Traditional Chinese Medicine Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer
Prospective Study With RCT Designed for Evaluation of TCM Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer
1 other identifier
interventional
146
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Feb 2009
Typical duration for not_applicable cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 19, 2009
CompletedFirst Posted
Study publicly available on registry
August 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedApril 23, 2012
April 1, 2012
2.5 years
August 19, 2009
April 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for < 70 year old group).
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).
Difference of(pro-post)treatment for KPS,Qol, Diary
Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for the >70 year old group).
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).
Difference of(pro-post)treatment for KPS,Qol, Diary
Study Arms (3)
five elements music
EXPERIMENTALListening TCM five elements music therapy（TCMMT）based on conventional therapy in China.
western music
ACTIVE COMPARATORListening western music based on conventional therapy in China.
Without music
NO INTERVENTIONno music therapy will be done in the arm.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Xi-Yuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091, China
Oncology Department of Xi Yuan hospital
Beijing, HaiDian District, 100091, China
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yang Yu fei, doctor
Oncology department of Xi Yuan Hospital, China Academy of Chinese Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Oncology Department of Xi Yuan Hospital, China Academy of Chinese Medicine Sciences
Study Record Dates
First Submitted
August 19, 2009
First Posted
August 24, 2009
Study Start
February 1, 2009
Primary Completion
August 1, 2011
Study Completion
October 1, 2011
Last Updated
April 23, 2012
Record last verified: 2012-04