STRIDE: Evidence-Based Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Coping with AET side effects as measured by the Management of Current Stress - Part A (MOCS-A) questionnaire.
Study Overview
Brief Summary
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.
Detailed Description
Adjuvant Endocrine Therapy (AET) is critical for most patients with hormone sensitive breast cancer. AET side effects cause distress, interfere with medication adherence, and are 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. 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, a telehealth evidence-based behavioral intervention, compared to Usual Care (UC), for improving patients' ability to cope with AET side effects. Analyses will also examine the effect of STRIDE on patients' self-reported and objective adherence. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female ≥ 21 years old
- •Diagnosis of early-stage (0-IIIb), hormone receptor positive (ER+/PR+) breast cancer
- •Completed primary treatment (surgery, chemotherapy, and/or radiation)
- •Within 3 to 12 months of starting oral adjuvant endocrine therapy (AET)
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Ability to read and respond in English or Spanish
- •Distress about AET ≥ 4 on a 0-10 scale
Exclusion Criteria
- •Cognitive impairment, uncontrolled psychosis, or serious mental illness prohibiting participation in the study as per the judgment of the treating oncologist
- •Enrolled in a clinical trial for AET
Arms & Interventions
STRIDE Intervention
Participants randomized to STRIDE will receive a brief, manualized, videoconference intervention with six weekly one-hour sessions in small groups of two to three patients and two individual semi-structured telephone check-ins. Participants will complete questionnaires at baseline, and 3, 6, and 12 months post-baseline.
Intervention: STRIDE (Behavioral)
Usual Care
Participants randomized to usual care will receive regular oncology follow-up care which entails one follow-up visit with the primary treating oncologist after prescription of AET and as needed contact with a nurse practitioner or RN for symptom control or other medication related questions. Participants will also complete questionnaires at baseline, and 3, 6, and 12 months post-baseline. Participants will be offered one optional STRIDE intervention visit upon completion of the 12-month questionnaire.
Intervention: Usual Care (Behavioral)
Outcomes
Primary Outcomes
Coping with AET side effects as measured by the Management of Current Stress - Part A (MOCS-A) questionnaire.
Time Frame: Up to 12 months post-baseline
Investigators will assess changes in coping via the Measure of Current Stress - Part A (MOCS-A). The MOCS-A is a 13-item survey used to evaluate participants' perceived ability to cope using several skills. Each item is scored on a 0-4 scale, with higher scores indicating greater coping ability.
Secondary Outcomes
- Self-reported adherence to AET as measured by the Medication Adherence Report Scale (MARS-5).(Up to 12 months post-baseline)
- Objective AET adherence rates as measured by the Medication Events Monitoring System (MEMS Caps).(Up to 12 months post-baseline)
Investigators
Jamie Jacobs
Principal Investigator
Massachusetts General Hospital