Brain TumorIMAGE-3DNCT04970615
Educating Brain Tumor Patients Using Patient-specific Actual-size Three-dimensional Printed Models
An observational study of Brain Tumor and Glioma, run by Sümeyye Sezer at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Brain Tumor, Glioma, Glioblastoma
- What is being tested?
- Three-dimensional printed model
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 May 2021to 15 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient with a brain tumor
- functional imaging (MRI, functional MRI (fMRI) and Diffusion Tensor Imaging (DTI)) requested for pre-operative planning
Who cannot join
- Inadequate understanding of the Dutch language
- Inability to independently use a computer
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Center
Nijmegen, Gelderland
Sümeyye Sezer, MD, +31640486170, Sumeyye.Sezer@radoudumc.nl
Mark ter Laan, MD, PhD, +31621175664, Mark.terLaan@radboudumc.nl
About this study
Official title: Educating Brain Tumor Patients Using Patient-specific Actual-size Three-dimensional Printed Models: a Case-control Study
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.
Read the 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.
- Conditions
- Brain Tumor, Glioma, Glioblastoma, Astrocytoma, Neoplasm, Brain, Oligodendroglioma
- Being tested
- Three-dimensional printed model
- Keywords
- brain tumor, glioma, three-dimensional printing, patient education, three-dimensional model
- Medical subject headings
- Brain Neoplasms, Glioma, Glioblastoma, Astrocytoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional printed modelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Three-dimensional printed model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate information recall
Measured: 24 hours
Delayed information recall
Measured: One week
Patient experiences
Measured: 24 hours
Secondary outcomes (6)
Inclusion rate of patients meeting the inclusion criteria
Measured: 30 months
Number of patients with completed follow-up at 1 week
Measured: 1 week
Time between pre-operative consultation and immediate information recall questionnaire
Measured: 24 hours
Time between pre-operative consultation and delayed information recall questionnaire
Measured: 1 week
Educational level
Measured: 30 months
Cognitive functioning
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start15 May 2021
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sümeyye Sezer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sümeyye Sezer, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970615
- Sponsor's protocol ID
- 2021-7292
- Acronym
- IMAGE-3D
- Status last verified
- Jul 2021
- First submitted
- 15 Jun 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available.
PubMed 12724430Rutten LJ, Arora NK, Bakos AD, Aziz N, Rowland J. Information needs and sources of information among cancer patients: a systematic review of research (1980-2003). Patient Educ Couns. 2005 Jun;57(3):250-61. doi: 10.1016/j.pec.2004.06.006.
PubMed 15893206Watson PW, McKinstry B. A systematic review of interventions to improve recall of medical advice in healthcare consultations. J R Soc Med. 2009 Jun;102(6):235-43. doi: 10.1258/jrsm.2009.090013.
PubMed 19531618Phelps EE, Wellings R, Griffiths F, Hutchinson C, Kunar M. Do medical images aid understanding and recall of medical information? An experimental study comparing the experience of viewing no image, a 2D medical image and a 3D medical image alongside a diagnosis. Patient Educ Couns. 2017 Jun;100(6):1120-1127. doi: 10.1016/j.pec.2016.12.034. Epub 2016 Dec 30.
PubMed 28081938Zhuang YD, Zhou MC, Liu SC, Wu JF, Wang R, Chen CM. Effectiveness of personalized 3D printed models for patient education in degenerative lumbar disease. Patient Educ Couns. 2019 Oct;102(10):1875-1881. doi: 10.1016/j.pec.2019.05.006. Epub 2019 May 8.
PubMed 31113688van de Belt TH, Nijmeijer H, Grim D, Engelen LJLPG, Vreeken R, van Gelder MMHJ, Ter Laan M. Patient-Specific Actual-Size Three-Dimensional Printed Models for Patient Education in Glioma Treatment: First Experiences. World Neurosurg. 2018 Sep;117:e99-e105. doi: 10.1016/j.wneu.2018.05.190. Epub 2018 Jun 2.
