5-element Music Therapy on Patients With Breast Cancer

NCT04442035 | Completed DMC

• 1 other identifier: B2016-043-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we observed the clinical effect of using music therapy of TCM to improve the status of liver depression in patients with postoperative breast cancer patients, Second we want to explore the efficacy and advantages of traditional Chinese medicine in patients with postoperative breast cancer, and to reveal the clinical use of the efficacy and superiority.

Conditions

Breast Cancer Female; Quality of Life; Depression, Anxiety

Keywords

breast cancer; music therapy; Quality of Life; Depression, Anxiety

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Self-Rating Anxiety Scale (SAS) score at 3 Months

  The SAS is validated,self-reported table assessing anxiety state over the past 3 month.Possible scores below 50 defined as no anxiety,range 50 to 59 is Mild anxiety,range 60 to 69 is Moderate anxiety , scores above 70 is Severe Anxiety.The higher the score the worse state change=( months 3 score -Baseline score )

  Baseline and months 3

• Change From Baseline in Self-Rating Depression Scale(SDS) score at 3 Months

  The SDS is validated,self-reported table assessing depression state over the past 3 month.Possible scores below 52 defined as no anxiety,range 53 to 62 is Mild anxiety,range 63 to 72 is Moderate anxiety , scores above 73 is Severe Anxiety.The higher the score the worse state change=( months 3 score -Baseline score )

  Baseline and months 3

• Change From Baseline in Quality of Life (FACT-B score) at 3 Months

  The FACT-B is validated,self-reported table assessing quality of life over the past 3 month. The scale evaluation breast cancer patient's quality of life for 5 - dimensional such as physiological, social\&family, emotions ; status ; breast cancer additional entries . The higher the score , the better state change=( months 3 score -Baseline score )

  Baseline and months 3

Study Arms (2)

The teatment group

EXPERIMENTAL

5-element misic therapy

Behavioral: 5-element music therapy

The control group

EXPERIMENTAL

health education

Behavioral: 5-element music therapy

Interventions

5-element music therapy BEHAVIORAL

participants were treated by TCM five-phase music therapy for not less than 30 minutes per day, and group music therapy was performed every three weeks. In addition, the therapeutic schedule is composed of treatment time (1pm-2pm, 9pm-11pm), frequency treatment (two times a day), intervention (10-15 minutes in the afternoon, 30 minutes in the evening) and content (individuals: dialectical selection of music; groups: community singing, every three weeks).

Also known as: health education

The control group; The teatment group

Eligibility Criteria

• Age: 27 Years - 66 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the diagnosis of breast cancer in clinical stage (Ⅰ, Ⅱ, Ⅲ) and postoperative breast cancer during one month;
• All participants had to have clinical depression and stagnation of liver qi;
• age 27-66;
• participants are conscious and willing to be followed up during the treatment.

You may not qualify if:

• Metastasis of breast cancer or serious complications;
• Patients with major depressive disorder;
• The past medical history of mental disorders;
• The primary diseases including liver, kidney, cerebrovascular, cardiovascular and hematopoietic system diseases;
• Participating in another clinical study or undergoing another intervention;
• Patients with hearing loss.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Provincial Chinese medicine hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Breast Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zheng zhuanfang

  Second Clinical College of Guangzhou University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 22, 2020
• Study Start: March 25, 2017
• Primary Completion: March 24, 2018
• Study Completion: June 3, 2018
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)