Educating Brain Tumor Patients Using Patient-specific Actual-size Three-dimensional Printed Models

NCT04970615 | Unknown

• 1 other identifier: 2021-7292
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor; Glioma; Glioblastoma; Astrocytoma; Neoplasm, Brain; Oligodendroglioma; Patient Education as Topic; Decision Making, Shared

Keywords

brain tumor; glioma; three-dimensional printing; patient education; three-dimensional model

Outcome Measures

Primary Outcomes (3)

• Immediate information recall

  24 hours

• Delayed information recall

  One week

• Patient experiences

  24 hours

Secondary Outcomes (6)

• Inclusion rate of patients meeting the inclusion criteria

  30 months

• Number of patients with completed follow-up at 1 week

  1 week

• Time between pre-operative consultation and immediate information recall questionnaire

  24 hours

• Time between pre-operative consultation and delayed information recall questionnaire

  1 week

• Educational level

  30 months

Study Arms (2)

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

Interventions

Three-dimensional printed model DEVICE

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.

Three-dimensional printed model

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient with a brain tumor
• functional imaging (MRI, functional MRI (fMRI) and Diffusion Tensor Imaging (DTI)) requested for pre-operative planning

You may not qualify if:

• Inadequate understanding of the Dutch language
• Inability to independently use a computer

Sponsors & Collaborators

• Sümeyye Sezer: lead

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

RECRUITING

Related Publications (7)

• Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available.

  PMID: 12724430 BACKGROUND

• Rutten 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.

  PMID: 15893206 BACKGROUND

• Watson 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.

  PMID: 19531618 BACKGROUND

• Phelps 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.

  PMID: 28081938 BACKGROUND

• Zhuang 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.

  PMID: 31113688 BACKGROUND

• van 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.

  PMID: 29870846 BACKGROUND

• Sezer 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.

  PMID: 33203047 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms; Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Sümeyye Sezer, MD

CONTACT

+31640486170; Sumeyye.Sezer@radboudumc.nl

Mark ter Laan, MD, PhD

CONTACT

+31621175664; Mark.terLaan@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 21, 2021
• Study Start: May 15, 2021
• Primary Completion: September 15, 2022
• Study Completion: December 15, 2023
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)