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

Official title

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

Overview

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.

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 Ses
• 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.

Primary outcome measures

• 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]

Secondary outcome measures (9)

• the MAEva program's efficacy on stress symptoms [Time frame: 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) [Time frame: From enrollment at 12 weeks after first session]
• the MAEva program's efficacy on different dimensions of quality of life [Time frame: From enrollment at 12 weeks after first session]
• the MAEva program's efficacy on quality of life in breast cancer patients [Time frame: From enrollment at 12 weeks after first session]
• the MAEva program's efficacy on fatigue [Time frame: From enrollment at 12 weeks after first session]
• the MAEva program's efficacy on Psychological Flexibility [Time frame: From enrollment at 12 weeks after first session]
• the MAEva program's efficacy on the psychological processes involved in acceptance and commitment therapy [Time frame: At 12 weeks after first session]
• Adherence [Time frame: From enrollment at 9 weeks after first session]
• Assessement of Satisfaction [Time frame: At 12 weeks after first session]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy

Publications

• 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. PMID 39021646

Identifiers

NCT: NCT07326800 · 2025-A01424-45

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