EVALUATION OF THE BENEFITS OF SOPHROLOGY FOR PATIENTS UNDERGOING RADIOTHERAPY (SORA-RT)
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Marion Mandon, PhD
- 电话号码:+33 6 78 27 76 72
- 邮箱:mmandon@vivalto-sante.com
学习地点
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-
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Brest、法国、29000
- Clinique Pasteur Lanroze
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接触:
- Marion Mandon, PhD
- 电话号码:+33 6 78 27 76 72
- 邮箱:mmandon@vivalto-sante.com
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adults with cancer requiring radiation therapy lasting at least 3 weeks,
- Primary sites: ENT cancers, Thoracic cancers, Breast cancers, Pelvic cancers, Gastrointestinal cancers
- WHO performance status 0 or 1
Exclusion Criteria:
- Patients undergoing treatment other than radiation therapy alone
- Patients already attending sophrology sessions elsewhere
- Patients under protective measures
- Patients receiving psychiatric care
- Pregnant or breastfeeding patients
- Patients not covered by social security
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Sophrology
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Here is the standard sequence of a sophrology session
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Anxiety measurement
大体时间:7 days before initiation of radiation therapy - 2 weeks after initiation of radiation therapy - 4 weeks after initiation of radiation therapy - 2 weeks after end of radiotherapy
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Anxiety level is assessed with STAI questionnaire. The STAI questionnaire is a self-report anxiety questionnaire. It consists of 40 items divided (20-20) into two subscales: "trait" anxiety (which represents the patient's baseline anxiety outside of any specific situation) and "state" anxiety, which corresponds to a given situation. Each subscale ranges from 20 to 80. The trait anxiety scale asks the respondent to assess their level of anxiety in life in general. The respondent indicates their answer using a 1-to-4 Likert scale. The state anxiety scale asks the respondent to assess their level of anxiety at the present moment. The respondent indicates their answer using a 1-to-4 Likert scale. |
7 days before initiation of radiation therapy - 2 weeks after initiation of radiation therapy - 4 weeks after initiation of radiation therapy - 2 weeks after end of radiotherapy
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.