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

May 1, 2018 updated by: Ruffo Freitas-Junior, Universidade Federal de Goias

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Goias
      • Goiania, Goias, Brazil, 74605070
        • Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
      • Goiania, Goias, Brazil, 74605070
        • Goias Anticancer Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Music therapy
Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days.
Behavioral: Music therapy
Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days
Other Names:
  • musictherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the reduction of depression
Time Frame: 45 days
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
Time Frame: 45 days
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
Time Frame: 45 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Goias

Collaborators

Associaçao de Combate ao Cancer em Goias

Investigators

  • Study Chair: Ruffo Freitas-Junior, PhD, Universidade Federal de Goias
  • Principal Investigator: Tereza R Alcantara-Silva, Ms Mus, Universidade Federal de Goias

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

March 17, 2012

First Submitted That Met QC Criteria

April 1, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGM-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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