Patients With CancerIMPLIC2NCT06041607
Shared Meditation Involving People With Cancer, Carers and Third Parties
A study testing Shared meditation and Meditation with patients oly in people with Patients With Cancer, run by Centre Francois Baclesse at 1 site in France.
Trial summary
Although the benefits of meditation are increasingly well documented, few hospitals offer this integrative approach in their supportive cancer care. Meditation is sometimes provided, but its potential benefits remain insufficiently evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients With Cancer
- What is being tested?
- Shared meditation and Meditation with patients oly
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2024to 26 Jun 2024
- 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
- Criteria for all participants (patients, carers and third parties)
- Participant with no current or previous experience of regular or intensive meditation or comparable practice. Practice is considered regular and/or intensive if :
- it occurs more than one day a week for more than 6 consecutive months over the last 10 years,
- and/or more than 5 consecutive days of intensive practice (course or retreat) in the last 10 years,
- and/or more than 25 consecutive days of retreat (cumulative) in the last 10 years.
- Patient-specific criteria (target population) - Cancer patients (regardless of location)
Show all 9Show fewer
- Specific criteria for carers
- All medical and/or paramedical care staff at the Centre François Baclesse in contact with patients (doctors, nurses, nursing assistants, radiotherapy technicians, etc.)
- Specific criteria for third parties- Any volunteer not belonging to the two categories above
Who cannot join
- Participants with significant vulnerability factors such as alcohol or drug dependence, severe depression, severe social anxiety, recent bereavement, etc.)
- Participant unable to undergo trial monitoring for geographical, social or psychopathological reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shared Meditation Involving People With Cancer, Carers and Third Parties: Any Added Value Compared With Meditation Conducted With Patients? IMPLIC 2, a Randomised Study
Although the benefits of meditation are increasingly well documented, few hospitals offer this integrative approach in their supportive cancer care. Meditation is sometimes provided, but its potential benefits remain insufficiently evaluated.
This project is based on the hypothesis that there could be a benefit in meditating together.
Read the detailed description
The main aims of this randomised study are to improve well-being, strengthen links between carers, patients and third parties and raise awareness of the importance of living together better by offering meditation as a shared activity. The expected benefits of meditation therefore primarily concern the relief of psychological suffering. Promoting better understanding between carers and patients, and looking at oneself and others in a different way are experiences that aim to encourage exchanges and interactions between populations. For cancer patients (the target population), pain and other symptoms associated with the disease and its treatment will be better managed.
The pain experienced by carers, which is essentially linked to professional overwork and contact with illness, will be considered and managed through meditation, resulting in benefits for carers and their way of interacting with their patients.
The expected collective benefit is to develop and better live together our interdependence and humanity, by recognising suffering as a shared characteristic, despite our specific problems (as patients, carers or third parties).
The overall aim is to alleviate suffering, which is an integral part of the human experience, by cultivating our common humanity.
- Conditions
- Patients With Cancer
- Being tested
- Shared meditation, Meditation with patients oly
- Keywords
- meditation, carer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared meditationBehavioural
Meditation sessions between patients, carers and third parties
- 12 weekly 2-hour sessions,
- 2 half-day 3-hour retreats after the 9th session and at the end of the programme
- 3 monthly follow-up sessions (2h) in remote format (videoconference)
Meditation with patients olyBehavioural
Meditation sessions between patients only
- 12 weekly 2-hour sessions,
- 2 half-day 3-hour retreats after the 9th session and at the end of the programme
- 3 monthly follow-up sessions (2h) in remote format (videoconference)
| Study group | Role | What they receive |
|---|---|---|
| Shared meditation | Experimental | Shared" meditation: mixed groups of patients, carers and third parties Receives: Behavioral: Shared meditation |
| Meditation "patients" | Active comparator | groups of patients only Receives: Behavioral: Meditation with patients oly |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the possible added value for patients (target population) of a meditation programme shared between patients, carers and third parties, compared with the same meditation programme conducted solely for patients.
Changes in self-efficacy scores according to the Generalized Self Efficacy Scale [min 10; max 40]
Measured: measured at the end of the meditation programme (after the 12 weekly sessions) compared with the measurement at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start9 Jan 2024
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients With 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041607
- Sponsor's protocol ID
- 2023-A01373-42
- Acronym
- IMPLIC2
- Status last verified
- Jul 2024
- First submitted
- 11 Sep 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prevost V, Christy F, Leconte A, Fernette M, Segura C, Tran T, Clarisse B. Effectiveness of shared meditation involving cancer patients, health professionals and third persons on well-being and psychosocial skills: a randomised study. BMC Complement Med Ther. 2026 Jul 3. doi: 10.1186/s12906-026-05449-5. Online ahead of print.
