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

NCT06962215 | Recruiting

• 2 other identifiers: 29BRC24.0039 - IPSIMANON2024-A00353-44
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 11

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.

Conditions

Brain Tumor Adult

Keywords

Brain tumor; Simulation Training; Paramedical; Neurosurgery

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• 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)

• Measuring patients' feelings

  The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days)

• Measuring Caregivers' Experiences/Quality of Life at Work

  Day 0 and Month 6

• Measurement of caregivers' listening skills.

  Day 0, after training and Month 6

• Measuring communication within the paramedical team

  Day 0 and Month 6

Study Arms (2)

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.

Other: Paramedic training

Interventions

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.

Paramedic training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (11)

CHU Brest

Brest, Brittany Region, 29200, France

NOT YET RECRUITING

CHU Amiens

Amiens, 80000, France

NOT YET RECRUITING

CHU Angers

Angers, 49100, France

NOT YET RECRUITING

CHU Bordeaux

Bordeaux, 33000, France

NOT YET RECRUITING

APHM Nord

Marseille, 13000, France

NOT YET RECRUITING

CHU Nantes

Nantes, 44000, France

NOT YET RECRUITING

CHU Nice

Nice, 06000, France

NOT YET RECRUITING

CHU Rouen

Rouen, 76000, France

NOT YET RECRUITING

CHU Saint Etienne

Saint-Etienne, 42270, France

RECRUITING

CHU Strasbourg

Strasbourg, 67000, France

NOT YET RECRUITING

CHU Tours

Tours, 37000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Valérie QUEMENEUR

  CHU Brest

  STUDY DIRECTOR

Central Study Contacts

Doriane Gautier

CONTACT

+33 229 020 174; doriane.gautier@chu-brest.fr

Generic address

CONTACT

+ 33 230 338 340; promotion-interne@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomization

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: May 8, 2025
• Study Start: May 15, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available from five years to fifteen years after completion of the final study report.
• Access Criteria: 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.

Locations

FR (11)