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

This study has been completed.
Sponsor:
Collaborator:
Associaçao de Combate ao Cancer em Goias
Information provided by (Responsible Party):
Ruffo Freitas-Junior, Universidade Federal de Goias
ClinicalTrials.gov Identifier:
NCT01570218
First received: March 17, 2012
Last updated: April 1, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Uterine Cancer
Ovarian Cancer
 Behavioral: Music therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Testing Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidade Federal de Goias:

Primary Outcome Measures:
  • Assess the influence of musicotherapy in the reduction of fatigue [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    To compare the levels of quality of life of patients with breast and gynecological cancer on radiotherapy, between the musicotherapy and the control group.


Enrollment: 164
Study Start Date: February 2010
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: musictherapy
No Intervention: Control

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).

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570218

Locations
Brazil
Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
Goiania, Goias, Brazil, 74605070
Goias Anticancer Association
Goiania, Goias, Brazil, 74605070
Sponsors and Collaborators
Universidade Federal de Goias
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
  More Information

No publications provided

Responsible Party: Ruffo Freitas-Junior, Professor, Universidade Federal de Goias
ClinicalTrials.gov Identifier: NCT01570218     History of Changes
Other Study ID Numbers: RGM-02
Study First Received: March 17, 2012
Last Updated: April 1, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal de Goias:
breast cancer
gynecological cancer
radiotherapy
fatigue
musicotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Ovarian Neoplasms
Uterine Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
 Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Diseases

ClinicalTrials.gov processed this record on May 19, 2013