NCT03837496

Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors

Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy (STRIDE) Among Breast Cancer Survivors: A Pilot Feasibility Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 21 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the feasibility and acceptability of a brief, virtual, group-based cognitive-behavioral intervention for breast cancer survivors taking hormonal therapy. The intervention (STRIDE) aims to alleviate symptoms related to hormonal therapy or breast cancer, optimize medication-taking (i.e., adherence), and reduce distress.

Detailed description

Background: The majority of breast cancer is hormone sensitive and treated with 10 years of adjuvant endocrine therapy (AET) (i.e., tamoxifen, aromatase inhibitors) to reduce risk of recurrence and improve survival; however, adherence to AET among breast cancer survivors (BCS) is a challenge, with half of women becoming non-adherent within five years. Difficulty coping with symptoms (e.g., sleep problems, hot flashes, weight gain, fatigue) and psychosocial distress (i.e., depression or anxiety symptoms), and other emotional and logistical factors are major barriers to adherence. There is a dearth of efficacious interventions targeting the needs and adherence challenges of BCS prescribed AET. Objective: To address this gap, the proposed study, funded by the National Cancer Institute, employs a mixed-methods design to develop and test an evidence-based intervention (STRIDE) to enhance adherence to AET, improve symptom management, and reduce distress in breast cancer survivors. Specific Aims: The primary aims of this study are: 1) to examine the feasibility and acceptability of a tailored, small-group, virtual intervention (STRIDE) compared to a medication monitoring control for survivors of breast cancer taking AET, and 2) to explore the effects of the STRIDE intervention on adherence to AET, symptom distress, and satisfaction with AET. Study Design: Phase 1 included (1) semi-structured interviews with BCS on AET (n=30) and intervention development with psychologists and oncology clinicians. The intervention is a a brief, virtual, small-group, cognitive-behavioral intervention that aims to alleviate symptoms and side effects related to hormonal therapy or breast cancer, optimize medication-taking, and reduce emotional distress for breast cancer survivors taking hormonal therapy. Phase 2 will entail a run-in phase (n=5) to evaluate acceptability and further refine the intervention, followed by a randomized controlled pilot trial (n=100) to assess the feasibility of comparing the STRIDE intervention to a medication monitoring control with assessments and adherence monitoring over the course of six months. Participants will be recruited at Massachusetts General Hospital Cancer Center and three community satellite sites. Eligible participants will be hormone-receptor positive breast cancer survivors prescribed AET who are experiencing distress related to AET (e.g., adherence difficulties, side effects, etc.). This research study involves completing 3 questionnaire batteries at the time of enrollment, 12 weeks, and 24 weeks. The participant will also be asked to store their hormonal therapy pills in a medication bottle provided by the study team throughout the 24 week study period. If the participants are randomized to receive the STRIDE intervention, the participant will have six weekly one-hour virtual (videoconferencing) sessions in small groups with a trained clinician followed by two 15-minute check-in phone calls later in the study.

Conditions

• Breast Cancer
• Adherence, Medication

Interventions

Type	Name	Description
OTHER	STRIDE	STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.
OTHER	Medication Monitoring Control	Care provided as standard by the hospital and medication monitoring

Timeline

• Start date: 2019-10-28
• Primary completion: 2021-08-17
• Completion: 2021-12-01
• First posted: 2019-02-12
• Last updated: 2022-11-18
• Results posted: 2022-11-18

Locations

1 site across 1 country: United States