- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06903104
Acceptability and Feasibility of a Stress Prevention Program Based on Meditation and Acceptance and Commitment Therapy for Staff at a Cancer Center (MAEva-pro)
The MAEva program seems to meet the challenges of implementing meditation for cancer care workers. As part of our Quality of Life and Working Conditions initiative, the investigator decided to offer it to staff at our Cancer Center. The MAEva program is delivered in a closed format: participants commit to following, as far as possible, the three sessions of the program - one session per week for 3 weeks. During the sessions, it will be proposed to train meditative practices and three different themes will be addressed (one theme per session): Meditation, Acceptance and Commitment to values.
Before and after the program, participants will complete a quality of life evaluation, a perceived stress scale, and a questionnaire to assess psychological flexibility.
At the end of the program, each participant will be asked to complete a satisfaction questionnaire and a semi-directive interview, by videoconference, or by telephone in the event of digital impossibility with voice recording, to enable a qualitative analysis.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vandœuvre-lès-Nancy, France, 54519
- Institut de Cancérologie de Lorraine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participant of legal age
- Willingness to participate in the program - voluntary registration
- Commitment to attend all 3 program sessions
- Schedule compatible with participation in the 3 program sessions
- Participant has understood, signed and dated the consent form
- Participant affiliated to the social security system
Exclusion Criteria:
- No desire to participate in the program - non-registration
- Previous participation in MAEva program
- No commitment to participate in the 3 program sessions
- Agenda incompatible with the 3 program sessions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MAEva program is delivered in a closed format
MAEva program is delivered in a closed format.
One session per week for 3 weeks.
|
MAEva program will be proposed with meditative practices and three different themes will be addressed (one theme per session): Meditation, Acceptance and Commitment to values.
The assessment will be carried out at inclusion and after completion of the program.
The assessment will be carried out at inclusion and after completion of the program.
The assessment will be carried out at inclusion and after completion of the program.
The assessments will be carried out after completion of the program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the feasibility and acceptability of the MAEva program among employees at a hospital (CLCC: Centre de Lutte Contre le Cancer or Cancer Center).
Time Frame: 5 weeks
|
Participation rate of employees at a hospital in the MAEva program and number of sessions attended (number of participants who completed the entire program)
|
5 weeks
|
|
Evaluate the feasibility and acceptability of the MAEva program among employees at a hospital (CLCC: Centre de Lutte Contre le Cancer or Cancer Center).
Time Frame: 5 weeks
|
Number of sessions attended (number of participants who completed the entire program)
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the initial effectiveness of the MAEva program on the well-being of employees at a hospital.
Time Frame: 5 weeks
|
Quality of working life assessment (subjective score between 1 and 10 on the Quality of Working Life Scale)
|
5 weeks
|
|
Evaluate the initial effectiveness of the MAEva program on the well-being of employees at a hospital.
Time Frame: 5 weeks
|
Stress assessment (Perceived Stress Scale - PSS-10)
|
5 weeks
|
|
Evaluate the initial effectiveness of the MAEva program on the well-being of employees at a hospital.
Time Frame: 5 weeks
|
Assessment of psychological flexibility (Multidimensional Inventory of Psychological Flexibility (MPFI-24))
|
5 weeks
|
|
Evaluate the initial effectiveness of the MAEva program on the well-being of employees at a hospital.
Time Frame: 5 weeks
|
Assessment of participant satisfaction (subjective score between 1 and 10; open-ended questions (qualitative analysis))
|
5 weeks
|
|
Evaluate the initial effectiveness of the MAEva program on the well-being of employees at a hospital.
Time Frame: 5 weeks
|
Assessment of processes at play during the intervention (semi-structured interviews (qualitative analysis))
|
5 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024-A02765-42
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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