Traditional Chinese Medicine Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer
This study has been completed.
Sponsor:
Ministry of Science and Technology of the People´s Republic of China
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Liao Juan, Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier:
NCT00964314
First received: August 19, 2009
Last updated: April 19, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer |
Other: music |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Prospective Study With RCT Designed for Evaluation of TCM Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer |
Resource links provided by NLM:
Further study details as provided by Ministry of Science and Technology of the People´s Republic of China:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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).
| Enrollment: | 146 |
| Study Start Date: | February 2009 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: five elements music
Listening TCM five elements music therapy（TCMMT）based on conventional therapy in China.
|
Other: music
Experimental Group one : Listening TCM five elements music therapy（TCMMT）based on conventional therapy in China. Experimental Group two: Listening western music based on conventional therapy in China. Control Group: no music therapy will be done. |
|
Active Comparator: western music
Listening western music based on conventional therapy in China.
|
Other: music
Experimental Group one : Listening TCM five elements music therapy（TCMMT）based on conventional therapy in China. Experimental Group two: Listening western music based on conventional therapy in China. Control Group: no music therapy will be done. |
|
No Intervention: Without music
no music therapy will be done in the arm.
|
Other: music
Experimental Group one : Listening TCM five elements music therapy（TCMMT）based on conventional therapy in China. Experimental Group two: Listening western music based on conventional therapy in China. Control Group: no music therapy will be done. |
Detailed Description:
Design: As randomized controlled trial (RCT) with un-blinded design will be done.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964314
Locations
| China, Beijing | |
| Xi-Yuan Hospital, China Academy of Chinese Medical Sciences | |
| Beijing, Beijing, China, 100091 | |
| China, HaiDian district | |
| Oncology Department of Xi Yuan hospital | |
| Beijing, HaiDian district, China, 100091 | |
Sponsors and Collaborators
Ministry of Science and Technology of the People´s Republic of China
M.D. Anderson Cancer Center
Investigators
| Study Director: | Yang Yu fei, doctor | Oncology department of Xi Yuan Hospital, China Academy of Chinese Medical Sciences |
More Information
Additional Information:
No publications provided
| Responsible Party: | 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 |
| ClinicalTrials.gov Identifier: | NCT00964314 History of Changes |
| Other Study ID Numbers: | WJB720603 |
| Study First Received: | August 19, 2009 |
| Last Updated: | April 19, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Ministry of Science and Technology of the People´s Republic of China:
|
advanced cancer TCM five elements music therapy quality of life (QOL) |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 22, 2013