Traditional Chinese Medicine Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer

Study Overview
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Brief Summary
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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
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Design: As randomized controlled trial (RCT) with un-blinded design will be done.

Official Title
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Prospective Study With RCT Designed for Evaluation of TCM Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer

Conditions
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Cancer

Intervention / Treatment
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* Other: music


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: five elements music<br>Listening TCM five elements music therapy（TCMMT）based on conventional therapy in China. | Other: music<br>* 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.<br>|
| Active Comparator: western music<br>Listening western music based on conventional therapy in China. | Other: music<br>* 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.<br>|
| No Intervention: Without music<br>no music therapy will be done in the arm. | Other: music<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced cancer, TCM five elements music therapy, quality of life (QOL)