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


N/A
18 Years
80 Years
Not Enrolling
Both
Cancer

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

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).

Outcome Time Frame:

Difference of(pro-post)treatment for KPS,Qol, Diary

Safety Issue:

Yes

Principal Investigator

Yang Yu fei, doctor

Investigator Role:

Study Director

Investigator Affiliation:

Oncology department of Xi Yuan Hospital, China Academy of Chinese Medical Sciences

Authority:

China: Ethics Committee

Study ID:

WJB720603

NCT ID:

NCT00964314

Start Date:

February 2009

Completion Date:

October 2011

Related Keywords:

  • Cancer
  • advanced cancer
  • TCM five elements music therapy
  • quality of life (QOL)
  • Neoplasms

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