Shared Meditation Involving People With Cancer, Carers and Third Parties

Patients With Cancer Clinical Trial

— IMPLIC2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041607
• Other study ID #: 2023-A01373-42
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patients With Cancer

Intervention

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)
• 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)

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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