Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET).


Adjuvant endocrine therapy (AET) is used to prevent recurrence and reduce mortality for women with hormone receptor positive breast cancer. Poor adherence to AET is a significant problem and contributes to increased medical costs and mortality. A variety of problematic symptoms associated with AET are related to non-adherence and early discontinuation of treatment. The goal of this study is to test a novel, telephone-based coping skills training that teaches patients adherence skills and techniques for coping with problematic symptoms (CST-AET). Adherence to AET will be assessed in real-time for 18 months using wireless smart pill bottles. Symptom interference (i.e., pain, vasomotor symptoms, sleep problems, vaginal dryness) and cost-effectiveness of the intervention protocol will be examined as secondary outcomes. Participants (N = 400) will be recruited from a tertiary care medical center or community clinics in medically underserved or rural areas. Participants will be randomized to receive CST-AET or a general health education intervention (comparison condition). CST-AET includes ten nurse-delivered calls delivered over 6 months. CST-AET provides systematic training in coping skills for managing symptoms that interfere with adherence. Interactive voice messaging provides reinforcement for skills use and adherence that is tailored based on real-time adherence data from the wireless smart pill bottles. Given the high rates of non-adherence and recent recommendations that women remain on AET for 10 years, we describe a timely trial. If effective, the CST-AET protocol may not only reduce the burden of AET use but also lead to cost-effective changes in clinical care and improve breast cancer outcomes. Trials registration: ClinicalTrials.gov, NCT02707471, registered 3/3/2016.





Published Version (Please cite this version)


Publication Info

Shelby, Rebecca A, Caroline S Dorfman, Hayden B Bosworth, Francis Keefe, Linda Sutton, Lynda Owen, Leonor Corsino, Alaattin Erkanli, et al. (2019). Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET). Contemporary clinical trials, 76. pp. 120–131. 10.1016/j.cct.2018.11.010 Retrieved from https://hdl.handle.net/10161/29871.

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Rebecca A Shelby

Associate Professor in Psychiatry and Behavioral Sciences

Rebecca Shelby, Ph.D. is an Associate Professor with Tenure in the Department of Psychiatry and Behavioral Sciences at Duke University and the Director of Education and Training for the Duke Cancer Patient Support Program.  Dr. Shelby is a member of the Duke Pain Prevention and Treatment Research Program and the Duke Cancer Control and Population Sciences Program. Dr. Shelby completed her graduate training in clinical psychology at the Ohio State University and her clinical internship and postdoctoral fellowship at Duke University Medical Center.  Her research focuses on developing and evaluating behavioral interventions for cancer patients, management of cancer pain and treatment side effects, and improving adherence to recommended care. Dr. Shelby serves on the Duke clinical psychology internship faculty and supervises clinical psychology fellows, interns, and clinical psychology graduate practicum students completing clinical rotations as part of the Duke Cancer Patient Support Program.   


Caroline Susan Dorfman

Assistant Professor in Psychiatry and Behavioral Sciences

Caroline Dorfman, Ph.D. is an Assistant Professor in the Department of Psychiatry and Behavioral Sciences at Duke University. Dr. Dorfman is a member of the Pain Prevention and Treatment Research Program and the Cancer Symptom Management and Support Program within the Duke Department of Psychiatry and Behavioral Sciences. She is also a member of the Duke Cancer Institute where she serves as the Director of Research and Behavioral Medicine for the Duke Teen and Young Adult Oncology Program. Dr. Dorfman completed her graduate training in clinical psychology at the Ohio State University and her clinical internship at Duke University Medical Center. Her research focuses on developing, implementing, and evaluating psychosocial and behavioral interventions designed to meet the needs of cancer survivors and their partners/families. She is particularly interested in conducting research to address the unique needs of adolescent and young adult cancer survivors. 


Hayden Barry Bosworth

Professor in Population Health Sciences

Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)  at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities. 

Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.

Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy


Francis Joseph Keefe

Professor in Psychiatry and Behavioral Sciences

I am Director of the Duke Pain Prevention and Treatment Research Program, an active NIH funded clinical research program focused on developing new and more effective ways of assessing and treating patients having acute and persistent pain.  I have been active in nationally and internationally in shaping the pain research agenda.  For the past 10 years I served as Editor in Chief of PAIN the premier journal in pain research.  I also have served as the Chair of a number of NIH Study Sections.   Finally, I was a member of the Institute of Medicine committee that published a report in 2011 (Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research) that has played a key role in shaping national policies in pain research and pain care.

Over my career, I have played a key role in the development of clinical pain services and pain research programs at Duke Medical Center.  For over 20 years, I directed the Duke Pain Management Program and was a leader in the development of Duke Medical Center's multidisciplinary pain programs (both out-patient and in-patient.)  I collaborate actively with investigators in other countries (e.g. United Kingdom, South Africa, China, and Australia). 

Over the course of my career, I have collaborated closely with investigators both in and outside my lab.  Together we have developed and refined a number of treatment protocols for persistent pain conditions (e.g. pain in patients with advanced cancer; sickle cell disease, and persistent joint pain due to osteo- and rheumatoid arthritis) including partner and caregiver-assisted pain coping skills training interventions.  We have conducted a number of NIH- and foundation- funded randomized clinical trials testing the efficacy of these and other behavioral interventions (e.g. aerobic exercise protocols, yoga based interventions, mindfulness-based interventions, forgiveness-based interventions, loving kindness meditation, and emotional disclosure). 

I currently serve as a Co-Investigator on a number of NIH grants, a number of which are funded by the HEAL Initiative.  Many of these grants are testing novel strategies for delivering training in pain coping skills (e.g. video over internet, web-based training, virtual reality interventions, and apps for mobile devices).  Along these lines, I collaborated with Dr. Chris Rini to develop an internet-based program for training in pain coping skills called painTRAINER (available at mypaintrainer.org). This program is free to any individuals or health professionals who wish to use it.  I have a keen interest in exploring the efficacy of these and other strategies (e.g. training physical therapists, social workers, and nurses) promise to increase access to behavioral pain management interventions making them more widely available to the large population of patients and caregivers who might benefit from them.

I have published over 490 papers on topics ranging from pain coping strategies used during mammography to behavioral approaches to managing acute pain and pain at end of life.  I have a longstanding interest in mentoring students and early career professionals interested in developing, testing, and disseminating novel protocols for managing pain, stress, and medical symptoms.



Linda Marie Sutton

Professor of Medicine



Alaattin Erkanli

Associate Professor of Biostatistics & Bioinformatics

Areas of research interests include Bayesian hierarchical models for longitudinal data, Bayesian optimal designs, finite mixtures and Mixtures of Dirichlet Processes, Markov transition models, nonparametrics smoothing and density estimation, survival analysis for recurrent-event data, biomarker selection and detecting early ovarian cancer.


Shelby Derene Reed

Professor in Population Health Sciences

Shelby D. Reed, PhD, is Professor in the Departments of Population Health Sciences and Medicine at Duke University’s School of Medicine.  She is the director of the Center for Informing Health Decisions and Therapeutic Area leader for Population Health Sciences at the Duke Clinical Research Institute (DCRI).  She also is core faculty at the Duke-Margolis Center for Health Policy. Dr. Reed has over 20 years of experience leading multidisciplinary health outcomes research studies. Dr. Reed has extensive expertise in designing and conducting trial-based and model-based cost-effectiveness analyses of diagnostics, drugs and patient-centered interventions. In 2016, she co-founded the Preference Evaluation Research (PrefER) Group at the DCRI, and she currently serves as its director. She and the group are frequently sought to conduct stated-preference studies to inform regulatory decisions, health policy, care delivery, value assessment and clinical decision making with applied projects spanning a wide range of therapeutic areas. She served as President for ISPOR in 2017-2018, and she currently is Past-Chair of the Society’s Health Science Policy Council.



Areas of expertise: Health Economics, Health Measurement, Stated Preference Research, Health Policy, and Health Services Research

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