Breast Cancer Survivors RESET (Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools): A Pilot, Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Adherence
Study Overview
Brief Summary
The overall object of this project is to test the feasibility and acceptability of an adapted stress management enhanced behavioral weight loss intervention for Black breast cancer survivors with obesity and elevated stress. We will also conduct pre- and post-intervention assessments of weight, allostatic load, and patient reported outcomes among study participants.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Self-identify as non-Hispanic Black
- •Self-identify as cisgendered female.
- •Are ≥ age
- •Have a history of stage 0-3 breast cancer diagnosis treated for curative intent.
- •Have completed all adjuvant or neoadjuvant chemotherapy, radiation, and surgery at least 21 days prior to study registration but may continue on hormonal therapy and Abemaciclib therapy.
- •Have a measured BMI ≥ 30 kg/m
- •Willing to participate for the entire 4-month duration.
Exclusion Criteria
- •Are pregnant or are planning to become pregnant during the study period.
- •Have a known major medical or psychological condition known to influence weight loss [e.g., medicated or poorly controlled diabetes (HbA1c > 8%), uncontrolled hypertension (BP>160 mm Hg systolic or BP>100 mm Hg diastolic), cardiovascular event in the past 12 months, history of gastric bypass or bariatric surgery].
- •History of psychiatric hospitalization in past 2 years.
- •History of substance abuse or eating disorder.
- •Any other condition by which a medical professional has suggested diet modification, physical activity, and/or weight loss would be contraindicated.
Arms & Interventions
Survivors RESET intervention
Intervention: Survivors RESET (Behavioral)
Outcomes
Primary Outcomes
Adherence
Time Frame: Baseline to Month 4
Adherence will be assessed by the number of treatment sessions attended.
Enrollment Rate
Time Frame: Baseline
Percentage of participants who are contacted and enroll in the study.
Retention Rate
Time Frame: Baseline to Month 4
Percentage of participants who enroll and complete assessments at both timepoints (Baseline and Month 4).
Adherence
Time Frame: Baseline to Month 4
Adherence will be assessed by the number of treatment sessions attended.
Secondary Outcomes
- 4-month mean change in weight(Baseline to Month 4)
- 4-month mean change in allostatic load score(Baseline to Month 4)
- 4-month mean change in weight(Baseline to Month 4)
- 4-month mean change in allostatic load score(Baseline to Month 4)