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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). Patients will be able to participate in one weekly session for nine consecutive weeks. |
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| 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). Patients will be able to participate in one weekly session for nine consecutive weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. 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. | At 12 weeks after first session |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| the MAEva program's efficacy on symptoms of anxiety and depression (identification of a cut-off level for anxiety and depression) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Louis Merlin, Professor | Contact | +33 3 83 59 84 00 | jl.merlin@nancy.unicancer.fr | |
| Lydie Lemoine | Contact | +33 3 83 59 86 89 | l.lemoine@nancy.unincancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| François Bourgognon, MD | Institut de Cancérologie de Lorraine | Principal Investigator |
| Denise BECHET, PhD | Institut de Cancérologie de Lorraine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de Lorraine | Recruiting | Vandœuvre-lès-Nancy | 54519 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39021646 | Background | 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. |
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| 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. |
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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). |
| From enrollment at 12 weeks after first session |
| 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 / QoL scale. | From enrollment at 12 weeks after first session |
| 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. | From enrollment at 12 weeks after first session |
| 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. | From enrollment at 12 weeks after first session |
| the MAEva program's efficacy on Psychological Flexibility | Assessment of psychological flexibility (Multidimensional Inventory of Psychological Flexibility (MPFI-24)) | From enrollment at 12 weeks after first session |
| 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)) | At 12 weeks after first session |
| Adherence | Patient participation rate. | From enrollment at 9 weeks after first session |
| 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)) | At 12 weeks after first session |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| C000728125 | Perceived Stress Scale |
| D000073222 | Patient Health Questionnaire |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011581 | Psychological Tests |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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