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

Completed · Not applicable

Conditions studied: Breast Cancer, Obesity

In brief

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.

Key facts

Study ID

NCT07101861

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

37

Starts

2024-01-20

Expected to finish

2025-08-01

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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