Shared Meditation Involving People With Cancer, Carers and Third Parties (IMPLIC2)

January 23, 2024 updated by: Centre Francois Baclesse

Shared Meditation Involving People With Cancer, Carers and Third Parties: Any Added Value Compared With Meditation Conducted With Patients? IMPLIC 2, a Randomised Study

Although the benefits of meditation are increasingly well documented, few hospitals offer this integrative approach in their supportive cancer care. Meditation is sometimes provided, but its potential benefits remain insufficiently evaluated.

This project is based on the hypothesis that there could be a benefit in meditating together.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main aims of this randomised study are to improve well-being, strengthen links between carers, patients and third parties and raise awareness of the importance of living together better by offering meditation as a shared activity. The expected benefits of meditation therefore primarily concern the relief of psychological suffering. Promoting better understanding between carers and patients, and looking at oneself and others in a different way are experiences that aim to encourage exchanges and interactions between populations. For cancer patients (the target population), pain and other symptoms associated with the disease and its treatment will be better managed.

The pain experienced by carers, which is essentially linked to professional overwork and contact with illness, will be considered and managed through meditation, resulting in benefits for carers and their way of interacting with their patients.

The expected collective benefit is to develop and better live together our interdependence and humanity, by recognising suffering as a shared characteristic, despite our specific problems (as patients, carers or third parties).

The overall aim is to alleviate suffering, which is an integral part of the human experience, by cultivating our common humanity.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Criteria for all participants (patients, carers and third parties)

  • Participant with no current or previous experience of regular or intensive meditation or comparable practice. Practice is considered regular and/or intensive if :
  • it occurs more than one day a week for more than 6 consecutive months over the last 10 years,
  • and/or more than 5 consecutive days of intensive practice (course or retreat) in the last 10 years,
  • and/or more than 25 consecutive days of retreat (cumulative) in the last 10 years.

Patient-specific criteria (target population) - Cancer patients (regardless of location)

Specific criteria for carers

- All medical and/or paramedical care staff at the Centre François Baclesse in contact with patients (doctors, nurses, nursing assistants, radiotherapy technicians, etc.)

Specific criteria for third parties- Any volunteer not belonging to the two categories above

Exclusion Criteria:

  • Participants with significant vulnerability factors such as alcohol or drug dependence, severe depression, severe social anxiety, recent bereavement, etc.)
  • Participant unable to undergo trial monitoring for geographical, social or psychopathological reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Shared meditation
Shared" meditation: mixed groups of patients, carers and third parties
Behavioral: Shared meditation

Meditation sessions between patients, carers and third parties

  • 12 weekly 2-hour sessions,
  • 2 half-day 3-hour retreats after the 9th session and at the end of the programme
  • 3 monthly follow-up sessions (2h) in remote format (videoconference)
Active Comparator: Meditation "patients"
groups of patients only
Behavioral: Meditation with patients oly

Meditation sessions between patients only

  • 12 weekly 2-hour sessions,
  • 2 half-day 3-hour retreats after the 9th session and at the end of the programme
  • 3 monthly follow-up sessions (2h) in remote format (videoconference)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the possible added value for patients (target population) of a meditation programme shared between patients, carers and third parties, compared with the same meditation programme conducted solely for patients.
Time Frame: measured at the end of the meditation programme (after the 12 weekly sessions) compared with the measurement at inclusion
Changes in self-efficacy scores according to the Generalized Self Efficacy Scale [min 10; max 40]
measured at the end of the meditation programme (after the 12 weekly sessions) compared with the measurement at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-A01373-42

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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