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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06962215
Acronym
IPSIMANON
Enrollment
250
Registered
2025-05-08
Start date
2025-05-15
Completion date
2027-10-01
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor Adult

Keywords

Brain tumor, Simulation Training, Paramedical, Neurosurgery

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.

Interventions

OTHERParamedic 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.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention model description

Cluster randomization

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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' feelingsThe 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 WorkDay 0 and Month 6Measurement of caregivers' experience/quality of life at work at D0 and 6 months, using the Delmas et al. questionnaire.
Measurement of caregivers' listening skills.Day 0, after training and Month 6Measurement of caregivers' listening attitude, using the Porter et al. questionnaire at D0, after training and 6 months.
Measuring communication within the paramedical teamDay 0 and Month 6Measurement of communication within the paramedical team, using the paramedical team communication evaluation questionnaire (Likert scales, 5 points) at D0 and 6 months.
Measuring communication between paramedical and medical teams.Day 0 and Month 6Measurement 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.

Countries

France

Contacts

CONTACTDoriane Gautier
doriane.gautier@chu-brest.fr+33 229 020 174
CONTACTGeneric address
promotion-interne@chu-brest.fr+ 33 230 338 340
STUDY_DIRECTORValérie QUEMENEUR

CHU Brest

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026