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

This study has been completed.
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Liao Juan, Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier:
NCT00964314
First received: August 19, 2009
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Cancer
Other: music

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Prospective Study With RCT Designed for Evaluation of TCM Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Ministry of Science and Technology of the People´s Republic of China:

Primary Outcome Measures:
  • Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for < 70 year old group). [ Time Frame: Difference of(pro-post)treatment for KPS,Qol, Diary ] [ Designated as safety issue: Yes ]
    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). [ Time Frame: Difference of(pro-post)treatment for KPS,Qol, Diary ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 146
Study Start Date: February 2009
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964314

Locations
China, Beijing
Xi-Yuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing, China, 100091
China, HaiDian district
Oncology Department of Xi Yuan hospital
Beijing, HaiDian district, China, 100091
Sponsors and Collaborators
Ministry of Science and Technology of the People´s Republic of China
M.D. Anderson Cancer Center
Investigators
Study Director: Yang Yu fei, doctor Oncology department of Xi Yuan Hospital, China Academy of Chinese Medical Sciences
  More Information

Additional Information:
No publications provided

Responsible Party: Liao Juan, Oncology Department of Xi Yuan Hospital, China Academy of Chinese Medicine Sciences, Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier: NCT00964314     History of Changes
Other Study ID Numbers: WJB720603
Study First Received: August 19, 2009
Last Updated: April 19, 2012
Health Authority: China: Ethics Committee

Keywords provided by Ministry of Science and Technology of the People´s Republic of China:
advanced cancer
TCM five elements music therapy
quality of life (QOL)

ClinicalTrials.gov processed this record on November 24, 2014