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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Institut de Cancérologie de Lorraine
RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Jean-Louis Merlin, Professor
jl.merlin@nancy.unicancer.fr
+33 3 83 59 84 00
Backup
Lydie Lemoine
l.lemoine@nancy.unincancer.fr
+33 3 83 59 86 89
Time Frame
Start Date: 2026-02-16
Estimated Completion Date: 2029-02-16
Participants
Target number of participants: 190
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Institut de Cancérologie de Lorraine

This content was sourced from clinicaltrials.gov