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Completed

NCT Number: NCT06041607

Shared Meditation Involving People With Cancer, Carers and Third Parties

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse

Caen, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

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.

    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]

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Official study 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

Acronym: IMPLIC2

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 18, 2023
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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