[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618067":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":44,"studyPopulation":44,"armGroups":51,"interventions":64,"overallOfficials":79,"centralContacts":86,"locations":96,"responsibleParty":109,"collaborators":44,"id":111,"slug":44,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":44,"enrollmentInfo":120,"targetDuration":44,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":98,"whyStopped":44,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Institut de Cancérologie de Lorraine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"Demonstrate the efficacy of the MAEva program versus discussion group on quality of life in patients with non-metastatic breast cancer.","Evolution in the overall QLQ-C30 quality of life (QoL) score at 12 weeks compared to a control group.\n\nDifferent 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 \u002F QoL scale.\n\nAll 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 \u002F healthy level of functioning, A high score for the global health status \u002F QoL represents a high QoL, A high score for a symptom scale \u002F item represents a high level of symptomatology \u002F problems.","At 12 weeks after first session",[14,18,22,25,28,31,34,37,41],{"measure":15,"description":16,"timeFrame":17},"the MAEva program's efficacy on stress symptoms","Improvement in symptoms of stress compared to a control group. Stress will be assessed using the Perceived Stress Scale (PSS-10).","From enrollement at 12 weeks after first session",{"measure":19,"description":20,"timeFrame":21},"the MAEva program's efficacy on symptoms of anxiety and depression (identification of a cut-off level for anxiety and depression)","Improvement in symptoms of anxiety, and depression compared to a control group. Anxiety and\u002For depression will be assessed using the Hospital Anxiety and Depression Scale (HADS).","From enrollment at 12 weeks after first session",{"measure":23,"description":24,"timeFrame":21},"the MAEva program's efficacy on different dimensions of quality of life","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 \u002F QoL scale.",{"measure":26,"description":27,"timeFrame":21},"the MAEva program's efficacy on quality of life in breast cancer patients","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.",{"measure":29,"description":30,"timeFrame":21},"the MAEva program's efficacy on fatigue","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.",{"measure":32,"description":33,"timeFrame":21},"the MAEva program's efficacy on Psychological Flexibility","Assessment of psychological flexibility (Multidimensional Inventory of Psychological Flexibility (MPFI-24))",{"measure":35,"description":36,"timeFrame":12},"the MAEva program's efficacy on the psychological processes involved in acceptance and commitment therapy","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))",{"measure":38,"description":39,"timeFrame":40},"Adherence","Patient participation rate.","From enrollment at 9 weeks after first session",{"measure":42,"description":43,"timeFrame":12},"Assessement of Satisfaction","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))",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":50,"maskingDescription":44,"whoMasked":44},"NONE",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"MAEva program group","EXPERIMENTAL","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).\n\nPatients will be able to participate in one weekly session for nine consecutive weeks.",[57],"Other: MAEva program (Meditation, Acceptance and Commitment to Values or \"Méditation, Acceptation et Engagements en direction des valeurs\")",{"label":59,"type":60,"description":61,"interventionNames":62},"Discussion group","ACTIVE_COMPARATOR","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).\n\nPatients will be able to participate in one weekly session for nine consecutive weeks.",[63],"Other: Discussion group",[65,75],{"type":6,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"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).\n\nBetween 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.",[53],[70,71,72,73,74],"Perceived Stress Scale","Anxiety and\u002For depression","Quality of life evaluations (Quality of Life Questionnaire, Breast Cancer module, Fatigue)","Multidimensional Psychological Flexibility Inventory","Satisfaction questionnaire and semi-structured interview",{"type":6,"name":59,"description":76,"armGroupLabels":77,"otherNames":78},"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.\n\nThe 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.",[59],[70,71,72,73,74],[80,83],{"name":81,"affiliation":5,"role":82},"François Bourgognon, MD","PRINCIPAL_INVESTIGATOR",{"name":84,"affiliation":5,"role":85},"Denise BECHET, PhD","STUDY_CHAIR",[87,92],{"name":88,"role":89,"phone":90,"phoneExt":44,"email":91},"Jean-Louis Merlin, Professor","CONTACT","+33 3 83 59 84 00","jl.merlin@nancy.unicancer.fr",{"name":93,"role":89,"phone":94,"phoneExt":44,"email":95},"Lydie Lemoine","+33 3 83 59 86 89","l.lemoine@nancy.unincancer.fr",[97],{"facility":5,"status":98,"city":99,"state":44,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":44},"RECRUITING","Vandœuvre-lès-Nancy","54519","France","FR",{"type":104,"coordinates":105},"Point",[106,107],6.17114,48.66115,{"lat":107,"lon":106},{"type":110,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100618067",false,"NCT07326800","Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer.","Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer : a Randomized, Multicenter Clinical Trial","MAEva-MCT","Inclusion Criteria:\n\n* Patients with non-metastatic breast cancer,\n* Patients who are able and willing to follow all study procedures in accordance with the protocol,\n* Patients who have understood, signed, and dated the consent form,\n* Patients who are affiliated with the social security system,\n* Patients who are able to remain seated during the 1.5-hour sessions.\n\nExclusion Criteria:\n\n* Patients with metastatic cancer,\n* Presence of an acute psychiatric disorder: acute depression, unstable bipolar disorder, psychotic disorder (delusions, hallucinations), etc.\n* Presence of recurrent uncontrolled panic attacks (particularly related to hypochondriacal concerns),\n* Insufficient attentional resources for meditation: major attention, memory, or reasoning disorders,\n* Presence of cognitive and neurocognitive disorders and deficits,\n* Presence of deafness,\n* Current participation in another mindfulness program,\n* Persons deprived of their liberty or under guardianship (including curatorship),\n* Inability to undergo medical monitoring for the trial for geographical, social, or psychological reasons.","FEMALE","18 Years",{"count":121,"type":122},190,"ESTIMATED","INTERVENTIONAL",[125],"NA","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.\n\nThis 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.\n\nPatients will be included and randomized into two arms:\n\n* In the first arm, patients will have the opportunity to participate in the MAEva program for nine consecutive weeks.\n* and the second arm patients will have the opportunity to participate in a discussion group for nine consecutive weeks.\n\nThe patients will be able to attend one session per week for nine consecutive weeks.\n\nQuantitative 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.\n\nAlso, 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.",[128],"Non Metastatic Breast Cancer",[130,131,132,133,134],"Cancer","MAEva program","Mindfulness","Acceptance and commitment therapy","Quality of life","2026-04-13",{"date":137,"type":138},"2026-04-16","ACTUAL",{"date":140,"type":138},"2026-02-16",{"date":142,"type":122},"2029-02-16",{"name":5,"class":6},1]