RN, BSBA; Sue Mahoney-Stombaugh, CNP; and Bahu Shaikh, MD, FACP; Toledo Clinic, OH

M

any experienced oncology nurses who are retiring or approaching retirement possess knowledge about oncology patient care that comes from years of experience. They have seen a transition from general oncology to specialties in bone marrow transplant, genetics, hematology, medical oncology, palliative care and hospice, radiation oncology, as well as site-specific and surgical oncology. What used to be a limited number of treatment resources has exploded to multiple new methodologies, many of which are based on specific tumor markers. How does a practice ensure that the knowledge, skills, and abilities of its senior nursing staff are transferred to newer nurses joining the practice?

Background

The Toledo Clinic is a multispecialty physician organization, of which oncology is one of its specialties. The practice was established in the 1960s, when the first medical oncologist was recruited to Toledo, and grew with the addition of new partners who specialized in both medical oncology and hematology. Today, the practice has 6 locations in Ohio and Michigan, with 8 physicians, 9 nurse practitioners, and approximately 79 employees—including 17 registered nurses—staffing the offices.

Its founding members have retired, but the group continues to expand. Today, several senior partners in the clinic are approaching retirement, some are in the middle of their careers, and new partners have joined. The practice recognizes a need to provide the new partners with a mentoring process that provides historical perspective and practical knowledge. The mentor can help in the transition from student to practicing physician.

As more experienced nurses and nurse practitioners prepared for retirement, the need for role development was identified. With an explosion of new advances in diagnosis and treatment, newer nurses need a longer learning curve.

We asked ourselves these questions: How does a practice ensure that its new nurses understand and appreciate the history of the practice, and how are ongoing learning opportunities provided for the nursing staff, especially in an era where there are competing priorities for nurses’ time?

Orientation

The process of educating new nursing staff has evolved over time. Today, the orientation program has been revised and extended to a minimum of 6 months, and includes mentorship and continuing education (CE) programs.

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December 2014 • Volume 5, number 6

Time is spent providing an orientation to the Toledo Clinic, as well as to overall practice operations. New registered nurses take a biotherapy/chemotherapy course online offered through the Oncology Nursing Society (ONS; www.

ONS.org/online-courses). Because the practice is also very involved in clinical research, newly hired nurses complete a human protection course through the National Institutes of Health Office of Extramural Research (https://phrp. nihtraining.com).

During the first few months, orientation is designed around the practice’s policies and procedures, electronic medical record system, chemotherapy order writing process, and documentation of patient assessment and treatment. Time is also spent with the practice administrator learning about the history of the practice. As with new physicians, understanding the practice’s goals, mission, and contributions to the community is important.

Implementation of the new nurse training program has changed the schedule on the practice’s end. Formalized CE and pharmaceutical programs have been integrated into quarterly nursing meetings. In the past year, an event approved for nurses to earn CE units (CEUs) was also added.

Mentorship

New nurses are assigned a mentor who is responsible for initiating an orientation checklist (Table) that includes activities from the office observation period to the responsibilities related to chemotherapy administration and patient care in the infusion room. When the mentor completes the checklist, the nurse can begin taking patients independently, but the mentor and other experienced nurses remain available to answer questions.

As nurses transition from orientation, they can continue their relationship with the mentor, or, if necessary, another nurse in the office. Experienced nurses are paid a differential because of the importance of their role in the orientation of the newer staff. Mentors are active participants in the initial orientation, and they complete the orientation checklist as well as a 90-day evaluation. Emphasis is also placed on chemotherapy safety, with mentors providing an assessment of skills and direct observation of performance in the mixing room.

Continuing Education Program

The practice has nursing personnel from all of its locations, including nursing staff and licensed nursing practitioners, attend quarterly meetings. Clinical topics are pro-

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Best Practices

Table Sample Nurse Orientation Checklist Front-desk operations

Yes

No

N/A

Yes

No

N/A

Schedule chemotherapy appointments utilizing appropriate cycle process Comments: Ensure appropriate laboratory tests/x-rays are ordered before upcoming visits, as required by treatment plan/protocol Comments: Chemotherapy orders Review order and demonstrate understanding of dosing and administration requirements; clarify with physician as necessary Comments: Complete dose calculations properly within 24 hours of receipt of order Comments: N/A indicates not applicable.

vided by one of the physicians, nurse practitioners, or nurses who brings back information from the national ONS meeting. However, none of these meetings have provided approved CEUs, which was an identified need. The agenda also includes updates on new drugs, legislative and reimbursement changes, as well as topics of interest, including practice updates, inventory management, safety topics, electronic medical record and documentation requirements, new drugs and updates from pharmaceutical representatives, as well as updates on quality initiatives, including depression screening.

To become a provider of approved nursing CEUs in Ohio, the Ohio Nurses Association (ONA) requires the following: • A clearly defined unit or department responsible for nursing CE • A nurse planner who meets the ONA’s specific qualifications • The organization to be functioning for at least 6 months, using accreditation criteria and the Ohio Board of Nursing’s rules, during which time at least 3 separate activities of at least 60 minutes in length must have been planned, approved by the ONA, implemented, and evaluated • The practice to submit a form and the required fees showing intent to apply as an accredited CE provider.

One of our nurse practitioners accepted responsibility for the role of nurse planner, and the practice has now received a preliminary CEU provider designation. Our first planned activity was a review of oncology drugs of the past, present, and future, which was presented by an oncology pharmacist. The objectives of the review were to state the mechanism, administration, and clinical pearls related to

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December 2014 • Volume 5, number 6

older, traditional chemotherapeutic agents, and to list a variety of targeted anticancer agents and explain their administration and common adverse effects.

The nurses who attended this session and completed an evaluation received 1.0 contact hour of CEUs. The first program was well-received by the staff, and evaluations will be used to develop future presentations. Assessment of the evaluations showed that nurses appreciated the pharmacist’s knowledge of chemotherapy and presentation of the information in a manner that enhanced their understanding of oncology drugs. Several individuals requested that the pharmacist attend the quarterly in-service meetings to review treatment regimens on an ongoing basis.

Based on the evaluations, programs are being developed on chronic lymphocytic leukemia, neuroendocrine tumors, genetic tests, and palliative care. A physician will provide clinical information on the topic and a nurse practitioner will provide nursing care–specific information.

Discussion

Developing an in-house nursing CEU program is beneficial to the practice. It demonstrates the practice’s commitment to CE and to staff development. For individual nurses, the program provides necessary information that is not readily available to them, and is an effective way for the practice to ensure nursing personnel have the information needed to care for patients. Other benefits include meeting the needs of busy nursing personnel, saving staff time, and minimizing travel time and expense.

In-house education programs should be customized to fit the needs of the nursing staff and the practice, which will keep doctors and nurses in tune with each other. The programs should provide the staff with updated information as changes occur and should provide a forum for responding to problems, issues, regulations, and new trends in a timely manner. These programs can offer an opportunity for knowledge transfer from experienced nurses to newer nurses, and can provide potential recruits with a reason to join the practice.

Conclusions

Using the above approach, our practice has developed a program to prepare for the sunset of retiring nurses and the sunrise of new nurses who will care for patients over the next decades. Orientation and mentorship programs allow newly hired nurses to learn about our clinic, including an overall understanding of processes, administrative procedures, the clinic’s role in the community, and expectations for the clinical care of patients. Educational programs and approved CE programs allow nurses to earn CEUs while maintaining clinical competency and helping to meet the practice’s clinical standards. g

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Literature Review

The Effect of Navigator Intervention on the Continuity of Care and Patient Satisfaction of Patients With Cancer Cheryl Bellomo, RN, BSN, OCN, CN-BN Huntsman-Intermountain Cancer Center, Cedar City, UT Nurses serving in the role of navigator can be instrumental in addressing the barriers of timely access to care, implementing interventions to reduce disparities, and improving overall patient satisfaction with cancer treatment. Using 10 primary studies published between 2008 and 2014, this literature review examines the effect of navigator intervention on the continuity of care and on patient satisfaction for those with cancer. The evidence provided by the quantitative and qualitative research studies utilizing a variety of tools supports the positive effect of navigator intervention on continuity of care and the satisfaction of patients during their cancer experience.

W

hen presented with a diagnosis of cancer, patients begin an overwhelming journey filled with fear, uncertainty, and anxiety. They experience varying levels of distress about their disease, treatment, and prognosis, which affects their daily lives and ability to comply with treatment regimens.1 In addition, patients face challenges of a fragmented healthcare system manifested by multiple appointments and difficulties inherent to timely access to care.

Advancements in cancer research and development have contributed to the complexity of cancer care and increased the interval of time from diagnosis to treatment.2 Patients with cancer face a knowledge/education gap in a healthcare system with unfamiliar medical language; they, with their families, also often face barriers to optimal cancer care, including a lack of emotional support and lack of resources (eg, transportation, health insurance, employment/legal issues, and prescription assistance). These challenges can lead to disruption in the continuity of patient care and a decrease in patient satisfaction.

The coordination of care and services, the provision of emotional and psychosocial support, and the provision of education and resources are significant components to the continuity of care and satisfaction with care for patients with cancer.3 The purpose of this literature review is to examine the effect of navigator intervention on the continuity of care (ie, timely access to care and resolution of barriers to care) and satisfaction of patients with their experience throughout their disease trajectory.

were also reviewed for inclusion. Key words searched in the databases used various combinations of “navigation roles,” “cancer,” “continuity of care,” and “patient satisfaction.”

To capture the most recent data, only articles published from 2008 to 2014 were included in the search.

Inclusion criteria for the literature review included the following: (1) peer-reviewed publications in English, (2) available in full text, (3) research article, (4) use of a navigator was clearly defined, and (5) reports of continuity of care and patient satisfaction outcomes. In all the studies, the navigator was considered the independent variable.

The effects and outcomes of the navigator varied from study to study. Overall, 10 studies met the inclusion criteria for this review.

A matrix was created and utilized to analyze the studies.

Authors, patient population, setting, type of study, purpose, credentials of the navigator, data collection method, tools used to collect data, outcomes or findings of the study, study limitations, and implications for nursing were included in the matrix. Both quantitative and qualitative research methods as well as various study designs (eg, experimental and nonexperimental) to examine the effect of navigator intervention on the continuity of care (ie, timely access to care and resolution of barriers) and patient satisfaction were included. The terms “patient navigator” and “nurse navigator” are used interchangeably, unless referring to a nonmedical lay navigator. The original matrix has been abbreviated to create a table that is suitable for publication (Table).

Methods

Results

The databases used to obtain research articles for this review included the Cumulative Index to Nursing and Allied Health Literature, PubMed, and manual searches.

Research reports, reference lists, and related article links

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December 2014 • Volume 5, number 6

Effect of Navigator Intervention on the Continuity of Care With regard to the continuity of cancer care, the researchers examined the effect of navigator intervention on

AONNonline.org

Literature Review

Table Studies Included in the Literature Review Study

Research type

Campbell C, et al.

Implementing and measuring the impact of patient navigation at a comprehensive community cancer center. Oncol Nurs Forum.

2010;37(1):61-68

Quantitative, experimental design

Fillion L, et al.

Professional navigation framework: elaboration and validation in a Canadian context.

Oncol Nurs Forum.

2012;39(1):E58-E69

Qualitative, descriptive design

Study population size

Outcome measures

Results

Conclusions

48 Patients with cancer and 26 employees in a community cancer center in the southeastern United States

Measured the variable of patient navigation on 5 areas/barriers significant to cancer care (ie, access, resources, education, financial assistance, and satisfaction) using Likert scale surveys

Statistical differences in the nonnavigated and navigated patient groups with regard to the 5 areas

Patient navigation is effective in improving patient satisfaction and decreasing barriers to care as reported by patient and staff surveys

59 Navigators, 18 patients with cancer, family members, medical oncologists, oncology staff, and administrators participated in focus groups and interviews; 13 clinical experts, managers, and researchers participated in formal consultations across Canada

Utilized the navigator role in facilitating continuity of care and promoting patient and family empowerment for oncology patients in focus groups and interviews

The 2-dimensional approach supported the role of professional navigators in facilitating continuity of care and promoting patient and family empowerment for oncology patients

Validates the role of navigator in facilitating continuity of care and in promoting patient and family empowerment for patients with cancer

Hook A, et al. Breast Quantitative, descriptive cancer navigation design and patient satisfaction: exploring a community-based patient navigation model in a rural setting. Oncol Nurs Forum.

2012;39(4):379-385

103 Patients with breast cancer using nurse navigation services at a community-based organization in southeast Georgia

Measured the variable of nurse navigation on overall breast cancer patient satisfaction in the areas of access, educational needs, emotional needs, services, and cancer experience using Likert-type scale surveys

Results of the Likert-type survey questions indicated that 73 of the participants strongly agreed about the benefits of nurse navigation

Patients of the community-based facility were highly satisfied with nurse navigation services during their cancer journey

Koh C, et al.

Evaluation of a patient navigation program. Clin J Oncol Nurs.

2011;15(1):41-48

Quantitative, descriptive design

55 Women with newly diagnosed breast cancer receiving oncology nurse navigator services were enrolled and an additional 55 women (who received care prior to the nurse navigator service) were matched as a control for this study at a breast center in Colorado

Measured the effectiveness of the oncology nurse navigator in terms of timeliness of access to care, identifying and resolving barriers to care, and patient satisfaction by chart review, patientâ&#x20AC;&#x201C;navigator log data, and a satisfaction questionnaire

Noted reduction in the time interval from biopsy to initiation of treatment, resolution of barriers prior to treatment, and high patient satisfaction results with nurse navigation services

Findings will be helpful to guide this program and other developing programs with regard to improving timely access to care, resolving barriers, and improving patient satisfaction

Korber SF, et al.

A breast navigator program: barriers, enhancers, and nursing interventions. Oncol Nurs Forum.

2011;38(1):44-50

Qualitative, phenomenology design

14 Women (1 group completed treatment and 1 group did not complete treatment) enrolled in the breast navigator programs in 2 hospitals in the northeastern United States

Utilized focus group and telephone interview methods to identify barriers and enhancers to breast cancer treatment from the patientâ&#x20AC;&#x2122;s perspective and the effectiveness of the interventions provided by the nurse navigator

Participants reported that the nurse navigatorâ&#x20AC;&#x2122;s interventions with symptom management, access to financial and community resources, and collaborative teamwork were influential in the completion of their treatment and continuity of care

Key roles of a nurse navigator in providing education and information to patients are valued by the participants of the study

Continued on page 16

JONS-online.com journal of Oncology Navigation & Survivorship

15

Literature Review

Table Studies Included in the Literature Review...Continued from page 15 Study

Research type

Lee T, et al. Effects of nurse navigators on health outcomes of cancer patients.

Cancer Nurs.

2011;34(5):376-384

Quantitative, experimental design

Study population size

Outcome measures

Results

Conclusions

78 Patients with newly diagnosed cancer (gastric, liver, gallbladder, and thyroid) in 2 hospitals in Korea; 53 patients in the experimental group using a nurse navigation program and 25 patients in the control group

3 Outcomes (ie, quality of life, satisfaction with care, and length of hospital stay) were measured for the 2 groups utilizing standardized, structured questionnaires

Better quality of life with higher social and physical functioning, lower financial burden, and better symptom management with nurse navigation; participants were more satisfied with their care and had shorter lengths of hospital stay with nurse navigation

Positive impact of a nurse navigator involved in the coordination of care on health outcomes of patients with cancer

Qualitative, Pieters HC, et al. descriptive Older women’s design reflections on accessing care across their breast cancer trajectory: navigating beyond the triple barriers. Oncol Nurs Forum.

