The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery (IPSIMANON)

Not Applicable

Recruiting

• Conditions: Brain Tumor Adult

• Registration Number: NCT06962215
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-05-07
• Study First Posted: 2025-05-08
• Study Start: 2025-05-15
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-29
• Last Update Posted: 2025-10-03
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measuring patient satisfaction following the discovery of a brain tumor.	The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days)	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.

Secondary Outcome Measures

Name	Time	Method
Measurement of patients' experiences following the discovery of a brain tumor via scores obtained (other questionnaire items)	The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days)	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.
Measuring patients' feelings	The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days)	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.
Measuring Caregivers' Experiences/Quality of Life at Work	Day 0 and Month 6	Measurement of caregivers' experience/quality of life at work at D0 and 6 months, using the Delmas et al. questionnaire.
Measuring communication within the paramedical team	Day 0 and Month 6	Measurement of communication within the paramedical team, using the paramedical team communication evaluation questionnaire (Likert scales, 5 points) at D0 and 6 months.
Measurement of caregivers' listening skills.	Day 0, after training and Month 6	Measurement of caregivers' listening attitude, using the Porter et al. questionnaire at D0, after training and 6 months.
Measuring communication between paramedical and medical teams.	Day 0 and Month 6	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.

Trial Locations

Locations (11)

CHU Amiens; 🇫🇷 Amiens, France

CHU Angers; 🇫🇷 Angers, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

APHM Nord; 🇫🇷 Marseille, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Nice; 🇫🇷 Nice, France

CHU Rouen; 🇫🇷 Rouen, France

CHU Saint Etienne; 🇫🇷 Saint-Etienne, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

CHU Tours; 🇫🇷 Tours, France

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