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

NCT ID: NCT01570218

Last Updated: 2018-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Breast Cancer Uterine Cancer Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Music therapy

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

Group Type EXPERIMENTAL

Music therapy

Intervention Type BEHAVIORAL

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music therapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

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musictherapy

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Associaçao de Combate ao Cancer em Goias

UNKNOWN

Sponsor Role collaborator

Universidade Federal de Goias

OTHER

Sponsor Role lead

Responsible Party

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Ruffo Freitas-Junior

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruffo Freitas-Junior, PhD

Role: STUDY_CHAIR

Universidade Federal de Goias

Tereza R Alcantara-Silva, Ms Mus

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Goias

Locations

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Goias Anticancer Association

Goiânia, Goiás, Brazil

Site Status

Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias

Goiânia, Goiás, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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RGM-02

Identifier Type: -

Identifier Source: org_study_id

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