Guided Imagery & Music in Active Treatment for Gynecologic or Breast Cancer: An RCT Pilot
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Profiles of Mood States (POMS) Brief version (adapted)
研究概览
简要总结
This is an RCT pilot study to explore the potential effects of the Guided Imagery & Music method for women with breast or gynecologic cancer, during active treatment. The study explores the potential impact in quality of life parameters such as mood, fatigue, and hope.
详细描述
Guided Imagery and Music is a music-assisted psychotherapy method which has been used as a complementary, supportive psychosocial therapy in cancer care. However, its effects have never been explored during the period of active chemotherapy or radiotherapy treatment in various cancer populations, and especially gynecologic and breast cancer. This pilot study is an effort to explore the feasibility of the method to increase quality of life in this population by possibly reducing side-effects of treatment such as fatigue, improving mood, and building resilience as expressed through levels of hope.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Speaking Greek
- •receiving chemotherapy or radiotherapy treatment for breast or gynecologic cancer
- •first occurrence or metastatic
- •have an interest in engaging in creative psychotherapies through music
排除标准
- •women with active psychosis or PTSD symptomatology
- •women receiving other psychological support
- •women too ill to participate according to doctors' instructions
结局指标
主要结局
Profiles of Mood States (POMS) Brief version (adapted)
时间窗: Baseline and up to 12 weeks (post-intervention)
Brief version adapted in Greek. A 30-item scale designed to assess six different moods namely tension, anger, vigor, fatigue, depression, confusion. It requires to indicate mood state over the last week, with a single word, each item ranging from 0(not at all) to 4 (extremely). The questionnaire is a sum of its 6 sub scales (each addressing the aforementioned moods), with a total score from 0 to 120. Lower scores indicate better mood states.
次要结局
- Cancer-related Fatigue Scale (CFS)(Baseline and up to 12 weeks (post-intervention))
- Herth Hope Index(Baseline and up to 12 weeks (post-intervention))
- Visual Analogue Scale for Hope (VAS-H)(obtained 6 times throughout the completion of intervention (up to 12 weeks))
- Visual Analogue Scale for Fatigue (VAS-F)(Obtained 6 times throughout the completion of intervention (up to 12 weeks))
研究者
Evangelia Papanikolaou
Evangelia Papanikolaou, music therapist, Principal Investigator
Aalborg University