Breast CancerNCT04751201
Meditation and Cancer, Pilot Feasibility Study (MAEva Pilot Study)
A study testing Mindfulness open and circular program in people with Breast Cancer and Prostate Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
MAEVA, which stands for Meditation, Acceptance and Commitment towards Values, is an open and circular program, made up of 3 themed sessions, following a weekly rhythm. It is proposed here to study this program over a period of 3 months, which will give participants the opportunity to complete up to three complete… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer
- What is being tested?
- Mindfulness open and circular program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 13 Jul 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patient
- Patient with non-metastatic prostate or breast cancer
- Newly diagnosed patients or those undergoing treatment
- Patient able and willing to follow all study procedures in accordance with the protocol.
- Patient having understood, signed and dated the consent form.
- Patient affiliated to the social security system
- Patient able to remain in a sitting position during the 2-hour session
Who cannot join
- Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons.
- Presence of an acute psychiatric disorder: depression in acute phase, unstabilised bipolar disorder, psychotic disorders (delusions, hallucinations), etc.
- Presence of recurrent uncontrolled panic attacks (notably linked to hypochondriac concerns)
- Presence of latent or patent post-traumatic stress disorder
- Lack of motivation to meditate
- Insufficient attentional resources to meditate: major problems with attention, memory or reasoning
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- Patient with metastatic cancer.
- Presence of cognitive and neurocognitive disorders and deficits
- Presence of deafness
- Membership in a meditation programme prior to inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Meditation and Cancer: Effectiveness of the MAEva Program on Symptoms and Quality of Life. Pilot Feasibility Study. (MAEva Pilot Study)
MAEVA, which stands for Meditation, Acceptance and Commitment towards Values, is an open and circular program, made up of 3 themed sessions, following a weekly rhythm. It is proposed here to study this program over a period of 3 months, which will give participants the opportunity to complete up to three complete cycles.
This program is based on the practice of and the processes of acceptance and commitment therapy. These approaches, used for several years, have proven their effectiveness in the management of stress, chronic anxiety, insomnia, chronic pain, distress in the face of chronic disease, as well as in the prevention of depressive relapses and management of impulsivity.
Read more
Unlike conventional 8-week meditation programs, the MAEva program allows patients to enter the study at any stage of the disease (within, outside the exclusion criteria) and from any session and to participate according to their possibilities.
The patient can participate in a weekly session of the program for 3 cycles. During the sessions, it will be proposed to train meditative practices and 3 different themes will be addressed (one theme per session): Meditation, Acceptance and Commitment to values.
.
- Conditions
- Breast Cancer, Prostate Cancer
- Being tested
- Mindfulness open and circular program
- Keywords
- Mindfulness, Quality of life, Cancer, Open and circular program, Meditation
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness open and circular programBehavioural
At the end of the first and the last cycle, as well as 3 weeks after the last cycle, the patient will be invited to answer different questionnaires evaluating his or her quality of life (HADS, QLQC30, FA12). This is why the observation period is 3 months (3 cycles of 3 weeks + 3 weeks).
Similarly, some of the patients included in the study will be asked to complete a semi-structured interview at the end of the MAEva programme.
Patients and nursing staff participating in the study will be asked to complete a satisfaction questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Receiving mindfulness open and circular program | Experimental | Not described Receives: Behavioral: Mindfulness open and circular program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the feasibility and acceptability of the MAEva programme to patients in a specialised care facility
Patient participation rate and number of sessions performed per patient
Measured: 3 months
Secondary outcomes (3)
Improved patient well-being
Hospital Anxiety et Depression Scale (HADS) and Quality of Life Questionnaire C30 (QLQC30) and QLQ -FA12 (EORTC Cancer Related Fatigue)
Measured: 3 months
Measure patient satisfaction
Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]
Measured: 3 months
Measure care staff satisfaction
Satisfaction questionnaire [1: unsatisfied - 10 very satisfied]
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Sep 2021
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Bourgognon, PhD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751201
- Sponsor's protocol ID
- 2020-A03205-34
- Status last verified
- Aug 2023
- First submitted
- 4 Feb 2021
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bourgognon F, Bechet D, Huin-Schohn C, Strelow A, Demarche L, Guillou M, Adam V, Fall E, Omorou AY. A mixed method feasibility and acceptability study of a flexible intervention based on acceptance and commitment therapy for patients with cancer. Front Psychol. 2024 Jul 3;15:1409308. doi: 10.3389/fpsyg.2024.1409308. eCollection 2024.
