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NCT Number: NCT07326800

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

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.

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Key information

Conditions

Non Metastatic Breast Cancer Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other 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

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.

Other 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

Primary outcomes

  1. Demonstrate the efficacy of the MAEva program versus discussion group on quality of life in patients with non-metastatic breast cancer.

    Time frame: At 12 weeks after first session

    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.

Secondary outcomes

  1. the MAEva program's efficacy on stress symptoms

    Time frame: From enrollement at 12 weeks after first session

    Improvement in symptoms of stress compared to a control group. Stress will be assessed using the Perceived Stress Scale (PSS-10).

  2. the MAEva program's efficacy on symptoms of anxiety and depression (identification of a cut-off level for anxiety and depression)

    Time frame: From enrollment at 12 weeks after first session

    Improvement in symptoms of anxiety, and depression compared to a control group. Anxiety and/or depression will be assessed using the Hospital Anxiety and Depression Scale (HADS).

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

    Time frame: From enrollment at 12 weeks after first session

    Assessement of quality of life compared to a control group. Different dimensions of quality of life will be assessed using the EORTC QLQ-C30 (Quality of Life 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.

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

    Time frame: From enrollment at 12 weeks after first session

    Assessement of quality of life compared to a control group. Quality of life in breast cancer patients will be assessed using the EORTC-BR23 (Breast Cancer module); it includes five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms.

  5. the MAEva program's efficacy on fatigue

    Time frame: From enrollment at 12 weeks after first session

    Assessement of quality of life compared to a control group. Fatigue will be assessed using the EORTC-FA12 (Fatigue); It includes three multi-item scales to assess physical fatigue, emotional fatigue, and cognitive fatigue.

  6. the MAEva program's efficacy on Psychological Flexibility

    Time frame: From enrollment at 12 weeks after first session

    Assessment of psychological flexibility (Multidimensional Inventory of Psychological Flexibility (MPFI-24))

  7. the MAEva program's efficacy on the psychological processes involved in acceptance and commitment therapy

    Time frame: At 12 weeks after first session

    Assessment of processes (i.e., contact with the present moment, self-as-context, acceptance, defusion, values, and committed action) at play during the intervention (semi-structured interviews (qualitative analysis))

  8. Adherence

    Time frame: From enrollment at 9 weeks after first session

    Patient participation rate.

  9. Assessement of Satisfaction

    Time frame: At 12 weeks after first session

    Assessment of patient satisfaction (subjective score between 1 and 10; open-ended questions (qualitative analysis)) Assessment of caregiver satisfaction (subjective score between 1 and 10; open-ended questions (qualitative analysis))

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Louis Merlin, Professor

CONTACT

[email protected]

+33 3 83 59 84 00

Lydie Lemoine

CONTACT

[email protected]

+33 3 83 59 86 89

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer : a Randomized, Multicenter Clinical Trial

Acronym: MAEva-MCT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 8, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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