PubMed 29870846Sezer S, Piai V, Kessels RPC, Ter Laan M. Information Recall in Pre-Operative Consultation for Glioma Surgery Using Actual Size Three-Dimensional Models. J Clin Med. 2020 Nov 13;9(11):3660. doi: 10.3390/jcm9113660.
PubMed 33203047
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educating Brain Tumor Patients Using Patient-specific Actual-size Three-dimensional Printed Models: a Case-control Study
- ClinicalTrials.gov ID
- NCT04970615
- Acronym / sponsor ID
- IMAGE-3D / 2021-7292
- Conditions
- Brain Tumor, Glioma, Glioblastoma, Astrocytoma, Neoplasm, Brain, Oligodendroglioma
- Keywords
- brain tumor, glioma, three-dimensional printing, patient education, three-dimensional model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sümeyye SezerUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Device: Three-dimensional printed modelPatients who receive pre-operative information while the three-dimensional printed models are being shown to them by the neurosurgeon. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patient with a brain tumor
- functional imaging (MRI, functional MRI (fMRI) and Diffusion Tensor Imaging (DTI)) requested for pre-operative planning
Key exclusion criteria (2 listed)
- Inadequate understanding of the Dutch language
- Inability to independently use a computer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-dimensional printed modelThree-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. | Device | Three-dimensional printed model |
Primary outcome
Immediate information recall
Time frame: 24 hours
Delayed information recall
Time frame: One week
Patient experiences
Time frame: 24 hours
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Background: PubMed 12724430Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available.
- Background: PubMed 15893206Rutten LJ, Arora NK, Bakos AD, Aziz N, Rowland J. Information needs and sources of information among cancer patients: a systematic review of research (1980-2003). Patient Educ Couns. 2005 Jun;57(3):250-61. doi: 10.1016/j.pec.2004.06.006.
- Background: PubMed 19531618Watson PW, McKinstry B. A systematic review of interventions to improve recall of medical advice in healthcare consultations. J R Soc Med. 2009 Jun;102(6):235-43. doi: 10.1258/jrsm.2009.090013.
- Background: PubMed 28081938Phelps EE, Wellings R, Griffiths F, Hutchinson C, Kunar M. Do medical images aid understanding and recall of medical information? An experimental study comparing the experience of viewing no image, a 2D medical image and a 3D medical image alongside a diagnosis. Patient Educ Couns. 2017 Jun;100(6):1120-1127. doi: 10.1016/j.pec.2016.12.034. Epub 2016 Dec 30.
- Background: PubMed 31113688Zhuang YD, Zhou MC, Liu SC, Wu JF, Wang R, Chen CM. Effectiveness of personalized 3D printed models for patient education in degenerative lumbar disease. Patient Educ Couns. 2019 Oct;102(10):1875-1881. doi: 10.1016/j.pec.2019.05.006. Epub 2019 May 8.
- Background: PubMed 29870846van de Belt TH, Nijmeijer H, Grim D, Engelen LJLPG, Vreeken R, van Gelder MMHJ, Ter Laan M. Patient-Specific Actual-Size Three-Dimensional Printed Models for Patient Education in Glioma Treatment: First Experiences. World Neurosurg. 2018 Sep;117:e99-e105. doi: 10.1016/j.wneu.2018.05.190. Epub 2018 Jun 2.
- Background: PubMed 33203047Sezer S, Piai V, Kessels RPC, Ter Laan M. Information Recall in Pre-Operative Consultation for Glioma Surgery Using Actual Size Three-Dimensional Models. J Clin Med. 2020 Nov 13;9(11):3660. doi: 10.3390/jcm9113660.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Glioma, run by Sümeyye Sezer at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sümeyye Sezer, MD (+31640486170, Sumeyye.Sezer@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate information recall (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04970615, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.