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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570218
• Other study ID #: RGM-02
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: February 2011

Study information

• Verified date: May 2018
• Source: Universidade Federal de Goias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Fatigue
• Ovarian Cancer
• Uterine Cancer
• Uterine Neoplasms

Intervention

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

Locations

Country	Name	City	State
Brazil	Goias Anticancer Association	Goiania	Goias
Brazil	Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias	Goiania	Goias

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Goias	Associaçao de Combate ao Cancer em Goias

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the influence of musicotherapy in the reduction of fatigue	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	Assess the reduction of depression	To compare the levels of depression of patients with breast and gynecological cancer on radiotherapy, between the musicotherapy and the control group.	45 days
Secondary	Asses the reduction of anxiety	To compare the levels of anxiety of patients with breast and gynecological cancer on radiotherapy, between the musicotherapy and the control group.	45 days
Secondary	Assess the quality of life	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