Randomized Clinical Trial Testing Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 4
- 主要终点
- Assess the influence of musicotherapy in the reduction of fatigue
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with breast and gynecological cancer with indication for radiotherapy
- •Performance status 0,1
排除标准
- •Hemoglobin < 10mg/dl
- •Patients in psychotherapy during the study
- •Use of antidepressants
- •Patients presenting more than one cancer type
研究组 & 干预措施
Music therapy
Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days.
干预措施: Music therapy (Behavioral)
Control
结局指标
主要结局
Assess the influence of musicotherapy in the reduction of fatigue
时间窗: 45 days
To study the influence of musicotherapy in reduction of fatigue related to cancer in patients with breast or gynecological cancer, during the radiotherapy treatment.
次要结局
- Assess the reduction of depression(45 days)
- Asses the reduction of anxiety(45 days)
- Assess the quality of life(45 days)
研究者
Ruffo Freitas-Junior
Professor
Universidade Federal de Goias