Pain of Patients, Suffering of Caregivers: Evaluation of... | NCT04410185

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

NCT04410185

Sponsor

Centre Francois Baclesse

Status

Completed

Last Update Posted

Mar 4, 2021Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Cancer
Pain

Interventions

Meditation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 10, 2020Actual

Primary Completion Date

Feb 11, 2021Actual

Completion Date

Feb 11, 2021Actual

First Submitted Date

May 27, 2020

First Submission Date that Met QC Criteria

May 27, 2020

First Posted Date

Jun 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2021

Last Update Posted Date

Mar 4, 2021Actual

Name	Class
Fondation de France	OTHER
Cancéropôle Nord-Ouest	UNKNOWN

Label	Type	Description	Intervention Names
MEDITATION	Experimental	Meditation sessions will take place over 12 weekly sessions of 1.5 hours. A retreat (3 hours) will be realized after the 9th session	Behavioral: Meditation

Name	Type	Description	Arm Group Labels	Other Names
Meditation	Behavioral	Meditation sessions will take place over 12 weekly sessions of 1.5 hours	MEDITATION

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

PubMed Identifier	Type	Citation	Retractions
41979169	Derived	Prevost V, Tran T, Clarisse B, Leconte A, Fernette M, Grandazzi G, Gouriot M. The Experience of Shared Meditation Involving People With Cancer, Health Professionals and Third Persons: A Qualitative Focus-Group Study. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261439128. doi: 10.1177/15347354261439128. Epub 2026 Apr 14.
37452577

ID	Term
D009369	Neoplasms
D010146	Pain

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026443	Spiritual Therapies