Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET).
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2019-01
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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.
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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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Scholars@Duke
Rebecca A Shelby
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
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.
Leonor Corsino
Dr. Leonor Corsino is a Board- Certified Adult Endocrinologist, an experienced physician-scientist, and an organizational and health professional education leader. She offers an extensive and diverse leadership background with successfully implementing innovative clinical, research, and workforce development and education programs. Her expertise and strengths lie in her diverse portfolio that expands from basic science to clinical and community-engaged research, innovative curriculum development, successful clinical program implementation, and collaborations.
Dr. Corsino's research focuses on diabetes, obesity, and related complications and health disparities, with a particular interest in Hispanic/Latino populations. She has successfully led and extensively collaborated with investigators locally, nationally, and internationally. Her research and contribution have been recognized locally and nationally with many awards, including the NIH/NIDDK Network of Minority Health Research Investigators medallion.
Dr. Corsino has extensive leadership experience, including her current roles as a member of the Executive Committee Member and Associate Director of the Duke School of Medicine Masters of Biomedical Sciences (MBS), Co-Director for the Duke Clinical and Translational Science Institute - Community Engagement Core / Community-Engaged Research Initiative (CERI) and Associate Dean for Students Affairs/Advisory Dean Duke School of Medicine MD program.
She is the former Co-Director, Education and Training Sub-core of the Duke Center for REsearch to AdvanCe Healthcare Equity, Director of the Duke Population Health Improvement Initiative Program, Associate Chair for the Department of Medicine Minority Recruitment and Retention Committee, and Associate Director for the Duke School of Medicine Office of Faculty Mentoring Training.
Dr. Corsino's leadership led to the successful development and implementation of unique and innovative programs, including the Duke MBS program selective curriculum, the REACH Equity Summer Undergraduate Research Program, the CTSI/CERI Population Health Improvement Award, E-library, consultation services, and the interactive platform for the Duke Population Health Improvement Program.
Her visionary and innovative initiatives have enhanced patient care, population health, and the recruitment, training, development, and support of health professions students, residents, fellows, and junior faculty, having a significant, palpable, impact on the diversity of health profession workforce and health disparities research.
Alaattin Erkanli
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
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
Sarah Arthur
Sarah Arthur is a doctoral candidate in the Clinical Psychology program at Duke University. She is a member of the Duke Pain Prevention and Treatment Research Program, working under Frank Keefe and Rebecca Shelby. She studies a variety of topics in the area of reproductive and sexual health, including: (1) defining, understanding, and enhancing sexual well-being during the transition to parenthood; and (2) identifying and understanding predictors of treatment-related pain, distress, and other symptoms in cancer patients (especially breast and gynecologic cancers).
Tamara J. Somers
Tamara J. Somers, PhD, is a Clinical Psychologist and Faculty Member in the Department of Psychiatry and Behavioral Sciences. Dr. Somers conducts research developing, testing, and implementing behavioral interventions for pain and other symptoms in patients with chronic disease (e.g., cancer, arthritis). She is particularly interested in developing behavioral interventions that are personalized to the needs of individual patients and using innovative delivery methods to deliver the interventions. Grant awards from the NIH, American Cancer Society, and other funding agencies support her research. Dr. Somers also co-directs a clinical psychology training program at the Duke Cancer Institute (DCI) that trains graduate students, clinical psychology interns, and post-doctoral fellows in psychosocial and behavioral symptom management interventions.
Scott Huettel
Research in my laboratory investigates the brain mechanisms underlying economic and social decision making; collectively, this research falls into the field of “decision neuroscience” or "neuroeconomics". My laboratory uses fMRI to probe brain function, behavioral assays to characterize individual differences, and other physiological methods (e.g., eye tracking, pharmacological manipulation, genetics) to link brain and behavior. Concurrent with research on basic processes, my laboratory has also investigated the application of new analysis methods for fMRI data, including functional connectivity analyses, pattern classification analyses, and combinatoric multivariate approaches. We have also been applying computational methods to problems in behavioral economics and consumer decision making.
I have also been very active in outreach, mentorship, and educational activities; as examples, I am lead author on the textbook Functional Magnetic Resonance Imaging (Sinauer Associates; 3rd edition in 2014), I teach Fundamentals of Decision Science, Decision Neuroscience and Neuroethics, and many of my postdoctoral and graduate trainees now lead research laboratories of their own.
Juan Marcos Gonzalez
Dr. Gonzalez is an Associate Professor in the Department of Population Health Sciences. He is an expert in the design of stated-preference survey instruments and the use of advanced statistical tools to analyze stated-preference data. His research has focused on the transparency in benefit-risk evaluations of medical interventions, and the elicitation of health preferences from multiple stakeholders to support shared decision making.
Dr. Gonzalez co-led the first FDA-sponsored preference study which was highlighted in FDA’s recent precedent-setting guidance for submitting patient-preference evidence to inform regulatory benefit-risk evaluations of new medical devices. More recently, Dr. Gonzalez collaborated with the Medical Devices Innovation Consortium (MDIC) to prepare the first catalog of preference-elicitation methods (part of the Patient-Centered Benefit-Risk Assessment Framework) suitable for benefit-risk assessments of medical devices. As a core group member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Conjoint Analysis Task Force, Dr. Gonzalez helped draft good-practice recommendations for statistical analysis, interpretation, and reporting of health preference data. Currently, he is working with the Center for Devices and Radiological Health at FDA to support the Center’s capabilities for the review of stated-preference data in regulatory decisions.
Areas of expertise: Clinical Decision Sciences and Health Measurement
Gretchen Genevieve Kimmick
Breast cancer; treatment of breast cancer; management of menopausal symptoms in breast cancer survivors; survivorship issues after breast cancer; supportive care in managment of cancer patients; breast cancer and treatment of cancer in older persons; diagnosis and management of cancer in underserved populations.
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