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Clinical Trial NCT06962215 (IPSIMANON) for Brain Tumor Adult is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery (IPSIMANON) 250
Clinical Trial NCT06962215 (IPSIMANON) is an interventional study for Brain Tumor Adult that is recruiting. It started on 15 May 2025 with plans to enroll 250 participants. Led by University Hospital, Brest, it is expected to complete by 1 March 2026. The latest data from ClinicalTrials.gov was last updated on 19 March 2026.
Brief Summary
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...
Show MoreOfficial Title
The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery
Conditions
Brain Tumor AdultOther Study IDs
- IPSIMANON
- 29BRC24.0039 - IPSIMANON
- 2024-A00353-44 (Other Identifier) (Agence Nationale de Sécurité du Médicament et des produits de santé (ID-RCB))
NCT ID Number
Start Date (Actual)
2025-05-15
Last Update Posted
2026-03-19
Completion Date (Estimated)
2026-03
Enrollment (Estimated)
250
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Brain tumor
Simulation Training
Paramedical
Neurosurgery
Simulation Training
Paramedical
Neurosurgery
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No InterventionStandard of care Centers whose paramedics will not follow the training proposed by the study. | N/A |
ExperimentalParamedic training Centers whose paramedics will benefit from the training proposed by the study. | Paramedic training 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | 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:
1. SATNIS = nurses interpersonal skills
2. SATNIP = nurses information provision
3. SATNAV = nurses availability
4. SATNTS = nurses technical skills,
5. SATGEN = overall quality rating All of the scales and single-item measures range in score from 0 to 100. A high score represents a high level of satisfaction with care. | The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days) |
| Outcome Measure | 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) :
* SATEXE = exchange of information between caregivers,
* SATDIS = doctors interpersonal skills,
* SATDIP = doctors information provision,
* SATDAV = doctors availability,
* SATDTS = doctors technical skills,
* SATOTH = other personal interpersonal skills, All of the scales and single-item measures range in score from 0 to 100. A high score represents a high level of satisfaction with care. | 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Patient over 18 years of age
- Patient covered by a social security scheme
- Patient signed informed consent form
- Patient found to have a brain tumor (potentially malignant, primary or secondary if this is the mode of entry into the disease)
- Hospitalization in the Neurosurgery Department at the time of tumor discovery, before the histological diagnosis is announced.
- Patients with a personal history of cancer
- Patient without family AND unable to receive information
University Hospital, BrestStudy Central Contact
Contact: Doriane Gautier, +33 229 020 174, [email protected]
Contact: Generic address, + 33 230 338 340, [email protected]
11 Study Locations in 1 Countries
Brittany Region
CHU Brest, Brest, Brittany Region, 29200, France
Doriane Gautier, Contact, +332 29 020 174, [email protected]
QUEMENEUR Valérie, Principal Investigator
Not yet recruiting
CHU Amiens, Amiens, 80000, France
Gabrielle BOUTIGNY, Nurse, Contact, +33 322 088 000, [email protected]
Not yet recruiting
CHU Angers, Angers, 49100, France
Jean-Michel LEMEE, Pr, Contact, +33 241 353 637, [email protected]
Not yet recruiting
CHU Bordeaux, Bordeaux, 33000, France
Françoise CHEVROLLIER, Nurse, Contact, +33 556 795 679, [email protected]
Not yet recruiting
APHM Nord, Marseille, 13000, France
Nawel BOUZID, Nurse, Contact, +33 491 380 000, [email protected]
Not yet recruiting
CHU Nantes, Nantes, 44000, France
Edouard SAMARUT, Dr, Contact, +33 240 083 333, [email protected]
Not yet recruiting
CHU Nice, Nice, 06000, France
Fabien ALMAIRAC, Pr, Contact, +33 492 037 777, [email protected]
Not yet recruiting
CHU Rouen, Rouen, 76000, France
Stéphane DERREY, Pr, Contact, + 33 232 888 990, [email protected]
Not yet recruiting
CHU Saint Etienne, Saint-Etienne, 42270, France
Francois VASSAL, Pr, Contact, +33 477 828 000, [email protected]
Recruiting
CHU Strasbourg, Strasbourg, 67000, France
Hélène CEBULA, Pr, Contact, +33 388 116 768, [email protected]
Not yet recruiting
CHU Tours, Tours, 37000, France
Ilyess ZEMMOURA, Pr, Contact, + 33 247 474 747, [email protected]
Not yet recruiting