Prospective, Randomized Study Aiming to Assess the Benefit of Autohypnosis Learning in the Care of Patients Treated by Adjuvant Chemotherapy for Colorectal or Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- >20% increase of the EORTC QLQC30 score (annexe 1) at the third week after the last chemotherapy session in the auto-hypnosis arm compared to the standard care arm.
研究概览
简要总结
Therapeutical hypnosis is proven to be an effective medical support to chemotherapy: it was shown that it can reduce the pain, anxiety, fatigue felt by the patient.
Yet, hypnosis requires the presence of an hypnotherapist, which is why auto-hypnosis could be an efficient alternative to handle the side effects of chemotherapy.
In this study, colorectal cancer and breast cancer patients are either taught auto-hypnosis or are taken in standard care for their chemotherapy.
The life quality score (QLQC30) assessed during and after chemotherapies will determine if auto-hypnosis is a good medical support in chemotherapies' adverse effects management.
The proven benefices of auto-hypnosis in the handling of the side effects of chemotherapies could improve the quality of life of cancer affected patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age superior or equal to 18 years old
- •Colorectal or breast cancer history, treated by surgery and that should undergo an adjuvant chemotherapy
- •In the case of breast cancer, adjuvant chemotherapy must involve anthracyclines
- •ECOG performance score < 3
- •Patient must be affiliated or beneficiary of social security or any similar regime
排除标准
- •Patients already included in another interventional clinical research protocol
- •Patients unable to proceed to hypnosis treatment due to their speech limitations (poor comprehension and expression of french, deafness, mental illness)
- •Patients protected by French law from clinical inclusion ( pregnant, in labour, breastfeeding, legally protected, under judiciary or administrative liberty deprivation...)
结局指标
主要结局
>20% increase of the EORTC QLQC30 score (annexe 1) at the third week after the last chemotherapy session in the auto-hypnosis arm compared to the standard care arm.
时间窗: 3 weeks after the last chemotherapy session
At the third week after the last chemotherapy session, patients answer the quality of life survey (EORTC QLQC30). Arms' mean score are compared, a minimal difference of 21% is needed for statistical significance.
次要结局
- Evaluation of auto-hypnosis effects on different components of quality of life specific to colorectal cancer.(3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment)
- Evaluation of auto-hypnosis effects on fatigue.(3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment)
- Evaluation of auto-hypnosis effects on different components of quality of life specific to breast cancer(3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment)
- Evaluation of auto-hypnosis impact on anxiety and/or depression.(3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment)
- Evaluation of auto-hypnosis effects on the life quality and global health of patients at short, mid, and long term.(3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment)
- Evaluation of auto-hypnosis effects on different components of quality of life.(3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment)
- Evaluation of auto-hypnosis effects on drug consumption.(3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment)
- Evaluation of patient's satisfaction about auto-hypnosis therapies.(3rd week and 6 month after the last treatment)
- Evaluation of auto-hypnosis impact on the global medical handling of their cancer.(3rd week and 6 month after the last treatment)