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

Sponsor
Thomas Jefferson University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05600556
Collaborator
(none)
20
1
2
12
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. Examine patient reported comprehension of their tumor characteristics and treatment plan following 3D virtual reality review of their imaging.
SECONDARY OBJECTIVE:
  1. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Role of Virtual Reality (VR) in Patient Experience When Used for Magnetic Resonance-Guided Radiation Therapy (MRgRT)
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging
  • Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • nuclear magnetic resonance imaging
  • Procedure: Computed Tomography
    Undergo CT
    Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • computerized axial tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography
  • Other: Best Practice
    Review imaging on standard computer screen
    Other Names:
  • standard of care
  • standard therapy
  • Other: Questionnaire Administration
    Complete questionnaire

    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:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging
  • Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • nuclear magnetic resonance imaging
  • Procedure: Computed Tomography
    Undergo CT
    Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • computerized axial tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography
  • Other: Virtual Technology Intervention
    Review virtual reality images
    Other Names:
  • Virtual Reality Intervention
  • Virtual Technology
  • Other: Questionnaire Administration
    Complete questionnaire

    Outcome Measures

    Primary Outcome Measures

    1. Increase in composite knowledge questionnaire score [At Baseline]

      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.

    2. Increase in composite knowledge questionnaire score [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.

    Secondary Outcome Measures

    1. General anxiety [At Baseline]

      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.

    2. General anxiety [At 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.

    3. MRI specific anxiety [Baseline 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.

    4. Plan review understanding [Baseline 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Thomas Jefferson University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT05600556
    Other Study ID Numbers:
    • 22C.714
    First Posted:
    Oct 31, 2022
    Last Update Posted:
    Jan 23, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 23, 2023