Meditation and Cancer: Effectiveness of the MAEva Program on Symptoms and Quality of Life. Pilot Feasibility Study. (MAEva Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Assess the feasibility and acceptability of the MAEva programme to patients in a specialised care facility
研究概览
简要总结
MAEVA, which stands for Meditation, Acceptance and Commitment towards Values, is an open and circular program, made up of 3 themed sessions, following a weekly rhythm. It is proposed here to study this program over a period of 3 months, which will give participants the opportunity to complete up to three complete cycles.
This program is based on the practice of and the processes of acceptance and commitment therapy. These approaches, used for several years, have proven their effectiveness in the management of stress, chronic anxiety, insomnia, chronic pain, distress in the face of chronic disease, as well as in the prevention of depressive relapses and management of impulsivity.
Unlike conventional 8-week meditation programs, the MAEva program allows patients to enter the study at any stage of the disease (within, outside the exclusion criteria) and from any session and to participate according to their possibilities.
The patient can participate in a weekly session of the program for 3 cycles. During the sessions, it will be proposed to train meditative practices and 3 different themes will be addressed (one theme per session): Meditation, Acceptance and Commitment to values.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Major patient
- •Patient with non-metastatic prostate or breast cancer
- •Newly diagnosed patients or those undergoing treatment
- •Patient able and willing to follow all study procedures in accordance with the protocol.
- •Patient having understood, signed and dated the consent form.
- •Patient affiliated to the social security system
- •Patient able to remain in a sitting position during the 2-hour session
排除标准
- •Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons.
- •Presence of an acute psychiatric disorder: depression in acute phase, unstabilised bipolar disorder, psychotic disorders (delusions, hallucinations), etc.
- •Presence of recurrent uncontrolled panic attacks (notably linked to hypochondriac concerns)
- •Presence of latent or patent post-traumatic stress disorder
- •Lack of motivation to meditate
- •Insufficient attentional resources to meditate: major problems with attention, memory or reasoning
- •Patient with metastatic cancer.
- •Presence of cognitive and neurocognitive disorders and deficits
- •Presence of deafness
- •Membership in a meditation programme prior to inclusion
结局指标
主要结局
Assess the feasibility and acceptability of the MAEva programme to patients in a specialised care facility
时间窗: 3 months
Patient participation rate and number of sessions performed per patient
次要结局
- Improved patient well-being(3 months)
- Measure patient satisfaction(3 months)
- Measure care staff satisfaction(3 months)