Clinical trial · Interventional
Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer.
Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer : a Randomized, Multicenter Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Metastatic Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Discussion group | Other | — | UNRESOLVED |
| MAEva program (Meditation, Acceptance and Commitment to Values or "Méditation, Acceptation et Engagements en direction des valeurs") | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MAEva program group
- description
- 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.
- interventionNames
- Other: MAEva program (Meditation, Acceptance and Commitment to Values or "Méditation, Acceptation et Engagements en direction des valeurs")
- type
- ACTIVE_COMPARATOR
- label
- Discussion group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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, * 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.
References
Publications (1)
- BACKGROUNDBourgognon 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. PMID 39021646