Breast Cancer Survivors RESET (Reducing Weight and Elevated Stress Levels Using Educational and B… (NCT07101861) | Clinical Trial Compass
CompletedNot Applicable
Breast Cancer Survivors RESET (Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools): A Pilot, Feasibility Study
United States37 participantsStarted 2024-01-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Enrollment Rate
Timeframe: Baseline
2
Retention Rate
Timeframe: Baseline to Month 4
3
Adherence
Timeframe: Baseline to Month 4
Trial details
NCT IDNCT07101861
SponsorH. Lee Moffitt Cancer Center and Research Institute