IMAGE-3D: Educating Brain Tumor Patients Using Patient-specific Actual-size Three-dimensional Printed Models

Sponsor
Sümeyye Sezer (Other)
Overall Status
Recruiting
CT.gov ID
NCT04970615
Collaborator
(none)
60
Enrollment
1
Location
31
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patient education plays an essential role in patient-centered care as it enhances patient satisfaction and information comprehension. However, about 40-80% of the information patients receive from healthcare professionals is forgotten and about half of the information patients remember is incorrect. To give informed consent, patients must be able to understand and recall the discussed information correctly. This is especially important in brain tumor patients, in which different treatment options determine outcome and risks. The goal of treatment in brain tumors is resection as completely as possible, without damaging healthy brain tissue. To this end, patients must understand the complex relation of the tumor to healthy brain tissue. This relation is different in each patient and three-dimensional (3D) in nature. Current two-dimensional visual tools lack the ability to properly display these complex 3D relations. In this study, we will investigate the effect of the use of 3D models in patient education, taking into account patient specific factors that might act as confounders. We will conduct a case control, multi-center study in the Radboud University Medical Center (Radboudumc) Maastricht University Medical Center (MUMC). Patients will be enrolled in the control group until inclusion for the control group is completed (n=30), after which patients will be enrolled in the intervention group (n=30). Patients will be cognitively tested using the Amsterdam Cognition Scale (ACS). After the consultation with their neurosurgeon, patients will be asked to fill out two questionnaires, consisting of two parts (patient experiences and information recall), one week apart.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Three-dimensional printed model

Detailed Description

Objectives The main goal of this project is to evaluate the role of 3D models on different aspects of patient education (patient experiences and information recall) in patients with brain tumors by comparing these to the use of standard 2D Magnetic Resonance (MR) images. A secondary goal is to gain more insight into the experiences of the close ones of the patients.

Study population We will conduct a case control, multi-center study in the Radboud University Medical Center (Radboudumc) Maastricht University Medical Center (MUMC). Patients will be enrolled in the control group until inclusion for the control group is completed (n=30), after which patients will be enrolled in the intervention group (n=30). The control group will consist of patients who will be informed using MR images during pre-operative consultations. The intervention group will be informed using personalized, life-size 3D models during pre-operative consultations. Inclusion time is estimated to be around 2 years.

Sample size Previous studies on this topic are scarce. In our experimental study on this subject [Sezer et al. 2020], we found an improvement of 5% (minimum expected difference, D) in information recall when using 3D models compared to 2D models. The standard deviation (SD) for information recall based on this study is approximately 5. With a significance criterion of 0.05 and power of 0.90 we calculated a total sample size of 42. For this study, however, we expect to find a smaller effect size due to the confounding factors (cognitive functioning, emotional status) which were eliminated in our experimental study in healthy individuals. Therefore we want to enroll 30 patients in each group (total sample size 60).

Study procedures Eligible patients will be asked to participate by their clinician or nurse practitioner who will they will receive an information letter and informed consent (attachment E1.1). The researcher will contact the patient to officially collect the informed consent form. Afterwards, the researcher will send out the link to the questionnaires collecting the baseline characteristics, emotional status questionnaire (HADS) and the ACS. The patient will be instructed to finish these questionnaires before the pre-operative consultation. Pre-operative preparation will be the same for the control and intervention group. The only difference will be the visual tool used in the pre-operative consult. Afterwards, the patient will be called by the researcher on the same or following day. A link will be sent out with the questionnaires on experiences, information recall and chosen treatment for the brain tumor. All questionnaires will be collected through Castor EDC © 2019.

The clinician will also be asked to fill out the questionnaire on information recall.

After the pre-operative consultation, we will ask the participant whether we can contact their close one. After reading the information letter and signing the informed consent the close one will receive the online questionnaires testing information recall and experiences. Both questionnaires will be collected through Castor EDC © 2019.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Educating Brain Tumor Patients Using Patient-specific Actual-size Three-dimensional Printed Models: a Case-control Study
Actual Study Start Date :
May 15, 2021
Anticipated Primary Completion Date :
Sep 15, 2022
Anticipated Study Completion Date :
Dec 15, 2023

Arms and Interventions

ArmIntervention/Treatment
Two-dimensional images

Patients who receive pre-operativeinformation while the two-dimensional MR images are being shown to them by the neurosurgeon.

Three-dimensional printed model

Patients who receive pre-operative information while the three-dimensional printed models are being shown to them by the neurosurgeon.

Device: Three-dimensional printed model
Three-dimensional printers are able to print physical objects in real size and colours. As a respresentative of the real tumor, a personalized three-dimensional model enables visualization of the patient-specific tumor and eloquent areas.

Outcome Measures

Primary Outcome Measures

  1. Immediate information recall [24 hours]

  2. Delayed information recall [One week]

  3. Patient experiences [24 hours]

Secondary Outcome Measures

  1. Inclusion rate of patients meeting the inclusion criteria [30 months]

  2. Number of patients with completed follow-up at 1 week [1 week]

  3. Time between pre-operative consultation and immediate information recall questionnaire [24 hours]

  4. Time between pre-operative consultation and delayed information recall questionnaire [1 week]

  5. Educational level [30 months]

  6. Cognitive functioning [30 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient with a brain tumor

  • functional imaging (MRI, functional MRI (fMRI) and Diffusion Tensor Imaging (DTI)) requested for pre-operative planning

Exclusion Criteria:
  • Inadequate understanding of the Dutch language

  • Inability to independently use a computer

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Radboud University Medical CenterNijmegenGelderlandNetherlands

Sponsors and Collaborators

  • Sümeyye Sezer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sümeyye Sezer, MD, Radboud University Medical Center
ClinicalTrials.gov Identifier:
NCT04970615
Other Study ID Numbers:
  • 2021-7292
First Posted:
Jul 21, 2021
Last Update Posted:
Jul 21, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sümeyye Sezer, MD, Radboud University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2021