Effect of Yoga on Weight and Fatigue in Breast Cancer Patients Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- quality of life, fatigue, and body weight
研究概览
简要总结
This purpose of this study is to test whether a 6-month yoga program improves quality of life and reduces fatigue and weight gain in breast cancer survivors.
详细描述
Women who are overweight or obese have a higher risk of breast cancer than normal weight women. Furthermore, women who are overweight or obese or gain weight after diagnosis have an increased risk of recurrence or dying from breast cancer compared with normal weight women. Yoga has been associated with reduced weight gain and weight loss in persons without cancer. However, no studies have tested whether yoga leads to less weight gain or weight loss in breast cancer patients. Both obesity and the sequelae of breast cancer therapy can result in reduced health-related quality of life and severe fatigue, which may also be favorably affected by yoga practice. The specific aims of the proposed trial are to examine, in women with Stage 0-IIIa breast cancer who are at least 3 months post primary treatment for their disease (other than tamoxifen or aromatase inhibitors), the effects of a 6-month yoga intervention on health-related quality of life, fatigue, and body weight.
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
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 21-75
- •Diagnosed with a primary breast cancer Stage 0-IIIa
- •Current tamoxifen or aromatase inhibitor use is allowed
- •At least 3 months post treatment (e.g., surgery, chemotherapy, or radiation therapy)
- •BMI: 24 kg/m2 or greater (If Asian or Asian-American BMI: 23 kg/m2 or greater)
- •No contraindications to participating in a yoga program
- •Able to come for clinic visits, and attend weekly classes, and fill out questionnaires and logs in English
- •Gives informed consent, agrees to be randomly assigned
排除标准
- •Plans to leave the study area within the follow-up period
- •Is pregnant or plans to become pregnant during the study period.
- •History of myocardial infarction (heart attack) or stroke in the previous 6 months, or diabetes (current diagnosis)
- •Has practiced yoga more than 1 time per month in the past six months.
- •Current use of medications likely to interfere with adherence to interventions or study outcomes
- •Alcohol or drug abuse, significant mental illness (as assessed by study staff impression)
结局指标
主要结局
quality of life, fatigue, and body weight
时间窗: baseline, 6 months, 12 months
次要结局
- waist and hip circumference(baseline, 6 months, 12 months)