Prospective Study With RCT Designed for Evaluation of TCM Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for < 70 year old group).
研究概览
简要总结
The study objective is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) five elements music therapy improving quality of life for patients with advanced cancer, as well as establishing the standard operating procedures (SOP) for it.
详细描述
Design: As randomized controlled trial (RCT) with un-blinded design will be done.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participation will be enrolled based on diagnostic criteria.
- •Advanced cancer patient with more than 50 scores of Karnofsky Performance Score (KPS).
- •Diagnosis of advanced cancer
- •Patients who are willing to be subject with taking part in this research voluntarily.
- •No prior experience with TCM music therapy.
- •Newly admitted to TCM oncology department for 3 weeks treatment course.
排除标准
- •Complicated diagnose or one who don't consistent with inclusion criteria.
- •Patients suffering from psychosis or diagnosis, or psychiatric diagnoses (e.g., schizophrenia).
- •Suffering from acute organ prostration or other condition of demanding to rescue，inability for accepting music therapy.
- •One don't read or fill in diary owing to some causes, such as state of the art or acuity of vision
- •One suffering from hearing disturbance
- •Accepted TCM five elements music therapy in the past.
结局指标
主要结局
Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for < 70 year old group).
时间窗: Difference of(pro-post)treatment for KPS,Qol, Diary
Comparison of Qol, KPS, Diary at baseline and endpoint, the result shown here were significantly different for all terms in TCM five elements music group, p=0. p=0.0015, p=0.0015 respectively. However, no significant difference was seen for all terms in Western music group and the no music group respectively (See Table 3).
Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for the >70 year old group).
时间窗: Difference of(pro-post)treatment for KPS,Qol, Diary
Comparison of Qol, KPS and Diary score at baseline and endpoint results show there was a significant difference for the QoL in TCM five elements music group, p value is 0.0062. However, there was no significant difference for the KPS and Diary score in each group respectively(See Table 4).
次要结局
未报告次要终点
研究者
Liao Juan
Oncology Department of Xi Yuan Hospital, China Academy of Chinese Medicine Sciences
Ministry of Science and Technology of the People´s Republic of China