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

Ministry of Science and Technology of the People´s Republic of China146 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

146

Conditions

Cancer

Interventions

musicOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

Xi-Yuan Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Oncology Department of Xi Yuan hospital

Beijing, HaiDian District, China

Outcomes

Primary Outcomes

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).

Time frame: 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).

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

Data from ClinicalTrials.gov

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