NCT04410185

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 10, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2021

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

May 27, 2020

Last Update Submit

March 3, 2021

Conditions

CancerPain

Keywords

meditationcaregiverspatients with cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

MeditationBEHAVIORAL

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

MEDITATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre François Baclesse

Caen, France

Location

Related Publications (3)

  • Prevost V, Tran T, Clarisse B, Leconte A, Duchange N, Moutel G, Gouriot M. Shared Meditation Involving Cancer Patients, Health Professionals and Third Persons: Perceptions of Participants Through a Focus Group Study. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231186995. doi: 10.1177/15347354231186995.

    PMID: 37452577DERIVED

  • 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.

    PMID: 35585593DERIVED

  • 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.

    PMID: 34772746DERIVED

MeSH Terms

Conditions

NeoplasmsPain

Interventions

Meditation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 3 separate populations will be recruited: Patients (n=10), caregivers (n=10), and control subjects (n=10)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 1, 2020

Study Start

September 10, 2020

Primary Completion

February 11, 2021

Study Completion

February 11, 2021

Last Updated

March 4, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)