Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer.

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). 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

• Non Metastatic Breast Cancer

Interventions

OTHER

MAEva program (Meditation, Acceptance and Commitment to Values or "Méditation, Acceptation et Engagements en direction des valeurs")

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.

OTHER

Discussion group

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.

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine

  lead OTHER

Principal Investigators

• François Bourgognon, MD · Institut de Cancérologie de Lorraine

• Denise BECHET, PhD · Institut de Cancérologie de Lorraine

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-16

Primary Completion

2029-02-16

Completion

2029-02-16

Countries

• France

Study Locations