CancerIMPLICNCT04410185
Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology
A study testing Meditation in people with Cancer and Pain, run by Centre Francois Baclesse at 1 site in France.
Trial summary
The study is based on the realization of a meditation program associating patients, caregivers and control subjects Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2020to 11 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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"
The study is based on the realization of a meditation program associating patients, caregivers and control subjects
- Being tested
- Meditation
- Keywords
- meditation, caregivers, patients with cancer
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
Meditation sessions will take place over 12 weekly sessions of 1.5 hours
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the adherence of all participants to the full meditation program
Proportion of participants adhering to the full meditation program (13 sessions)
Measured: 3 months after the beginning of program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start10 Sep 2020
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3 separate populations will be recruited: Patients (n=10), caregivers (n=10), and control subjects (n=10)
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France, Cancéropôle Nord-Ouest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410185
- Sponsor's protocol ID
- 2020-A00485-34
- Acronym
- IMPLIC
- Status last verified
- Mar 2021
- First submitted
- 27 May 2020
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41979169Prevost 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.
PubMed 37452577Prevost 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.
PubMed 35585593Prevost 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.
PubMed 34772746
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT04410185
- Acronym / sponsor ID
- IMPLIC / 2020-A00485-34
- Keywords
- meditation, caregivers, patients with cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Fondation de France, Cancéropôle Nord-Ouest
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is based on the realization of a meditation program associating patients, caregivers and control subjects
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3 separate populations will be recruited: Patients (n=10), caregivers (n=10), and control subjects (n=10)
| Arm | Type | Receives |
|---|---|---|
| MEDITATION | Experimental | Behavioral: MeditationMeditation sessions will take place over 12 weekly sessions of 1.5 hours. A retreat (3 hours) will be realized after the 9th session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeditationMeditation sessions will take place over 12 weekly sessions of 1.5 hours | Behavioural | MEDITATION |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Derived from this study: PubMed 41979169Prevost 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.
- Derived from this study: PubMed 37452577Prevost 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.
- Derived from this study: PubMed 35585593Prevost 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.
- Derived from this study: PubMed 34772746Prevost 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Cancer and Pain, run by Centre Francois Baclesse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the adherence of all participants to the full meditation program (time frame: 3 months after the beginning of program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04410185, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.