Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) in Breast Cancer Patients Undergoing Chemotherapy

NCT ID: NCT07326800

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2029-01-01

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 undergoing chemotherapy.

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; Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

MAEva program group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Discussion group

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.

Group Type: ACTIVE_COMPARATOR

Discussion group

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

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; 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

Eligibility Criteria

Inclusion Criteria

• Patients with non-metastatic breast cancer currently undergoing chemotherapy,
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de Lorraine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Bourgognon, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Denise BECHET, PhD

Role: STUDY_CHAIR

Institut de Cancérologie de Lorraine

Central Contacts

Jean-Louis Merlin, Professor

Role: CONTACT

jl.merlin@nancy.unicancer.fr

+33 3 83 59 84 00

Lydie Lemoine

Role: CONTACT

l.lemoine@nancy.unincancer.fr

+33 3 83 59 86 89

References

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.

Reference Type: BACKGROUND

PMID: 39021646 (View on PubMed)

Other Identifiers

2025-A01424-45

Identifier Type: -

Identifier Source: org_study_id