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NCT Number: NCT06962215

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

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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Key information

Conditions

Brain Tumor Adult Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brest, Brest, Brittany Region, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Measuring patient satisfaction following the discovery of a brain tumor.

    Time frame: 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:

    • SATNIS = nurses interpersonal skills
    • SATNIP = nurses information provision
    • SATNAV = nurses availability
    • SATNTS = nurses technical skills,
    • 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 outcomes

  1. Measurement of patients' experiences following the discovery of a brain tumor via scores obtained (other questionnaire items)

    Time frame: 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.

  2. Measuring patients' feelings

    Time frame: 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.

  3. Measuring Caregivers' Experiences/Quality of Life at Work

    Time frame: 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.

  4. Measurement of caregivers' listening skills.

    Time frame: 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.

  5. Measuring communication within the paramedical team

    Time frame: 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.

  6. Measuring communication between paramedical and medical teams.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Doriane Gautier

CONTACT

[email protected]

+33 229 020 174

Generic address

CONTACT

[email protected]

+ 33 230 338 340

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: IPSIMANON

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 8, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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