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OpenTrials
Completed

NCT Number: NCT04410185

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

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

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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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Meditation

Behavioral

Meditation sessions will take place over 12 weekly sessions of 1.5 hours

Primary outcomes

  1. Evaluate the adherence of all participants to the full meditation program

    Time frame: 3 months after the beginning of program

    Proportion of participants adhering to the full meditation program (13 sessions)

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

  • Cancéropôle Nord-Ouest
  • Fondation de France

Registry information

Official study title

Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology to Improve Stress and Quality of Life With Joint Participation of "Witness / Patient / Caregivers"

Acronym: IMPLIC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2020
Registry last updated
Mar 4, 2021

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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