Evaluation of a Yoga-Based Cancer Rehabilitation Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 399
- 试验地点
- 2
- 主要终点
- Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL)
研究概览
简要总结
This clinical trial studies yoga-based rehabilitation in reducing physical and emotional side effects of living with cancer or its treatment. Yoga-based rehabilitation may reduce side effects and improve the quality of life of patients with breast, lung, or colorectal cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the effects of yoga on quality of life (QOL) of breast cancer patients on different treatment regimens.
II. To pilot the effects of a yoga-based rehabilitation program versus standard care on QOL impairment reported by newly diagnosed (a) lung and (b) colorectal patients.
III. To evaluate program compliance and satisfaction among breast, lung and colorectal cancer patients as well as among the various sociocultural subgroups (e.g., ethnicity, language).
OUTLINE: Participants are randomized to 1 of 2 arms.
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
- •Have been diagnosed with breast, lung or colorectal cancer in the previous 8 weeks
- •Are to receive oncologic care at the Albert Einstein Cancer Center (AECC)
- •Have a life-expectancy of at least 6 months
- •Are either English- or Spanish-speaking
- •Do not practice yoga regularly (> 1 month)
- •Receive medical clearance by oncologic personnel on the study
排除标准
- •Eastern Cooperative Oncology Group performance status >= 3
- •Existence of any of the following:
- •Seizure disorder
- •Musculoskeletal conditions
- •Heart problems
- •Major psychiatric disorder
结局指标
主要结局
Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL)
时间窗: Baseline to up to 6 months
A repeated measures analysis of covariance will be performed for each of the five patient groups. This analysis will examine between and within group differences at T2 and T3 assessment points, after controlling for baseline levels of QOL.
Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form
时间窗: Up to 6 months
Descriptive analyses (percentages) will be conducted to examine levels of compliance (class attendance + home practice) for each patient group, self-identified ethnic group, and language of preference. Logistic regression analyses will be performed to identify patients in the top 25% for compliance based on sociocultural, medical, and lifestyle factors.
Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form
时间窗: Up to 6 months
Descriptive analyses (percentages) will be conducted to examine levels of satisfaction (total score on yoga evaluation form) for each patient group, self-identified ethnic group, and language of preference. Logistic regression analyses will be performed to identify patients in the top 25% for satisfaction based on sociocultural, medical, and lifestyle factors.
次要结局
- Pain(Baseline to up to 6 months)
- spiritual well-being(Baseline to up to 6 months)
- Mood(Baseline to up to 6 months)