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Contemp Clin Trials. 2019 Jan;76:120-131. doi: 10.1016/j.cct.2018.11.010. Epub 2018 Nov 22.

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

Author information

1
Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States. Electronic address: rebecca.shelby@duke.edu.
2
Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States. Electronic address: caroline.dorfman@duke.edu.
3
Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States; Department of Population Health Sciences, Duke University, Durham, NC, United States; Department of Medicine, Duke University, Durham, NC, United States. Electronic address: boswo001@duke.edu.
4
Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States. Electronic address: francis.keefe@duke.edu.
5
Duke Cancer Network, Duke University, Durham, NC, United States. Electronic address: sutto006@mc.duke.edu.
6
Duke Cancer Network, Duke University, Durham, NC, United States. Electronic address: lynda.owen@dulke.edu.
7
Division of Endocrinology, Duke University, Durham, NC, United States. Electronic address: leonor.corsinonunez@duke.edu.
8
Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States. Electronic address: Alaattin.erkanli@duke.edu.
9
Department of Population Health Sciences, Duke University, Durham, NC, United States; Department of Medicine, Duke University, Durham, NC, United States. Electronic address: Shelby.reed@duke.edu.
10
Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States. Electronic address: sarah.staley.arthur@duke.edu.
11
Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States. Electronic address: tamara.somers@duke.edu.
12
Office of Health Equity and Disparities, Duke Cancer Institute, Duke University, Durham, NC, United States. Electronic address: Nadine.barrett@dule.ed.
13
Department of Psychology and Neuroscience, Duke University, Durham, NC, United States. Electronic address: scott.huettel@duke.edu.
14
Department of Population Health Sciences, Duke University, Durham, NC, United States. Electronic address: jm.gonzalez@duke.edu.
15
Division of Medical Oncology, Duke University, Durham, NC, United States. Electronic address: Gretchen.kimmick@duke.edu.

Abstract

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.

KEYWORDS:

Adherence; Adjuvant endocrine therapy; Breast cancer; RCT; Self-management

PMID:
30472215
PMCID:
PMC6346744
[Available on 2020-01-01]
DOI:
10.1016/j.cct.2018.11.010

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