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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964314
• Other study ID #: WJB720603
• Status: Completed
• Phase: N/A
• First received: August 19, 2009
• Last updated: April 19, 2012
• Start date: February 2009
• Est. completion date: October 2011

Study information

• Verified date: April 2012
• Source: Ministry of Science and Technology of the People´s Republic of China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
China	Oncology Department of Xi Yuan hospital	Beijing	HaiDian district
China	Xi-Yuan Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Science and Technology of the People´s Republic of China	M.D. Anderson Cancer Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes

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