Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer : a Randomized, Multicenter Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- Demonstrate the efficacy of the MAEva program versus discussion group on quality of life in patients with non-metastatic breast cancer.
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
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.
Arms & Interventions
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.
Intervention: Discussion group (Other)
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.
Intervention: MAEva program (Meditation, Acceptance and Commitment to Values or "Méditation, Acceptation et Engagements en direction des valeurs") (Other)
Outcomes
Primary Outcomes
Demonstrate the efficacy of the MAEva program versus discussion group on quality of life in patients with non-metastatic breast cancer.
Time Frame: 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.
Demonstrate the efficacy of the MAEva program versus discussion group on quality of life in patients with non-metastatic breast cancer undergoing chemotherapy.
Time Frame: 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 Outcomes
- the MAEva program's efficacy on stress symptoms(From enrollement at 12 weeks after first session)
- the MAEva program's efficacy on fatigue(From enrollment 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)(From enrollment at 12 weeks after first session)
- the MAEva program's efficacy on different dimensions of quality of life(From enrollment at 12 weeks after first session)
- the MAEva program's efficacy on quality of life in breast cancer patients(From enrollment at 12 weeks after first session)
- the MAEva program's efficacy on Psychological Flexibility(From enrollment at 12 weeks after first session)
- the MAEva program's efficacy on the psychological processes involved in acceptance and commitment therapy(At 12 weeks after first session)
- Adherence(From enrollment at 9 weeks after first session)
- Assessement of Satisfaction(At 12 weeks after first session)