NCT04410185已完成不适用
Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology to Improve Stress and Quality of Life With Joint Participation of "Witness / Patient / Caregivers"
Centre Francois Baclesse1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2020年9月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Evaluate the adherence of all participants to the full meditation program
研究概览
简要总结
The study is based on the realization of a meditation program associating patients, caregivers and control subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •for all participants (patients, caregivers and control subjects)
- •Participants aged 18 or over
- •Curious and motivated participant to participate in the program
- •Participant with no current or previous experience of regular or intensive practice of meditation or a comparable practice. The practice is considered regular and / or intensive if:
- •it occurs more than one day per week for more than 6 consecutive months over the last 10 years,
- •and / or in case of more than 5 consecutive days of intensive practice (internship or retirement) in the last 10 years,
- •and / or more than 25 consecutive days of (cumulative) retirement over the last 10 years.
- •Participant available to follow the full meditation program (3 month period)
- •Participant agreeing to participate by signing the study information note
- •Participant able to understand, speak and read French
- •Patient capable of using digital media and having an internet connection
- •Patient-specific criteria (target population)
- •Patients with cancer,
- •State of health compatible with the study meditation program
- •Patient affiliated to a social Health sytem
- •Caregiver-specific criteria
- •All medical and / or paramedical staff of the sponsor Center in contact with patients (doctors, nurse, caregiver, radiotherapy manipulator MERM)
- •Criteria specific to the control population - Any voluntary person not belonging to the two categories above
排除标准
- •For all participants
- •Participant with significant vulnerability factors dependence on alcohol and drugs, severe depression, severe social anxiety, recent mourning etc.).
- •Participant who cannot submit to the follow-up of the trial for geographic, social or psychopathological reasons
- •For patients
- •Very advanced stage of cancer disease with life-threatening commitment,
- •Participant deprived of liberty or under guardianship
- •For control subjects
- •Nursing staff, regardless of their place of practice
结局指标
主要结局
Evaluate the adherence of all participants to the full meditation program
时间窗: 3 months after the beginning of program
Proportion of participants adhering to the full meditation program (13 sessions)
次要结局
未报告次要终点
研究者
研究点 (1)
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