Clinical trial NCT04540471: Music Therapy in Patients With Breast Cancer- a Randomized Controlled Trial
Official title: Department of Nursing, Chang Gang Memorial Hospital
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Music Therapy, Breast Cancer, Anxiety, Fatigue
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: an assessor blinded, randomized, controlled, parallel group trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

- We design this study as an assessor blinded, randomized, controlled, parallel group trial. The participants will be recruited from OPD unit of tertiary referral hospital in Southern Taiwan. Inclusion criteria will be as follows: (1) patients with breast cancer between 20\~80 years old at stage (1-6 months post surgery) (2) able to follow basic orders (verbal or gesture) and tolerated music therapy by 1 hour.

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. -

Primary outcomes:
measure: State anxiety inventory (STAI) Survey
timeFrame: 12 weeks
Secondary outcomes:
measure: Brief Fatigue Inventory-Taiwan (BFI-T) Survey
timeFrame: 12 weeks
Other outcomes:
measure: WHOQOL Survey
timeFrame: 12 weeks
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung
Study officials:
affiliation: Chang Gung Medical Foundation
name: Chinghui Chuang, PhD
role: PRINCIPAL_INVESTIGATOR
References: