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Clinical Trials/NCT01570218
NCT01570218CompletedNot Applicable

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

Universidade Federal de Goias2 sites in 1 country164 target enrollmentStarted: February 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
164
Locations
2
Primary Endpoint
Assess the influence of musicotherapy in the reduction of fatigue

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Investigator)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Music therapy

Experimental

Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days.

Intervention: Music therapy (Behavioral)

Control

No Intervention

Outcomes

Primary Outcomes

Assess the influence of musicotherapy in the reduction of fatigue

Time Frame: 45 days

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 Outcomes

  • Assess the reduction of depression(45 days)
  • Asses the reduction of anxiety(45 days)
  • Assess the quality of life(45 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ruffo Freitas-Junior

Professor

Universidade Federal de Goias

Study Sites (2)

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