Effect of a Yoga Intervention on Fatigue, Distress, and Quality of Life in Breast Cancer Patients: A Randomized Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Determine if an 8 week yoga program designed for breast cancer patients improves subjective reports of overall well being and fatigue
研究概览
简要总结
A randomized trial from the British National Health Service found that supervised exercise benefits women with early stage breast cancer with improved functional and psychological benefit after a 12-week intervention and 6 months later. Considering the needs of breast cancer patients and survivors and the reported benefits of exercise and yoga intervention, the investigators propose a pilot study of an 8-week yoga intervention in breast cancer patients. This study would specifically address measures of fatigue and psychosocial distress in the population of breast cancer patients during treatment and within the year following treatment. Currently there is very limited literature on yoga intervention in this population.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Potential subjects must have had histologically or cytologically confirmed breast cancer. This includes, but is not limited to: breast cancer-in situ; ductal carcinoma in situ; lobular carcinoma in situ; cystosarcoma phyllodes; inflammatory breast carcinoma; invasive breast carcinoma; and breast cancer not otherwise specified; cancer must be stage 0 through stage III.
- •Treatment completion within the past calendar year.
- •Age ≥ 18 years. While breast cancer can occur in the pediatric population, the pediatric population is best served by trials specifically designed for their age group.
- •Life expectancy of greater than 1 year.
- •Karnofsky ≥ 60%; see Appendix A.
- •Women of childbearing potential are eligible for this study.
- •Pregnant women are eligible for this study pending a doctor's note.
- •The ability to understand and complete the study questionnaires.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- •Patients with known metastasis.
- •Patients who are actively participating in a yoga class.
- •Known uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would compromise subject health during yoga.
结局指标
主要结局
Determine if an 8 week yoga program designed for breast cancer patients improves subjective reports of overall well being and fatigue
时间窗: 8 weeks
次要结局
- Analyze symptoms of depression and anxiety(8 weeks)