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Clinical Trials/NCT06962215
NCT06962215RecruitingNot Applicable

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

University Hospital, Brest11 sites in 1 country250 target enrollmentStarted: May 15, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
250
Locations
11
Primary Endpoint
Measuring patient satisfaction following the discovery of a brain tumor.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

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

Arms & Interventions

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.

Intervention: Paramedic training (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Measuring Caregivers' Experiences/Quality of Life at Work(Day 0 and Month 6)
  • Measurement of caregivers' listening skills.(Day 0, after training and Month 6)
  • Measuring communication within the paramedical team(Day 0 and Month 6)
  • Measuring communication between paramedical and medical teams.(Day 0 and Month 6)
  • 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))
  • Measuring patients' feelings(The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days))
  • Measuring Caregivers' Experiences/Quality of Life at Work(Day 0 and Month 6)
  • Measuring communication within the paramedical team(Day 0 and Month 6)
  • Measurement of caregivers' listening skills.(Day 0, after training and Month 6)
  • Measuring communication between paramedical and medical teams.(Day 0 and Month 6)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (11)

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