Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology

NCT ID: NCT04410185

Last Updated: 2021-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-10

Study Completion Date

2021-02-11

Brief Summary

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The study is based on the realization of a meditation program associating patients, caregivers and control subjects

Detailed Description

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Conditions

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Cancer Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

3 separate populations will be recruited: Patients (n=10), caregivers (n=10), and control subjects (n=10)
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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MEDITATION

Meditation sessions will take place over 12 weekly sessions of 1.5 hours. A retreat (3 hours) will be realized after the 9th session

Group Type EXPERIMENTAL

Meditation

Intervention Type BEHAVIORAL

Meditation sessions will take place over 12 weekly sessions of 1.5 hours

Interventions

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Meditation

Meditation sessions will take place over 12 weekly sessions of 1.5 hours

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondation de France

OTHER

Sponsor Role collaborator

Cancéropôle Nord-Ouest

UNKNOWN

Sponsor Role collaborator

Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre François Baclesse

Caen, , France

Site Status

Countries

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France

References

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Prevost V, Tran T, Clarisse B, Leconte A, Duchange N, Moutel G, Gouriot M. Shared Meditation Involving Cancer Patients, Health Professionals and Third Persons: Perceptions of Participants Through a Focus Group Study. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231186995. doi: 10.1177/15347354231186995.

Reference Type DERIVED
PMID: 37452577 (View on PubMed)

Prevost V, Lefevre-Arbogast S, Leconte A, Delorme C, Benoit S, Tran T, Clarisse B. Shared meditation involving cancer patients, health professionals and third persons is relevant and improves well-being: IMPLIC pilot study. BMC Complement Med Ther. 2022 May 18;22(1):138. doi: 10.1186/s12906-022-03599-w.

Reference Type DERIVED
PMID: 35585593 (View on PubMed)

Prevost V, Clarisse B, Leconte A, Delorme C, Benoit S, Tran T. Meditation involving people with cancer, medical staff and witnesses: a pilot study exploring improvement in wellness and connectedness. BMJ Open. 2021 Nov 12;11(11):e048164. doi: 10.1136/bmjopen-2020-048164.

Reference Type DERIVED
PMID: 34772746 (View on PubMed)

Other Identifiers

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2020-A00485-34

Identifier Type: -

Identifier Source: org_study_id

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