A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy: Effects on Quality of Life and Chemotherapy-associated Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change in quality of life
研究概览
简要总结
The primary aim of this study is to assess and compare change in QOL during chemotherapy as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between patients receiving yoga and those not receiving yoga. Secondary endpoints will include other measures of QOL such as sleep quality measured with the Pittsburg Sleep Quality Inventory (PSQI), anxiety and depression using Hospital Anxiety and Depression Scale (HADS), and adherence to yoga and to chemotherapy treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age>18 years
- •History of stage I-III breast cancer
- •Patient scheduled to receive or within 2 weeks of receiving intravenous chemotherapy for their breast cancers
- •Eastern Cooperative Oncology Group Performance status of <3
- •Ability to understand English
排除标准
- •Planning to start yoga on their own within the next 12 weeks
- •Maintained a regular personal practice or yoga within the 3 months before enrolling onto the study
- •Severe chronic obstructive pulmonary disease
- •Class III or IV heart failure
- •Child C cirrhosis
- •End-Stage renal disease
- •Exclusion Criteria:
- •Planning to start yoga on their own within the next 12 weeks
- •Maintained a regular personal practice or yoga within the 3 months before enrolling onto the study
- •Severe chronic obstructive pulmonary disease
- •Class III or IV heart failure
- •Child C cirrhosis
- •End-Stage renal disease
研究组 & 干预措施
start yoga classes immediately
12 weekly 60-minute yoga classes taught by a certified yoga instructor with cancer-specific yoga training that will commence concurrently with the start of chemotherapy.
干预措施: Yoga (Other)
Start yoga classes after 3 months
12 weekly 60-minute yoga classes taught by a certified yoga instructor with cancer-specific yoga training that will commence 3 months after start of chemotherapy
干预措施: Yoga (Other)
结局指标
主要结局
change in quality of life
时间窗: 12 weeks
to assess and compare change in QOL during chemotherapy as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between patients receiving yoga immediately and those start yoga 3 months later.
次要结局
未报告次要终点
研究者
Theresa Shao
Assistant Professor
Icahn School of Medicine at Mount Sinai