2011;38(2):175-184

18 Women (aged ≥70 years) who had recently completed breast cancer treatment and were from the Los Angeles and southern California areas and 2 neighboring states

To describe, using semistructured interviews, the experience of older women with breast cancer along the trajectory of their care with regard to access to care, barriers to care (eg, knowledge deficits, comorbidities, and multiple appointments), and the services of an oncology nurse navigator

All participants verbalized that they had ≥1 of the triple barriers of knowledge deficit, comorbidities, and multiple appointments; women who had access to the services of an oncology nurse navigator benefited from the coordinated care, information/education, and emotional support

Demonstrated the value of the nurse navigator for older breast cancer survivors; a reminder that healthcare professionals recognize patients as a whole person and not just the disease process itself in regard to the planning of their cancer care

Quantitative, Skrutkowski M, et al. Impact of a pivot experimental nurse in oncology on design patients with lung or breast cancer: symptom distress, fatigue, quality of life, and use of healthcare resources.

Oncol Nurs Forum.

2008;35(6):948-954

113 Patients with lung cancer and 77 patients with breast cancer received treatment at 3 outpatient oncology facilities in Quebec, Canada; experimental group 2 received service of a PNO, as well as usual care by oncology nurses, and control group received usual care from oncology clinic nurses only

To describe the impact on the continuity of care delivered by a PNO with regard to symptom management, fatigue, QOL, and use of resources by patients with lung and breast cancer utilizing the measurement instruments of the Symptom Distress Scale, FACT-G, and the Brief Fatigue Inventory

No statistically significant difference was found between the 2 groups with regard to symptom distress, fatigue, QOL, and healthcare usage; significant differences were found between the cancer types: patients with lung cancer in both the experimental and control groups exhibiting more distress, more fatigue, lower quality of life, and longer hospitalization than patients with breast cancer

There were no significant differences in the continuity of care between the 2 groups because both groups were receiving care from oncology clinic nurses who were experienced in the assessment and management of complications

Quantitative, Swanson J, Koch L. correlational The role of the design oncology nurse navigator in distress management of adult inpatients with cancer: a retrospective study.

Oncol Nurs Forum.

2010;37(1):69-76

55 Patients with a primary or secondary cancer diagnosis (all types of cancer included) admitted to Saint Elizabeth Regional Medical Center in Nebraska over a 5-month period

The retrospective chart review of the NCCN Distress Thermometer was designed to evaluate the ONN role as an intervention in decreasing the distress levels of adult inpatients with cancer by providing resources and education for the continuity of care upon discharge

Overall, no significant difference in distress levels between the patients who had visits by the ONN and patients who did not receive ONN visits; decrease in the distress scores (initial and prior to discharge) for patients seen by the ONN with a significant decrease for rural patients and patients aged ≤65 years

Patients with cancer living in rural areas or are ≤65 years of age have higher distress levels regarding their cancer and would benefit from interventions of the ONN to develop plans to address barriers, coordinate care, education, symptom management, and emotional support

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December 2014 • Volume 5, number 6

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Literature Review

Table Studies Included in the Literature Review Study

Research type

Wagner EH, et al.

Nurse navigators in early cancer care: a randomized controlled trial.

J Clin Oncol.

2014;30(1):12-18

Quantitative, experimental design

Study population size

Outcome measures

Results

Conclusions

251 Patients with newly diagnosed primary breast, colo­ rectal, or lung cancer in Washington state and Idaho were randomized to participating primary care physicians to receive either enhanced usual care or the support of a nurse navigator for 4 months

During phone interviews, the nurse navigator utilized Distress and Fatigue thermometers to identify patient problems and assess progress; patient-reported measures were collected at baseline, 4 months, and 12 months, which included the FACT-G, PACIC, and Picker Institute Patient Experience Survey

The FACT-G scores increased for both groups with no difference noted between the groups; PACIC scores were higher among the patients receiving nurse navigator services and with fewer problems reported

With no difference in FACT-G scores, the nurse navigator intervention did not impact the QOL or the timeliness of care for the patients with cancer; PACIC results revealed that patients with the nurse navigator intervention felt more informed, involved in their care, and better prepared for their cancer journey

FACT-G indicates Functional Assessment of Cancer Therapy-General; NCCN, National Comprehensive Cancer Network; ONN, oncology nurse navigator; PACIC, Patient Assessment of Chronic Illness Care; PNO, pivotal nurse in oncology; QOL, quality of life.

the timely access to care and on the resolution of barriers to care. A qualitative, 2-dimensional study of patients with cancer, their family members, and oncology healthcare providers validated the role of professional navigators in facilitating the continuity of care and in promoting patient and family empowerment for patients with cancer.4 In addition, a quantitative, experimental study of 251 patients with newly diagnosed cancer indicated higher scores in the coordination of care, psychosocial care, and health education among the patients receiving nurse navigation services; patients with access to a navigator intervention felt more informed, involved in their care, and better prepared for their cancer journey.5 Furthermore, a quantitative chart review of emotional distress levels indicated a decrease in distress levels (at admission and prior to discharge) with regard to barriers, coordination of care, education, symptom management, and emotional support for patients with cancer seen by an oncology nurse navigator.1 In a qualitative, phenomenological study, the participants reported that the navigator’s interventions with symptom management, access to financial and community resources, and collaborative teamwork were influential in the completion of their treatment and in their continuity of care.6 Finally, a qualitative, descriptive study of older women with breast cancer demonstrated that those having access to the services of a nurse navigator benefited from coordinated care, information/education, and emotional support.7 Effect of Navigator Intervention on Patients’ Satisfaction The effect of navigator intervention on patients’ satis-

faction with their cancer care throughout their disease trajectory was examined in several studies. In a quantitative, descriptive study that involved 103 patients with breast cancer who used navigation services, researchers concluded that the patients were highly satisfied with navigation services offered during their cancer journey.8 In addition, in a quantitative, experimental study of patients with newly diagnosed cancer in 2 hospitals in Korea, researchers concluded that patients in nurse navigation programs were more satisfied with their care and had significantly shorter lengths of hospital stays compared with patients who did not participate in nurse navigation programs.9 Furthermore, in a quantitative, descriptive study of patients with newly diagnosed breast cancer, the breast center noted a reduction in the time interval from biopsy to treatment, resolution of barriers prior to treatment, and high patient satisfaction results after participating in oncology nurse navigator services.2 The evidence of the research in the reviewed articles supports the positive effect of navigator intervention on patient satisfaction.

Tools Used to Measure Effectiveness of Navigation Services

Researchers in the reviewed literature used a variety of tools to measure the impact of a navigator intervention on the continuity of care and on the satisfaction of patients during their cancer experience. These tools allowed for the reliable collection and statistical analysis of data, and replication of results.

To collect measurable data for statistical analysis, several researchers who used quantitative research methods implemented standardized healthcare assessment tools, includ-

JONS-online.com journal of Oncology Navigation & Survivorship

17

Literature Review

ing the Functional Assessment of Cancer Therapy-General (FACT-G), Patient Assessment of Chronic Illness Care (PACIC), the National Comprehensive Cancer Network Distress Thermometer, the Brief Fatigue Inventory, and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30. These standardized assessment tools revealed quality of life (QOL) issues, barriers to care, emotional distress, and coordination of care.

Other researchers who used quantitative research methods implemented standardized survey tools, such as the Picker Institute Patient Experience Survey, as well as researcher-developed survey tools, such as the Likert-type scale, to measure the effect of navigation service on the resolution of barriers and patient satisfaction. The tools utilized in the quantitative research methods allowed for consistent measurement of the researchersâ&#x20AC;&#x2122; topics of interest (ie, the effect of navigation services on patient satisfaction).

The investigators who used qualitative research methods implemented different ways to gather descriptive data regarding the continuity of care and patient satisfaction. The researchers who followed a descriptive or phenomenology design in their method used focus groups and interviews; they conducted telephone or in-person interviews with patients with cancer, using structured and semistructured questions about the interventions provided by the navigator with regard to the continuity of care and their satisfaction with their experience (Table). Several of the researchers also used focus groups of patients with cancer to gather data regarding the role of the navigator in eliminating barriers to care, facilitating continuity of care, and providing emotional support (Table).

Discussion

Since its initiation by Harold P. Freeman, MD, in 2001, navigation as a health-accessed, barrier-focused intervention has become increasingly adopted in the healthcare system as a means to address cancer-related health outcomes. The disparities and barriers with regard to healthcare faced by individuals of varying income, ethnicity, and cultural status have been well documented in the literature. With recent policy changes, specifically the Affordable Care Act of 2010, healthcare delivery models that improve outcomes and the quality of care need to be identified and implemented to match the expanded insurance coverage to millions of previously uninsured individuals.

In the area of oncology, navigation was initially instituted to improve cancer screening, early detection, and timely follow-up among low-income populations. Over time, navigation programs have expanded their purpose and goals by addressing the barriers to care to improve the continuity of care and patient satisfaction. Because of the

18

December 2014 â&#x20AC;˘ Volume 5, number 6

complexity of cancer care, patients often face overwhelming challenges, including emotional distress, timeliness of care, lack of coordination of care, and lack of resources (eg, transportation and financial). These challenges can lead to a disruption in the continuity of patient care and decreased patient satisfaction.

This review examined the effect of navigation on the continuity of care and patient satisfaction in different healthcare settings and countries. The review was based on 10 primary research articles that involved navigation intervention involving various types of patients with different types of cancers. Taewha Lee and colleagues measured 3 outcomes of QOL, satisfaction with care, and length of hospital stay of 78 participants with newly diagnosed gastric, liver, gallbladder, and thyroid cancers.9 Jay Swanson, RN, BSN, OCN, and Lisa Koch, RN, BSN, MSHS, included all types of cancer diagnosed in their quantitative study evaluating the oncology nurse navigator intervention in decreasing distress levels of patients.1 Edward H. Wagner, MD, MPH, and colleagues included primary breast, colorectal, and lung patients with cancer in their study of the nurse navigator intervention on QOL FACT-G scores and coordination-of-care PACIC scores.5 Cheryl Campbell, RN, BSN, OCN, and colleagues measured the variable of navigation on 5 areas/barriers significant to cancer care (access, resources, education, financial assistance, and satisfaction) for patients with cancer in a comprehensive community cancer center.3 Susan F. Korber, MS, RN, OCN, and colleagues looked at the effectiveness of the interventions provided by a navigator in a hospital setting.6 Myriam Skrutkowski, RN, MSc, CON(c), and colleagues examined the impact on continuity of care (symptom management, fatigue, QOL, and resources) delivered by a pivotal nurse in oncology with outpatient oncology facilities in Quebec, Canada.10 The previously mentioned study conducted by Dr Lee enrolled patients with cancer from 2 hospitals in Korea.9 Evidence in the literature review indicated that regardless of whether the studies included only 1 type of cancer or various types of primary cancers, and in varying healthcare settings, there was a positive effect of navigator intervention on the continuity of care and satisfaction for the patients with cancer. Patients with access to navigation services had better coordination of care, information/education, and emotional support. In addition, patients received resolution of their barriers, experienced decreased distress levels, experienced increased QOL, and were highly satisfied with navigation services and their care.

Conclusion

The findings from the studies revealed that patients with cancer who had access to navigation services benefited

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Literature Review

from the resolution of barriers, coordination of care, and emotional support; these patients experienced less distress, improved QOL, and greater satisfaction with their care.

The navigator can play an important role in improving quality and outcomes in the healthcare system. As indicated by the evidence of the research studies, the nursing strategy of navigator intervention can be implemented in hospital settings at the time of diagnosis, as well as throughout the cancer trajectory in outpatient oncology centers. Also, patients of varying types of cancer can benefit from navigation services. The navigator can eliminate the barriers to care, thus improving the continuity of care and patient satisfaction for patients with cancer. g Author Disclosure Statement: Author reports being an employee of Huntsman-Intermountain Cancer Center.

Corresponding Author: Cheryl Bellomo, RN, BSN, OCN, CN-BN, Huntsman-Intermountain Cancer Center, 1303 North Main Street, Cedar City, UT 84720. E-mail: cheryl. bellomo@imail.org.

References

1. Swanson J, Koch L. The role of the oncology nurse navigator in distress management of adult inpatients with cancer: a retrospective study. Oncol Nurs Forum. 2010;37(1):69-76.

2. Koh C, Nelson JM, Cook PF. Evaluation of a patient navigation program.

Clin J Oncol Nurs. 2011;15(1):41-48.

3. Campbell C, Craig J, Eggert J, Bailey-Dorton C. Implementing and measuring the impact of patient navigation at a comprehensive community cancer center. Oncol Nurs Forum. 2010;37(1):61-68.

4. Fillion L, Cook S, Veillette A, et al. Professional navigation framework: elaboration and validation in a Canadian context. Oncol Nurs Forum. 2012; 39(1):E58-E69.

5. Wagner EH, Ludman EJ, Aiello Bowles EJ, et al. Nurse navigators in early cancer care: a randomized controlled trial. J Clin Oncol. 2014;30(1):12-18.

6. Korber SF, Padula C, Gray J, Powell M. A breast navigator program: barriers, enhancers, and nursing interventions. Oncol Nurs Forum. 2011;38(1):44-50.

7. Pieters HC, Heilemann MV, Grant M, Maly RC. Older womenâ&#x20AC;&#x2122;s reflections on accessing care across their breast cancer trajectory: navigating beyond the triple barriers. Oncol Nurs Forum. 2011;38(2):175-184.

8. Hook A, Ware L, Siler B, Packard A. Breast cancer navigation and patient satisfaction: exploring a community-based patient navigation model in a rural setting. Oncol Nurs Forum. 2012;39(4):379-385.

9. Lee T, Ko I, Lee I, et al. Effects of nurse navigators on health outcomes of cancer patients. Cancer Nurs. 2011;34(5):376-384.

10. Skrutkowski M, Saucier S, Eades M, et al. Impact of a pivot nurse in oncology on patients with lung or breast cancer: symptom distress, fatigue, quality of life, and use of healthcare resources. Oncol Nurs Forum. 2008;35(6):948-954.

A forum for nurse and patient navigators to discuss the day-to-day operations of navigating patients with cancer. The goal is to share ideas and practices and to provide a resource to help navigate patients and improve care.

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December 2014 â&#x20AC;˘ Volume 5, number 6

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IN PLANNING DURATION OF THERAPY WITH VELCADE® (bortezomib)

WHAT MORE CAN YOU DO FOR YOUR PATIENTS WITH MULTIPLE MYELOMA?

An online resource—created just for nurses—is available to help you do more to manage your patients’ treatment.

The VELCADE (bortezomib) Nurse Portal features: ▼

Patient education tools to help support your patients throughout their journey with multiple myeloma

▼

A learning center to help you and your patients get the most out of their treatment

▼

Case studies to support you in managing different clinical scenarios

Start learning more today at www.VELCADE-RN.com

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR VELCADE® (bortezomib) INDICATIONS VELCADE (bortezomib) is indicated for the treatment of patients with multiple myeloma. VELCADE is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.

