Music Therapy in Patients With Breast Cancer- a Randomized Controlled Trial

NCT ID: NCT04540471

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-12-31

Brief Summary

Comprehensive inpatient rehabilitation for breast cancer consist of interdisciplinary team care but few researchers investigate the efficacy of music therapy, which have shown some benefits in breast cancer rehabilitation. According to previous research, music therapy has been proposed to improve quality of life, as well as depression and stress of breast cancer patients. However, to the best of our knowledge, only few studies have investigated the impact of music therapy among health-related parameter of patient with breast cancer. Considering the fact that music therapy had merely no adverse events, we assume music therapy is an optimal add-on therapy for patient with breast cancer. Therefore, we plan to conduct a study to evaluate the impact of music therapy on anxiety, and fatigue on patients with breast cancer.

Detailed Description

Patients and Method:

We designed this study as an assessor blinded, randomized, controlled, parallel group trial. The participants will be recruited from general surgery unit of tertiary referral hospital in Southern Taiwan. Inclusion criteria will be as follows: (1) patients with first-ever breast cancer between 20~80 years old (1 to 6 months post- surgery) (2) able to follow basic orders (verbal or gesture) and tolerated music therapy by 1 hour. Individuals will be excluded from the study if they (1) are unable to cooperate with music therapy, (2) undergoing psychotherapeutic treatment during the study period, using antidepressants during the study period, (3) are significantly hearing impaired, not agree to sign the informed consent, or do not agree further evaluation, and (4) pregnant women. Randomization in a 1:1 ratio will be performed with computer-generated randomization list. All the included patients will be categorized into two groups: music therapy (MT) group and control group. Both groups will receive comprehensive in-patient education program for 12consecutive weeks, but the MT group will receive additional music therapy in the 12 consecutive weeks. The participants in MT group will receive neurologic music therapy 1 day per week for 1 hour with total 4 hours in 4 consecutive weeks after initial enrollment. The primary outcome is anxiety and fatigue. The Brief Fatigue Inventory-Taiwan (BFI-T) State anxiety inventory (STAI) and WHOQOL until 12 weeks after randomization. All health-related parameters will be evaluation prior to intervention and after intervention.

Aim of the study:

The aim of the study is to explore the impact of music therapy on anxiety and fatigue among patients with breast cancer. We aim to investigate whether music therapy is an optimal add-on therapeutic model for patients with breast cancer.

Conditions

Music Therapy, Breast Cancer, Anxiety, Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MT group

The participants in MT group will receive music therapy 1 day per week for 1 hour with total 12hours in12 consecutive weeks after initial enrollment. Initial evaluation at the first session, including patient's vital sign, consciousness and spirit. The music therapy will consist of therapeutic singing, interpersonal communication, melody intonation therapy and rhythmic hands slapping. During therapeutic singing session, the music therapists will sing a song first and then the patients sing it after them. Interpersonal communication activity will be led by the music therapist and passed on to one patient to another patient. Melody intonation therapy will comprise communication, chatting and read aloud by using melody.

Group Type: EXPERIMENTAL

music

Intervention Type: OTHER

MT group receives additional music therapy

comprehensive in-patient education program

Intervention Type: OTHER

comprehensive in-patient education program

Control group

control groups will receive comprehensive in-patient education program for 12 consecutive weeks

Group Type: PLACEBO_COMPARATOR

comprehensive in-patient education program

Intervention Type: OTHER

comprehensive in-patient education program

Interventions

music

MT group receives additional music therapy

Intervention Type: OTHER

comprehensive in-patient education program

comprehensive in-patient education program

Intervention Type: OTHER

Other Intervention Names

education

Eligibility Criteria

Exclusion Criteria

Individuals will be excluded from the study if they are unable to cooperate with music therapy, are significantly hearing impaired, are severely mentally impaired (MMSE<10), or not agree to sign the informed consent, uncontrolled seizure or do not agree further evaluation. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chinghui Chuang, PhD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Medical Foundation

Locations

Chang Gung

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

201901698B0

Identifier Type: -

Identifier Source: org_study_id