MAEva program (mindfulness, acceptance, and commitment to values) for people treated for non‑metastatic breast cancer
Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer : a Randomized, Multicenter Clinical Trial
This trial tests whether the MAEva program — combining mindfulness and Acceptance and Commitment Therapy — can improve quality of life for people treated for non‑metastatic breast cancer compared with a nine‑week discussion group.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut de Cancérologie de Lorraine Academic / other |
| Locations | 1 site (Vandœuvre-lès-Nancy) |
| Trial ID | NCT07326800 on ClinicalTrials.gov |
What this trial studies
This randomized, multicenter trial compares a nine‑week MAEva program to a nine‑week active discussion group in patients treated for non‑metastatic breast cancer. Participants are randomized to attend one weekly 1.5‑hour session for nine consecutive weeks of either MAEva (mindfulness, acceptance, and values‑based commitment exercises) or a discussion group. Quantitative measures of quality of life and psychological well‑being are collected at baseline and follow‑up to compare outcomes between groups. Eligible participants must be able to attend in‑person sessions and have no major psychiatric, cognitive, or sensory impairments that would prevent participation.
Who should consider this trial
Good fit: Ideal candidates are adults treated for non‑metastatic breast cancer who can attend weekly 1.5‑hour in‑person sessions, provide informed consent, and do not have major psychiatric, cognitive, or sensory impairments.
Not a fit: Patients with metastatic disease, acute psychiatric disorders, significant cognitive or attentional deficits, deafness, or those already participating in another mindfulness program are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, the MAEva program could improve psychological well‑being and overall quality of life after treatment for non‑metastatic breast cancer.
How similar studies have performed: Previous studies of mindfulness- and Acceptance and Commitment Therapy–based programs in cancer populations have shown improvements in distress and quality of life, and an initial feasibility study of MAEva found it acceptable though larger randomized evidence is still needed.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Vandœuvre-lès-Nancy
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Principal investigator: François Bourgognon, MD — Institut de Cancérologie de Lorraine
- Study coordinator: Jean-Louis Merlin, Professor
- Email: jl.merlin@nancy.unicancer.fr
- Phone: +33 3 83 59 84 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.