CONTRAINDICATIONS VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of VELCADE. WARNINGS, PRECAUTIONS, AND DRUG INTERACTIONS ▼ Peripheral neuropathy: Manage with dose modification or discontinuation. Patients with preexisting severe neuropathy should be treated with VELCADE only after careful riskbenefit assessment. ▼ Hypotension: Use caution when treating patients taking antihypertensives, with a history of syncope, or with dehydration. ▼ Cardiac toxicity: Worsening of and development of cardiac failure have occurred.

Closely monitor patients with existing heart disease or risk factors for heart disease. ▼ Pulmonary toxicity: Acute respiratory syndromes have occurred. Monitor closely for new or worsening symptoms. ▼ Posterior reversible encephalopathy syndrome: Consider MRI imaging for onset of visual or neurological symptoms; discontinue VELCADE if suspected.

Gastrointestinal toxicity: Nausea, diarrhea, constipation, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement. ▼ Thrombocytopenia or Neutropenia: Monitor complete blood counts regularly throughout treatment. ▼ Tumor lysis syndrome: Closely monitor patients with high tumor burden. ▼ Hepatic toxicity: Monitor hepatic enzymes during treatment. ▼ Embryo-fetal risk: Women should avoid becoming pregnant while being treated with VELCADE. Advise pregnant women of potential embryo-fetal harm. ▼ Closely monitor patients receiving VELCADE in combination with strong CYP3A4 inhibitors.

Avoid concomitant use of strong CYP3A4 inducers.

ADVERSE REACTIONS Most commonly reported adverse reactions (incidence ≥20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia. ▼

Please see Brief Summary for VELCADE on the next page of this advertisement.

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Brief Summary

VELC3X0043_A_Velcade_BS_7x10_r3.indd 1

Embryo-fetal: Pregnancy Category D. Women of reproductive potential should avoid becoming pregnant while being treated with VELCADE. Bortezomib administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post-implantation loss and a decreased number of live fetuses.

ADVERSE EVENT DATA: Safety data from phase 2 and 3 studies of single-agent VELCADE 1.3 mg/m2/dose administered intravenously twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously-treated multiple myeloma (N=1008) and previously-treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma.

In the integrated analysis, the most commonly reported (≥10%) adverse reactions were nausea (49%), diarrhea NOS (46%), fatigue (41%), peripheral neuropathies NEC (38%), thrombocytopenia (32%), vomiting NOS (28%), constipation (25%), pyrexia (21%), anorexia (20%), anemia NOS (18%), headache NOS (15%), neutropenia (15%), rash NOS (13%), paresthesia (13%), dizziness (excl vertigo 11%), and weakness (11%). Eleven percent (11%) of patients experienced at least 1 episode of ≥Grade 4 toxicity, most commonly thrombocytopenia (4%) and neutropenia (2%). A total of 26% of patients experienced a serious adverse reaction during the studies. The most commonly reported serious adverse reactions included diarrhea, vomiting, and pyrexia (3% each), nausea, dehydration, and thrombocytopenia (2% each), and pneumonia, dyspnea, peripheral neuropathies NEC, and herpes zoster (1% each).

In the phase 3 VELCADE+melphalan and prednisone study in previously untreated multiple myeloma, the safety profile of VELCADE administered intravenously in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/prednisone. The most commonly reported adverse reactions in this study (VELCADE+melphalan/prednisone vs melphalan/prednisone) were thrombocytopenia (48% vs 42%), neutropenia (47% vs 42%), peripheral neuropathy (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia (34% vs <1%), anemia (32% vs 46%), leukopenia (32% vs 28%), vomiting (26% vs 12%), fatigue (25% vs 14%), lymphopenia (23% vs 15%), constipation (23% vs 4%), anorexia (19% vs 6%), asthenia (16% vs 7%), pyrexia (16% vs 6%), paresthesia (12% vs 1%), herpes zoster (11% vs 3%), rash (11% vs 2%), abdominal pain upper (10% vs 6%), and insomnia (10% vs 6%).

In the phase 3 VELCADE subcutaneous vs intravenous study in relapsed multiple myeloma, safety data were similar between the two treatment groups. The most commonly reported adverse reactions in this study were peripheral neuropathy NEC (37% vs 50%), thrombocytopenia (30% vs 34%), neutropenia (23% vs 27%), neuralgia (23% vs 23%), anemia (19% vs 23%), diarrhea (19% vs 28%), leukopenia (18% vs 20%), nausea (16% vs 14%), pyrexia (12% vs 8%), vomiting (9% vs 11%), asthenia (7% vs 16%), and fatigue (7% vs 15%). The incidence of serious adverse reactions was similar for the subcutaneous treatment group (20%) and the intravenous treatment group (19%). The most commonly reported SARs were pneumonia and pyrexia (2% each) in the subcutaneous treatment group and pneumonia, diarrhea, and peripheral sensory neuropathy (3% each) in the intravenous treatment group.

DRUG INTERACTIONS: Bortezomib is a substrate of cytochrome P450 enzyme 3A4, 2C19 and 1A2. Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the exposure of bortezomib by 35% in 12 patients. Monitor patients for signs of bortezomib toxicity and consider a bortezomib dose reduction if bortezomib must be given in combination with strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir). Co-administration of omeprazole, a strong inhibitor of CYP2C19, had no effect on the exposure of bortezomib in 17 patients. Co-administration of rifampin, a strong CYP3A4 inducer, is expected to decrease the exposure of bortezomib by at least 45%. Because the drug interaction study (n=6) was not designed to exert the maximum effect of rifampin on bortezomib PK, decreases greater than 45% may occur. Efficacy may be reduced when VELCADE is used in combination with strong CYP3A4 inducers; therefore, concomitant use of strong CYP3A4 inducers is not recommended in patients receiving VELCADE. St. John’s wort (Hypericum perforatum) may decrease bortezomib exposure unpredictably and should be avoided. Co-administration of dexamethasone, a weak CYP3A4 inducer, had no effect on the exposure of bortezomib in 7 patients. Co-administration of melphalan-prednisone increased the exposure of bortezomib by 17% in 21 patients. However, this increase is unlikely to be clinically relevant.

USE IN SPECIFIC POPULATIONS: Nursing Mothers: It is not known whether bortezomib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from VELCADE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: The safety and effectiveness of VELCADE in children has not been established.

Geriatric Use: No overall differences in safety or effectiveness were observed between patients ≥age 65 and younger patients receiving VELCADE; but greater sensitivity of some older individuals cannot be ruled out.

Patients with Renal Impairment: The pharmacokinetics of VELCADE are not influenced by the degree of renal impairment. Therefore, dosing adjustments of VELCADE are not necessary for patients with renal insufficiency. Since dialysis may reduce VELCADE concentrations, VELCADE should be administered after the dialysis procedure. For information concerning dosing of melphalan in patients with renal impairment, see manufacturer’s prescribing information.

Patients with Hepatic Impairment: The exposure of bortezomib is increased in patients with moderate and severe hepatic impairment. Starting dose should be reduced in those patients.

Patients with Diabetes: During clinical trials, hypoglycemia and hyperglycemia were reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetic medication.

Please see full Prescribing Information for VELCADE at VELCADEHCP.com.

VELCADE, MILLENNIUM and are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners.

Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright © 2013, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA V-14-0087a Printed in USA 4/14

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INDICATIONS: VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma. VELCADE for Injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.

CONTRAINDICATIONS: VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of VELCADE. WARNINGS AND PRECAUTIONS: Peripheral Neuropathy: VELCADE treatment causes a peripheral neuropathy that is predominantly sensory; however, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with pre-existing symptoms (numbness, pain, or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy (including ≥Grade 3) during treatment with VELCADE. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. In the Phase 3 relapsed multiple myeloma trial comparing VELCADE subcutaneous vs intravenous, the incidence of Grade ≥2 peripheral neuropathy events was 24% for subcutaneous and 39% for intravenous. Grade ≥3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 15% in the intravenous treatment group.

Starting VELCADE subcutaneously may be considered for patients with pre-existing or at high risk of peripheral neuropathy.

Patients experiencing new or worsening peripheral neuropathy during VELCADE therapy may require a decrease in the dose and/or a less dose-intense schedule. In the VELCADE vs dexamethasone phase 3 relapsed multiple myeloma study, improvement in or resolution of peripheral neuropathy was reported in 48% of patients with ≥Grade 2 peripheral neuropathy following dose adjustment or interruption. Improvement in or resolution of peripheral neuropathy was reported in 73% of patients who discontinued due to Grade 2 neuropathy or who had ≥Grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma.

Hypotension: The incidence of hypotension (postural, orthostatic, and hypotension NOS) was 8%. These events are observed throughout therapy. Caution should be used when treating patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated. Management of orthostatic/postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics.

Cardiac Toxicity: Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have occurred during VELCADE therapy, including reports in patients with no risk factors for decreased left ventricular ejection fraction. Patients with risk factors for, or existing, heart disease should be closely monitored. In the relapsed multiple myeloma study of VELCADE vs dexamethasone, the incidence of any treatment-related cardiac disorder was 8% and 5% in the VELCADE and dexamethasone groups, respectively.

The incidence of adverse reactions suggestive of heart failure (acute pulmonary edema, pulmonary edema, cardiac failure, congestive cardiac failure, cardiogenic shock) was ≤1% for each individual reaction in the VELCADE group. In the dexamethasone group, the incidence was ≤1% for cardiac failure and congestive cardiac failure; there were no reported reactions of acute pulmonary edema, pulmonary edema, or cardiogenic shock. There have been isolated cases of QT-interval prolongation in clinical studies; causality has not been established.

Pulmonary Toxicity: Acute Respiratory Distress Syndrome (ARDS) and acute diffuse infiltrative pulmonary disease of unknown etiology, such as pneumonitis, interstitial pneumonia, and lung infiltration have occurred in patients receiving VELCADE. Some of these events have been fatal.

In a clinical trial, the first two patients given high-dose cytarabine (2 g/m2 per day) by continuous infusion with daunorubicin and VELCADE for relapsed acute myelogenous leukemia died of ARDS early in the course of therapy. There have been reports of pulmonary hypertension associated with VELCADE administration in the absence of left heart failure or significant pulmonary disease.

In the event of new or worsening cardiopulmonary symptoms, consider interrupting VELCADE until a prompt, comprehensive, diagnostic evaluation is conducted.

Posterior Reversible Encephalopathy Syndrome (PRES): Posterior Reversible Encephalopathy Syndrome (PRES; formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS)) has occurred in patients receiving VELCADE. PRES is a rare, reversible, neurological disorder, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. Brain imaging, preferably MRI (Magnetic Resonance Imaging), is used to confirm the diagnosis. In patients developing PRES, discontinue VELCADE. The safety of reinitiating VELCADE therapy in patients previously experiencing PRES is not known.

Gastrointestinal Toxicity: VELCADE treatment can cause nausea, diarrhea, constipation, and vomiting, sometimes requiring use of antiemetic and antidiarrheal medications. Ileus can occur.

Fluid and electrolyte replacement should be administered to prevent dehydration. Interrupt VELCADE for severe symptoms.

Thrombocytopenia/Neutropenia: VELCADE is associated with thrombocytopenia and neutropenia that follow a cyclical pattern, with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle. The cyclical pattern of platelet and neutrophil decreases and recovery remained consistent over the 8 cycles of twice-weekly dosing, and there was no evidence of cumulative thrombocytopenia or neutropenia. The mean platelet count nadir measured was approximately 40% of baseline.

The severity of thrombocytopenia was related to pretreatment platelet count. In the relapsed multiple myeloma study of VELCADE vs dexamethasone, the incidence of bleeding (≥Grade 3) was 2% on the VELCADE arm and <1% on the dexamethasone arm. Complete blood counts (CBC) should be monitored frequently during treatment with VELCADE. Platelet counts should be monitored prior to each dose of VELCADE. Patients experiencing thrombocytopenia may require change in the dose and schedule of VELCADE. Gastrointestinal and intracerebral hemorrhage has been reported in association with VELCADE. Transfusions may be considered.

Tumor Lysis Syndrome: Tumor lysis syndrome has been reported with VELCADE therapy.

Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment.

Monitor patients closely and take appropriate precautions.

Hepatic Toxicity: Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic reactions include hepatitis, increases in liver enzymes, and hyperbilirubinemia. Interrupt VELCADE therapy to assess reversibility. There is limited re-challenge information in these patients.

development of a navigation model

Relationship-Based Care: Creating a Patient Navigation Program Through a Professional Practice Model Krista Moore, RN, BSN, MS; Amy Rettig, MSN, MALM, RN, ACNS-BC, PMHNP-BC, CBCN The Ohio State University Wexner Medical Center, James Cancer Hospital and Solove Research Institute Patient navigation has become essential for the care of the oncology patient in a complex healthcare environment; however, the term “navigation” has been used loosely to describe several functions of the role of a patient liaison, social worker, or registered nurse. A navigation program was created recently for patients who were newly diagnosed with breast cancer. This pilot program utilizes (1) relationship-based care, an established nursing professional practice model that employs primary nursing as a care delivery method; (2) the communication functions of the electronic medical record (EMR); and (3) a multidisciplinary team. Using the EMR, essential patient information was entered preoperatively by an ambulatory primary nurse into the care coordination note (CCN). The use of the CCN, which could be viewed by multiple disciplines throughout the continuum of care, provided a means of gathering information related to each patient’s specific healthcare needs associated with the diagnosis of breast cancer, both in the hospital and at home. It also created a link of communication between the ambulatory and inpatient settings, a barrier that has been difficult to overcome for many organizations. Removing the barriers of communication experienced by care providers in ambulatory and inpatient settings facilitates continuity of care and restores patient confidence in the care they are receiving during an extremely challenging experience.

Key words: navigation, relationship-based care, primary nursing

Relationship-Based Care: Creating Patient Navigation Through a Professional Practice Model

In recent years, the terms “patient navigator” and “patient navigation” have become common buzzwords throughout the oncology nursing community; the terms, however, have been used loosely. There are several definitions of what this role means for the patient as well as the qualifications needed to hold this position within an organization. Although many patient navigation specialists are registered nurses, there are also social workers who take on this role and those with other, varied backgrounds.1 Patient navigation is especially important for oncology patients who are thrust into an unknown and complex healthcare world with little or no warning. It provides the tools needed to help transition the patient from initial diagnosis through treatment and into survivorship.1 For navigation to be successful, effective communication with multiple disciplines throughout the treatment journey is essential.1 A lack of effective communication leads to fragmented care and a sense of poor care coordination.2 Using a nursing professional practice model (PPM) with primary nursing as the framework, a pilot project was implemented to provide a communication solution across the continuum of care. Utilizing primary nursing to navigate patients who were undergoing breast cancer surgery and employing tools through an existing electronic medical record (EMR) system, a multidisciplinary team of stake-

holders created a communication process for nurses as well as other disciplines to share information throughout the continuum of care. The team included ambulatory and inpatient nurses, managers, informatics personnel, social workers, nurse practitioners, patient care resource managers, and clinical nurse specialists.

