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Virtual Reality for the Improvement of Patients Understanding of Disease and Treatment (MRgRT)

Not Applicable
Withdrawn
Conditions
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Interventions
Procedure: Magnetic Resonance Imaging
Procedure: Computed Tomography
Other: Best Practice
Other: Virtual Technology Intervention
Other: Questionnaire Administration
Registration Number
NCT05600556
Lead Sponsor
Thomas Jefferson University
Brief Summary

This clinical trial explores if using virtual reality (VR) headsets will help to improve patient understanding of their disease and decrease anxiety about treatment. Three-dimensional (3D) images may help the patient visualize their tumor and location better and therefore understand potential side effects. Visualizing a virtual representation of the magnetic resonance imaging (MRI) linear accelerator (Linac) may decrease treatment related anxiety.

Detailed Description

PRIMARY OBJECTIVE:

I. Examine patient reported comprehension of their tumor characteristics and treatment plan following 3D virtual reality review of their imaging.

SECONDARY OBJECTIVE:

I. Examine patient reported treatment related anxiety prior to and following virtual reality (VR) simulation of the MRI Linac treatment process.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT I: Patients receive two-dimensional (2D) image review using standard computer screen on study. Patients undergo MRI and computed tomography (CT) imaging at screening and on study.

COHORT II: Patients receive image review using virtual reality stimulation on study. Patients also view MRI treatment room using virtual reality stimulation. Patients undergo MRI and CT imaging at screening and on study.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Age: above 18 years
  • Participants must be histologically proven neoplasm
  • Planned to undergo radiation treatment using the MR Linac
Exclusion Criteria
  • Inability to tolerate virtual reality headset
  • Non-English speaking patients
  • Pediatric patients are ineligible

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Cohort I (standard imaging)Best PracticePatients receive 2D image review using standard computer screen on study. Patients undergo MRI and CT imaging at screening and on study
Cohort I (standard imaging)Computed TomographyPatients receive 2D image review using standard computer screen on study. Patients undergo MRI and CT imaging at screening and on study
Cohort II (virtual reality)Magnetic Resonance ImagingPatients receive image review using virtual reality stimulation on study. Patients also view MRI treatment room using virtual reality stimulation. Patients undergo MRI and CT imaging at screening and on study
Cohort II (virtual reality)Computed TomographyPatients receive image review using virtual reality stimulation on study. Patients also view MRI treatment room using virtual reality stimulation. Patients undergo MRI and CT imaging at screening and on study
Cohort I (standard imaging)Magnetic Resonance ImagingPatients receive 2D image review using standard computer screen on study. Patients undergo MRI and CT imaging at screening and on study
Cohort II (virtual reality)Virtual Technology InterventionPatients receive image review using virtual reality stimulation on study. Patients also view MRI treatment room using virtual reality stimulation. Patients undergo MRI and CT imaging at screening and on study
Cohort II (virtual reality)Questionnaire AdministrationPatients receive image review using virtual reality stimulation on study. Patients also view MRI treatment room using virtual reality stimulation. Patients undergo MRI and CT imaging at screening and on study
Cohort I (standard imaging)Questionnaire AdministrationPatients receive 2D image review using standard computer screen on study. Patients undergo MRI and CT imaging at screening and on study
Primary Outcome Measures
NameTimeMethod
Increase in composite knowledge questionnaire scoreAt first on treatment visit (after starting radiation)

Pre- and post-intervention knowledge summary scores and anxiety scores will be summarized using means, standard deviations, and ranges. Average change will be estimated for each group along with 95% confidence intervals and the difference between groups will be estimated with a 95% confidence interval.

Secondary Outcome Measures
NameTimeMethod
General anxietyAt first on treatment visit (after starting radiation)

Post-intervention knowledge summary scores and anxiety scores will be summarized using means, standard deviations, and ranges. Average change will be estimated for each group along with 95% confidence intervals and the difference between groups will be estimated with a 95% confidence interval.

MRI specific anxietyBaseline and after MRI scan at time of planning scan

Pre- and post-intervention knowledge summary scores and anxiety scores will be summarized using means, standard deviations, and ranges. Average change will be estimated for each group along with 95% confidence intervals and the difference between groups will be estimated with a 95% confidence interval.

Plan review understandingBaseline and at first on treatment visit (after starting radiation)

Pre- and post-intervention knowledge summary scores and anxiety scores will be summarized using means, standard deviations, and ranges. Average change will be estimated for each group along with 95% confidence intervals and the difference between groups will be estimated with a 95% confidence interval.

Trial Locations

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

🇺🇸

Philadelphia, Pennsylvania, United States

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