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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Brain Tumor Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomization

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Paramedic training

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

Group Type EXPERIMENTAL

Paramedic training

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valérie QUEMENEUR

Role: STUDY_DIRECTOR

CHU Brest

Locations

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