Professional Practice Model According to Johnson and Ezekielian, PPM is defined as “a schematic description of a theory, phenomenon, or system that depicts how nurses practice, collaborate, communicate, and develop professionally to provide the highest quality of care for those served by the organization.”3 Hoffart and Woods also described the PPM as a method of giving control directly to the registered nurse regarding the nursing care that is delivered.4 Having a PPM gives nurses a sense of ownership and autonomy regarding their care delivery. They are able to make independent decisions regarding patient care, have the authority to develop a patient’s care plan, and place orders accordingly.5 An example of PPM—and the specific model used for the project discussed in this article—is relationship­based care (RBC), which was introduced to the nursing profession in 2004 and includes 3 main relationships: care of patient and family, care of self, and care of colleague.6 The relationship with patients and their families is considered to be the most important within the model. In the

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context of the RBC model, the patient and family are encouraged to take a very active role in developing a plan of care. This helps build the relationship with all members of the healthcare team and fosters an environment of trust and accountability within the healthcare environment.6 The second relationship within the model is the relationship with self. The model conveys that a nurse cannot safely, effectively, and competently care for a patient if he or she has not first taken care of himself or herself.6 All members of the patient’s care team should encourage team members and involve themselves in good self-care practices. Taking the time to care for self helps to reduce the risk of burnout while increasing the ability to provide the quality of care required and expected by patients and their families.6 The final relationship within the model is the nurse’s relationship with his or her peers and other essential members of the healthcare team. Collaboration is crucial within complex healthcare environments. One must take great care to establish healthy relationships with other disciplines that may have a direct effect on the patient. Having healthy working relationships increases effective communication while positively impacting care coordination and patient outcomes.6

The first studies on patient navigation date back to 1990 and were originally designed to reduce barriers for low-income patients.

Recent research has revealed a connection between having a PPM in place and improved patient outcomes.

One year after the RBC professional practice model was implemented at a small hospital in rural Texas, a study demonstrated favorable patient satisfaction outcomes as well as readmission rates after 24 hours.7 Although the sample size was small, the results suggest that the increase in consistency of care had an impact on overall patient experience and satisfaction scores.7 Primary Nursing Primary nursing is the care delivery model used in correlation with PPM, or RBC specifically, as described in this article. This form of care delivery was introduced in 1968 at the University of Minnesota and has continued to evolve over the past 40 years.8 The emphasis of this care delivery model, much like the previously mentioned PPM, is on the relationship between the nurse and the patient. Having a patient-centered relationship provides the patient with a sense of continuity across all treatment environments.6

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In the RBC model, the primary nurse is assigned at the initial point of contact, whether that is an office visit or a hospital admission. The primary nurse then assumes responsibility for the design of the patient’s nursing plan of care and works closely with other disciplines to make sure the patient’s goals are achieved. When the primary nurse is unavailable, an associate nurse is assigned to the patient’s care with the expectation that he or she will continue to carry out the previously designed plan of care agreed on by the primary nurse and the patient.9 Patient Navigation The first studies on patient navigation date back to 1990 and were originally designed to reduce barriers for low-income patients receiving treatment for breast cancer.

The purpose of the patient navigator was to make sure the patients remained in contact with providers throughout the follow-up period.2 Studies dating from 2007 to 2010 showed that patient navigation programs varied depending on the medical setting and the needs of the population served.10 These findings are consistent with recent studies that continue to suggest a high level of variability in patient navigation programs and navigator roles and responsibilities.11 Although early patient navigation studies focused on the low-income patient with breast cancer, more current studies have included the newly diagnosed patient with breast cancer across all socioeconomic demographics. A randomized controlled trial published in 2014 focused on adults who had been recently diagnosed with breast, lung, or colorectal cancer. One group was given standard care, whereas the other group was given access to a nurse navigator for 4 months.11 The study participants identified 3 major challenges, including poor care coordination, lack of relevant information regarding their treatment process, and insufficient attention given to their emotional issues.

Participants receiving standard care indicated that a navigator or advocate would have been helpful in the period immediately after diagnosis.11 The participants in the experimental group were contacted by a nurse navigator (NN) within 2 weeks of their diagnosis. The NN served as a patient advocate and source of support, assisted the patients throughout their treatment process, and worked with them to create goals and action plans related to their care.11 The results of the study showed that patients who experienced interventions provided by the NN reported significantly less issues relating to care coordination, improved levels of health information as it related to their treatment, and increased satisfaction in how their psychosocial needs were addressed.11 It was also shown that the effects of this intervention persisted even after the contact with the NN was eliminated.11 Because this study was conducted within

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development of a navigation model

an environment where all care was provided in 1 building, many issues with care coordination were effectively eliminated. A replication of this study in a more fragmented care setting may show even more promising results.11 The Pilot: Creating a Communication Plan The first step in this pilot process was to identify the problem, which was determined to be the lack of communication between ambulatory and inpatient staff regarding a patient’s plan of care in the different environments. The ambulatory staff setting was a freestanding comprehensive breast center affiliated with a large, academic medical center with a freestanding cancer hospital where the inpatient staff was located. Lack of communication among these teams caused care of the patient after surgery to become fragmented, which was not in alignment with PPM and the care delivery model of primary nursing. Evidence of this process could be seen when reviewing verbatim patient comments captured in the organization’s patient satisfaction surveys.

After pinpointing the issue, all key players related to the problem were identified, and each was formally invited to be an active participant in the change process. The key players included a multidisciplinary team of inpatient and ambulatory nurses, managers, clinical nurse specialists, nurse practitioners, physicians, nursing informatics staff, social workers, and patient care resource managers.

The group was brought together for an informal meeting to discuss the issue at hand. It was quite difficult to coordinate a meeting that accommodated everyone’s schedules.

This created a sense of frustration that turned to empathy for what our patients must have been experiencing while trying to navigate care provided in multiple settings.

Therefore, all meetings were conducted via the Internet.

Attendance was high, and participants could attend from a location that was convenient for them.

The next step was to concentrate on the lack of communication between clinical settings and how this could potentially be improved. Utilizing the EMR system available in the ambulatory and inpatient settings became the focus of the team’s efforts. The key was to identify a means by which ambulatory and inpatient care providers could communicate patient information before and after the planned surgical procedure.

The EMR contained an appropriate communication tool; however, ambulatory and inpatient care providers had different viewing capabilities, and research revealed the tool was not being utilized in either setting. The nursing informatics specialist assisted with this part of the project and navigated the group through the EMR. The communication tool was easy to locate, user-friendly, viewable by any care provider in either setting, and was aptly named the care coordination note (CCN).

The group decided that the initial CCN should be completed by the primary nurse. For the purposes of this project, it was determined that the nurse in the ambulatory setting would be the primary nurse, whereas the inpatient nurse would take on the role of the associate nurse, as defined in the primary nurse model. This decision was made based on information provided by frontline nursing staff from the ambulatory clinic and inpatient hospital unit, as well as the patient’s length of stay after the surgical procedure (≤24 hours). According to the inpatient nurses and their manager, the short time frame of the patient stay was making it difficult for the nurses to develop a meaningful relationship with the patient and to implement the primary nursing model of care delivery.

The first step in this pilot process was to identify the problem.

The nursing staff, social workers, nurse practitioners, and patient care resource managers collaborated and devised a system of communication that would provide useful patient information to others who may be involved in the care. Two sets of questions, termed in the EMR system as smart phrases, were created within the CCN. The first set of questions was to be answered by the patient during the preoperative appointment with his or her primary nurse in the ambulatory clinic. The second set of questions would be answered before the patient’s discharge postoperatively by the associate nurse in the hospital. The questions were entered as smart phrases into the EMR using the CCN function. The nurses simply entered the smart phrase, and all questions were automatically populated into the note.

The associate nurses from the inpatient unit also followed up with patients by contacting them via a postdischarge phone call. These calls were made to the patient, a designated caregiver, or a family member within 24 to 48 hours after discharge from the hospital. The information gathered from the phone call was entered into the CCN as a telephone encounter and could be viewed by the primary nurse before or during the first postoperative ambulatory visit. This allowed the patient and/or family needs to be identified, reported, and addressed by the appropriate providers throughout the continuum of care. The process utilizing the CCN across both care settings can be viewed in the Box (see page 26).

Discussion

In this project, the driving force was the PPM shared by the ambulatory and inpatient nursing staff. Expanding the role of the primary nurse to an ambulatory care site for this specific patient population allowed better navigation and

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communication across the continuum of care, keeping in mind that how and what we communicate impacts patient care. The CCN created a visible time line of the patient’s

Patient Flow Through Ambulatory and Inpatient Care Environments Utilizing the Care Coordination Note Ambulatory Initial diagnosis: primary nurse assigned as patient is roomed • Establish primary nurse relationship • Introduce the nursing plan of care • Gather information from patient and place into the electronic medical record (EMR) Patient is seen by nurse practitioner • Preoperative teaching completed • Primary nurse communicates to other members of the patient care team (ie, associate nurses, patient care resource managers, social workers) through documentation in the care coordination note (CCN) in the EMR Inpatient Associate nurse admits patient from postanesthesia care unit • Checks CCN • Discusses plan of care with patient • Reinforce education on discharge • Advise patient to expect a follow-up phone call 24-48 hours after discharge • CCN updated in EMR by associate nurse with any issues encountered during hospital stay (ie, pain, nausea and vomiting, anxiety, problems with anesthesia) Follow-up Phone Call Phone call to be made by associate nurse or other designee • Will utilize call-back tool in EMR • This will be reviewed in ambulatory setting by primary nurse Postoperative Visit Primary nurse reviews CCN • Discusses patient concerns • Reinforces postoperative education • Reinforces need for physical restriction • Makes note regarding any specific educational needs • Updates CCN in the EMR, if necessary

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progress through the continuum of care. Patient responses to questions provided valuable information from the ambulatory nursing staff and nurse practitioners to inpatient nurses, social workers, and patient care resource managers who assist in the discharge planning process.

The project was implemented in a relatively short time frame with appropriate available resources and could be easily replicated in other healthcare organizations. Mandatory EMR systems allow easier and more efficient communication options for healthcare systems. With more acute symptom management taking place in ambulatory settings, fragmented care will continue to be an issue because of a disconnect between care settings. Developing a patient navigation process that improves care coordination throughout the continuum will likely vary depending on the patient population, demographics, and healthcare setting. However, implementing a navigation process may prove to be invaluable for patients and worth the organization resources and time invested. g Author Disclosure Statement: Both authors have nothing to disclose.

Corresponding Author: Amy Rettig, MSN, MALM, RN, ACNS-BC, PMHNP-BC, CBCN, The Ohio State University Wexner Medical Center, James Cancer Hospital and Solove Research Institute, 58 Olentangy Street, Columbus, OH 43202. E-mail: amy.rettig@osumc.edu.

References

1. Oncology Nursing Society. ONS positions: Oncology Nursing Society, the Association of Oncology Social Work, and the National Association of Social Workers Joint Position on the Role of Oncology Nursing and Oncology Social Work in Patient Navigation. www2.ons.org/Publications/Positions/ Navigation. Accessed December 4, 2014.

2. Hendren S, Fiscella K. Patient navigation improves the care experience for patients with newly diagnosed cancer. J Clin Oncol. 2014;32:3-4.

3. Johnson L, Ezekielian J. Use of a professional practice model to illuminate the importance of relationships. Creat Nurs. 2014;20:127-136.

4. Hoffart N, Woods CQ. Elements of a nursing professional practice model.

J Prof Nurs. 1996;12:354-364.

5. Arford PH, Zone-Smith L. Organizational commitment to professional practice models. J Nurs Adm. 2005;35:467-472.

6. Koloroutis M. Introduction. In: Koloroutis M, ed. Relationship-Based Care: A Model for Transforming Practice. Minneapolis, MN: Creative Health Care Management, Inc; 2011:1-22.

7. Cropley S. The relationship-based care model: evaluation of the impact on patient satisfaction, length of stay, and readmission rates. J Nurs Adm. 2012; 42:333-339.

8. Manthey M. The 40th anniversary of primary nursing: setting the record straight. Creat Nurs. 2009;15:36-38.

9. Tiedeman ME, Lookinland S. Traditional models of care delivery: what have we learned? J Nurs Adm. 2004;34:291-297.

10. Paskett ED, Harrop JP, Wells KJ. Patient navigation: an update on the state of the science. CA Cancer J Clin. 2011;61:237-249.

11. Wagner EH, Ludman EJ, Bowles A, et al. Nurse navigators in early cancer care: a randomized, controlled trial. J Clin Oncol. 2014;32:12-18.

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THE EVOLVING MBC LANDSCAPE...

Indication

Halaven is indicated for the treatment of patients with metastatic breast cancer (MBC) who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.

Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

Please see Important Safety Information on the following spread and accompanying brief summary of Halaven full Prescribing Information.

HALAVEN Ž is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. Š 2013 Eisai Inc. All rights reserved.

Printed in USA/November 2013 HALA0479

IN MBC, ONCOLOGISTS ARE CONSISTENTLY

EXTENDING THE CONTINUUM OF MEANINGFUL CARE1-3 With MBC treatment potentially extending to 6 lines and beyond, third-line chemotherapy can still be early in the fight for some patients2

LINES OF THERAPY GIVEN

1L 2L

3L 4L

2001 and earlier4

5L 6L 7L+

2005-20093,5

2010-20112,6

Indication Halaven is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

Important Safety Information Neutropenia

Monitor complete blood counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days Severe neutropenia (ANC <500/mm3) lasting more than 1 week occurred in 12% (62/503) of patients. Patients with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels Grade 3 and Grade 4 neutropenia occurred in 28% and 29%, respectively, of patients who received Halaven. Febrile neutropenia occurred in 5% of patients and two patients (0.4%) died from complications

Peripheral Neuropathy Patients should be monitored closely for signs of peripheral motor and sensory neuropathy

Grade 3 peripheral neuropathy occurred in 8% of patients, and Grade 4 in 0.4% of patients who received Halaven. Delay administration of Halaven until resolution to Grade 2 or less Neuropathy lasting more than 1 year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days) Peripheral neuropathy (5%) was the most common adverse reaction resulting in discontinuation

Pregnancy Category D Halaven is expected to cause fetal harm when administered to a pregnant woman and patients should be advised of these risks

QT Prolongation In an uncontrolled ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no prolongation on Day 1. ECG monitoring is recommended for patients with congestive heart failure; bradyarrhythmias;

HALAVEN ® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. © 2013 Eisai Inc. All rights reserved.

Printed in USA/November 2013 HALA0479

GIVE YOUR PATIENTS

AN OPPORTUNITY FOR MORE LIFE The FIRST and ONLY single agent that significantly extended OVERALL SURVIVAL in third-line MBC7-14

UPDATED OVERALL SURVIVAL (OS) ANALYSIS (UNPLANNED): MEDIAN OS, MONTHS (95% CI)1,15,a

P R O P O R T I O N O F PAT I E N T S A L I V E

1.0 0.9 0.8

Halaven

0.77

25% (2.6 month)

(n=508)

13.2

INCREASE

(12.1, 14.4)

0.6

IN MEDIAN OS

Deaths=386

0.5

Treatment of Physician’s Choice

0.4

(n=254)

0.3

10.6

0.2

(9.2, 12.0)

0.1

Deaths=203

0.0 0

6

12

18

24

30

36

54 26

11 5

0 Halaven 0 TPC

TIME (MONTHS)

Number of patients at risk

508 254

406 178

274 106

142 61

Results from an updated, unplanned survival analysis of the Phase III, randomized, openlabel, multicenter, multinational Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice versus E7389 (Eribulin) (EMBRACE) trial of Halaven versus Treatment of Physician’s Choice (TPC) in patients with MBC (N=762), conducted when 77% of events (deaths) had been observed. The primary endpoint was OS. Patients were randomized (2:1) to receive either Halaven 1.4 mg/m2 intravenously for 2 to 5 minutes on Days 1 and 8 of a 21-day cycle, or any singleagent therapy, selected prior to randomization.

