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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
History of Changes

August 19, 2009
April 19, 2012
February 2009
August 2011   (final data collection date for primary outcome measure)
  • 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).
Improvement for Primary symptoms: using patient diary [ Time Frame: (seeing appendix 6), three times per day with 7 times one week. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00964314 on ClinicalTrials.gov Archive Site
Not Provided
Karnofsky performance scores (KPS) [ Time Frame: two time of baseline, the third week respectively ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

Design: As randomized controlled trial (RCT) with un-blinded design will be done.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Cancer
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.
  • Experimental: five elements music
    Listening TCM five elements music therapy（TCMMT）based on conventional therapy in China.
    Intervention: Other: music
  • Active Comparator: western music
    Listening western music based on conventional therapy in China.
    Intervention: Other: music
  • No Intervention: Without music
    no music therapy will be done in the arm.
    Intervention: Other: music
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
October 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00964314
WJB720603
Yes
Liao Juan, Ministry of Science and Technology of the People´s Republic of China
Ministry of Science and Technology of the People´s Republic of China
M.D. Anderson Cancer Center
Study Director: Yang Yu fei, doctor Oncology department of Xi Yuan Hospital, China Academy of Chinese Medical Sciences
Ministry of Science and Technology of the People´s Republic of China
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP