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

Regional University Hospital Center (CHRU)

Status: Not yet enrolling

Conditions: Brain Tumor Adult

Treatments: Other: Paramedic training

Study type: Interventional

Funder types: Other

Identifiers

NCT06962215

29BRC24.0039 - IPSIMANON

2024-A00353-44 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Untrained arms

No Intervention group

Description:

Centers whose paramedics will not follow the training proposed by the study.

Formed arms

Experimental group

Description:

Centers whose paramedics will benefit from the training proposed by the study.

Treatment:

Other: Paramedic training