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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Procedure: Magnetic Resonance Imaging
* Procedure: Computed Tomography
* Other: Best Practice
* Other: Questionnaire Administration
* Procedure: Magnetic Resonance Imaging
* Procedure: Computed Tomography
* Other: Virtual Technology Intervention
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort I (standard imaging)<br>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<br>* Undergo MRI<br>* Other names: nuclear magnetic resonance imaging;Procedure: Computed Tomography<br>* Undergo CT<br>* Other names: tomography;Other: Best Practice<br>* Review imaging on standard computer screen<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Complete questionnaire<br>|
| Experimental: Cohort II (virtual reality)<br>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<br>* Undergo MRI<br>* Other names: nuclear magnetic resonance imaging;Procedure: Computed Tomography<br>* Undergo CT<br>* Other names: tomography;Other: Virtual Technology Intervention<br>* Review virtual reality images<br>* Other names: Virtual Technology;Other: Questionnaire Administration<br>* Complete questionnaire<br>|

What is the study measuring?
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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) |