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临床试验/NCT04751201
NCT04751201
已完成
不适用

Meditation and Cancer: Effectiveness of the MAEva Program on Symptoms and Quality of Life. Pilot Feasibility Study. (MAEva Pilot Study)

Institut de Cancérologie de Lorraine1 个研究点 分布在 1 个国家目标入组 40 人2021年9月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Breast Cancer
发起方
Institut de Cancérologie de Lorraine
入组人数
40
试验地点
1
主要终点
Assess the feasibility and acceptability of the MAEva programme to patients in a specialised care facility
状态
已完成
最后更新
2年前

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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注册库
clinicaltrials.gov
开始日期
2021年9月1日
结束日期
2022年7月13日
最后更新
2年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
Institut de Cancérologie de Lorraine
责任方
Sponsor

入排标准

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)

研究点 (1)

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