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

Institut de Cancérologie de Lorraine

Status: Not yet enrolling

Conditions: Chemotherapy; Non Metastatic Breast Cancer

Treatments: Other: MAEva program (Meditation, Acceptance and Commitment to Values or "Méditation, Acceptation et Engagements en direction des valeurs"); Other: Discussion group

Study type: Interventional

Funder types: Other

Identifiers

NCT07326800

2025-A01424-45

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

MAEva program group

Experimental group

Description:

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.

Treatment:

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

Discussion group

Active Comparator group

Description:

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.

Treatment:

Other: Discussion group