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
|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|
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 Type :||Observational|
|Estimated Enrollment :||60 participants|
|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|
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.
- Immediate information recall [ Time Frame: 24 hours ]
- Delayed information recall [ Time Frame: One week ]
- Patient experiences [ Time Frame: 24 hours ]
- Inclusion rate of patients meeting the inclusion criteria [ Time Frame: 30 months ]
- Number of patients with completed follow-up at 1 week [ Time Frame: 1 week ]
- Time between pre-operative consultation and immediate information recall questionnaire [ Time Frame: 24 hours ]
- Time between pre-operative consultation and delayed information recall questionnaire [ Time Frame: 1 week ]
- Educational level [ Time Frame: 30 months ]
- Cognitive functioning [ Time Frame: 30 months ]
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
|Contact: Sümeyye Sezer, MD||+31640486170||Sumeyye.Sezer@radboudumc.nl|
|Contact: Mark ter Laan, MD, PhD||+31621175664||Mark.terLaan@radboudumc.nl|