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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00353-44 | Other Identifier | Agence Nationale de Sécurité du Médicament et des produits de santé (ID-RCB) |
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The goal of this clinical trial is to demonstrate that simulation training for paramedical staff in neurosurgery departments, in announcing and accompanying patients with a brain tumor, improves patient satisfaction when a (potentially malignant) brain tumor is discovered, compared with usual care.
The main question it aims to answer is:
- Are patients more satisfied (as measured by scores on the EORCT IN-PATSAT32 questionnaire) with their neurosurgical hospitalization following the discovery of a brain tumor in centers where paramedics have been trained by simulation?
Researchers will compare the results of the EORTC IN-PATSAT32 questionnaire to determine whether paramedic training improves patient satisfaction between simulation-trained and untrained centers.
Participants will be asked to complete the EORT IN-PATSAT32 questionnaire at the end of their hospital stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | Centers whose paramedics will not follow the training proposed by the study. | |
| Paramedic training | Experimental | Centers whose paramedics will benefit from the training proposed by the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paramedic training | Other | Nurses and care assistants at the centers randomized to the "with training" arm will undergo a day-and-a-half of training to help them support patients diagnosed with brain tumors. Training consists of half a day of theory, followed by a day of simulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring patient satisfaction following the discovery of a brain tumor. | Measurement of patient satisfaction following the discovery of a brain tumor via scores obtained, at the end of their neurosurgical hospitalization, in response to the EORCT IN-PATSAT32 (European Organisation of Research and Treatment of Cancer IN PATient SATisfaction 32) questionnaire, whose dimensions of interest are ordered as follows for hierarchical analysis:
| The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of patients' experiences following the discovery of a brain tumor via scores obtained (other questionnaire items) | Measurement of patients' experiences following the discovery of a brain tumor via the scores obtained at the end of their neurosurgical hospitalization in response to the other items of the EORTC IN-PATSAT32 questionnaire (European Organisation of Research and Treatment of Cancer IN PATient SATisfaction 32) :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doriane Gautier | Contact | +33 229 020 174 | doriane.gautier@chu-brest.fr | |
| Generic address | Contact | + 33 230 338 340 | promotion-interne@chu-brest.fr |
| Name | Affiliation | Role |
|---|---|---|
| Valérie QUEMENEUR | CHU Brest | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brest | Not yet recruiting | Brest | Brittany Region | 29200 | France |
All collected data that underlie results in a publication
Data will be available from five years to fifteen years after completion of the final study report.
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
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Cluster randomization
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|
| The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days) |
| Measuring patients' feelings | Measuring patients' feelings with the INCA (French National Cancer Institute) questionnaire (Sick people - Survey on the announcement of the diagnosis and the feelings of sick people) at the end of their neurosurgical hospital hospitalization. | The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days) |
| Measuring Caregivers' Experiences/Quality of Life at Work | Measurement of caregivers' experience/quality of life at work at D0 and 6 months, using the Delmas et al. questionnaire. | Day 0 and Month 6 |
| Measurement of caregivers' listening skills. | Measurement of caregivers' listening attitude, using the Porter et al. questionnaire at D0, after training and 6 months. | Day 0, after training and Month 6 |
| Measuring communication within the paramedical team | Measurement of communication within the paramedical team, using the paramedical team communication evaluation questionnaire (Likert scales, 5 points) at D0 and 6 months. | Day 0 and Month 6 |
| Measuring communication between paramedical and medical teams. | Measurement of communication between the paramedical and medical teams, using a questionnaire to evaluate communication between the paramedical and medical teams (Likert scales, 5 points) at D0 and 6 months. | Day 0 and Month 6 |
| CHU Amiens | Not yet recruiting | Amiens | 80000 | France |
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| CHU Angers | Not yet recruiting | Angers | 49100 | France |
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| CHU Bordeaux | Not yet recruiting | Bordeaux | 33000 | France |
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| APHM Nord | Not yet recruiting | Marseille | 13000 | France |
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| CHU Nantes | Not yet recruiting | Nantes | 44000 | France |
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| CHU Nice | Not yet recruiting | Nice | 06000 | France |
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| CHU Rouen | Not yet recruiting | Rouen | 76000 | France |
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| CHU Saint Etienne | Recruiting | Saint-Etienne | 42270 | France |
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| CHU Strasbourg | Not yet recruiting | Strasbourg | 67000 | France |
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| CHU Tours | Not yet recruiting | Tours | 37000 | France |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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