Shared Meditation Involving People With Cancer, Carers and Third Parties

NCT06041607 | Completed

• 1 other identifier: 2023-A01373-42
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Cancer

Keywords

meditation; carer

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (2)

Shared meditation

EXPERIMENTAL

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

Behavioral: Shared meditation

Meditation "patients"

ACTIVE COMPARATOR

groups of patients only

Behavioral: Meditation with patients oly

Interventions

Shared meditation 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)

Shared meditation

Meditation with patients oly 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)

Meditation "patients"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (1)

Centre François Baclesse

Caen, France

Location

Related Publications (1)

• 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.

  PMID: 39232668 DERIVED

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: January 9, 2024
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)