Fatigue
Conditions
Interventions
This is a three-arm, non-blinded, randomized controlled clinical trial. The participant will be approached and explained about the Musas project, objectives and possibilities of randomization ("raffle
E02.190.888.500
Sponsors
Liga Paranaense de Combate ao Câncer
Grupo Hadiak
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women. Age 18 years or more. Auditory and cognitivelly able to understand the study and react to auditory stimuli. Diagnosed with initial or locally advanced breast cancer. Referred to adjuvant or neoadjuvant chemotherapy
Exclusion criteria
Exclusion criteria: Palliative care. Less than 6 total cycles of chemotherapy. Significant comorbidities. Psychotic episodes. Severe intellectual disability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A decrease in cancer-related fatigue, as assessed by the FACT-F scale, is expected to be found within a difference of 10%, in the experimental groups compared to the control group -- with the greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before the intervention and approximately 21 days after the intervention.;We expect to find a decrease in cancer-related fatigue, as assessed by the CRP (c-reactive protein) test, with a mean difference of at least 0.025 pg/mL, in the experimental groups compared to the control group -- with a greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before the intervention and approximately 21 days after the intervention.;We expect to find a decrease in cancer-related fatigue, as assessed by IL-6 (interleukin 6) test, with a mean difference of at least 0.02 pg/mL, in the experimental groups compared to the control group -- with a greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before intervention and approximately 21 days after intervention.;We expect to find a decrease in cancer-related fatigue, as assessed by IL-10 (interleukin 10) test, with a mean difference of at least 0.02 pg/mL, in the experimental groups compared to the control group -- with a greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before intervention and approximately 21 days after intervention.;We expect to find a decrease in cancer-related fatigue, as assessed by the Interferon-gamma exam, with a mean difference of at least 0.03 pg/mL, in the experimental groups compared to the control group -- with a greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before the intervention and approximately 21 days after the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find a decrease in emotional symptoms, assessed by the HADS scale, with a difference of 10%, in the experimental groups compared to the control group -- with the greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before intervention and approximately 21 days after intervention.;An improvement in health-related quality of life, as assessed by the FACT-G scale, is expected to be found within a difference of 10%, in the experimental groups compared to the control group -- with the greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before the intervention and approximately 21 days after the intervention.;It is expected to find a decrease in adverse reactions, assessed by the CTCAE questionnaire items vomiting, nausea, myalgia, fatigue and insomnia, with a 15% difference, in the experimental groups compared to the control group -- with the greater difference in the Clotilde, Music Therapy experimental group. Data collected 3 to 7 days before intervention and approximately 21 days after intervention. | — |
Countries
Brazil
Contacts
Public ContactCamila SG Acosta Goncalves
Pontificia Universidade Catolica do Parana - PUCPR
Outcome results
None listed