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

doi:10.1016/j.cct.2018.11.010

Cited by 18Medication Adherence and ComplianceCancer survivorship and careMobile Health and mHealth Applications

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

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Shelby, Rebecca A., Dorfman, Caroline S., Bosworth, Hayden B., Keefe, Francis, Sutton, Linda, Owen, Lynda, Corsino, Leonor, Erkanli, Alaattin +7 more·2019·Contemporary Clinical Trials

DOI 10.1016/j.cct.2018.11.010PMC PMC6346744

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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.

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The IGHE and SGHE arms were selected as active comparison groups to address possible non-specific intervention effects.
“IGHE/SGHE were chosen as active comparison groups to address possible non-specific aspects of intervention effects based on our prior studies36–38.”
From Improving well-being for individuals with persistent pain after surgery for breast cancer, lobular carcinoma in situ, or ductal carcinoma in situ: A randomized clinical trial (2022) · cites this paper as [38]
The Materials and Methods (Interventions; page not available) says general health education was chosen as a comparison condition to control for attention and time, supporting the rationale for addressing nonspecific effects. The paper describes one individual, phone-based general-health-education comparison group, not separate IGHE and SGHE arms. (LLM, conf=0.86)
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THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer
Paladino, A. J., Anderson, J. N., Krukowski, R. A., Waters, T. M., Koçak, M., Graff, J. C., Blue, R., Jones, T. N., Buzaglo, J. S., Vidal, G. A., et al. (2019) · BMC Health Services Research · doi:10.1186/s12913-019-4588-x · Cited by 27 · see citing works
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Method
Medication adherence for atrial fibrillation patients: triangulating measures from a smart pill bottle, e-prescribing software, and patient communication through the electronic health record
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Background
Assessing Adherence to Adjuvant Hormone Therapy in Breast Cancer Patients in Routine Clinical Practice
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“Some actions are very simple but no less important, such as reminder text messages or phone calls to patients, paying particular attention to cases in which they fail to attend the consultation or take excessive time before doing so [32, 33].”
Background
Symptom Monitoring App Use Associated With Medication Adherence Among Woman Survivors of Breast Cancer on Adjuvant Endocrine Therapy
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Identification of patient subgroups who benefit from a behavioral intervention to improve adjuvant endocrine therapy adherence: a randomized-controlled trial
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“Existing medication adherence programs for other medical populations (e.g., HIV) are also being adapted to target AET adherence, and other intervention trials are currently on-going [18, 19, 23].”
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Follow-up Routines Matter for Adherence to Endocrine Therapy in the Adjuvant Setting of Breast Cancer
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Arthralgias
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“Self-efficacy levels among patients represent a potentially modifiable area that can be addressed through behavioral interventions that target self-regulation and coping skills [36].”
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Introduction
Given, B. A., & GRANT, M. M. (2011) · Seminars in Oncology Nursing · doi:10.1016/j.soncn.2011.02.001 · Cited by 1 · see citing works
THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer
Paladino, A. J., Anderson, J. N., Krukowski, R. A., Waters, T. M., Koçak, M., Graff, J. C., Blue, R., Jones, T. N., Buzaglo, J. S., Vidal, G. A., et al. (2019) · BMC Health Services Research · doi:10.1186/s12913-019-4588-x · Cited by 27 · see citing works
A telehealth intervention for symptom management, distress, and adherence to adjuvant endocrine therapy: A randomized controlled trial
Jacobs, J. M., Post, K. E., Massad, K., Horick, N., Walsh, E. A., Cohn, J. G., Rapoport, C. S., Clara, A. J., Antoni, M. H., Safren, S. A., et al. (2022) · Cancer · doi:10.1002/cncr.34409 · Cited by 41 · see citing works
Adjuvant endocrine therapy adherence changes among patients after a virtual behavioral intervention.
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Effects of Adjuvant Endocrine Therapy–Specific Perceptions on Response to a Behavioral Intervention for Adjuvant Endocrine Therapy Adherence in Patients With Breast Cancer
Willis, K. D., Walsh, E. A., Dunderdale, L., Post, K. E., Horick, N., Antoni, M. H., Safren, S. A., Partridge, A. H., Peppercorn, J. M., Park, E. R., et al. (2024) · JCO Oncology Practice · doi:10.1200/op.24.00316 · Cited by 3 · see citing works

Authors: Shelby, R. A., Dorfman, C. S., Bosworth, H. B., Keefe, F., Sutton, L., Owen, L., Corsino, L., Erkanli, A., Reed, S. D., Arthur, S. S., Somers, T., Barrett, N., Huettel, S., Gonzalez, J. M., & Kimmick, G.
Affiliations: Duke University (US)
Corresponding author: Shelby, Rebecca A.
ORCID: Shelby, Rebecca A.
Dorfman, Caroline S.
Bosworth, Hayden B.
Keefe, Francis
Sutton, Linda
Owen, Lynda
Corsino, Leonor
Reed, Shelby D.
Arthur, Sarah S.
Somers, Tamara
Barrett, Nadine
Huettel, Scott
Kimmick, Gretchen
Venue: Contemporary Clinical Trials
Publisher: Elsevier BV
Published: 2019-01
Volume: 76
Pages: 120-131
ISSN: 1551-7144 (ISSN-L)
DOI: 10.1016/j.cct.2018.11.010
PMC: PMC6346744
OpenAlex: W2901184135
Cited by: 18
References: 119
Citations by year: 2026: 1 · 2025: 1 · 2024: 4 · 2023: 4 · 2022: 3 · 2021: 2 · 2020: 2 · 2019: 1
FWCI: 1.43
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Contemporary Clinical Trials (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Institutes of Health (1R01CA193673-01A1)
Topics: Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
Health Sciences › Medicine › Oncology › Cancer survivorship and care
Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
Keywords: adjuvant endocrine therapy, medication adherence, hormone receptor-positive breast cancer, telephone-delivered intervention, coping skills training, symptom interference, vasomotor symptoms, vaginal dryness, sleep disorders, cost-effectiveness
MeSH terms: Self-Management, Adaptation, Psychological, Breast Neoplasms, Fatigue, Female, Humans, Pain, Sleep Wake Disorders, Sweating, Tamoxifen, Telephone, Vaginal Diseases, Randomized Controlled Trials as Topic, Chemotherapy, Adjuvant, Telemedicine, Arthralgia, Antineoplastic Agents, Hormonal, Hot Flashes, Aromatase Inhibitors, Medication Adherence

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

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