At baseline, all patients had received ≥2 prior chemotherapeutic regimens for metastatic disease and demonstrated disease progression within 6 months of their last chemotherapeutic regimen. All patients received prior anthracyclineand taxane-based chemotherapy, unless contraindicated. Therapies in the TPC arm consisted of 97% chemotherapy (26% vinorelbine, 18% gemcitabine, 18% capecitabine, 16% taxanes [included paclitaxel, docetaxel, nab-paclitaxel, and ixabepilone], 9% anthracyclines, 10% other chemotherapy), and 3% hormonal therapy.

CI=confidence interval.

Conducted in the intent-to-treat population.

a

The updated OS analysis was consistent with the primary analysis7 The primary analysis, conducted when ~50% of events (deaths) had been observed, demonstrated a median OS for Halaven vs TPC of 13.1 months (95% CI: 11.8, 14.3) vs 10.6 months (95% CI: 9.3, 12.5), hazard ratio=0.81 (95% CI: 0.66, 0.99) (P=0.041)7,15

concomitant use of drugs that prolong QT interval, including Class Ia and III antiarrhythmics; and electrolyte abnormalities Correct hypokalemia or hypomagnesemia prior to initiating Halaven and monitor electrolytes periodically during therapy.

Avoid in patients with congenital long QT syndrome

Hepatic and Renal Impairment For patients with mild (Child-Pugh A) or moderate (ChildPugh B) hepatic and/or moderate (CrCl 30-50 mL/min) renal impairment, a reduction in starting dose is recommended

Most Common Adverse Reactions Most common adverse reactions (≥25%) reported in patients receiving Halaven were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%) The most common serious adverse reactions reported in patients receiving Halaven were febrile neutropenia (4%) and neutropenia (2%)

References: 1. Dufresne A, et al. Breast Cancer Res Treat. 2008;107(2):275-279.

2. Planchat E, et al. Breast. 2011;20(6):574-578. 3. Ray S, et al. In: J Clin Oncol.

San Francisco, CA: ASCO Breast Cancer Symposium; 2012. Abstract 116.

4. Cardoso F, et al. Ann Oncol. 2002;13(2):197-207. 5. Seah DS, et al. Poster presented at: 2012 ASCO Annual Meeting; June 1–5, 2012; Chicago, IL. Abstract 6089. 6. Lin NU, et al. Lancet. 2011;377(9769):878-880. 7. Halaven [package insert]. Woodcliff Lake, NJ: Eisai Inc; 2013. 8. Saad ED, et al. J Clin Oncol. 2010;28(11):1958-1962. 9. Slamon DJ, et al.

N Engl J Med. 2001;344(11):783-792. 10. Geyer CE, et al. N Engl J Med. 2006;355(26): 2733-2743. 11. von Minckwitz G, et al. J Clin Oncol. 2009;27(12):1999-2006.

12. Miller K, et al. N Engl J Med. 2007;357(26):2666-2676. 13. Robert NJ, et al.

J Clin Oncol. 2011;29(10):1252-1260. 14. Sparano JA, et al. J Clin Oncol. 2010;28(20): 3256-3263. 15. Cortes J, et al. Lancet. 2011;377(9769):914-923.

Please see accompanying brief summary of Halaven full Prescribing Information.

Visit www.halaven.com/hcp.aspx

S:7"

Table 2 (cont'd) MedDRA ver 10.0

HALAVEN (n=503) All Grades ≥ Grade 3

Control Group (n=247) All Grades ≥ Grade 3

Infections and Infestations Urinary Tract Infection 10% 1% 5% 0 Based upon laboratory data. b Includes neuropathy peripheral, neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, and paraesthesia. c Not applicable; (grading system does not specify > Grade 2 for alopecia).

Cytopenias: Grade 3 neutropenia occurred in 28% (143/503) of patients who received HALAVEN in Study 1, and 29% (144/503) of patients experienced Grade 4 neutropenia. Febrile neutropenia occurred in 5% (23/503) of patients; two patients (0.4%) died from complications of febrile neutropenia. Dose reduction due to neutropenia was required in 12% (62/503) of patients and discontinuation was required in <1% of patients. The mean time to nadir was 13 days and the mean time to recovery from severe neutropenia (<500/mm3) was 8 days. Grade 3 or greater thrombocytopenia occurred in 1% (7/503) of patients. G-CSF (granulocyte colony-stimulating factor) or GM-CSF (granulocyte–macrophage colony-stimulating factor) was used in 19% of patients who received HALAVEN. Peripheral Neuropathy: In Study 1, 17% of enrolled patients had Grade 1 peripheral neuropathy and 3% of patients had Grade 2 peripheral neuropathy at baseline. Dose reduction due to peripheral neuropathy was required by 3% (14/503) of patients who received HALAVEN. Four percent (20/503) of patients experienced peripheral motor neuropathy of any grade and 2% (8/503) of patients developed Grade 3 peripheral motor neuropathy.

Liver Function Test Abnormalities: Among patients with Grade 0 or 1 ALT levels at baseline, 18% of HALAVEN-treated patients experienced Grade 2 or greater ALT elevation. One HALAVEN-treated patient without documented liver metastases had concomitant Grade 2 elevations in bilirubin and ALT; these abnormalities resolved and did not recur with re-exposure to HALAVEN. Less Common Adverse Reactions: The following additional adverse reactions were reported in ≥5% to <10% of the HALAVEN-treated group: Eye Disorders: increased lacrimation; Gastrointestinal Disorders: dyspepsia, abdominal pain, stomatitis, dry mouth; General Disorders and Administration Site Conditions: peripheral edema; Infections and Infestations: upper respiratory tract infection; Metabolism and Nutrition Disorders: hypokalemia; Musculoskeletal and Connective Tissue Disorders: muscle spasms, muscular weakness; Nervous System Disorders: dysgeusia, dizziness; Psychiatric Disorders: insomnia, depression; Skin and Subcutaneous Tissue Disorders: rash.

6.2 Postmarketing Experience The following adverse drug reactions have been identified during post-approval of HALAVEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders: lymphopenia; Gastrointestinal Disorders: pancreatitis; Hepatobiliary Disorders: hepatitis; Immune System Disorders: drug hypersensitivity; Infections and Infestations: pneumonia, sepsis/neutropenic sepsis; Metabolism and Nutrition Disorders: hypomagnesemia, dehydration; Respiratory, thoracic, and mediastinal disorders: interstitial lung disease; Psychiatric Disorders: anxiety; Skin and Subcutaneous Tissue Disorders: pruritus.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Category D There are no adequate and well-controlled studies with HALAVEN in pregnant women. HALAVEN is a microtubule inhibitor; therefore, it is expected to cause fetal harm when administered to a pregnant woman. Embryo-fetal toxicity and teratogenicity occurred in rats that received eribulin mesylate at approximately half of the recommended human dose based on body surface area. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

In a developmental toxicity study, pregnant rats received intravenous infusion of eribulin mesylate during organogenesis (Gestation Days 8, 10, and 12) at doses approximately 0.04, 0.13, 0.43 and 0.64 times the recommended human dose, based on body surface area (mg/m2). Increased abortion and severe external or soft tissue malformations were observed in offspring at doses 0.64 times the recommended human dose based on body surface area (mg/m2), including the absence of a lower jaw, tongue, stomach and spleen.

Increased embryo-fetal death/resorption, reduced fetal weights, and minor skeletal anomalies consistent with developmental delay were also reported at or above doses of 0.43 times the recommended human dose.

Maternal toxicity of eribulin mesylate was reported in rats at or above doses of 0.43 times the recommended human dose (mg/m²), and included enlarged spleen, reduced maternal weight gain and decreased food consumption.

8.3 Nursing Mothers It is not known whether HALAVEN is excreted into human milk. No studies in humans or animals were conducted to determine if HALAVEN is excreted into milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in human milk fed infants from HALAVEN, a decision should be made whether to discontinue nursing or to discontinue HALAVEN taking into account the importance of the drug to the mother.

8.4 Pediatric Use The safety and effectiveness of HALAVEN in pediatric patients below the age of 18 years have not been established.

8.6 Hepatic Impairment Administration of HALAVEN at a dose of 1.1 mg/m2 to patients with mild hepatic impairment and 0.7 mg/m2 to patients with moderate hepatic impairment resulted in similar exposure to eribulin as a dose of 1.4 mg/m2 to patients with normal hepatic function. Therefore, a lower starting dose of 1.1 mg/m2 is recommended for patients with mild hepatic impairment (Child-Pugh A) and of 0.7 mg/m2 is recommended for patients with moderate hepatic impairment (Child-Pugh B). HALAVEN was not studied in patients with severe hepatic impairment (Child-Pugh C).

8.7 Renal Impairment For patients with moderate renal impairment (CrCl 30-50 mL/min), the geometric mean dose-normalized systemic exposure increased 2-fold compared to patients with normal renal function. A lower starting dose of 1.1 mg/m2 is recommended for patients with moderate renal impairment. The safety of HALAVEN was not studied in patients with severe renal impairment (CrCl <30 mL/min).

10 OVERDOSAGE Overdosage of HALAVEN has been reported at approximately 4 times the recommended dose, which resulted in Grade 3 neutropenia lasting seven days and a Grade 3 hypersensitivity reaction lasting one day.

There is no known antidote for HALAVEN overdose.

12 CLINICAL PHARMACOLOGY 12.3 Pharmacokinetics Specific Populations Hepatic Impairment A study evaluated the PK of eribulin in patients with mild (Child-Pugh A; n=7) and moderate (Child-Pugh B; n=5) hepatic impairment.

Compared to patients with normal hepatic function (n=6), eribulin exposure increased 1.8-fold and 2.5-fold in patients with mild and moderate hepatic impairment, respectively. Administration of HALAVEN at a dose of 1.1 mg/m2 to patients with mild hepatic impairment and 0.7 mg/m2 to patients with moderate hepatic impairment resulted in similar exposure to eribulin as a dose of 1.4 mg/m2 to patients with normal hepatic function.

Renal Impairment No formal PK trials were conducted with HALAVEN in patients with renal impairment. Available data suggests that geometric mean dose-normalized systemic exposure is similar for patients with mild renal impairment (CrCl 50-80 mL/min) relative to patients with normal renal function. However, for patients with moderate renal impairment (CrCl 30-50 mL/min), the geometric mean dose-normalized systemic exposure increased 2-fold compared to patients with normal renal function.

12.6 Cardiac Electrophysiology The effect of HALAVEN on the QTc interval was assessed in an open-label, uncontrolled, multicenter, single-arm dedicated QT trial. A total of 26 patients with solid tumors received 1.4 mg/m2 of HALAVEN on Days 1 and 8 of a 21-day cycle. A delayed QTc prolongation was observed on Day 8, with no prolongation observed on Day 1. The maximum mean QTcF change from baseline (95% upper confidence interval) was 11.4 (19.5) ms.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, mutagenesis, impairment of fertility Carcinogenicity studies have not been conducted with eribulin mesylate.

Eribulin mesylate was not mutagenic in in vitro bacterial reverse mutation assays (Ames test). Eribulin mesylate was positive in mouse lymphoma mutagenesis assays, and was clastogenic in an in vivo rat bone marrow micronucleus assay.

The effects of HALAVEN on human fertility are unknown. Fertility studies have not been conducted with eribulin mesylate in humans or animals. However, nonclinical findings in repeated-dose dog and rat toxicology studies suggest that male fertility may be compromised by treatment with eribulin mesylate. Rats exhibited testicular toxicity (hypocellularity of seminiferous epithelium with hypospermia/aspermia) following dosing with eribulin mesylate at or above 0.43 times the recommended human dose (mg/m2) given once weekly for 3 weeks, or at or above 0.21 times the recommended human dose (mg/m2) given once weekly for 3 out of 5 weeks, repeated for 6 cycles. Testicular toxicity was also observed in dogs given 0.64 times the recommended human dose (mg/m2) weekly for 3 out of 5 weeks, repeated for 6 cycles.

17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling • Advise patients to contact their health care provider for a fever of 100.5°F or greater or other signs or symptoms of infection such as chills, cough, or burning or pain on urination.

• Advise women of childbearing potential to avoid pregnancy and to use effective contraception during treatment with HALAVEN. a

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– HALAVEN® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. © 2013 Eisai Inc. All rights reserved. Printed in USA / November 2013 HALA0475

S:10"

HALAVEN® (eribulin mesylate) Injection BRIEF SUMMARY – See package insert for full prescribing information.

2.2 Dose Modification Assess for peripheral neuropathy and obtain complete blood cell counts prior to each dose.

Recommended dose delays • Do not administer HALAVEN on Day 1 or Day 8 for any of the following: – ANC <1,000/mm3 – Platelets <75,000/mm3 – Grade 3 or 4 non-hematological toxicities.

• The Day 8 dose may be delayed for a maximum of 1 week.

– If toxicities do not resolve or improve to ≤ Grade 2 severity by Day 15, omit the dose.

– If toxicities resolve or improve to ≤ Grade 2 severity by Day 15, administer HALAVEN at a reduced dose and initiate the next cycle no sooner than 2 weeks later.

Recommended dose reductions • If a dose has been delayed for toxicity and toxicities have recovered to Grade 2 severity or less, resume HALAVEN at a reduced dose as set out in Table 1.

• Do not re-escalate HALAVEN dose after it has been reduced.

Table 1 Recommended Dose Reductions Recommended Event Description HALAVEN Dose 2 Permanently reduce the 1.4 mg/m HALAVEN dose for any of the following: ANC <500/mm3 for >7 days ANC <1,000 /mm3 with fever or infection 1.1 mg/m2 Platelets <25,000/mm3 Platelets <50,000/mm3 requiring transfusion Non-hematologic Grade 3 or 4 toxicities Omission or delay of Day 8 HALAVEN dose in previous cycle for toxicity Occurrence of any event requiring permanent dose reduction while receiving 1.1 mg/m2 0.7 mg/m2 Occurrence of any event requiring permanent dose reduction while receiving 0.7 mg/m2 Discontinue HALAVEN ANC = absolute neutrophil count.

Toxicities graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

5 WARNINGS AND PRECAUTIONS 5.1 Neutropenia Severe neutropenia (ANC <500/mm3) lasting more than one week occurred in 12% (62/503) of patients in Study 1, leading to discontinuation in <1% of patients. Patients with alanine aminotransferase or aspartate aminotransferase >3 × ULN (upper limit of normal) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal aminotransferase levels. Patients with bilirubin >1.5 × ULN also had a higher incidence of Grade 4 neutropenia and febrile neutropenia.

Monitor complete blood counts prior to each dose; increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias.

