Music Therapy, Breast Cancer, Anxiety, Fatigue Clinical Trial
Official title:
Department of Nursing, Chang Gang Memorial Hospital
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.
| Status | Recruiting |
| Enrollment | 130 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | December 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. - |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Chang Gung | Kaohsiung |
| Lead Sponsor | Collaborator |
|---|---|
| Chang Gung Memorial Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | WHOQOL Survey | 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). | 12 weeks | |
| Primary | State anxiety inventory (STAI) Survey | 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). | 12 weeks | |
| Secondary | Brief Fatigue Inventory-Taiwan (BFI-T) Survey | 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) |
12 weeks |