The Effectiveness of a Comprehensive Physical Activity Behavioral Intervention on Underserved Diverse Obese Endometrial Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Proportion of participants completing at least 150 minutes of moderate-vigorous physical activity, assessed by the Yale Physical Activity Survey (YPAS)
研究概览
简要总结
This randomized clinical trial studies a physical activity behavioral intervention in obese endometrial cancer survivors. Learning about physical activity behavior while participating in a fitness class may help increase physical activity and improve the quality of life of obese endometrial cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. To determine the effect of a 12-week behavior/exercise intervention on moderate-vigorous physical activity (> 150 minutes) among ethnically diverse endometrial cancer survivors.
SECONDARY OBJECTIVES:
I. To determine the effects of a 12-week behavior/exercise intervention on body composition among ethnically diverse endometrial cancer survivors.
TERTIARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent form signed and dated by the subject
- •English and/or Spanish speaking
- •History of endometrial cancer stage I-IV > 6 months < 5 years, not currently receiving cancer treatment
- •Overweight (body mass index [BMI] >= 30)
- •Eastern Cooperative Oncology Group performance status (PS) of 0 - 2
- •Medically capable of performing moderate intensity exercise
排除标准
- •Must not have engaged in a regular (> 3x/week, physical activity program in the last 6 months)
- •Medical contraindication to exercise
研究组 & 干预措施
Exercise Intervention
Participants partake in 30 minutes of group discussions regarding physical activity behavior followed by 60 minutes of moderate-intensity exercise comprised of 5 minutes warm-up, 25 minutes cardiovascular training, 20 minutes of resistance training exercises using body weight and exercise band, and 10 minutes of cool-down and stretching once weekly for 12 weeks. Participants also complete a brisk walk for 90 minutes per week outside of class for 12 weeks.
干预措施: Exercise Intervention (Behavioral)
wait-list for intervention
Participants receive a handout indicating the importance of physical activity and improved nutrition for health outcomes. After 12 weeks, patients are invited to participate in the physical behavior intervention as in Group I.
结局指标
主要结局
Proportion of participants completing at least 150 minutes of moderate-vigorous physical activity, assessed by the Yale Physical Activity Survey (YPAS)
时间窗: 12 weeks
Data will be analyzed using Pearson Chi-square test.
次要结局
- Fatigue, assessed by the FACT-Fatigue(Up to 12 weeks)
- Waist circumference(Up to 12 weeks)
- Change in ability to perform activities of daily living, assessed with the YPAS(Baseline to 12 weeks)
- Barrier avoidance/coping, measured using 5 point Likert scales(Up to 12 weeks)
- Change in sedentary time, assessed with the YPAS(Baseline to 12 weeks)
- Outcome expectations, measured using 5 point Likert scales(Up to 12 weeks)
- Physical function score(Up to 12 weeks)
- Self-regulation, measured using 5 point Likert scales(Up to 12 weeks)
- BMI(Up to 12 weeks)
- Exercise efficacy, measured using 5 point Likert scales(Up to 12 weeks)
- Quality of life, assessed by the Functional Assessment of Cancer Therapy (FACT)-Endometrial Cancer(Up to 12 weeks)
- Social support, measured using 5 point Likert scales(Up to 12 weeks)
研究者
Nicole Nevadunsky
Principal Investigator
Albert Einstein College of Medicine