Delay administration of HALAVEN and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days. Clinical studies of HALAVEN did not include patients with baseline neutrophil counts below 1,500/mm3.

5.2 Peripheral Neuropathy Grade 3 peripheral neuropathy occurred in 8% (40/503) of patients, and Grade 4 in 0.4% (2/503) of patients in Study 1. Peripheral neuropathy was the most common toxicity leading to discontinuation of HALAVEN (5% of patients; 24/503). Neuropathy lasting more than one year occurred in 5% (26/503) of patients. Twenty-two percent (109/503) of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Monitor patients closely for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.

5.3 Embryo-Fetal Toxicity There are no adequate and well-controlled studies of HALAVEN in pregnant women. HALAVEN is a microtubule inhibitor; therefore, it is expected to cause fetal harm when administered to a pregnant woman. Embryo-fetal toxicity and teratogenicity occurred in rats that received eribulin mesylate at approximately half of the recommended human dose based on body surface area. If this drug is used during pregnancy, or if a patient becomes pregnant while taking this drug, she should be apprised of the potential hazard to the fetus.

5.4 QT Prolongation In an uncontrolled open-label ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no QT prolongation observed on Day 1. ECG monitoring is recommended if therapy is initiated in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid HALAVEN in patients with congenital long QT syndrome.

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience The following adverse reactions are discussed in detail in other sections of the labeling: • Neutropenia • Peripheral neuropathy • QT interval prolongation The most common adverse reactions (≥25%) reported in patients receiving HALAVEN were neutropenia, anemia, asthenia/ fatigue, alopecia, peripheral neuropathy, nausea, and constipation. The most common serious adverse reactions reported in patients receiving HALAVEN were febrile neutropenia (4%) and neutropenia (2%). The most common adverse reaction resulting in discontinuation of HALAVEN was peripheral neuropathy (5%).

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

In clinical trials, HALAVEN has been administered to 1,222 patients with multiple tumor types, including 240 patients exposed to HALAVEN for 6 months or longer. The majority of the 1,222 patients were women (82%) with a median age of 58 years (range: 26 to 91 years). The racial and ethnic distribution was Caucasian (83%), Black (5%), Asian (2%), and other (5%).

The adverse reactions described in Table 2 were identified in 750 patients treated in Study 1. In Study 1, patients were randomized (2:1) to receive either HALAVEN (1.4 mg/m2 on Days 1 and 8 of a 21-day cycle) or single agent treatment chosen by their physician (control group). A total of 503 patients received HALAVEN, and 247 patients in the control group received therapy consisting of chemotherapy [total 97% (anthracyclines 10%, capecitabine 18%, gemcitabine 19%, taxanes 15%, vinorelbine 25%, other chemotherapies 10%)] or hormonal therapy (3%). The median duration of exposure was 118 days for patients receiving HALAVEN and 63 days for patients receiving control therapy. Table 2 reports the most common adverse reactions occurring in at least 10% of patients in either group.

Table 2 Adverse Reactions with a Per-Patient Incidence of at Least 10% in Study 1 MedDRA ver 10.0 HALAVEN (n=503) Control Group (n=247) All Grades ≥ Grade 3 All Grades ≥ Grade 3 a Blood and Lymphatic System Disorders Neutropenia 82% 57% 53% 23% Anemia 58% 2% 55% 4% Nervous system disorders Peripheral neuropathyb 35% 8% 16% 2% Headache 19% <1% 12% <1% General disorders and administrative site conditions Asthenia/Fatigue 54% 10% 40% 11% Mucosal inflammation 9% 1% 10% 2% Pyrexia 21% <1% 13% <1% Gastrointestinal disorders Constipation 25% 1% 21% 1% Diarrhea 18% 0 18% 0 Nausea 35% 1% 28% 3% Vomiting 18% 1% 18% 1% Musculoskeletal and connective tissue disorders Arthralgia/Myalgia 22% <1% 12% 1% Back pain 16% 1% 7% 2% Bone pain 12% 2% 9% 2% Pain in extremity 11% 1% 10% 1% Investigations Weight decreased 21% 1% 14% <1% Metabolism and nutrition disorders Anorexia 20% 1% 13% 1% Respiratory, thoracic, and mediastinal disorders Cough 14% 0 9% 0 Dyspnea 16% 4% 13% 4% Skin and subcutaneous tissue disorders c Alopecia 45% NA 10% NAc

interview with the innovators

Providing Therapeutic Guidance for Breast Cancer Patients in the Molecular Era With the Breast Cancer IndexSM Assay: An Interview With Stephen C. Malamud, MD, and Susan K. Boolbol, MD, of Mount Sinai Beth Israel Hospital

W T:10.5"

ith the advent of gene expression profiling, we have gained the ability to objectively advise patients with breast cancer, among other cancers, on their risk of recurrence and potential benefit of therapies through the administration of assays designed to provide predictive and prognostic data. This is welcome news for a patient who has successfully endured treatment for cancer and remains fearful of the risk of relapse.

Also welcome news for patients with estrogen receptor– positive (ER+) breast cancer, recently presented data suggest a survival benefit for some patients by extending endocrine therapy to 10 years, rather than stopping at 5 years.

But the question remains, which subset of ER+ patients stands to benefit?

Physicians have a variety of choices on the assays to apply to their patients. There are many genetic expression profiling and expanded immunohistochemistry (IHC) tests to guide the adjuvant therapy of women with breast cancer, including Breast Cancer Index (BCI), MammaPrint, Oncotype DX, and Prosigna. In this installment of Interview With the Innovators, we focus on BCI – the only validated test available to physicians and patients that provides guidance on the benefit of extending endocrine therapy for an additional 5 years.

Navigate

BCI is a biomarker test that assesses distinct biological pathways for breast cancer. It predicts both early recurrence (0-5 years) and late distant recurrence (5-10 years) as well as the likelihood of benefit from extended endocrine therapy. About two-thirds of breast cancer patients are ER+, and the risk of late distant recurrence is a Stephen C. concern, with more than 50% of re- Malamud, MD currences occurring after 5 years.

The publishers of Personalized Medicine in Oncology (PMO) had the unique opportunity to discuss the utility of BCI with Dr Stephen Malamud and Dr Susan Boolbol of Mount Sinai Beth Israel Hospital about their collaboration as a medical and surgical oncology team to employ a test such as BCI in the treatment decision-making process for Susan K. Boolbol, MD patients. What follows are highlights from their thoughtful exchange. To view the video of their discussion, please visit www.personalizedmedonc.com.

THE EVOLVING MBC LANDSCAPE...

PMO Thank you for talking with us today about guiding stage of the cancer. Second comes a variety of these biothe adjuvant therapy of women with Indication breast cancer using markers that we now use to help differentiate who needs the Breast Cancer Index (BCI). To begin, can you describe hormone therapy, or combinations of those Halaven is indicatedchemotherapy, for the treatment of patients with metastatic the circumstance in which you would use this test? therapies and predictions in terms of outcome of treatment breast cancer (MBC) who have previously received at least two Dr Malamud At the time of diagnosis, a woman with regimens and the benefits those sameof therapies. chemotherapeutic for theoftreatment metastatic disease. breast cancer will come to the office toPrior maketherapy that critical The markers we have considered date include the should have included an anthracyclinetoand a taxane decision on how to move forward with in their adjuvant therestrogen or progesterone receptor by IHC, but more imeither the adjuvant or metastatic setting. apy. There are many parameters we will use to ascertain portantly, as we enter the era of personalized medicine, we risk and determine what the best treatment might be. look at the genomic analysis of the tumor to decide what First and foremost is the clinical presentation in the needs to happen in the first 5 years. If they are hormone positive, do they need chemotherapy in addition to their Please see Important Safety Information on the following hormone therapy? Secondly, what should we do when Dr Malamud is Associate Professor of Medicine, Hematology and spread accompanying summary thosefull patients have survived without a recurrence for their Medical Oncologyand at Mount Sinai Hospital in brief New York, New York.of Halaven Prescribing Information. first 5 years and we need to decide how to move forward?

Dr Boolbol is Chief of Breast Surgery, Appel-Venet Comprehensive Breast Service at Mount Sinai Beth Israel Hospital in New York, New York.

We now have genomic analysis for both of those scenarios.

HALAVEN ® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. © 2013 Eisai Inc. All rights reserved.

Printed in USA/November 2013 HALA0479 JONS-online.com journal of Oncology Navigation & Survivorship

31

interview with the innovators

The most critical new question is what to do at that fifth year when we have been relatively stuck with information that tells us that only a small percentage of women will benefit from an additional time on anti-estrogen therapy beyond the fifth year.

The Breast Cancer Index (BCI), a newly developed second-generation genomic assay, will tell us who is likely to benefit with the additional therapy (Figure 1). Other women, who have a low likelihood of benefit, may be absolved from continuing therapy. We can look at BCI to determine not only the risk of recurrence but the likelihood of benefit from additional therapy. We determine the risk of recurrence over those next 5 years, defined as low or high risk, and use that information as a segue to the discussion of the potential additional benefit of therapy. Based on data from the MA.17 study, those patients who have anything other than a low BCI predictive are more likely to benefit from an additional 5 years of therapy.

Dr Boolbol This field has changed enormously over the past 20 years. We wouldn’t think of treating a patient now without information from the initial biopsy, IHC of estrogen and progesterone, and Her2 status. And now we need genomic information when we’re discussing the potential benefit of chemotherapy. We now have assays to help guide us in treatment decisions.

Only a small percentage of women will benefit from an additional time on anti-estrogen therapy beyond the fifth year.

We have several clinical trials showing that 10 years of endocrine treatment is better than 5 years. That benefit for the overall population of women with breast cancer is relatively small, single digits. But, with BCI, we now have an assay to give us more information, to personalize the treatment for individual patients. We can tell a patient, we’ve run this assay on you and you are not likely to derive much benefit from an additional 5 years or, you will likely derive benefit. It’s a paradigm shift of great benefit to patients.

PMO Can you discuss the importance of the multidisciplinary treatment team and the value of gene expression profile tests to the team?

Dr Boolbol A critical part of taking care of women with breast cancer is the team approach. A surgeon cannot take care of a breast cancer patient alone, a medical oncologist cannot do it alone, and a radiation oncologist cannot do it alone. It really is a working, functioning team that needs to take care of the individual patient. In doing that, part of the surgeon’s job as potentially the first interaction with the patient is educating the patient on how their team

32

December 2014 • Volume 5, number 6

Figure 1 Predictive and Prognostic Indications

BCI Predictive

Predicts Likelihood of Benefit From Endocrine Therapy (5-10 yrs)

BCI Prognostic

Assesses Individual Risk of Late Recurrence (5-10 yrs)

functions and all the treatment options, from surgery to systemic therapy.

Considering these new genomic tests and patients’ involvement with the multidisciplinary team, it’s important that the patient understands that there are tests that the treatment team uses for early and late treatment. The patient should anticipate interaction with all of the team members, and that will make a difference to their overall care. In fact, studies have shown that patients treated at high-volume centers, meaning centers that take care of a lot of breast patients, treat patients in a multidisciplinary fashion, and the patients have better outcomes.

Dr Malamud Dr Boolbol and I are very fortunate in that when patients come in for their first visit after they’ve had a diagnosis established, we have the opportunity to see patients together or within several days of each other. Patients really pick up on that, and they understand that there is a multidisciplinary collaborative effort to maintain their health and continue their care for years. I’m not going to take care of you only for these couple of months and then I’m gone and will turn you over to this person. It is a team that continues for at least 5 years and usually more.

That kind of interaction is appreciated, and having us both in the same room sometimes at the same time where you’re talking about the surgical aspects and the postoperative care and introducing the concept of genomic testing, prognostic testing, hormonal therapy, chemotherapy, etcetera.

The treatments segue into my role quite nicely, and then if at the end of the day they still have some questions, the fact that we can assure them that the following day their case is going to be presented at an even larger, multidisciplinary session again affords some relief because now they’re going to have 20-odd heads discussing their case, hopefully getting a check mark of approval to what we’ve already discussed.

Dr Boolbol As I tell patients, breast cancer is too big for them to handle alone. They need support. And it’s the same thing for those of us caring for them. As a multidisciplinary team we support each other in order to take care of the individual patient. It’s important for patients to know

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how the team interacts and functions. For example, since I am the first one seeing the patient postoperatively and seeing their pathology first, I’m the one who orders any genomic test that will aid in the decision of chemotherapy.

As the patient moves through treatment and follows up with me and with Dr Malamud, then we start discussing other tests that will aid in the decision of long-term treatment, specifically endocrine treatment such as BCI. PMO BCI touts the unique ability to predict risk of both early and late recurrence, as well as likelihood of benefit from extended endocrine therapy in early ER+ breast cancer. In your experience, are these performance characteristics unique for BCI compared with the other assays?

Dr Malamud Yes, BCI testing has become an important adjunct in our care of patients, especially as we make decisions about therapy beyond 5 years. Normally it’s been the paradigm in the adjuvant treatment of breast cancer that the endocrine treatment continue for 5 years, and we’ve been hard-pressed to find data to support going past the 5-year mark.

Recently, however, several trials, including the ATLAS, MA.17, and others, have shown that there is an advantage for some women to go on with extended adjuvant treatment beyond the fifth year.

The BCI test can help us decide which of those women are actually likely to see benefit from an additional 5 years.

If one looks at those trials that were done years ago and now beyond the 10-year mark, the absolute benefit for most of the women if one looks at the mean is only about 5% or 6%, which means that most women do not benefit from being on 5 years of additional therapy. Our goal is to try and isolate those patients who are going to benefit from treatment and not give extended 5 or 10 more years of hormonal therapy to those women who are not likely to realize benefit.

So BCI is a test that separates those patients who are more likely to benefit from those who are unlikely to benefit. It offers a genomic profile of the tumor using a geno­mic panel completely distinct from the one that they may have had 5 years earlier and looks at the likelihood of benefit from continuing that treatment.

We are able to explain to the patient that this test is designed to help tell us whether or not there’s more therapy that’s likely to work for them in preventing this disease from coming back. It will help tell us whether or not you need to be treated beyond that fifth year or if we can just stop and be comfortable with that idea.

The idea of being able to stop potentially problematic hormonal therapy that they’ve endured for the 5 years prior is an amazing relief for these women who do not have to continue therapy. And for the women who are likely to benefit from continuing therapy, knowing that there is

something that’s going to help them if they are at high risk is again almost of the same benefit.

Dr Boolbol If you compare how we treated patients 10 years ago to now, it’s vastly different. That was really just a cookie-cutter mold. You have breast cancer, it’s this size, it’s this stage, this is what you get. We still have a long way to go, but we really have moved so far past that, and it’s because of these genomic tests.

So BCI is a test that separates those patients who are more likely to benefit from those who are unlikely to benefit. It offers a genomic profile of the tumor using a genomic panel completely distinct from the one that they may have had 5 years earlier and looks at the likelihood of benefit from continuing that treatment.

If the patient is not likely deriving any benefit and this treatment is not helping them, why would we put them at risk for any side effect? I only want to give a patient treatment if they will benefit. The studies show that there is a small benefit for longer than 5 years of treatment, up to 10 years of endocrine treatment. When we exclude the low-benefit patients and treat the patients who stand to benefit, we’re making strides in treating their disease.

