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

Shelby, Rebecca A

Dorfman, Caroline S

Bosworth, Hayden B

Keefe, Francis

Sutton, Linda

Owen, Lynda

Corsino, Leonor

Erkanli, Alaattin

Reed, Shelby D

Arthur, Sarah S

Somers, Tamara

Barrett, Nadine

Huettel, Scott

Gonzalez, Juan Marcos

Kimmick, Gretchen

2024-01-26T00:17:59Z

2024-01-26T00:17:59Z

2019-01

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.

S1551-7144(18)30487-7

1551-7144

1559-2030

https://hdl.handle.net/10161/29871

eng

Elsevier BV

Contemporary clinical trials

10.1016/j.cct.2018.11.010

https://creativecommons.org/licenses/by-nc/4.0

Humans

Breast Neoplasms

Arthralgia

Pain

Vaginal Diseases

Fatigue

Hot Flashes

Tamoxifen

Antineoplastic Agents, Hormonal

Aromatase Inhibitors

Chemotherapy, Adjuvant

Adaptation, Psychological

Telemedicine

Sweating

Telephone

Female

Medication Adherence

Sleep Wake Disorders

Self-Management

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

Journal article

Dorfman, Caroline S|0000-0002-2391-1128

Bosworth, Hayden B|0000-0001-6188-9825

Keefe, Francis|0000-0003-0583-9326

Corsino, Leonor|0000-0001-6859-9097

Erkanli, Alaattin|0000-0002-5437-4900

Reed, Shelby D|0000-0002-7654-4464

Somers, Tamara|0000-0002-8809-2979

Huettel, Scott|0000-0002-5092-4936

Gonzalez, Juan Marcos|0000-0002-5386-0907

120

131

Duke

Sanford School of Public Policy

School of Medicine

Trinity College of Arts & Sciences

Student

Faculty

Duke Population Research Institute

Basic Science Departments

Clinical Science Departments

Institutes and Centers

Biostatistics & Bioinformatics

Neurobiology

Anesthesiology

Medicine

Psychiatry & Behavioral Sciences

Medicine, Endocrinology, Metabolism, and Nutrition

Medicine, General Internal Medicine

Medicine, Medical Oncology

Medicine, Rheumatology and Immunology

Duke Cancer Institute

Psychology & Neuroscience

Duke Clinical Research Institute

Institutes and Provost's Academic Units

University Institutes and Centers

Duke Institute for Brain Sciences

Center for the Study of Aging and Human Development

Initiatives

Duke Science & Society

Center for Cognitive Neuroscience

Center for Population Health & Aging

Duke Population Research Center

Center for Child and Family Policy

Population Health Sciences

Duke Innovation & Entrepreneurship

Psychiatry & Behavioral Sciences, Behavioral Medicine & Neurosciences

Duke - Margolis Center For Health Policy

Biostatistics & Bioinformatics, Division of Biostatistics

Published

76