Shared Meditation Involving People With Cancer, Carers and Third Parties

NCT ID: NCT06041607

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2024-06-26

Brief Summary

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.

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.

Conditions

Patients With Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Shared meditation

Shared" meditation: mixed groups of patients, carers and third parties

Group Type: EXPERIMENTAL

Shared meditation

Intervention Type: BEHAVIORAL

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)

Meditation "patients"

groups of patients only

Group Type: ACTIVE_COMPARATOR

Meditation with patients oly

Intervention Type: BEHAVIORAL

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Francois Baclesse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre François Baclesse

Caen, , France

Countries

France

References

Prevost V, Tran T, Leconte A, Lequesne J, Fernette M, Segura C, Chevigne S, Gouriot M, Clarisse B. A randomised study to evaluate the potential added value of shared meditation involving people with cancer, health professionals and third persons compared to meditation conducted with patients only: design of the Implic-2 protocol. BMC Cancer. 2024 Sep 4;24(1):1097. doi: 10.1186/s12885-024-12521-1.

Reference Type: DERIVED

PMID: 39232668 (View on PubMed)

Other Identifiers

2023-A01373-42

Identifier Type: -

Identifier Source: org_study_id