Telehealth Intervention for Breast Cancer
(STRIDE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Jamie M Jacobs, PhD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for people with hormone-sensitive breast cancer who are taking adjuvant endocrine therapy (AET). Participants should be able to join small-group telehealth sessions and follow the study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the STRIDE telehealth intervention with six weekly one-hour sessions and two individual semi-structured telephone check-ins
Follow-up
Participants are monitored for coping ability, adherence, mood, symptom distress, and quality of life
Optional STRIDE Intervention Visit
Participants in the Usual Care group are offered one optional STRIDE intervention visit upon completion of the 12-month questionnaire
What Are the Treatments Tested in This Trial?
Interventions
- STRIDE
Trial Overview
The study compares a telehealth program called STRIDE, which offers group support and education to help manage AET side effects and stick to medication, against usual care without this extra support.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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