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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

March 17, 2012
April 1, 2012
February 2010
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01570218 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Breast Cancer
  • Uterine Cancer
  • Ovarian Cancer
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
  • Experimental: Music therapy
    Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days.
    Intervention: Behavioral: Music therapy
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
164
February 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01570218
RGM-02
No
Ruffo Freitas-Junior, Universidade Federal de Goias
Universidade Federal de Goias
Associaçao de Combate ao Cancer em Goias
Study Chair: Ruffo Freitas-Junior, PhD Universidade Federal de Goias
Principal Investigator: Tereza R Alcantara-Silva, Ms Mus Universidade Federal de Goias
Universidade Federal de Goias
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP