CTRI/2017/08/009336已完成2 期
Effect of Yoga on Health related quality of life amongst the patients undergoing multi agent chemotherapy for treatment of Aggressive Malignant Lymphoma-A Randomised Controlled Trial
Gurpreet Kaur1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2017年3月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- FACT Health related quality scores
研究概览
简要总结
This is a randomised controlled trail to assess the effectiveness of yoga intervention in patients suffering from malignant Lymphoma undergoing multi agent chemotherapy. Intervention group will be administered Yoga protocol along with routine care, the control group will receive only routine care. The primary outcome variable will be health related quality of life, and secondary outcomes will be fatigue, depression , anxiety, sleep quality and pain. These outcome variables will be assessed at the baseline i.e before start of chemotherapy, at 2nd, 4th and 6th month of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients diagnosed with aggressive malignant Lymphoma Stage II-IV, planned to receive chemotherapy between the age of 18-65yrs with ECOG performance score of 0-2 2.Patients willing to participate in the study, and should have access to audio-video displaying device (CD player, multimedia phone /smart phone/laptop) 3.Patients who will be able to understand English, Hindi, Punjabi.
排除标准
- •1.Patients with stage I Lymphoma 2.Patients who continued to have ECOG score 3-4 even at 2nd chemotherapy cycle.
结局指标
主要结局
FACT Health related quality scores
时间窗: Before start of chemotherapy, at 2nd, 4th and 6th month of chemotherapy
次要结局
- Morbidity profile: Fatigue, sleep quality, depression, anxiety and pain(Adherence)
研究者
研究点 (1)
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