Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology (IMPLIC)

Centre Francois Baclesse

Status: Completed

Conditions: Cancer; Pain

Treatments: Behavioral: Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT04410185

2020-A00485-34

Details and patient eligibility

About

The study is based on the realization of a meditation program associating patients, caregivers and control subjects

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for all participants (patients, caregivers and control subjects)

• Participants aged 18 or over

• Curious and motivated participant to participate in the program

• Participant with no current or previous experience of regular or intensive practice of meditation or a comparable practice. The practice is considered regular and / or intensive if:

  • it occurs more than one day per week for more than 6 consecutive months over the last 10 years,
  • and / or in case of more than 5 consecutive days of intensive practice (internship or retirement) in the last 10 years,
  • and / or more than 25 consecutive days of (cumulative) retirement over the last 10 years.

• Participant available to follow the full meditation program (3 month period)

• Participant agreeing to participate by signing the study information note

• Participant able to understand, speak and read French

• Patient capable of using digital media and having an internet connection

Patient-specific criteria (target population)

• Patients with cancer,
• State of health compatible with the study meditation program
• Patient affiliated to a social Health sytem

Caregiver-specific criteria

• All medical and / or paramedical staff of the sponsor Center in contact with patients (doctors, nurse, caregiver, radiotherapy manipulator MERM)

Criteria specific to the control population - Any voluntary person not belonging to the two categories above

Exclusion Criteria:

For all participants

• Participant with significant vulnerability factors dependence on alcohol and drugs, severe depression, severe social anxiety, recent mourning etc.).
• Participant who cannot submit to the follow-up of the trial for geographic, social or psychopathological reasons

For patients

• Very advanced stage of cancer disease with life-threatening commitment,
• Participant deprived of liberty or under guardianship

For control subjects

• Nursing staff, regardless of their place of practice

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

MEDITATION

Experimental group

Description:

Meditation sessions will take place over 12 weekly sessions of 1.5 hours. A retreat (3 hours) will be realized after the 9th session

Treatment:

Behavioral: Meditation