Breast Cancer Survivors RESET (Reducing Weight and Elevated Stress Levels Using Educational and Behavioral Tools): A Pilot, Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Self-identify as non-Hispanic Black
- •Self-identify as cisgendered female.
- •Are ≥ age
- •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/m
- •Willing to participate for the entire 4-month duration.
排除标准
- •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.
研究组 & 干预措施
Survivors RESET intervention
干预措施: Survivors RESET (Behavioral)
结局指标
主要结局
Adherence
时间窗: Baseline to Month 4
Adherence will be assessed by the number of treatment sessions attended.
Enrollment Rate
时间窗: Baseline
Percentage of participants who are contacted and enroll in the study.
Retention Rate
时间窗: Baseline to Month 4
Percentage of participants who enroll and complete assessments at both timepoints (Baseline and Month 4).
Adherence
时间窗: Baseline to Month 4
Adherence will be assessed by the number of treatment sessions attended.
次要结局
- 4-month mean change in weight(Baseline to Month 4)
- 4-month mean change in allostatic load score(Baseline to Month 4)
- 4-month mean change in weight(Baseline to Month 4)
- 4-month mean change in allostatic load score(Baseline to Month 4)