Grant Number:	1R01CA316494-01 Interpret this number
Primary Investigator:	Jacobs, Jamie
Organization:	Massachusetts General Hospital
Project Title:	STRIDE: Evidence-Based Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy
Fiscal Year:	2026

PROJECT SUMMARY/ABSTRACT Overview: The goal of this study is to demonstrate the efficacy of an evidence-based, small-group, telehealth intervention (‘STRIDE’) for improving patients’ ability to cope with side effects from adjuvant endocrine therapy (AET) and adhere to AET medication regimens for patients with hormone-sensitive breast cancer. Background: AET is critical for most patients with hormone sensitive breast cancer; however, patients’ adherence to AET is poor and declines over time, increasing their risk for breast cancer recurrence and mortality. In addition to myriad patient-, systems-, and economic-related factors, adverse AET side effects are the primary barrier to AET adherence and patients lack skills for coping with these side effects, receiving minimal support during the up to ten-year regimen. In addition to interfering with adherence, AET symptom distress is associated with poorer quality of life (QOL), and higher anxiety. There is a critical need to increase patients’ ability to cope with AET side effects and reduce adherence barriers to AET; however, no such interventions exist. An evidence-based, telehealth intervention, STRIDE, was developed and tested in a single center pilot trial for patients reporting AET symptom distress and/or adherence difficulties. STRIDE was delivered in small groups over six weekly one-hour sessions and two brief follow-up telephone calls. STRIDE was feasible, acceptable, and showed promising benefits for improving patients’ ability to cope with AET side effects, mood (i.e., anxiety, depression), breast cancer symptom distress, QOL, and adherence. STRIDE was then adapted using patient feedback for testing in a multisite, fully powered efficacy trial of STRIDE with a representative patient sample to maximize future generalizability. Research Plan: This project proposes to conduct a multisite randomized controlled efficacy trial in 400 patients taking AET after breast cancer to test the efficacy of STRIDE, compared to UC, for improving patients’ ability to cope with AET side effects (primary). Analyses will also examine the effect of STRIDE on patients’ self-reported and objective adherence (secondary). Finally, the investigative team will explore the effects of the STRIDE intervention on mood, breast cancer symptom distress, and QOL, and whether improvements in coping ability mediate the effects of the STRIDE intervention on AET adherence. Environment: This project will be conducted at the Massachusetts General Hospital (MGH) Cancer Center and Moffitt Cancer Center, which collectively have a volume of >1,150 patients starting AET each year. These sites and investigators have the supportive oncology research processes, infrastructure, and breast cancer expertise to conduct this trial. The MGH research team has the expertise in iteratively developing and testing multi-site supportive oncology care interventions for patients with cancer to ensure the successful implementation and evaluation of STRIDE across both study sites. Relevance of Research: This project will establish the essential foundation for a future implementation and dissemination trial of STRIDE into clinical practice and may be relevant for patients taking other oral anti-cancer drugs.





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