PubMed 39021646
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation and Cancer: Effectiveness of the MAEva Program on Symptoms and Quality of Life. Pilot Feasibility Study. (MAEva Pilot Study)
- ClinicalTrials.gov ID
- NCT04751201
- Acronym / sponsor ID
- 2020-A03205-34
- Conditions
- Breast Cancer, Prostate Cancer
- Keywords
- Mindfulness, Quality of life, Cancer, Open and circular program, Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 12 Feb 2021 (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.
MAEVA, which stands for Meditation, Acceptance and Commitment towards Values, is an open and circular program, made up of 3 themed sessions, following a weekly rhythm. It is proposed here to study this program over a period of 3 months, which will give participants the opportunity to complete up to three complete cycles.
This program is based on the practice of and the processes of acceptance and commitment therapy. These approaches, used for several years, have proven their effectiveness in the management of stress, chronic anxiety, insomnia, chronic pain, distress in the face of chronic disease, as well as in the prevention of depressive relapses and management of impulsivity.
Unlike conventional 8-week meditation programs, the MAEva program allows patients to enter the study at any stage of the disease (within, outside the exclusion criteria) and from any session and to participate according to their possibilities.
The patient can participate in a weekly session of the program for 3 cycles. During the sessions, it will be proposed to train meditative practices and 3 different themes will be addressed (one theme per session): Meditation, Acceptance and Commitment to values.
.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving mindfulness open and circular program | Experimental | Behavioral: Mindfulness open and circular program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Major patient
- Patient with non-metastatic prostate or breast cancer
- Newly diagnosed patients or those undergoing treatment
- Patient able and willing to follow all study procedures in accordance with the protocol.
- Patient having understood, signed and dated the consent form.
Key exclusion criteria (10 listed)
- Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons.
- Presence of an acute psychiatric disorder: depression in acute phase, unstabilised bipolar disorder, psychotic disorders (delusions, hallucinations), etc.
- Presence of recurrent uncontrolled panic attacks (notably linked to hypochondriac concerns)
- Presence of latent or patent post-traumatic stress disorder
- Lack of motivation to meditate
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 |
|---|---|---|
| Mindfulness open and circular programAt the end of the first and the last cycle, as well as 3 weeks after the last cycle, the patient will be invited to answer different questionnaires evaluating his or her quality of life (HADS, QLQC30, FA12). This is why the observation period is 3 months (3 cycles of 3 weeks + 3 weeks). Similarly, some of the patients included in the study will be asked to complete a semi-structured interview at the end of the MAEva programme. Patients and nursing staff participating in the study will be asked to complete a satisfaction questionnaire | Behavioural | Receiving mindfulness open and circular program |
Primary outcome
Assess the feasibility and acceptability of the MAEva programme to patients in a specialised care facility
Time frame: 3 months
Patient participation rate and number of sessions performed per patient
3 secondary outcomes
Improved patient well-being
Time frame: 3 months
Measure patient satisfaction
Time frame: 3 months
Measure care staff satisfaction
Time frame: 3 months
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 7 Aug 2023.
- Derived from this study: PubMed 39021646Bourgognon F, Bechet D, Huin-Schohn C, Strelow A, Demarche L, Guillou M, Adam V, Fall E, Omorou AY. A mixed method feasibility and acceptability study of a flexible intervention based on acceptance and commitment therapy for patients with cancer. Front Psychol. 2024 Jul 3;15:1409308. doi: 10.3389/fpsyg.2024.1409308. eCollection 2024.
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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.
François Bourgognon, PhD principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness open and circular program in people with Breast Cancer and Prostate Cancer, run by Institut de Cancérologie de Lorraine 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 7 inclusion and 10 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 7 Aug 2023. 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?
Assess the feasibility and acceptability of the MAEva programme to patients in a specialised care facility (time frame: 3 months). 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 NCT04751201, which also lists 1 linked publication.
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 7 Aug 2023.