NCT04513444招募中2 期
Phase II Study Aiming to Evaluate the Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Rate of patients with at least a 10-point decrease in anxiety score (evolution between the baseline and the 6th and last radiotherapy session)
研究概览
简要总结
This phase II, randomized, non-comparative and monocentric study aims to evaluate the interest of medical hypnosis in the management of anxiety in patients who are moderately anxious, anxious or very anxious during their radiotherapy treatment.
45 patients will be randomized into the following arms:
- Arm A (standard): relaxation with music listening during radiotherapy treatment
- Arm B (experimental): relaxation with music listening and hypnosis during radiotherapy treatment
For the study each patient will be followed during 2 months.
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 ≥ 18 years at the time of enrollment into the study.
- •Patient with localized or metastatic solid malignant tumor.
- •Patient being followed for the cancer pathology at IUCT-O and to receive, for the first time in the follow-up, treatment by radiotherapy (radiotherapy treatment should not have been initiated prior to inclusion in the study).
- •Patient for whom radiotherapy treatment includes at least 15 sessions of radiation therapy.
- •Patient defined as moderately anxious, anxious or very anxious after completing the STAI-Y self-assessment questionnaire (i.e. ≥ 46 score at inclusion).
- •ECOG patient ≤
- •Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
- •Patient affiliated to a Social Health Insurance in France.
排除标准
- •Patient doesn't understand the French language.
- •Patient with psychiatric disorders requiring antidepressant or antipsychotic treatment.
- •Patient with hearing problems.
- •Pregnant or breastfeeding women.
- •Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
- •Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
研究组 & 干预措施
Standard arm (A): music listening therapy
Other
干预措施: Relaxation with music listening during radiotherapy treatment: (Other)
Experimental arm (B): music listening and hypnosis therapy
Experimental
干预措施: Relaxation with music listening and medical hypnosis during radiotherapy treatment: (Other)
结局指标
主要结局
Rate of patients with at least a 10-point decrease in anxiety score (evolution between the baseline and the 6th and last radiotherapy session)
时间窗: 2 months for each patient
Anxiety will be assessed using the STAI-Y questionnaire (Spielberger State-Trait Anxiety Inventory - State Anxiety form).
次要结局
- Quality of life assessed using the EORTC (European Organization for Research and Treatment of Cancer) Quality of life questionnaire (QLQ-C30).(2 months for each patient)
- Anxiety assessed using a numerical scale from 0 to 10 (0 being "not at all anxious" and 10 being "extremely anxious")(2 months for each patient)
研究者
研究点 (2)
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