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

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.

Medication adherence for atrial fibrillation patients: triangulating measures from a smart pill bottle, e-prescribing software, and patient communication through the electronic health record

“… 11 Research on technologies that support medication adherence, including adherence among those with cardiovascular conditions, has flourished in recent years. 12–19 These technologies track and/or support adherence through a variety of mechanisms. One such technology is electronic pill bottles, the newest versions of which can not only track pill bottle openings, but also alert patients to missed doses and remotely transmit signals so that clinicians can be alerted of such misses.…”

Do Histopathology and Clinical Outcomes of Breast Atypia Vary by Race/Ethnicity?

“…44 In a study of 22 breast cancer survivors, semi-structured in-depth interviews identified that social support provides some women with educational, physical, and emotional benefits that may influence their continuation of AET. 45 On-going clinical trials are investigating alternative interventions using telephone-based coping skills training 46 and web-based applications that collects patient-reported symptoms to their healthcare teams 47 . Thus, drawing parallels to endocrine therapy adherence for carcinoma, our study reiterates the currently unmet clinical need for interventions geared specifically towards minimizing racial and ethnic gaps in the use of chemoprevention among high-risk populations of different backgrounds.…”

“…Although the median age at diagnosis was comparable between non-Hispanic white and non-Hispanic black women, Hispanic women tended to be younger at the time of an atypia diagnosis (median age in years [IQR]; Hispanic: 46 [42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57]; non-Hispanic black: 57 [49-65]; non-Hispanic white: 54 [47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63]; p=0.05; Table 1). Accordingly, pre-menopausal status was over-represented among Hispanic women (Hispanic: 40%; non-Hispanic black: 15%; non-Hispanic white: 16.9%; p=0.02).…”

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

“…Given past research demonstrating that negative side effects are the leading cause of AET nonadherence [11], leveraging technologies such as the THRIVE app that connect patients with their care teams to facilitate timely changes to clinical management may reduce symptom burden and promote adherence. Other ongoing trials are similarly testing behavioral interventions to increase AET adherence [69, 70], using interactive messaging and nurse-delivered self-management training telephone call to improve symptom coping and side-effect management. An examination of the relative differences between results will be of great interest.…”