Prospective Study With RCT Designed for Evaluation of TCM Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Enrollment
- 146
- Locations
- 2
- Primary Endpoint
- Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for < 70 year old group).
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Detailed Description
Design: As randomized controlled trial (RCT) with un-blinded design will be done.
Investigators
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
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for < 70 year old group).
Time Frame: 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).
Time Frame: 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).