Non Metastatic Breast CancerMAEva-MCTNCT07326800
Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer.
A study testing MAEva program (Meditation, Acceptance and Commitment to Values or "Méditation, Acceptation et Engagements en direction des valeurs") and Discussion group in people with Non Metastatic Breast Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
The MAEva program combines Acceptance and Committment Therapy (ACT) and mindfulness practices. It is an open and circular intervention, in three sessions (Mindfulness, Acceptance, and Commitment to values). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Non Metastatic Breast Cancer
- What is being tested?
- MAEva program (Meditation, Acceptance and Commitment to Values or "Méditation, Acceptation et Engagements en direction des valeurs") and Discussion group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2026to 16 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-metastatic breast cancer,
- Patients who are able and willing to follow all study procedures in accordance with the protocol,
- Patients who have understood, signed, and dated the consent form,
- Patients who are affiliated with the social security system,
- Patients who are able to remain seated during the 1.5-hour sessions.
Who cannot join
- Patients with metastatic cancer,
- Presence of an acute psychiatric disorder: acute depression, unstable bipolar disorder, psychotic disorder (delusions, hallucinations), etc.
- Presence of recurrent uncontrolled panic attacks (particularly related to hypochondriacal concerns),
- Insufficient attentional resources for meditation: major attention, memory, or reasoning disorders,
- Presence of cognitive and neurocognitive disorders and deficits,
- Presence of deafness,
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- Current participation in another mindfulness program,
- Persons deprived of their liberty or under guardianship (including curatorship),
- Inability to undergo medical monitoring for the trial for geographical, social, or psychological reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
Official title: Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer : a Randomized, Multicenter Clinical Trial
The MAEva program combines Acceptance and Committment Therapy (ACT) and mindfulness practices. It is an open and circular intervention, in three sessions (Mindfulness, Acceptance, and Commitment to values). It is designed for cancer patients and was the subject of an initial study that explored its feasibility and acceptability, as well as the initial results on psychological well-being.
This randomized, multicenter clinical trial is necessary to demonstrate the efficacy of the MAEva program compared to a discussion group with non metastatic breast cancer patients.
Read more
Patients will be included and randomized into two arms:
- In the first arm, patients will have the opportunity to participate in the MAEva program for nine consecutive weeks.
- and the second arm patients will have the opportunity to participate in a discussion group for nine consecutive weeks.
The patients will be able to attend one session per week for nine consecutive weeks.
Quantitative assessments of quality of life, symptoms of stress, anxiety, and depression, as well as psychological flexibility, will be conducted before the first session, after 3 weeks, 9 weeks, and 12 weeks.
Also, a qualitative analysis will be conducted based on satisfaction questionnaire and a semistructured interview performed after the end of the program. The interview analysis will described the extent to which the intervention is adapted to the realities on the ground and the needs of the target population. It will enable to identify how patients appropriate the psychological flexibility processes taught in the program in relation to the conceptual framework of ACT therapy (i.e., contact with the present moment, self-as-context, acceptance, defusion, values, and committed action) and integrate them into their daily lives.
- Conditions
- Non Metastatic Breast Cancer
- Being tested
- MAEva program (Meditation, Acceptance and Commitment to Values or "Méditation, Acceptation et Engagements en direction des valeurs"), Discussion group
- Keywords
- Cancer, MAEva program, Mindfulness, Acceptance and commitment therapy, Quality of life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAEva program (Meditation, Acceptance and Commitment to Values or "Méditation, Acceptation et Engagements en direction des valeurs")Other
Also called Perceived Stress Scale, Anxiety and/or depression, Quality of life evaluations (Quality of Life Questionnaire, Breast Cancer module, Fatigue), Multidimensional Psychological Flexibility Inventory
MAEva program combines ACT and mindfulness practices, and comprises three group sessions of 1 h 30 min each, following a weekly schedule. Each session addresses a specific theme and contains short meditative practices (10-15 min), as well as sharing times with feedback of experience and theoretical contributions: Session 1: Mindfulness Meditation (targeted processes: contact with the present moment and self-as-context), Session 2: Acceptance (targeted processes: acceptance and defusion), and Session 3: Commitment to Values (targeted processes: values and committed action).
Between sessions, participants were encouraged to engage in daily practice of the ACT therapeutic processes covered. Moreover, they were invited to cultivate mindfulness in daily life through informal exercises, that is, to devote oneself attentively to routine activities.
Discussion groupOther
Also called Perceived Stress Scale, Anxiety and/or depression, Quality of life evaluations (Quality of Life Questionnaire, Breast Cancer module, Fatigue), Multidimensional Psychological Flexibility Inventory
Discussion group comprises three group sessions of 1 h 30 min each, following a weekly schedule. Each session addresses a specific theme : Session 1: Treatments, Session 2: Fatigue, and Session 3: Social life.
The facilitators will limit themselves to supportive interview techniques (listening, open-ended questions, rephrasing, expressing empathy) and, if necessary, will refer participants to the resources available at each center.
| Study group | Role | What they receive |
|---|---|---|
| MAEva program group | Experimental | The MAEva program is an open group intervention (i.e., patients can enter the program at any session), and it is circular (i.e., it is possible to do the three sessions in any order and repeat the program to benefit from a training effect). Patients are invited to participate according to their possibilities and without having to commit to carrying out the whole program (i.e., it is fully acceptable for a patient to participate in only one or two of the three sessions of a complete cycle).
Patients will be able to participate in one weekly session for nine consecutive weeks. Receives: Other: MAEva program (Meditation, Acceptance and Commitment to Values or "Méditation, Acceptation et Engagements en direction des valeurs") |
| Discussion group | Active comparator | The discussion group is structured according to the same schedule as MAEva program. It is an open group intervention (i.e., patients can enter at any session), and it is circular (i.e., it is possible to do the three sessions in any order and repeat the program to benefit from a training effect). Patients are invited to participate according to their possibilities and without having to commit to carrying out the whole program (i.e., it is fully acceptable for a patient to participate in only one or two of the three sessions of a complete cycle).
Patients will be able to participate in one weekly session for nine consecutive weeks. Receives: Other: Discussion group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the efficacy of the MAEva program versus discussion group on quality of life in patients with non-metastatic breast cancer.
Evolution in the overall QLQ-C30 quality of life (QoL) score at 12 weeks compared to a control group.
Different dimensions of quality of life will be assessed using the EORTC QLQ-C30 (QoL Questionnaire); It includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high / healthy level of functioning, A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: At 12 weeks after first session
Secondary outcomes (9)
the MAEva program's efficacy on stress symptoms
Improvement in symptoms of stress compared to a control group. Stress will be assessed using the Perceived Stress Scale (PSS-10).
Measured: From enrollement at 12 weeks after first session
the MAEva program's efficacy on symptoms of anxiety and depression (identification of a cut-off level for anxiety and depression)
Improvement in symptoms of anxiety, and depression compared to a control group. Anxiety and/or depression will be assessed using the Hospital Anxiety and Depression Scale (HADS).
Measured: From enrollment at 12 weeks after first session
the MAEva program's efficacy on different dimensions of quality of life
Assessement of quality of life compared to a control group. Different dimensions of quality of life will be assessed using the EORTC QLQ-C30 (Quality of Life Questionnaire); It includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale.
Measured: From enrollment at 12 weeks after first session
the MAEva program's efficacy on quality of life in breast cancer patients
Assessement of quality of life compared to a control group. Quality of life in breast cancer patients will be assessed using the EORTC-BR23 (Breast Cancer module); it includes five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms.
Measured: From enrollment at 12 weeks after first session
the MAEva program's efficacy on fatigue
Assessement of quality of life compared to a control group. Fatigue will be assessed using the EORTC-FA12 (Fatigue); It includes three multi-item scales to assess physical fatigue, emotional fatigue, and cognitive fatigue.
Measured: From enrollment at 12 weeks after first session
the MAEva program's efficacy on Psychological Flexibility
Assessment of psychological flexibility (Multidimensional Inventory of Psychological Flexibility (MPFI-24))
Measured: From enrollment at 12 weeks after first session
the MAEva program's efficacy on the psychological processes involved in acceptance and commitment therapy
Assessment of processes (i.e., contact with the present moment, self-as-context, acceptance, defusion, values, and committed action) at play during the intervention (semi-structured interviews (qualitative analysis))
Measured: At 12 weeks after first session
Adherence
Patient participation rate.
