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

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ClinicalTrials.gov Identifier: NCT04970615
Recruitment Status : Recruiting
First Posted : July 21, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Sümeyye Sezer, Radboud University

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 disease Intervention/treatment
Brain Tumor Glioma Glioblastoma Astrocytoma Neoplasm, Brain Oligodendroglioma Patient Education as Topic Decision Making, Shared 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.

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : September 15, 2022
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Group/Cohort Intervention/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.




Primary Outcome Measures :
  1. Immediate information recall [ Time Frame: 24 hours ]
  2. Delayed information recall [ Time Frame: One week ]
  3. Patient experiences [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Inclusion rate of patients meeting the inclusion criteria [ Time Frame: 30 months ]
  2. Number of patients with completed follow-up at 1 week [ Time Frame: 1 week ]
  3. Time between pre-operative consultation and immediate information recall questionnaire [ Time Frame: 24 hours ]
  4. Time between pre-operative consultation and delayed information recall questionnaire [ Time Frame: 1 week ]
  5. Educational level [ Time Frame: 30 months ]
  6. Cognitive functioning [ Time Frame: 30 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a brain tumor who undergo functional imaging (MRI, functional MRI (fMRI) and Diffusion Tensor Imaging (DTI)) requested for pre-operative planning after which they undergo a pre-operative consultation.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04970615


Contacts
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Contact: Sümeyye Sezer, MD +31640486170 Sumeyye.Sezer@radboudumc.nl
Contact: Mark ter Laan, MD, PhD +31621175664 Mark.terLaan@radboudumc.nl

Locations
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Netherlands
Radboud University Medical Center Recruiting
Nijmegen, Gelderland, Netherlands
Contact: Sümeyye Sezer, MD    +31640486170    Sumeyye.Sezer@radoudumc.nl   
Contact: Mark ter Laan, MD, PhD    +31621175664    Mark.terLaan@radboudumc.nl   
Sponsors and Collaborators
Sümeyye Sezer
Publications:

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Responsible Party: Sümeyye Sezer, MD, Radboud University
ClinicalTrials.gov Identifier: NCT04970615    
Other Study ID Numbers: 2021-7292
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sümeyye Sezer, Radboud University:
brain tumor
glioma
three-dimensional printing
patient education
three-dimensional model
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Glioblastoma
Glioma
Astrocytoma
Oligodendroglioma
Brain Diseases
Nervous System Diseases