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

Abstract

BackgroundLong-term use of adjuvant endocrine therapy (AET) among women with early-stage, hormone receptor-positive breast cancer significantly reduces the risk of hospitalizations, cancer recurrence, and mortality. AET is associated with adverse symptoms that often result in poor adherence. A web-enabled app offers a novel way to communicate and manage symptoms for women on AET. In a region with significant racial disparities in breast cancer outcomes, our study tests the impact of a web-enabled app that collects and transmits patient-reported symptoms to healthcare teams to facilitate timely and responsive symptom management on medication adherence.MethodsIn this randomized controlled trial, we randomize 300 patients initiating AET to one of three arms: 1) an “App” group (n = 100) that receives weekly reminders to use the THRIVE study app; 2) an “App+Feedback” group (n = 100) that receives weekly reminders and tailored feedback based on their use of the app; or 3) a “Usual Care” group (n = 100) that receives usual care only. Participants are stratified by race: 50% White and 50% Black. The duration of the intervention is six months following enrollment, and outcomes are assessed at 12-months. The primary outcome is adherence, which is captured using an electronic monitoring pillbox. Secondary outcomes include symptom burden, quality of life, self-efficacy for managing symptoms, and healthcare costs. We also evaluate the impact of the intervention on racial disparities in adherence. Data are derived from three sources: electronic health record data to capture treatment changes, healthcare utilization, and health outcomes; self-report survey data related to adherence, symptom burden, and quality of life; and an electronic medication monitoring device that captures adherence.DiscussionA successful web-enabled intervention could be disseminated across systems, conditions, and populations. By evaluating the impact of this intervention on a comprehensive set of measures, including AET adherence, patient outcomes, and costs, our study will provide valuable and actionable results for providers, policy makers, and insurers who strive to achieve the “Triple Aim” – reduce costs while improving health outcomes and the patient care experience.Trial registrationNCT03592771. Prospectively registered on July 19, 2018.

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).…”

Remote Oncology Care: Review of Current Technology and Future Directions

“…The study will randomize 300 patients into three separate arms: 1. a group that receives weekly reminders through the application, 2. a group that receives weekly reminders and tailored feedback, and a usual care group. The primary endpoint is medication adherence as determined using an electronic pillbox [ 31 ].…”

Perceptions of Endocrine Therapy in African-American Breast Cancer Survivors: Mixed Methods Study

“…We conducted a literature review on interventions that improve endocrine therapy adherence, which identified 2 consequential gaps in existing intervention research: use of education only interventions and a lack of cultural adaptations [9][10][11][12][13][14][15][16]. Next, we examined commercially available cancer and medication adherence mobile health (mHealth) apps as a possible option to address these gaps and assist African-American women with endocrine therapy adherence [17][18][19][20][21]. Unfortunately, available cancer and medication adherence apps also have several areas that cause concern: (1) a lack of adequate development or testing in clinical practice [17,22,23], (2) a lack of input from patients or providers resulting in significant usability problems [24][25][26], and (3) a lack of scientifically valid information, with the majority of cancer-related apps created to promote a pharmacy or organization and not to assist African-American women with endocrine therapy adherence [20,26].…”

“…Importantly, over 90% of medication adherence mHealth apps were simple reminders and not effective in improving adherence [20]. Cancer mHealth apps research has explored functionality and acceptability, but only one evaluated effectiveness or clinical outcomes [17][18][19].…”