Measured: From enrollment at 9 weeks after first session
Assessement of Satisfaction
Assessment of patient satisfaction (subjective score between 1 and 10; open-ended questions (qualitative analysis)) Assessment of caregiver satisfaction (subjective score between 1 and 10; open-ended questions (qualitative analysis))
Measured: At 12 weeks after first session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start16 Feb 2026
- Primary completion16 Feb 2029 (estimated)
- Study completion16 Feb 2029 (estimated)
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 Non Metastatic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Bourgognon, MD, Principal investigator, Institut de Cancérologie de LorraineDenise BECHET, PhD, Study chair, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326800
- Sponsor's protocol ID
- 2025-A01424-45
- Acronym
- MAEva-MCT
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2025
- Last updated
- 23 Oct 2026
- Results posted
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer : a Randomized, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT07326800
- Acronym / sponsor ID
- MAEva-MCT / 2025-A01424-45
- Conditions
- Non Metastatic Breast Cancer
- Keywords
- Cancer, MAEva program, Mindfulness, Acceptance and commitment therapy, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 16 Feb 2029 (estimated)
- Study completion
- 16 Feb 2029 (estimated)
- First posted
- 8 Jan 2026 (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 MAEva program combines Acceptance and Committment Therapy (ACT) and mindfulness practices. It is an open and circular intervention, in three sessions (Mindfulness, Acceptance, and Commitment to values). It is designed for cancer patients and was the subject of an initial study that explored its feasibility and acceptability, as well as the initial results on psychological well-being.
This randomized, multicenter clinical trial is necessary to demonstrate the efficacy of the MAEva program compared to a discussion group with non metastatic breast cancer patients.
Patients will be included and randomized into two arms:
- In the first arm, patients will have the opportunity to participate in the MAEva program for nine consecutive weeks.
- and the second arm patients will have the opportunity to participate in a discussion group for nine consecutive weeks.
The patients will be able to attend one session per week for nine consecutive weeks.
Quantitative assessments of quality of life, symptoms of stress, anxiety, and depression, as well as psychological flexibility, will be conducted before the first session, after 3 weeks, 9 weeks, and 12 weeks.
Also, a qualitative analysis will be conducted based on satisfaction questionnaire and a semistructured interview performed after the end of the program. The interview analysis will described the extent to which the intervention is adapted to the realities on the ground and the needs of the target population. It will enable to identify how patients appropriate the psychological flexibility processes taught in the program in relation to the conceptual framework of ACT therapy (i.e., contact with the present moment, self-as-context, acceptance, defusion, values, and committed action) and integrate them into their daily lives.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAEva program group | Experimental | Other: MAEva program (Meditation, Acceptance and Commitment to Values or "Méditation, Acceptation et Engagements en direction des valeurs")The MAEva program is an open group intervention (i.e., patients can enter the program at any session), and it is circular (i.e., it is possible to do the three sessions in any order and repeat the program to benefit from a training effect). Patients are invited to participate according to their possibilities and without having to commit to carrying out the whole program (i.e., it is fully acceptable for a patient to participate in only one or two of the three sessions of a complete cycle). Patients will be able to participate in one weekly session for nine consecutive weeks. |
| Discussion group | Active comparator | Other: Discussion groupThe discussion group is structured according to the same schedule as MAEva program. It is an open group intervention (i.e., patients can enter at any session), and it is circular (i.e., it is possible to do the three sessions in any order and repeat the program to benefit from a training effect). Patients are invited to participate according to their possibilities and without having to commit to carrying out the whole program (i.e., it is fully acceptable for a patient to participate in only one or two of the three sessions of a complete cycle). Patients will be able to participate in one weekly session for nine consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with non-metastatic breast cancer,
- Patients who are able and willing to follow all study procedures in accordance with the protocol,
- Patients who have understood, signed, and dated the consent form,
- Patients who are affiliated with the social security system,
- Patients who are able to remain seated during the 1.5-hour sessions.
