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

Pain Clinical Trial

— IMPLIC  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410185
• Other study ID #: 2020-A00485-34
• Status: Completed
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: February 11, 2021

Study information

• Verified date: March 2021
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 11, 2021
• Est. primary completion date: February 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Pain
• Stress, Psychological

Intervention

Behavioral:
• Meditation
Meditation sessions will take place over 12 weekly sessions of 1.5 hours

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen

Sponsors (3)

Lead Sponsor	Collaborator
Centre Francois Baclesse	Cancéropôle Nord-Ouest, Fondation de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the adherence of all participants to the full meditation program	Proportion of participants adhering to the full meditation program (13 sessions)	3 months after the beginning of program