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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: music

• Registration Number: NCT00964314
• Lead Sponsor: Ministry of Science and Technology of the People´s Republic of China

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-21
• Study First Posted: 2009-08-24
• Primary Completion: 2011-08
• Study Completion: 2011-10
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-19
• Last Update Posted: 2012-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
western music	music	Listening western music based on conventional therapy in China.
Without music	music	no music therapy will be done in the arm.
five elements music	music	Listening TCM five elements music therapy（TCMMT）based on conventional therapy in China.

Primary Outcome Measures

Name	Time	Method
Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for < 70 year old group).	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).	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).

Trial Locations

Locations (2)

Xi-Yuan Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China

Oncology Department of Xi Yuan hospital; 🇨🇳 Beijing, HaiDian district, China