Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy

Study Overview
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Brief Summary
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OBJETIVE: To study the influence of musicotherapy in reduction of fatigue related to cancer in patients with breast's or gynecology's cancer, during the radiotherapy treatment.

Detailed Description
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METHODS: This is a randomized controled study (Control Group - CG e musicotherapy Group - MTG) wich values fatigue, life's quality, anxiety, depression by using evaluative instruments Functional Assessment of Cancer Therapy: Fatigue (FACT-F), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) in three different moments (during first week of radiotherapy, in the intermediate phase's week and during the last week of radiotherapy) for patients of both groups. Women allocated in MTG, in addition to the scales described above, answered the musicotherapy Questionary (MQ), and the Subjective Impression of the Subject's Questionary in last meeting. Musicotherapy sessions were individual and lasted an average of 40 minutes. Music therapeutic techniques used were Musical Audition (MA) and Therapeutic Musical Audition (TMA).

Official Title
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Randomized Clinical Trial Testing Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy.

Conditions
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Breast Cancer, Uterine Cancer, Ovarian Cancer

Intervention / Treatment
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* Behavioral: Music therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with breast and gynecological cancer with indication for radiotherapy Performance status 0,1 Exclusion Criteria: Hemoglobin < 10mg/dl Patients in psychotherapy during the study Use of antidepressants Patients presenting more than one cancer type

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music therapy<br>Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days. | Behavioral: Music therapy<br>* Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days<br>* Other names: musictherapy;|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the influence of musicotherapy in the reduction of fatigue | To study the influence of musicotherapy in reduction of fatigue related to cancer in patients with breast or gynecological cancer, during the radiotherapy treatment. | 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the reduction of depression | To compare the levels of depression of patients with breast and gynecological cancer on radiotherapy, between the musicotherapy and the control group. | 45 days | 
| Asses the reduction of anxiety | To compare the levels of anxiety of patients with breast and gynecological cancer on radiotherapy, between the musicotherapy and the control group. | 45 days | 
| Assess the quality of life | To compare the levels of quality of life of patients with breast and gynecological cancer on radiotherapy, between the musicotherapy and the control group. | 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, gynecological cancer, radiotherapy, fatigue, musicotherapy