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


Phase 3
20 Years
80 Years
Not Enrolling
Both
Breast Cancer, Uterine Cancer, Ovarian Cancer

Thank you

Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Assess the influence of musicotherapy in the reduction of fatigue

Outcome Description:

To study the influence of musicotherapy in reduction of fatigue related to cancer in patients with breast or gynecological cancer, during the radiotherapy treatment.

Outcome Time Frame:

45 days

Safety Issue:

No

Principal Investigator

Ruffo Freitas-Junior, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Universidade Federal de Goias

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

RGM-02

NCT ID:

NCT01570218

Start Date:

February 2010

Completion Date:

February 2011

Related Keywords:

  • Breast Cancer
  • Uterine Cancer
  • Ovarian Cancer
  • breast cancer
  • gynecological cancer
  • radiotherapy
  • fatigue
  • musicotherapy
  • Breast Neoplasms
  • Fatigue
  • Ovarian Neoplasms
  • Uterine Neoplasms

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