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

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05600556
• Other study ID #: 22C.714
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: January 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Procedure:
• Magnetic Resonance Imaging
Undergo MRI
• Computed Tomography
Undergo CT

Other:
• Best Practice
Review imaging on standard computer screen
• Questionnaire Administration
Complete questionnaire

Procedure:
• Magnetic Resonance Imaging
Undergo MRI
• Computed Tomography
Undergo CT

Other:
• Virtual Technology Intervention
Review virtual reality images
• Questionnaire Administration
Complete questionnaire

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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)