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

NCT05600556 | Withdrawn DMC

• 2 other identifiers: 22C.714JT 20764
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• General anxiety

  At Baseline

• General anxiety

  At first on treatment visit (after starting radiation)

• MRI specific anxiety

  Baseline and after MRI scan at time of planning scan

• Plan review understanding

  Baseline and at first on treatment visit (after starting radiation)

Study Arms (2)

Cohort I (standard imaging)

ACTIVE COMPARATOR

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; Procedure: Computed Tomography; Other: Best Practice; Other: Questionnaire Administration

Cohort II (virtual reality)

EXPERIMENTAL

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; Procedure: Computed Tomography; Other: Virtual Technology Intervention; Other: Questionnaire Administration

Interventions

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, nuclear magnetic resonance imaging

Cohort I (standard imaging)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography, Computerized Tomography, CT, CT SCAN, tomography

Cohort I (standard imaging)

Best Practice OTHER

Review imaging on standard computer screen

Also known as: standard of care, standard therapy

Cohort I (standard imaging)

Questionnaire Administration OTHER

Complete questionnaire

Cohort I (standard imaging)

Virtual Technology Intervention OTHER

Review virtual reality images

Also known as: Virtual Reality Intervention, Virtual Technology

Cohort II (virtual reality)

Eligibility Criteria

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

You may qualify if:

• Age: above 18 years
• Participants must be histologically proven neoplasm
• Planned to undergo radiation treatment using the MR Linac

You may not qualify if:

• Inability to tolerate virtual reality headset
• Non-English speaking patients
• Pediatric patients are ineligible

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Magnetic Resonance Spectroscopy; X-Rays; Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Adam Mueller, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 31, 2022
• Study Start: June 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)