Clinical trial NCT04410185: Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology
Official 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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Pain
Keywords: meditation
caregivers
patients with cancer
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: Fondation de France
name: Cancéropôle Nord-Ouest
First posted: 2020-06-01
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 3 separate populations will be recruited: Patients (n=10), caregivers (n=10), and control subjects (n=10)
Primary purpose: OTHER

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


Eligibility 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

Primary outcomes:
measure: Evaluate the adherence of all participants to the full meditation program
timeFrame: 3 months after the beginning of program
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
References:
citation: Prevost V, Lefevre-Arbogast S, Leconte A, Delorme C, Benoit S, Tran T, Clarisse B. Shared meditation involving cancer patients, health professionals and third persons is relevant and improves well-being: IMPLIC pilot study. BMC Complement Med Ther. 2022 May 18;22(1):138. doi: 10.1186/s12906-022-03599-w.
citation: Prevost V, Clarisse B, Leconte A, Delorme C, Benoit S, Tran T. Meditation involving people with cancer, medical staff and witnesses: a pilot study exploring improvement in wellness and connectedness. BMJ Open. 2021 Nov 12;11(11):e048164. doi: 10.1136/bmjopen-2020-048164.