Music Therapy, Breast Cancer, Anxiety, Fatigue
Conditions
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.
Interventions
OTHERmusic
MT group receives additional music therapy
OTHERcomprehensive in-patient education program
comprehensive in-patient education program
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Block randomisation was implemented (block size = 4). A random number generator was used to generate random numbers, and all participants were subsequently given an MP3 player.
Intervention model description
an assessor blinded, randomized, controlled, parallel group trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State anxiety inventory (STAI) Survey | 12 weeks | We accessed anxiety by State anxiety inventory (STAI) it has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: I am tense; I am worried and I feel calm; I feel secure. Trait anxiety items include: I worry too much over something that really doesn't matter and I am content; I am a steady person. All items are rated on a 4-point scale (e.g., from Almost Never to Almost Always). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level. Internal consistency coefficients for the scale have ranged from .86 to .95; test-retest reliability coefficients have ranged from .65 to .75 over a 2-month interval (Spielberger et al., 1983). Test-retest coefficients for this measure in the present study ranged from .69 to .89. Considerable evidence attests to the construct and concurrent validity of the scale (Spielberger, 1989). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Fatigue Inventory-Taiwan (BFI-T) Survey | 12 weeks | The BFI-T scoring total ranges from0 to 90 points; a higher score corresponds to higher fatigue. The BFI-T's internal consistency showed a Cronbach's ! value of .97. Construct validity of the BFI-T was estimated by factor analysis with a factor loading range of 0.80 to 0.94 on a single factor. Convergent validity was examined by correlations between the BFI ''worst'' fatigue and fatigue severity scores with Profile of Mood States vigor (r = j0.69 and j0.71, respectively) and fatigue subscale scores (r = 0.82 and 0.87, respectively)(Chou, Hsieh, Yao, & Barsevick, 2016) |
Other
| Measure | Time frame | Description |
|---|---|---|
| WHOQOL Survey | 12 weeks | The WHOQOL scoring total ranges from4 to20points; a higher score corresponds to good quality of life. The WHOQOL's internal consistency showed a Cronbach's value of .90. Test-retest reliability of WHOQOL was 0.75. Construct validity was examined by Person correlations (r =0.48-0.82) (Yao et al., 2000). |
Countries
Taiwan
Outcome results
None listed