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

NCT07326800 | Recruiting

• 1 other identifier: 2025-A01424-45
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cancer; MAEva program; Mindfulness; Acceptance and commitment therapy; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  At 12 weeks after first session

Secondary Outcomes (9)

• the MAEva program's efficacy on stress symptoms

  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)

  From enrollment at 12 weeks after first session

• the MAEva program's efficacy on different dimensions of quality of life

  From enrollment at 12 weeks after first session

• the MAEva program's efficacy on quality of life in breast cancer patients

  From enrollment at 12 weeks after first session

• the MAEva program's efficacy on fatigue

  From enrollment at 12 weeks after first session

Study Arms (2)

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.

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.

Other: Discussion group

Interventions

Discussion group OTHER

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.

Also known as: Perceived Stress Scale, Anxiety and/or depression, Quality of life evaluations (Quality of Life Questionnaire, Breast Cancer module, Fatigue), Multidimensional Psychological Flexibility Inventory, Satisfaction questionnaire and semi-structured interview

Discussion group

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

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.

Also known as: Perceived Stress Scale, Anxiety and/or depression, Quality of life evaluations (Quality of Life Questionnaire, Breast Cancer module, Fatigue), Multidimensional Psychological Flexibility Inventory, Satisfaction questionnaire and semi-structured interview

MAEva program group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Meditation; Perceived Stress Scale; Patient Health Questionnaire

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• François Bourgognon, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

• Denise BECHET, PhD

  Institut de Cancérologie de Lorraine

  STUDY CHAIR

Central Study Contacts

Jean-Louis Merlin, Professor

CONTACT

+33 3 83 59 84 00; jl.merlin@nancy.unicancer.fr

Lydie Lemoine

CONTACT

+33 3 83 59 86 89; l.lemoine@nancy.unincancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: January 8, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): February 16, 2029
• Study Completion (Estimated): February 16, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-03

Locations

FR (1)