Back to resultsMusicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy
Primary Purpose
Breast Cancer, Uterine Cancer, Ovarian Cancer
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Music therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, gynecological cancer, radiotherapy, fatigue, musicotherapy
Eligibility Criteria
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
Sites / Locations
- Goias Anticancer Association
- Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Music therapy
Control
Arm Description
Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT01570218
First Posted
March 17, 2012
Last Updated
May 1, 2018
Sponsor
Universidade Federal de Goias
Collaborators
Associaçao de Combate ao Cancer em Goias
1. Study Identification
Unique Protocol Identification Number
NCT01570218
Brief Title
Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy
Official Title
Randomized Clinical Trial Testing Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Goias
Collaborators
Associaçao de Combate ao Cancer em Goias
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Uterine Cancer, Ovarian Cancer
Keywords
breast cancer, gynecological cancer, radiotherapy, fatigue, musicotherapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music therapy
Arm Type
Experimental
Arm Description
Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Music therapy
Other Intervention Name(s)
musictherapy
Intervention Description
Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days
Primary Outcome Measure Information:
Title
Assess the influence of musicotherapy in the reduction of fatigue
Description
To study the influence of musicotherapy in reduction of fatigue related to cancer in patients with breast or gynecological cancer, during the radiotherapy treatment.
Time Frame
45 days
Secondary Outcome Measure Information:
Title
Assess the reduction of depression
Description
To compare the levels of depression of patients with breast and gynecological cancer on radiotherapy, between the musicotherapy and the control group.
Time Frame
45 days
Title
Asses the reduction of anxiety
Description
To compare the levels of anxiety of patients with breast and gynecological cancer on radiotherapy, between the musicotherapy and the control group.
Time Frame
45 days
Title
Assess the quality of life
Description
To compare the levels of quality of life of patients with breast and gynecological cancer on radiotherapy, between the musicotherapy and the control group.
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruffo Freitas-Junior, PhD
Organizational Affiliation
Universidade Federal de Goias
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tereza R Alcantara-Silva, Ms Mus
Organizational Affiliation
Universidade Federal de Goias
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goias Anticancer Association
City
Goiania
State/Province
Goias
ZIP/Postal Code
74605070
Country
Brazil
Facility Name
Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
City
Goiania
State/Province
Goias
ZIP/Postal Code
74605070
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy
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