Ignite Creation Date:
2024-05-06 @ 4:25 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04970615
Status:
UNKNOWN
Last Update Posted:
2021-07-21
First Post:
2021-06-15
Brief Title:
Educating Brain Tumor Patients Using Patient-specific Actual-size Three-dimensional Printed Models
Sponsor:
Sümeyye Sezer
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Educating Brain Tumor Patients Using Patient-specific Actual-size Three-dimensional Printed Models a Case-control Study
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMAGE-3D
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 n30 after which patients will be enrolled in the intervention group n30 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
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 n30 after which patients will be enrolled in the intervention group n30 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 005 and power of 090 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 E11 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 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 n30 after which patients will be enrolled in the intervention group n30 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 005 and power of 090 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 E11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None