Clinical trial NCT06962215: The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery (IPSIMANON)
Official title: The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Tumor Adult
Keywords: Brain tumor
Simulation Training
Paramedical
Neurosurgery
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomization
Primary purpose: SUPPORTIVE_CARE

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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients with a personal history of cancer
* Patient without family AND unable to receive information

Primary outcomes:
measure: Measuring patient satisfaction following the discovery of a brain tumor.
timeFrame: The day of discharge from neurosurgery, on average between 10 and 15 days (between 3 days and 4 weeks)
Secondary outcomes:
measure: Measurement of patients' experiences following the discovery of a brain tumor via scores obtained (other questionnaire items)
timeFrame: The day of discharge from neurosurgery, on average between 10 and 15 days (between 3 days and 4 weeks)
measure: Measuring patients' feelings
timeFrame: The day of discharge from neurosurgery, on average between 10 and 15 days (between 3 days and 4 weeks)
measure: Measuring Caregivers' Experiences/Quality of Life at Work
timeFrame: Day 0 and Month 6
measure: Measurement of caregivers' listening skills.
timeFrame: Day 0, after training and Month 6
measure: Measuring communication within the paramedical team
timeFrame: Day 0 and Month 6
measure: Measuring communication between paramedical and medical teams.
timeFrame: Day 0 and Month 6
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
state: Bretagne
Study officials:
affiliation: CHU Brest
name: Valérie QUEMENEUR
role: STUDY_DIRECTOR
References: