Clinical trial · Interventional
Breast Cancer Survivors RESET (Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools): A Pilot, Feasibility Study
NCT07101861CI-TRIAL-00111903RESETcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Survivors RESET | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Survivors RESET intervention
- interventionNames
- Behavioral: Survivors RESET
Primary outcomes (3)
- measure
- Enrollment Rate
- timeFrame
- Baseline
- description
- Percentage of participants who are contacted and enroll in the study.
- measure
- Retention Rate
- timeFrame
- Baseline to Month 4
- description
- Percentage of participants who enroll and complete assessments at both timepoints (Baseline and Month 4).
- measure
- Adherence
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.