Key exclusion criteria (9 listed)
- Patients with metastatic cancer,
- Presence of an acute psychiatric disorder: acute depression, unstable bipolar disorder, psychotic disorder (delusions, hallucinations), etc.
- Presence of recurrent uncontrolled panic attacks (particularly related to hypochondriacal concerns),
- Insufficient attentional resources for meditation: major attention, memory, or reasoning disorders,
- Presence of cognitive and neurocognitive disorders and deficits,
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 |
|---|---|---|
| MAEva program (Meditation, Acceptance and Commitment to Values or "Méditation, Acceptation et Engagements en direction des valeurs")Also: Perceived Stress Scale, Anxiety and/or depression, Quality of life evaluations (Quality of Life Questionnaire, Breast Cancer module, Fatigue), Multidimensional Psychological Flexibility InventoryMAEva program combines ACT and mindfulness practices, and comprises three group sessions of 1 h 30 min each, following a weekly schedule. Each session addresses a specific theme and contains short meditative practices (10-15 min), as well as sharing times with feedback of experience and theoretical contributions: Session 1: Mindfulness Meditation (targeted processes: contact with the present moment and self-as-context), Session 2: Acceptance (targeted processes: acceptance and defusion), and Session 3: Commitment to Values (targeted processes: values and committed action). Between sessions, participants were encouraged to engage in daily practice of the ACT therapeutic processes covered. Moreover, they were invited to cultivate mindfulness in daily life through informal exercises, that is, to devote oneself attentively to routine activities. | Other | MAEva program group |
| Discussion groupAlso: Perceived Stress Scale, Anxiety and/or depression, Quality of life evaluations (Quality of Life Questionnaire, Breast Cancer module, Fatigue), Multidimensional Psychological Flexibility InventoryDiscussion group comprises three group sessions of 1 h 30 min each, following a weekly schedule. Each session addresses a specific theme : Session 1: Treatments, Session 2: Fatigue, and Session 3: Social life. The facilitators will limit themselves to supportive interview techniques (listening, open-ended questions, rephrasing, expressing empathy) and, if necessary, will refer participants to the resources available at each center. | Other | Discussion group |
Primary outcome
Demonstrate the efficacy of the MAEva program versus discussion group on quality of life in patients with non-metastatic breast cancer.
Time frame: At 12 weeks after first session
Evolution in the overall QLQ-C30 quality of life (QoL) score at 12 weeks compared to a control group. Different dimensions of quality of life will be assessed using the EORTC QLQ-C30 (QoL Questionnaire); It includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high / healthy level of functioning, A high score for the global health status / QoL represents a high QoL, A high score for a symptom scale / item represents a high level of symptomatology / problems.
9 secondary outcomes
the MAEva program's efficacy on stress symptoms
Time frame: From enrollement at 12 weeks after first session
the MAEva program's efficacy on symptoms of anxiety and depression (identification of a cut-off level for anxiety and depression)
Time frame: From enrollment at 12 weeks after first session
the MAEva program's efficacy on different dimensions of quality of life
Time frame: From enrollment at 12 weeks after first session
the MAEva program's efficacy on quality of life in breast cancer patients
Time frame: From enrollment at 12 weeks after first session
the MAEva program's efficacy on fatigue
Time frame: From enrollment at 12 weeks after first session
the MAEva program's efficacy on Psychological Flexibility
Time frame: From enrollment at 12 weeks after first session
the MAEva program's efficacy on the psychological processes involved in acceptance and commitment therapy
Time frame: At 12 weeks after first session
Adherence
Time frame: From enrollment at 9 weeks after first session
Assessement of Satisfaction
Time frame: At 12 weeks after first session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: 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.
François Bourgognon, MD principal investigator
Institut de Cancérologie de Lorraine
Denise BECHET, PhD study chair
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 MAEva program (Meditation, Acceptance and Commitment to Values or "Méditation, Acceptation et Engagements en direction des valeurs") and Discussion group in people with Non Metastatic Breast 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 23 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Louis Merlin, Professor (+33 3 83 59 84 00, jl.merlin@nancy.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the efficacy of the MAEva program versus discussion group on quality of life in patients with non-metastatic breast cancer. (time frame: At 12 weeks after first session). 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 NCT07326800, 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 23 Oct 2026.