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RecruitingNCT06962215IPSIMANONUpdated Jun 23, 2026

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

An interventional study of Paramedic training in Brain Tumor Adult, sponsored by University Hospital, Brest. Recruiting at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Brain Tumor Adult

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Keywords

  • Brain tumor
  • Simulation Training
  • Paramedical
  • Neurosurgery
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In context

Brain Neoplasms

1,959 studies on the registry are indexed under Brain Neoplasms; 515 are open to participants now.

This study's planned enrollment of 250 is above the median of 40 across 1,457 interventional studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
250 participants (estimated)

Study arms

  • No intervention
    Standard of care

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

  • Experimental
    Paramedic training

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

    Other: Paramedic training

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.

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What researchers measure

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.

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

Secondary outcomes

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

    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.

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

  2. Measuring patients' feelings

    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.

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

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

    Measurement of caregivers' experience/quality of life at work at D0 and 6 months, using the Delmas et al. questionnaire.

    Time frame: Day 0 and Month 6

  4. Measurement of caregivers' listening skills.

    Measurement of caregivers' listening attitude, using the Porter et al. questionnaire at D0, after training and 6 months.

    Time frame: Day 0, after training and Month 6

  5. Measuring communication within the paramedical team

    Measurement of communication within the paramedical team, using the paramedical team communication evaluation questionnaire (Likert scales, 5 points) at D0 and 6 months.

    Time frame: Day 0 and Month 6

  6. Measuring communication between paramedical and medical teams.

    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.

    Time frame: Day 0 and Month 6

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Study locations

1 of 11 sites recruiting
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References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06962215
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
May 8, 2025
Start date
May 15, 2025
Primary completion
May 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Jun 23, 2026

Study contacts

Doriane Gautier
Contact
doriane.gautier@chu-brest.fr
+33 229 020 174
Generic address
Contact
promotion-interne@chu-brest.fr
+ 33 230 338 340
Valérie QUEMENEUR
study director · CHU Brest

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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