When we look at chemotherapy, we see the same thing.

When we look at the overall benefit of chemotherapy, it was only about 4% for the individual patient. But when you remove the low-risk patients and you just treat the high-risk patients with chemotherapy, you’re now seeing benefits of over 25%. That’s what we’re doing now in the extended endocrine phase of their treatment.

If we eliminate the low-risk patients who really are not likely to derive any benefit, and we’re only treating the high-risk patients who are likely to benefit, that’s where we’re going to see an enormous difference in outcome.

Dr Malamud To take data from 10,000 people and point to the 3% or 5% that may benefit and guess that you might be in that 5% is now an unnecessary gamble. That’s 5 years of treatment with the side effects of anti-estrogen therapy for a potential 5% difference in outcome. It is a big deal for a 40-year-old to continue another 5 years of tamoxifen or for a 60-year-old to continue another 5 years of an aromatase inhibitor (AI). There can be consequences of the treatments that may be in excess of that 5% to 6% difference in the long-term survivorship, or disease-free survivorship.

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Figure 2 BCI Validation Studies

MA.17 RCT

Stockholm RCT

Multiinstitutional

TransATAC RCT

Predictive

Prognostic

Prognostic

Prognostic

J Natl Cancer Inst, 2013

Clinical Cancer Research, 2013

Clinical Cancer Research, 2013

Lancet Oncology, 2013

Validation in Prospective RCT Cohort

Validation in Multi-institutional Cohort of Consecutive Cases

Validation in Prospective RCT Cohort & Head to Head with Oncotype Dx

249 Patients

317 Patients

358 Patients

665 Patients

Post-menopausal

Post-menopausal

Pre- and Postmenopausal

Post-menopausal

ER+ LN- and LN+

ER+ LN-

ER+ LN-

ER+ LN-

Extended AI

Adjuvant TAM

Adjuvant TAM

Adjuvant TAM or AI

Validation in Prospective RCT Cohort

Case-control design to enrich for recurrences

Over 1,500 patients across 4 study cohorts

Dr Boolbol It’s no longer one size fits all – we’re really treating the individual patient. Ten years ago I could tell a patient with a tumor measuring greater than 1 centimeter they were getting chemotherapy. We’ve moved into the era of genomic testing that looks at the individual cancer to determine if the patient will benefit from chemotherapy.

Now my discussion with a patient includes educating them on a test to help with the decision for chemotherapy, and at 4½ to 5 years we’ll be implementing another test to help us with the decision of continuing endocrine or anti-estrogen treatment for another 5 years.

Dr Malamud BCI testing has now become a critical part of our decision making in that 4-, 4½-year mark and provides another opportunity to educate the patients. It behooves us as physicians to stay educated because breast cancer patients come in with that information. I relish that discussion because this is something that’s going to help us decide who gets treated.

PMO Please describe the prognostic and predictive characteristics of this assay.

Dr Malamud The Breast Cancer Index has 2 unique qualities. The first is that it is prognostic in terms of the re-

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currence of breast cancer in those second 5 years of disease-free state, and secondly, it will give us a prediction in terms of the value of the additional hormonal therapy for the additional 5 years. Those data are actually the only validated data for any test in demonstrating likelihood of benefit for some patients in treating beyond 5 years (Figure 2).

Those data actually come from a very large multicenter trial, a randomized trial done from the NCIC in Canada called the MA.17, which looked at continued adjuvant therapy, continuing an AI after the first 5 years of tamoxifen.

When that patient population was analyzed, there was a demonstrable benefit for those patients who received the additional AI therapy 2 years or more. In fact, at the 2-year mark, when the code was broken, it already was such a dramatic difference that the patients were unblinded and offered cross-over, which has been a criticism of that protocol.

But when one looks at that protocol and looks at the outcome, again the results were relatively small for the overall population. When that tumor population was looked at and classified by BCI analysis, it was quite clear there were 2 groups – those that were benefiting and those that were not. Those that were benefiting had a 15% or

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more, perhaps even 16% difference in terms of likelihood of benefit, or likelihood of recurrence versus the group that was statistically not getting any benefit at all.

PMO How has BCI changed the discussions you have had with your patients?

Dr Malamud Using those data and the discussion with the patient regarding risk and benefits, we’re able to separate out those patients who are more likely to be getting an increased benefit from that additional time on drug. Without that, we were obliged to offer at least the discussion regarding continued adjuvant therapy, and patients would look at those data relatively quizzically and wonder whether or not they were going to be in that small subgroup of patients who are actually benefiting and whether or not converting from a tamoxifen to an AI was worth that little incremental gain and the toxicities associated with the AIs. The Breast Cancer Index has made that discussion not only objective but more acceptable at the patient’s level.

BCI occupies a pivotal role now in our decision making when a woman receiving hormone adjuvant therapy reaches the fourth to fifth year of their treatment.

Dr Boolbol You hit on some key points, especially that this now gives us objective evidence. BCI allows us to have this objective discussion with our patients and move away from that one size fits all to where we have a validated test to show us that you are not likely to benefit or that you are likely to benefit. And we know that 50% or more of patients are of low benefit for extended treatment, and that makes a big difference to those patients.

Dr Malamud To be able to point to the other bar graph and say look, you’re going to be one of the women who’s more likely to benefit from additional therapy; you’ve already done the first 5 years, let’s go the full-court press. We have the evidence that you’re in the potential group that’s going to benefit from treatment, let’s move forward.

That kind of objective information will oftentimes convince the patient to get off the fence and to move forward.

That’s incredibly important for us now at that fifth year where we’re sort of stuck in terms of weighing the benefits without data. The Breast Cancer Index has provided the data that allow for an objective discussion.

Dr Boolbol We know with endocrine treatment compliance is an issue with most of our patients. Patients have heard for years that you take 5 years of endocrine treatment and you’re done. But then we’re asking for another 5 years because we have studies to show that an

additional 5 years may be of benefit, many patients think “I’m not doing this another 5 years. I’ve endured side effects from this for 5 years.”

But if we tell a patient, listen, we’ve done the BCI test for you, and we know you are likely to benefit from this, they may be much more likely to be compliant with the next 5 years of treatment.

It’s a paradigm shift in how we’re treating patients with breast cancer.

Dr Malamud If one has that information and it’s there in black and white, and anyone tells them that this test was devised just for this purpose and there is a strong likelihood that you’re in this category that will benefit from treatment, it turns an hour-long discussion as to risks and benefits into something much more manageable and focused such that the patient who thought, “Gee whiz, I’m all finished,” now can at least be given some objective data that there is value for more.

PMO Extending endocrine therapy past 5 years is a notion recently studied in the ATLAS and MA.17 trials. Can you please discuss this development, the role BCI plays in making the decision of whether to continue therapy, and the impact on patients?

Dr Malamud BCI occupies a pivotal role now in our decision making when a woman receiving hormone adjuvant therapy reaches the fourth to fifth year of their treatment.

That has been the paradigm and the therapy for women with hormone-positive breast cancer such that they remain on anti-estrogen therapy for 5 years. We’ve been struggling to find that population of women who will benefit from extended adjuvant, meaning continuing that anti-estrogen therapy onto the fifth and now into the tenth year.

Several clinical trials showed definitively that there is improvement in a population of women to be treated beyond that fifth year. Both the ATLAS and MA.17 trials demonstrate an improvement somewhere between 3% and 6% for the overall population. However, the woman sitting in front of you at that fourth to fifth year is not really interested in the general population of 5000 or more women.

They really want to know what the likelihood is that they’re going to benefit, and pointing out that there is a 3% to 6% difference is not helpful to me because it also means that they’re also at risk for all the complications of treatment that take place beyond the fifth year; whether that’s a continued menopausal symptomatology of tamoxifen or the potential risk of osteoporosis, and other complications of the aromatase inhibitors.

It’s also worth noting that BCI can be used to revisit a previously made treatment decision. For example, if you have a 42-year-old patient, 7 years postdiagnosis, who

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Figure 3 Treatment Implications

BCI Result

Treatment implications

Low likelihood of benefit Low risk of recurrence

May allow you to confidently stop endocrine therapy after year 5 – and avoid unwanted side effects

High likelihood of benefit High risk of recurrence

May allow you to strongly recommend extending and adhering to endocrine therapy

opted to discontinue tamoxifen 2 years ago at the 5-year point, you can obtain the BCI test to provide reassurance of that treatment decision. If the test result for this patient shows a high likelihood of benefit from an additional 5 years of therapy, the patient can be offered to restart endocrine treatment. The reverse is also true; you may have a patient who decided to continue anti-estrogen treatment for an additional 5 years, but obtaining the BCI test at the seventh year yielded a result of low likelihood of benefit.

For this patient, I may recommend discontinuation of therapy at this point.

Dr Boolbol I think that the Breast Cancer Index and really the ATLAS trial and the MA.17 trial are pivotal changes or paradigm shifts in how we’re taking care of patients. Prior to the release of these studies I would tell a patient that they were on endocrine treatment for 5 years. Again, this goes on during their initial consult as part of their overall treatment plan. Now I tell them that they’ll be on it for 5 to 10 years depending on the results of this test.

I do not know whether they will benefit from extended therapy or not. I have trials to say yes, the population at large benefits, but sitting in front of that patient, they’re really not interested in the population at large. They’re interested in what will benefit them, and I now can sit there and say we have a test, BCI or Breast Cancer Index, that we’ll be doing around 4½ years to tell us and give us that information of whether you are likely to benefit from extended therapy.

If there is a low likelihood of benefit, I may recommend that you don’t need it. No one wants to be taking a medication with potential side effects for little to no benefit. If there is benefit, you will want to take it, and that’s really what we’ve gotten down to. It’s a paradigm shift in how we’re treating patients with breast cancer (Figure 3).

Dr Malamud We always think that it’s relatively easy to convince somebody to take their medication that’s going to be potentially lifesaving for the first 5 years. Compliance in the first 5 years is critical. Convincing someone who’s already endured some considerable discomfort for those first

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5 years to consider going on for another 5 years can be difficult. It’s nice, in fact, it’s critical to have this information that justifies the continuation of therapy.

PMO Can you share your thoughts on how BCI affects patients in terms of their notions of survivorship or the psychological impact of stopping versus continuing treatment?

Dr Malamud The Breast Cancer Index is an important tool to help at the decision point at that 4½- to 5-year mark. Clearly, it’s important for the patient to know whether additional therapy will be beneficial for them over the next 5 years. But probably, almost of equal importance, is the reliance on Breast Cancer Index in helping us decide to stop after 5 years.

Medicare has recently provided coverage for patients receiving testing with the Breast Cancer Index.

A breast cancer patient, when she hits that 4½-year mark, is looking toward that goal line as the time that they can finally stop treatment. They need to go on with their life off of medication, be assured their disease is under control and likely to stay under control for the next 5 to 10 years.

In the past, we were reluctant to do that without testing that could help us, especially after the recent trials of the ATLAS or MA.17 and the extended adjuvant trial to tell us more might be better. But more is only better in a few patients. Being able to tell a patient with more confidence that I think it is safe to stop, that I think it’s safe to go on with your life without additional medication, that it’s safer to perhaps not have any of these side effects that are destined or at least likely to happen over these next 5 years is very important.

I often tell the patient they’re a survivor from the minute they meet me. But that 5-year mark has become a goalpost for many women with breast cancer and, frankly, for many people with all sorts of cancer, that 5-year mark has been their unofficial guidepost, and now being able to

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actually tell them in an objective way that after the fifth year, I think it’s safe to stop. You don’t need to go on.

Breast cancer is a scary disease for many women, and stopping therapy is every bit as difficult as continuing treatment and being able to show them with reliance that their likelihood of recurrence is small and their likelihood of benefit is equally small gives us the ammunition to support that decision.

Dr Boolbol It’s interesting how patients fall into 1 of 2 camps, and as a surgeon, at the 4-, 4½-year mark this discussion really is ramping up where you have the patient who cannot wait to get off their endocrine treatment and they’re marking it on their calendar. And then you have the other camp of patients that this is really their crutch, and they feel like taking this pill everyday is really helping them – it’s saving their life. We really do now have objective data with BCI to help them through this period at the 5-year mark – we now can say this will continue to help you or this is not likely to give you any additional benefit.

Now we have genomic testing that looks at the production and expression of genes associated with risk of recurrence and value of endocrine therapy in years 5-10.

And it helps both camps of patients, because for the women who really feel as though this pill is making an enormous difference and they never want to stop it, we now have a test in BCI to say we’ve run this test and we know that the likelihood of benefit is small for you. At that point the risk/benefit ratio switches. There may be more risks than benefits. That helps them.

For the other patients where the benefits outweigh the risks, that helps them. So really, every step along the way we as physicians are weighing the risk/benefit profile along with the patients to help determine the best, most ideal treatment for them.

Dr Malamud The best survivorship with the best quality of life. That’s what we’re trying to do.

PMO How does the use of this test (BCI) impact patient confidence in their treatment plan and ensure adherence to medication? How difficult is it to explain gene expression profiling and BCI to patients and how this technology will impact their care?

Dr Boolbol It comes down to risk/benefit. If we have a test result telling us that there’s low likelihood of benefit to continued treatment, the patients, knowing that this is a validated test, are going to go along with that. And the reverse is true. If we have a test telling us that they will

derive benefit from continued treatment, although they may not be thrilled about continuing endocrine treatment for another 5 years, they will willingly go along with it and are more likely to be compliant.

Dr Malamud For the 5 years prior we’ve talked about survivorship and getting through the treatment. We tell our patients to win the battle, fight the battle today to survive the next couple of years so when the next test or next treatment becomes available, you’re there to participate.

Had we not been in clinical trials, had we not stored your tumor, had we not survived these 5 years, we wouldn’t be having this discussion, so here we are, here’s the information, and it is individualized.

Dr Boolbol We have to remember it’s validated, predictive data, and that’s critically important. I talk to patients about short term and long term and we want to get through the short term so that we have the long term, and that’s really what it comes down to.

PMO How can payers be educated on the value of these technologies to ensure patient access and cost reimbursement?

Dr Malamud Medicare has recently provided coverage for patients receiving testing with the Breast Cancer Index.

This is clearly appropriate in my mind, and I would certainly support that it extends onto the other private insurers because, frankly, anyone receiving hormonal therapy, whether they’re Medicare eligible or not, should have the opportunity for this sort of test to be applied to them when they hit the appropriate time frame. Medicare is often the first to adopt new technologies and new treatments, but they’re also a signpost for the third-party coverage to look with a critical eye at the test and appropriately adopt them into their treatment plans as well.

Clearly, if one looks at the advantages to them, the Breast Cancer Index score that would indicate a patient should come off of therapy is advantageous not only to the patient in terms of their side effects and risks, but also advantageous to the insurer to avoid having not only to pay for the course of the drugs over the next 5 years but also to potentially deal with risks and complications over those 5 years to come.

Dr Boolbol I think that insurance coverage really goes back to personalized medicine and now we have coverage for BCI from Medicare, it really seems as though every insurance company out there should follow suit. Just as we want to individually take care of our patients, insurance companies should want the same. There is no medication without potential side effects, and limiting access to a test such as BCI that’s out there and available to tell us whether or not a patient will benefit from therapy or withhold coverage really does not make any sense and it is not in the patient’s best interest.

