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

Publication ,  Journal Article
Shelby, RA; Dorfman, CS; Bosworth, HB; Keefe, F; Sutton, L; Owen, L; Corsino, L; Erkanli, A; Reed, SD; Arthur, SS; Somers, T; Barrett, N ...
Published in: Contemp Clin Trials
January 2019

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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Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

January 2019

Volume

76

Start / End Page

120 / 131

Location

United States

Related Subject Headings

  • Vaginal Diseases
  • Telephone
  • Telemedicine
  • Tamoxifen
  • Sweating
  • Sleep Wake Disorders
  • Self-Management
  • Randomized Controlled Trials as Topic
  • Public Health
  • Pain
 

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Shelby, R. A., Dorfman, C. S., Bosworth, H. B., Keefe, F., Sutton, L., Owen, L., … Kimmick, G. (2019). Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET). Contemp Clin Trials, 76, 120–131. https://doi.org/10.1016/j.cct.2018.11.010
Shelby, Rebecca A., Caroline S. Dorfman, Hayden B. Bosworth, Francis Keefe, Linda Sutton, Lynda Owen, Leonor Corsino, et al. “Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET).Contemp Clin Trials 76 (January 2019): 120–31. https://doi.org/10.1016/j.cct.2018.11.010.
Shelby RA, Dorfman CS, Bosworth HB, Keefe F, Sutton L, Owen L, et al. Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET). Contemp Clin Trials. 2019 Jan;76:120–31.
Shelby, Rebecca A., et al. “Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET).Contemp Clin Trials, vol. 76, Jan. 2019, pp. 120–31. Pubmed, doi:10.1016/j.cct.2018.11.010.
Shelby RA, Dorfman CS, Bosworth HB, Keefe F, Sutton L, Owen L, Corsino L, Erkanli A, Reed SD, Arthur SS, Somers T, Barrett N, Huettel S, Gonzalez JM, Kimmick G. Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET). Contemp Clin Trials. 2019 Jan;76:120–131.
Journal cover image

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

January 2019

Volume

76

Start / End Page

120 / 131

Location

United States

Related Subject Headings

  • Vaginal Diseases
  • Telephone
  • Telemedicine
  • Tamoxifen
  • Sweating
  • Sleep Wake Disorders
  • Self-Management
  • Randomized Controlled Trials as Topic
  • Public Health
  • Pain