Clinical trial NCT04751201: Meditation and Cancer, Pilot Feasibility Study (MAEva Pilot Study)
Official title: Meditation and Cancer: Effectiveness of the MAEva Program on Symptoms and Quality of Life. Pilot Feasibility Study. (MAEva Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Keywords: Mindfulness
Quality of life
Cancer
Open and circular program
Meditation
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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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Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Assess the feasibility and acceptability of the MAEva programme to patients in a specialised care facility
timeFrame: 3 months
Secondary outcomes:
measure: Improved patient well-being
timeFrame: 3 months
measure: Measure patient satisfaction
timeFrame: 3 months
measure: Measure care staff satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancerologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: François Bourgognon, PhD
role: PRINCIPAL_INVESTIGATOR
References: