Brain Tumor AdultIPSIMANONNCT06962215
The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery (IPSIMANON)
A study testing Paramedic training in people with Brain Tumor Adult, run by University Hospital, Brest at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor Adult
- What is being tested?
- Paramedic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 11 sitesFrance
- Study dates
- 15 May 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with a personal history of cancer
- Patient without family AND unable to receive information
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Not yet recruiting
CHU Amiens
Amiens, 80000
Gabrielle BOUTIGNY, Nurse, +33 322 088 000, boutigny.gabrielle@chu-amiens.fr
- Not yet recruiting
CHU Angers
Angers, 49100
Jean-Michel LEMEE, Pr, +33 241 353 637, jean-michel.lemee@univ-angers.fr
- Not yet recruiting
CHU Bordeaux
Bordeaux, 33000
Françoise CHEVROLLIER, Nurse, +33 556 795 679, francoise.chevrollier@chu-bordeaux.fr
- Not yet recruiting
CHU Brest
Brest, Brittany Region, 29200
Doriane Gautier, +332 29 020 174, doriane.gautier@chu-brest.fr
QUEMENEUR Valérie
- Not yet recruiting
APHM Nord
Marseille, 13000
Nawel BOUZID, Nurse, +33 491 380 000, nawel.bouzid@ap-hm.fr
- Not yet recruiting
CHU Nantes
Nantes, 44000
Edouard SAMARUT, Dr, +33 240 083 333, edouard.samarut@chu-nantes.fr
- Not yet recruiting
CHU Nice
Nice, 06000
Fabien ALMAIRAC, Pr, +33 492 037 777, almairac.f@chu-nice.fr
- Not yet recruiting
CHU Rouen
Rouen, 76000
Stéphane DERREY, Pr, + 33 232 888 990, stephane.derrey@chu-rouen.fr
- Recruiting
CHU Saint Etienne
Saint-Etienne, 42270
Francois VASSAL, Pr, +33 477 828 000, francois.vassal@chu-st-etienne.fr
- Not yet recruiting
CHU Strasbourg
Strasbourg, 67000
Hélène CEBULA, Pr, +33 388 116 768, helene.cebula@chru-strasbourg.fr
- Not yet recruiting
CHU Tours
Tours, 37000
Ilyess ZEMMOURA, Pr, + 33 247 474 747, ilyess.zemmoura@univ-tours.fr
About this study
Official title: The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery
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:
Read more
- 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.
- Conditions
- Brain Tumor Adult
- Being tested
- Paramedic training
- Keywords
- Brain tumor, Simulation Training, Paramedical, Neurosurgery
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paramedic trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Centers whose paramedics will not follow the training proposed by the study. |
| Paramedic training | Experimental | Centers whose paramedics will benefit from the training proposed by the study. Receives: Other: Paramedic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days)
Secondary outcomes (6)
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.
Measured: The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days)
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.
Measured: The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days)
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.
Measured: Day 0 and Month 6
Measurement of caregivers' listening skills.
Measurement of caregivers' listening attitude, using the Porter et al. questionnaire at D0, after training and 6 months.
Measured: Day 0, after training and Month 6
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.
Measured: Day 0 and Month 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.
Measured: Day 0 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start15 May 2025
- Primary completionMay 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor AdultStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomization
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie QUEMENEUR, Study director, CHU Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962215
- Sponsor's protocol ID
- 29BRC24.0039 - IPSIMANON
- Other IDs
- 2024-A00353-44
- Acronym
- IPSIMANON
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery
- ClinicalTrials.gov ID
- NCT06962215
- Acronym / sponsor ID
- IPSIMANON / 29BRC24.0039 - IPSIMANON
- Conditions
- Brain Tumor Adult
- Keywords
- Brain tumor, Simulation Training, Paramedical, Neurosurgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster randomization
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Centers whose paramedics will not follow the training proposed by the study. |
| Paramedic training | Experimental | Other: Paramedic trainingCenters whose paramedics will benefit from the training proposed by the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with a personal history of cancer
- Patient without family AND unable to receive information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paramedic trainingNurses 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. | Other | Paramedic training |
Primary outcome
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: 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.
6 secondary outcomes
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)
Measuring patients' feelings
Time frame: The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days)
Measuring Caregivers' Experiences/Quality of Life at Work
Time frame: Day 0 and Month 6
Measurement of caregivers' listening skills.
Time frame: Day 0, after training and Month 6
Measuring communication within the paramedical team
Time frame: Day 0 and Month 6
Measuring communication between paramedical and medical teams.
Time frame: Day 0 and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valérie QUEMENEUR study director
CHU Brest
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paramedic training in people with Brain Tumor Adult, run by University Hospital, Brest at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doriane Gautier (+33 229 020 174, doriane.gautier@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.