Non Metastatic Breast Cancer, Chemotherapy
Conditions
Keywords
Cancer, MAEva program, Mindfulness, Acceptance and commitment therapy, Quality of life
Brief 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 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.
Interventions
OTHERMAEva 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). 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.
OTHERDiscussion 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.
Sponsors
Institut de Cancérologie de Lorraine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate the efficacy of the MAEva program versus discussion group on quality of life in patients with non-metastatic breast cancer undergoing chemotherapy. | At 12 weeks after first session | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the MAEva program's efficacy on stress symptoms | From enrollement at 12 weeks after first session | Improvement in symptoms of stress compared to a control group. Stress will be assessed using the Perceived Stress Scale (PSS-10). |
| the MAEva program's efficacy on symptoms of anxiety and depression (identification of a cut-off level for anxiety and depression) | From enrollment at 12 weeks after first session | 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). |
| the MAEva program's efficacy on different dimensions of quality of life | From enrollment at 12 weeks after first session | 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. |
| the MAEva program's efficacy on quality of life in breast cancer patients | From enrollment at 12 weeks after first session | 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. |
| the MAEva program's efficacy on fatigue | From enrollment at 12 weeks after first session | 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. |
| the MAEva program's efficacy on Psychological Flexibility | From enrollment at 12 weeks after first session | Assessment of psychological flexibility (Multidimensional Inventory of Psychological Flexibility (MPFI-24)) |
| the MAEva program's efficacy on the psychological processes involved in acceptance and commitment therapy | At 12 weeks after first session | 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)) |
| Adherence | From enrollment at 9 weeks after first session | Patient participation rate. |
| Assessement of Satisfaction | At 12 weeks after first session | 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)) |
Countries
France
Contacts
CONTACTJean-Louis Merlin, Professor
CONTACTLydie Lemoine
PRINCIPAL_INVESTIGATORFrançois Bourgognon, MD
Institut de Cancérologie de Lorraine
STUDY_CHAIRDenise BECHET, PhD
Institut de Cancérologie de Lorraine
Outcome results
None listed