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OpenTrials
Completed

NCT Number: NCT07101861

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Survivors RESET

Behavioral

16-session adaptation of the Diabetes Prevention Program Intensive Lifestyle Intervention plus stress management training

Primary outcomes

  1. Enrollment Rate

    Time frame: Baseline

    Percentage of participants who are contacted and enroll in the study.

  2. Retention Rate

    Time frame: Baseline to Month 4

    Percentage of participants who enroll and complete assessments at both timepoints (Baseline and Month 4).

  3. Adherence

    Time frame: Baseline to Month 4

    Adherence will be assessed by the number of treatment sessions attended.

Secondary outcomes

  1. 4-month mean change in weight

    Time frame: Baseline to Month 4

    Weight change as measured by a SECA scale in kilograms at baseline and month 4 will be calculated and averaged

  2. 4-month mean change in allostatic load score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Acronym: RESET

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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