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

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"

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

Study Overview

• Status: Completed
• Conditions: Pain; Cancer
• Intervention / Treatment: Behavioral: Meditation

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France
    • Centre Francois Baclesse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Meditation; Meditation sessions will take place over 12 weekly sessions of 1.5 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the adherence of all participants to the full meditation program	Proportion of participants adhering to the full meditation program (13 sessions)	3 months after the beginning of program

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse
• Collaborators: Fondation de France; Cancéropôle Nord-Ouest

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Actual): February 11, 2021
• Study Completion (Actual): February 11, 2021

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: meditation; caregivers; patients with cancer
• Other Study ID Numbers: 2020-A00485-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No