Breast Cancer Survivors RESET (Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools): A Pilot, Feasibility Study

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Obesity

• Registration Number: NCT07101861
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-20
• Primary Completion: 2025-06-07
• Status Verified: 2025-07
• Study First Submitted: 2025-07-28
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03
• Study Completion: 2026-06-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 37

Inclusion Criteria

• Self-identify as non-Hispanic Black
• Self-identify as cisgendered female.
• Are ≥ age 18.
• 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/m2.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Enrollment Rate	Baseline	Percentage of participants who are contacted and enroll in the study.
Retention Rate	Baseline to Month 4	Percentage of participants who enroll and complete assessments at both timepoints (Baseline and Month 4).
Adherence	Baseline to Month 4	Adherence will be assessed by the number of treatment sessions attended.

Secondary Outcome Measures

Name	Time	Method
4-month mean change in weight	Baseline to Month 4	Weight change as measured by a SECA scale in kilograms at baseline and month 4 will be calculated and averaged
4-month mean change in allostatic load score	Baseline to Month 4	Allostatic load score will be calculated using a validated equation. Change from baseline to month 4 will be calculated and averaged.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States