PubMed 42399863Prevost 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, Leconte A, Lequesne J, Fernette M, Segura C, Chevigne S, Gouriot M, Clarisse B. A randomised study to evaluate the potential added value of shared meditation involving people with cancer, health professionals and third persons compared to meditation conducted with patients only: design of the Implic-2 protocol. BMC Cancer. 2024 Sep 4;24(1):1097. doi: 10.1186/s12885-024-12521-1.
PubMed 39232668
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Meditation Involving People With Cancer, Carers and Third Parties: Any Added Value Compared With Meditation Conducted With Patients? IMPLIC 2, a Randomised Study
- ClinicalTrials.gov ID
- NCT06041607
- Acronym / sponsor ID
- IMPLIC2 / 2023-A01373-42
- Conditions
- Patients With Cancer
- Keywords
- meditation, carer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 18 Sep 2023 (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.
Although the benefits of meditation are increasingly well documented, few hospitals offer this integrative approach in their supportive cancer care. Meditation is sometimes provided, but its potential benefits remain insufficiently evaluated.
This project is based on the hypothesis that there could be a benefit in meditating together.
Detailed description
The main aims of this randomised study are to improve well-being, strengthen links between carers, patients and third parties and raise awareness of the importance of living together better by offering meditation as a shared activity. The expected benefits of meditation therefore primarily concern the relief of psychological suffering. Promoting better understanding between carers and patients, and looking at oneself and others in a different way are experiences that aim to encourage exchanges and interactions between populations. For cancer patients (the target population), pain and other symptoms associated with the disease and its treatment will be better managed.
The pain experienced by carers, which is essentially linked to professional overwork and contact with illness, will be considered and managed through meditation, resulting in benefits for carers and their way of interacting with their patients.
The expected collective benefit is to develop and better live together our interdependence and humanity, by recognising suffering as a shared characteristic, despite our specific problems (as patients, carers or third parties).
The overall aim is to alleviate suffering, which is an integral part of the human experience, by cultivating our common humanity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared meditation | Experimental | Behavioral: Shared meditationShared" meditation: mixed groups of patients, carers and third parties |
| Meditation "patients" | Active comparator | Behavioral: Meditation with patients olygroups of patients only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Criteria for all participants (patients, carers and third parties)
- Participant with no current or previous experience of regular or intensive meditation or comparable practice. Practice is considered regular and/or intensive if :
- it occurs more than one day a week for more than 6 consecutive months over the last 10 years,
- and/or more than 5 consecutive days of intensive practice (course or retreat) in the last 10 years,
- and/or more than 25 consecutive days of retreat (cumulative) in the last 10 years.
Key exclusion criteria (2 listed)
- Participants with significant vulnerability factors such as alcohol or drug dependence, severe depression, severe social anxiety, recent bereavement, etc.)
- Participant unable to undergo trial monitoring for geographical, social or psychopathological reasons
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 |
|---|---|---|
| Shared meditationMeditation sessions between patients, carers and third parties * 12 weekly 2-hour sessions, * 2 half-day 3-hour retreats after the 9th session and at the end of the programme * 3 monthly follow-up sessions (2h) in remote format (videoconference) | Behavioural | Shared meditation |
| Meditation with patients olyMeditation sessions between patients only * 12 weekly 2-hour sessions, * 2 half-day 3-hour retreats after the 9th session and at the end of the programme * 3 monthly follow-up sessions (2h) in remote format (videoconference) | Behavioural | Meditation "patients" |
Primary outcome
To assess the possible added value for patients (target population) of a meditation programme shared between patients, carers and third parties, compared with the same meditation programme conducted solely for patients.
Time frame: measured at the end of the meditation programme (after the 12 weekly sessions) compared with the measurement at inclusion
Changes in self-efficacy scores according to the Generalized Self Efficacy Scale [min 10; max 40]
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 11 Jul 2024.
- Derived from this study: PubMed 42399863Prevost V, Christy F, Leconte A, Fernette M, Segura C, Tran T, Clarisse B. Effectiveness of shared meditation involving cancer patients, health professionals and third persons on well-being and psychosocial skills: a randomised study. BMC Complement Med Ther. 2026 Jul 3. doi: 10.1186/s12906-026-05449-5. Online ahead of print.
- 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 39232668Prevost V, Tran T, Leconte A, Lequesne J, Fernette M, Segura C, Chevigne S, Gouriot M, Clarisse B. A randomised study to evaluate the potential added value of shared meditation involving people with cancer, health professionals and third persons compared to meditation conducted with patients only: design of the Implic-2 protocol. BMC Cancer. 2024 Sep 4;24(1):1097. doi: 10.1186/s12885-024-12521-1.
- 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 Shared meditation and Meditation with patients oly in people with Patients With Cancer, 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 9 inclusion and 2 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 11 Jul 2024. 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?
To assess the possible added value for patients (target population) of a meditation programme shared between patients, carers and third parties, compared with the same meditation programme conducted solely for patients. (time frame: measured at the end of the meditation programme (after the 12 weekly sessions) compared with the measurement at inclusion). 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 NCT06041607, which also lists 3 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 11 Jul 2024.