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PMO What are the next steps in comprehensive personalized medicine for patients with breast cancer.

Dr Malamud As we move forward in the treatment of women with breast cancer, we will continue to see increasing use of a personalized approach. We’ve seen personalization of treatment, first in the development of the estrogen and progesterone receptor for those women who would benefit from hormone therapy. After that came Her2 testing to figure out who required anti-Her2 therapy. Now we have genomic testing that looks at the production and expression of genes associated with risk of recurrence and value of endocrine therapy in years 5-10. And now with the Breast Cancer Index, helping us to decide what to do when they hit that fifth-year mark.

There are a variety of other genomic tests out there to determine the interactions or potential resistance mechanisms for chemotherapy, resistance mechanisms in Her2, mTOR inhibition, PI3 kinase. There are companies where you can send tumors for complete geno­mic analysis to find actionable mutations with the hope that if there’s a mutation for which we have an appropriate drug, we can use that drug to target that mutation.

Dr Boolbol The way in which we treat patients 10 years from now will be completely different from what we’re

doing today. Systemic issues, local treatment of breast cancer, how we do surgery, when we do surgery, what options we’re offering the patients, all these will be very different 10 years down the road.

I think that we’re going to be taking a minimally invasive approach to surgery such as cryoablation as opposed to excising the patient’s cancer in the operating room.

We’re making advances in all of the arenas of how we treat breast cancer.

Radiation, for instance, there will be fewer patients who receive radiation. We’re also moving into the era of determining who will benefit from radiation rather than just treating every patient who has undergone breast conservation with radiation.

In every discipline of our multidisciplinary team, we’re making advances in the treatment of breast cancer, all taking a personalized approach. If you look at genetic testing, we’ve made incredible advances; so many advances that we don’t have answers to everything that we know right now. That’s one of the things that clinical trials will help us with.

PMO Thank you both very much for your time today, and our best to you and your continued success in your treatment of patients with breast cancer. g

Call for Papers The Journal of Oncology Navigation & Survivorship® (JONS), launched in 2010, is the nation’s first peer-reviewed clinical journal for Oncology Nurse and Patient Navigators. As this critical area of specialty and expertise grows, research and sharing of best practices are integral to both improving the clinical care of cancer patients as well as expanding the existing literature and knowledge base. Our goal at JONS is to help facilitate that growth.

Papers can be in the following forms: • Original Research • Case Study • Review Article (a synopsis/review of current • “How To” article designed to transfer literature in a specific area of research) successes to fellow practitioners Each manuscript is subject to an internal review to see that it fits the scope and mission of our journal. Papers that pass the initial review could be subject to a blind peer review; final acceptance is based on that review.

If you are interested in submitting a paper or have any questions, please feel free to visit our website www.JONS-online.com or e-mail our editorial department at acooper@the-lynx-group.com.

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AONNonline.org

Evasion of apoptosis may be a question of balance Increased BCL-2 expression helps cancer cells to survive1

BCL-2

Displacement of pro-apoptotic proteins may trigger apoptosis1

Pro-apoptotic proteins sequestered

by BCL-2

Free pro-apoptotic proteins

Increased expression of BCL-2 impairs the pathway to programmed cell death Like normal cells, cancer cells will often induce expression of pro-apoptotic proteins in response to stressors like limited metabolic resources, rapid cell division, or exposure to cytotoxic agents1.

Cancer cells may increase expression of the anti-apoptotic protein, BCL-21.

Pro-apoptotic proteins are bound and sequestered by BCL-2, helping the cancer cell to avoid programmed cell death2.

Mitochondria

Pro-apoptotic proteins—if displaced from BCL-2—have the potential to trigger apoptosis1.

To learn more about the BCL-2 pathway, visit BOOTH #1343 and #1909 at the ASH annual meeting

References: 1. Letai, A.G., Diagnosing and exploiting cancer’s addiction to blocks in apoptosis. Nat Rev Cancer, 2008. 8(2): p. 121-32. 2. Garcia-Saez, A.J., The secrets of the Bcl-2 family.

Cell Death Differ, 2012. 19(11): p. 1733-40.

© 2014 Genentech USA, Inc. All rights reserved. BIO/102214/0063 Printed in USA.

A3469581

quality care

What Constitutes Good Oncology Care?

Sheryl Riley, RN, OCN, CMCN, Director of Clinical Services, SAI Systems, Shelton, CT

Q

uite often I am asked what constitutes “good” oncology care. Many people have their opinions; patients, doctors, allied medical professionals, and even health plan administrators like to weigh in on this issue. Those in the industry often use buzzwords—eg, quality, outcomes, and cost—interchangeably, but are they really the same? Unfortunately, no one seems to be in agreement on the answer.

Most healthcare professionals know that good oncology care is essential, but without a set of unified standards or distinct definitions on how to measure good care, it is almost impossible for everyone to speak the same language.

We must then ask ourselves, “What is our benchmark?”

Should we turn to medical terminology—overall survival, time to recurrence, and response—in order to standardize our language? Perhaps the cost of a drug versus total treatment should be considered, and, consequently, whether we can demonstrate any savings in this analysis? In this ever-­ changing world of healthcare, where so many of the services we provide are guided by a bottom line, would it be prudent to teach more self-management skills to patients and families, such as how to monitor tumor markers and laboratory results, so they can ascertain the effectiveness of their treatment?

A defining element of good care may also come in the form of a standardized care plan that allows patients to stay in their homes rather than in the hospital, or helps to maintain their health during and after treatment, maximizing patients’ time in normal pursuits, such as work and family experiences. Yet often we must also assist with endof-life care (ie, helping patients and families determine whether a clinical trial, palliative care, or hospice care would provide the greatest quality of life).

After surveying available data on this subject of good, quality care, one of the key problems I have seen is that the medical profession has a set of criteria, payers may have another, and, subsequently, patients and patient advocacy groups may have yet another set of criteria. This separation begs the question: If we are all attempting to provide what is best for the patient, how do we blend these criteria together so that they make sense, not just for us, but for our patients and their families?

A close review of the literature identifies organizations responsible for creating standards for oncology care, as well as those that monitor these standards to make certain they

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are given appropriate attention. Speaking with colleagues, practicing oncologists, oncology care management nurses, medical directors from health plans, and those working in cancer education and advocacy also provides insights into standards of care. Finally, in order to round out the analysis, one should speak with patients and families to see how they measure quality care. Recent literature and Internet research demonstrated some of the following findings.

On its website, the Susan G. Komen Foundation for Breast Cancer states, “Every person diagnosed with breast cancer deserves the best care possible. Quality of care is a measure of how well your breast cancer is treated [and] how well you are cared for during and after treatment.”1

After surveying available data on this subject of good, quality care, one of the key problems I have seen is that the medical profession has a set of criteria, payers may have another, and, subsequently, patients and patient advocacy groups may have yet another set of criteria.

The Institute of Medicine (IOM) defines quality healthcare as “The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”2 IOM advises that a quality hospital or medical center should have clean, up-to-date facilities; well-stocked examination and operating rooms; up-to-date diagnostic equipment; and healthcare providers with appropriate professional credentials.

In an April 1999 IOM report, “Ensuring Quality Cancer Care,” the National Cancer Policy Board suggested that many patients with cancer are not receiving the care known to be effective for their disease. The board believed the problem to be significant, but observed there was insufficient evidence to determine the true magnitude.3 Organizations such as the American Society of Clinical Oncology (ASCO) recognize the importance of integrat-

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2014-2015

SCIENTIFIC CONFERENCES Presenting the most significant research on cancer etiology, prevention, diagnosis, and treatment

Translation of the Cancer Genome Co-Chairpersons: William C. Hahn, Lynda Chin, and William R. Sellers February 7-9, 2015 • San Francisco, CA Computational and Systems Biology of Cancer Co-Chairpersons: Andrea Califano, Brenda Andrews, and Peter Jackson February 8-11, 2015 • San Francisco, CA AACR-Society of Nuclear Medicine and Molecular Imaging Joint Conference: Molecular Imaging in Cancer Biology and Therapy Co-Chairpersons: Carolyn J. Anderson, Christopher H. Contag, and David Piwnica-Worms February 11-14, 2015 • San Diego, CA Tumor Angiogenesis and Vascular Normalization: Bench to Bedside to Biomarkers Co-Chairpersons: Rakesh K. Jain, Peter Carmeliet, Helen Chen, Harold F. Dvorak, and Napoleone Ferrara March 5-8, 2015 • Orlando, FL AACR Annual Meeting 2015 Program Committee Chairperson: Lewis C. Cantley April 18-22, 2015 • Philadelphia, PA Advances in Brain Cancer Research Co-Chairpersons: Eric C. Holland, Franziska Michor, Martine F. Roussel, and Michael D. Taylor May 27-30, 2015 • Washington, DC Metabolism and Cancer Co-Chairpersons: Ralph J. DeBerardinis, David M. Sabatini, and Almut Schulze June 7-10, 2015 • Bellevue, WA Methods in Cancer Biostatistics Workshop: Clinical Trial Designs for Targeted Agents Director: Steven Piantadosi June 7-13, 2015 • Lake Tahoe, CA AACR Precision Medicine Series: Integrating Clinical Genomics and Cancer Therapy Co-Chairpersons: Charles L. Sawyers, Elaine R. Mardis, and Arul M. Chinnaiyan June 13-16, 2015 • Salt Lake City, UT

www.AACR.org/Calendar

EACR-AACR-SIC Special Conference on Anticancer Drug Action and Drug Resistance: From Cancer Biology to the Clinic Co-Chairpersons: Richard M. Marais, Pasi Jänne, and Riccardo Dolcetti, June 20-23, 2015 • Florence, Italy Chromatin and Epigenetics in Cancer Co-Chairpersons: Sharon Y. R. Dent, Peter A. Jones, and Charles W. M. Roberts September 24-27, 2015 • Atlanta, GA CRI-CIMT-EATI-AACR The Inaugural International Cancer Immunotherapy Conference: Translating Science into Survival 2015 September 27-30, 2015 • New York, NY Advances in Breast Cancer Research Co-Chairpersons: Matthew J. Ellis, Charles M. Perou, and Jane E. Visvader October 17-20, 2015 • Bellevue, WA Advances in Ovarian Cancer Co-Chairpersons: Kathleen R. Cho, Douglas A. Levine, and Benjamin G. Neel October 17-20, 2015 • Orlando, FL Fourth AACR International Conference on Frontiers in Basic Cancer Research Chairperson: M. Celeste Simon; Co-Chairpersons: James P. Allison, John E. Dick, Nathanael S. Gray, and Victor E. Velculescu October 23-26, 2015 • Philadelphia, PA Basic Science of Sarcomas Co-Chairpersons: Robert G. Maki, Jonathan A. Fletcher, Lee J. Helman, Angelo Paolo Dei Tos, and Brian Van Tine November 3-4, 2015 • Salt Lake City, UT New Horizons in Cancer Research Co-Chairpersons: Lewis C. Cantley and Carlos L. Arteaga November 2015 • Shanghai, China AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Scientific Committee Co-Chairpersons: Levi A. Garraway, Lee J. Helman, and Jean-Charles Soria November 5-9, 2015 • Boston, MA

quality care

ing continuous quality improvement into patient-centered clinical practice; it has collaborated with the world’s leading cancer care experts to develop 2 key quality programs: the Quality Oncology Practice Initiative (QOPI) and the QOPI Certification Program.4 These tools assist oncologists and their practice in creating programs that effectively measure and compare their care with other practices in a continuous and meaningful way.

Oncology nurses, care managers, and alike believe that good oncology care is related to early detection, early and accurate diagnosis, and timely implementation of accurate first-line treatment, followed by proper monitoring of tumor markers for treatment adjustments and proactive control of side effects, as well as strong patient advocacy for palliative and end-of-life care when appropriate. Subsequently, they focus on the patient’s physical, emotional, and social needs being met early on in the process and throughout. Oncology professionals who manage, treat, and educate patients and families measure good care based on the patient’s ability to continue to function in daily routines, including work and family life.

For us to truly measure good care, we need to make certain that we address our patients’ needs in the beginning, and continue to reassess and reevaluate their needs throughout the process.

As I have spoken with physician colleagues throughout the United States, in my daily work as an oncology care manager, as a moderator at regional and national meetings, and as an educator and presenter, the feedback I have received from physicians indicates that their focus has been on cost and efficiency. That focus seems to be driven by the necessity of serving dual roles as physicians and business owners. Another key factor in this conundrum is the healthcare reimbursement system. While physicians want to do what is best for their patients and patients’ families, sometimes they may be influenced by the wrong incentives.

In my conversations with health plan medical directors in the same forums as stated above, it appears they are looking for ways to cut costs and be effective, but also to partner with community oncologists and their practices.

We have discussed their ideas and thoughts around the oncology patient-centered medical home and how that may work to improve care as well as cost. The ideas include

42

December 2014 • Volume 5, number 6

giving more control of patient care and management back to the oncologist, but also requesting assurances based on the use of treatment guidelines, clinical trials, and strong oncology care management that patients and their needs remain at the center of care and treatment plans.

Finally, I have spoken extensively with patients, their families, and other caregivers, and their focus is much different from that of the oncology patient-centered medical home. They view good cancer care as whether the patient or family member was diagnosed correctly and given the right treatment the first time, how rapidly their social and emotional needs were met, and the type of experience they had moving a family member to palliative care or hospice.

Most national organizations do their best to manage the process, place tools in the hands of practicing oncologists and their teams, and promote the best care possible for patients and their families. However, I am still concerned that they have lost sight of what the patient’s care expectations are, and how the patient gauges good care. Quite often, the focus is on the diagnosis, which is important, but in doing so we forget to ask patients what their goals and expectations are in the process of treating their cancer. For us to truly measure good care, we need to make certain that we address our patients’ needs in the beginning, and continue to reassess and reevaluate their needs throughout the process.

The collective oncology community must work together more closely and begin to gather and assess patients’ expectations of care; this information has been lacking in our quality metrics. Just as we set goals for our patients, we should make our primary goal asking the patient, “What are your expectations through your treatment process?” In doing so, we may be surprised at some of the answers, and, subsequently, how that may affect the treatment path followed. By making this step part of the workflow and operational process, we will have the missing information needed to measure good oncology care and treatment. Without this information, we may never reach this goal in patients’ eyes, and they are the ones who matter the most. g

References

1. Susan G. Komen. What is Quality of Care (Good Care)? ww5.komen.org/ BreastCancer/WhatisGoodCare.html. Updated March 24, 2014. Accessed April 20, 2014.

2. US Department of Health & Human Services, Health Resources and Services Administration. What is Quality? http://www.hrsa.gov/healthit/ toolbox/HealthITAdoptiontoolbox/QualityImprovement/whatisquality.html.

Accessed April 30, 2014.

3. National Cancer Policy Board, Institute of Medicine and Commission on Life Sciences, National Research Council. Summary. In: Hewitt M, Simone JV, eds. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press, 1999:1-12. http://books.nap.edu/openbook.php?record_id=6467 &page=1. Accessed April 30, 2014.

4. American Society of Clinical Oncology. Guidelines. http://www.asco.org/ quality-guidelines/guidelines. Accessed April 30, 2014.

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Good Manufacturing Practice Lillie D. Shockney, RN, BS, MAS

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

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