Patients receive 2D image review using standard computer screen on study. Patients undergo MRI and CT imaging at screening and on study

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

Magnetic Resonance Imaging

Computed Tomography

Review imaging on standard computer screen

Best Practice

Questionnaire Administration

Virtual Technology Intervention

Adam Mueller, MD

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.

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.

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

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

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.

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.

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.

Thomas Jefferson University

Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Anxiety Disorders

Breast Neoplasms

Head and Neck Neoplasms

Thoracic Neoplasms

Breast Diseases

Skin Diseases

Patients use VR during chemotherapy infusion on study.

Patients use smartphone during chemotherapy infusion on study.

Telephone-Based Intervention

Ryan J Li

This clinical trial evaluates the use of virtual reality (VR) goggles during chemotherapy infusion to reduce anxiety-related symptoms in patients with head and neck, thoracic, hematologic, and breast cancers. Virtual reality headsets provide the ability for users to explore a simulated, three-dimensional environment with which users can interact. In virtual reality users can play interactive games, enjoy relaxing experiences, and watch immersive videos. The use of VR goggles may help with anxiety management during chemotherapy infusion.

PRIMARY OBJECTIVE:

I. To evaluate the effectiveness of VR therapy in reducing severity of anxiety symptoms during chemotherapy infusion, compared to participants utilizing a smartphone as a control.

SECONDARY OBJECTIVES:

I. To evaluate whether there is a short-term effect of VR use in anxiety levels.

II. To assess participant satisfaction with their chemotherapy infusion experience in the control and treatment groups.

EXPLORATORY OBJECTIVE:

I. To assess participants' reported adverse effects associated with VR headset use.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP 1: Patients use VR during chemotherapy infusion on study.

GROUP 2: Patients use smartphone during chemotherapy infusion on study.

Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms

Anxiety in the Context of Chemotherapy Infusion: Is There an Association Between the Use of Virtual Reality Goggles and Changes in Anxiety-Related Symptoms?

Will be assessed in the treatment and control groups determined by the difference in the scores provided by the State Anxiety Inventory before and right after VR use. Range of scores is 20-80, the higher score indicating greater anxiety. Will be compared using two-sample t-test to compare the anxiety levels change before and after VR between intervention group and control group (VR vs control). The effect of VR on anxiety levels will be described using a linear regression model addressing the unanticipated imbalance between treatment groups after randomization adjusting for the confounder.

Will be assessed by the difference in anxiety levels right before VR use and immediately after chemotherapy infusion is completed as provided by the State Anxiety Inventory using a two sample t-test. Range of scores is 20-80, with a higher score indicating greater anxiety.

Will be assessed by an investigator-designed satisfaction questionnaire after chemotherapy completion to assess participants' satisfaction with the VR device using descriptive statistics to summarize this data.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Virtual Reality for the Improvement of Patients Understanding of Disease and Treatment (MRgRT)	NCT05600556	Hematopoietic a... Malignant Solid...	Magnetic Resona... Computed Tomogr... Best Practice Questionnaire A... Magnetic Resona... Computed Tomogr... Virtual Technol... Questionnaire A...	18 Years -	Thomas Jefferson University
Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms	NCT05793957	Hematopoietic a... Malignant Breas... Malignant Head ... Malignant Solid... Malignant Thora...	Questionnaire A... Telephone-Based... Virtual Technol...	18 Years - 89 Years	OHSU Knight Cancer Institute
Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms	NCT05793957	Hematopoietic a... Malignant Breas... Malignant Head ... Malignant Solid... Malignant Thora...	Questionnaire A... Telephone-Based... Virtual Technol...	18 Years - 89 Years	OHSU Knight Cancer Institute

Spots Global Cancer Trial Database for virtual technology intervention