An experimental study to evaluate the effectiveness of Multi-component Intervention (MCI) on Radiotherapy Induced Fatigue and its correlates among breast cancer patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean Fatigue Scores
研究概览
简要总结
This study is a cluster randomized, open label, parallel group, single-centre trial comparing the effectiveness of nurse led multicomponent intervention (MCI) that includes guided imagery, information booklet, weekly messaging reminders for 6 weeks on radiotherapy induced fatigue and its co relates among 100 breast cancer patients receiving radiation therapy that will be conducted in Punjab, India. The primary outcome measures will be Mean Cancer Fatigue Scores, Mean Zung Anxiety Scores, Mean Zung Depression Score, Mean Pittsburg Sleep Quality Index, Mean PG-SGA point Score, Mean Hemoglobin Levels at Four weeks and Six weeks. The secondary outcome will be user satisfaction for MCI at Six weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female Breast cancer patients who are: above the age of 18 years willing to participate prescribed radiation therapy for at least 6 weeks having smartphone able to read and understand Hindi or English.
排除标准
- •Females Breast cancer patients diagnosed with comorbidities like severe depression, cardiovascular diseases, endocrine diseases, and sleep disorders unable to follow instructions owing to compromised physical and mental health enrolled in another study that involves a similar intervention having compliance less than 75% for MCI.
结局指标
主要结局
Mean Fatigue Scores
时间窗: Four weeks and Six Weeks
Mean nutritional status score
时间窗: Four weeks and Six Weeks
Mean Anxiety Scores
时间窗: Four weeks and Six Weeks
Mean Sleep Quality Index
时间窗: Four weeks and Six Weeks
Mean Depression Score
时间窗: Four weeks and Six Weeks
次要结局
- User Satisfaction for MCI(Six Weeks)