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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05600556
Other study ID # 22C.714
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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)
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