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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: music

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100091
      • Xi-Yuan Hospital, China Academy of Chinese Medical Sciences
  • HaiDian district
    • Beijing, HaiDian district, China, 100091
      • Oncology Department of Xi Yuan hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ministry of Science and Technology of the People´s Republic of China
• Collaborators: M.D. Anderson Cancer Center
• Investigators: Study Director: Yang Yu fei, doctor, Oncology department of Xi Yuan Hospital, China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: August 19, 2009
• First Submitted That Met QC Criteria: August 21, 2009
• First Posted (Estimate): August 24, 2009

Study Record Updates

• Last Update Posted (Estimate): April 23, 2012
• Last Update Submitted That Met QC Criteria: April 19, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: advanced cancer; quality of life (QOL); TCM five elements music therapy
• Other Study ID Numbers: WJB720603