Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy
Randomized Clinical Trial Testing Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy.
1 other identifier
interventional
164
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Feb 2010
Shorter than P25 for not_applicable breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 17, 2012
CompletedFirst Posted
Study publicly available on registry
April 4, 2012
CompletedMay 4, 2018
May 1, 2018
10 months
March 17, 2012
May 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Assess the reduction of depression
45 days
Asses the reduction of anxiety
45 days
Assess the quality of life
45 days
Study Arms (2)
Music therapy
EXPERIMENTALMusic therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days.
Control
NO INTERVENTIONInterventions
Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days
Eligibility Criteria
You may qualify if:
- Patients with breast and gynecological cancer with indication for radiotherapy
- Performance status 0,1
You may not qualify if:
- Hemoglobin \< 10mg/dl
- Patients in psychotherapy during the study
- Use of antidepressants
- Patients presenting more than one cancer type
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Goias Anticancer Association
Goiânia, Goiás, 74605070, Brazil
Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
Goiânia, Goiás, 74605070, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ruffo Freitas-Junior, PhD
Universidade Federal de Goias
- PRINCIPAL INVESTIGATOR
Tereza R Alcantara-Silva, Ms Mus
Universidade Federal de Goias
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 17, 2012
First Posted
April 4, 2012
Study Start
February 1, 2010
Primary Completion
December 1, 2010
Study Completion
February 1, 2011
Last Updated
May 4, 2018
Record last verified: 2018-05