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

The Role of Virtual Reality (VR) in Patient Experience When Used for Magnetic Resonance-Guided Radiation Therapy (MRgRT)

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.

Study Overview

• Status: Withdrawn
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography; Other: Questionnaire Administration; Other: Best Practice; Other: Virtual Technology Intervention

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Mueller, MD; Phone Number: 215-955-6700; Email: adam.mueller@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cohort I (standard imaging); Patients receive 2D image review using standard computer screen on study. Patients undergo MRI and CT imaging at screening and on study	Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Medical Imaging; Magnetic Resonance / Nuclear Magnetic Resonance; nuclear magnetic resonance imaging; Procedure: Computed Tomography; Undergo CT; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Tomography; tomography; CT SCAN; computerized axial tomography; Other: Questionnaire Administration; Complete questionnaire; Other: Best Practice; Review imaging on standard computer screen; Other Names: standard of care; standard therapy
Experimental: Cohort II (virtual reality); 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	Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Medical Imaging; Magnetic Resonance / Nuclear Magnetic Resonance; nuclear magnetic resonance imaging; Procedure: Computed Tomography; Undergo CT; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Tomography; tomography; CT SCAN; computerized axial tomography; Other: Questionnaire Administration; Complete questionnaire; Other: Virtual Technology Intervention; Review virtual reality images; Other Names: Virtual Reality Intervention; Virtual Technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in composite knowledge questionnaire score	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.	At Baseline
Increase in composite knowledge questionnaire score	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.	At first on treatment visit (after starting radiation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General anxiety	Pre-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.	At Baseline
General anxiety	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.	At first on treatment visit (after starting radiation)
MRI specific anxiety	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.	Baseline and after MRI scan at time of planning scan
Plan review understanding	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.	Baseline and at first on treatment visit (after starting radiation)

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Adam Mueller, MD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 22C.714

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No