Benefits of an Intervention Combining Hypnosis and Self-care for Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Change in Fatigue
研究概览
简要总结
This study aims to assess the impact of a group intervention combining self-hypnosis and self-care techniques on prostate patients' well-being. More specifically, the investigators want to investigate the effects of that intervention on sleep, fatigue and emotional distress of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18-years-old,
- •ability to read, write and speak French
- •prostate cancer diagnosis
- •treatment with surgery and/or radiotherapy.
排除标准
- •metastases
- •cancer recurrence at the moment of inclusion
- •major cognitive or psychiatric disorder.
研究组 & 干预措施
Intervention group : hypnosis + self-care
Groupal intervention combining self-care techniques and self-hypnosis exercises
干预措施: Self-hypnosis + Self-care (Behavioral)
Control group : no intervention
Control group receiving usual care but not the intervention
结局指标
主要结局
Change in Fatigue
时间窗: T0 (before the intervention) and T1 (after the intervention : 6 months later).
A sense of tiredness or exhaustion linked with cancer and its treatments, that is not alleviated by sleep. Measured by the European Organization for Research and Treatment of Cancer - Quality of Life Core Questionnaire-30 (EORTC-QLCQ30). One symptom-related scale (fatigue, score based on 3 items, varies from 0 to 100, 100 being the worst fatigue endured) and the global health status (2 items, score varies from 0 to 100, 100 being the best quality of life) are used in this study.
Change in emotional distress
时间窗: T0 (before the intervention) and T1 (after the intervention : 6 months later).
Anxiety + Depression, measured with the Hospital Anxiety and Depression Scale (HADS). Scores range (total): 0-42 (0-14: absence of anxio-depressive disorder ; 15-42: presence of anxio-depressive disorder). Two scales: anxiety and depression. For each, scores range 0-21 (0-7: absence of anxious or depressive disorder; 8-10: possibility of an anxious or depressive disorder; 11-21: presence of anxious or depressive disorder).
Change in sleep difficulties
时间窗: T0 (before the intervention) and T1 (after the intervention : 6 months later).
Sleep difficulties (difficulties to stay asleep, to fall asleep...) and their severity. Measured by the Insomnia Severity Index. One score is calculated and ranges from 0 to 22 (0-7: absence of insomnia; 8-14: subclinical insomnia; 15-21: moderate insomnia; 22-28: severe insomnia).
次要结局
未报告次要终点
研究者
Isabelle Bragard
Lecturer
University of Liege