This trial studies how well the STRIDE behavioral intervention works in reducing distress and improving medication adherence in breast cancer survivors on endocrine therapy. Breast cancer survivors prescribed hormonal therapy may have difficulties with these medications for reasons related to symptoms and side effects (e.g., sleep problems, hot flashes, weight gain, fatigue), or experience mood changes after breast cancer. The STRIDE intervention involves virtual (videophone) or in-person sessions with trained clinicians, and may support women in taking hormonal therapy, alleviate symptoms from hormonal therapy or breast cancer, and reduce distress.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03837496.
PRIMARY OBJECTIVE:
I. To examine the feasibility and acceptability of a tailored, small-group, telehealth intervention (Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy among Breast Cancer Survivors [STRIDE]) compared to a medication monitoring control for survivors of breast cancer taking adjuvant endocrine therapy (AET).
SECONDARY OBJECTIVE:
I. To assess effects of the STRIDE intervention on adherence to AET, symptom distress, and satisfaction with AET.
EXPLORATORY OBJECTIVES:
I. To assess the effects of the STRIDE intervention on several psychosocial constructs, exploring potential mediator and moderators of the intervention.
II. To examine reasons for deciding not to participate in this social behavioral trial.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive 6 weekly STRIDE videoconference or in-person sessions which incorporate aspects of cognitive behavioral therapy over 60 minutes, and 2 phone check-ins over 15-30 minutes in months 4 and 5. Patients also monitor medication-taking with the Medication Event Monitoring System (MEMS) Caps for 6 months. Patients may also participate in an interview over 15 minutes.
GROUP II: Patients receive standard of care and monitor medication-taking with MEMS Caps for 6 months. Patients may also participate in an interview over 15 minutes.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorJamie Jacobs
