Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy

The primary objective is to demonstrate the feasibility of incorporating VR distraction into the brachytherapy and radiotherapy clinical workflow.

The secondary objective is to determine if VR distraction during brachytherapy treatment for cervical cancer improves subjects' satisfaction, procedural/acute pain, and need for analgesics or anxiolytics.

Study Overview

• Status: Recruiting
• Conditions: Endocervical Cancer
• Intervention / Treatment: Device: The Oculus Quest 2 Virtual Reality Headset

Detailed Description

This will be a prospective pilot study conducted at UAMS. All subjects will experience VR distraction using a crossover design in which each subject receives four rounds of brachytherapy: two rounds with VR distraction and two rounds without VR distraction. Brachytherapy will be conducted per SoC workflow. Subjects will be placed into four treatment-sequence groups in a 1:1:1:1 allocation ratio via permuted block randomization with randomized block sizes of four or eight.

The four treatment-sequence groups will follow the four-session treatment schedules outlined below, in which "V" denotes the sessions when VR distraction is used while "N" denotes the sessions when it is not:

• Sequence Group A will be treated according to schedule VVNN.
• Sequence Group B will be treated according to schedule VNNV.
• Sequence Group C will be treated according to schedule NNVV.
• Sequence Group D will be treated according to schedule NVVN.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph A Holley; Phone Number: 501-686-8274; Email: JAHolley@uams.edu
• Study Contact Backup: Name: Matthew R Kovak; Phone Number: 501-686-8274; Email: mrkovak@uams.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • University of Arkansas for Medical Sciences
      • Contact: Joseph A Holley; Phone Number: 501-686-8274; Email: JAHolley@uams.edu
      • Contact: Matthew R Kovak; Phone Number: 501-686-8274; Email: mrkovak@uams.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female, ≥ 18 years of age
• Histopathologic diagnosis of gynecologic cancer (endometrial, cervical, vaginal, vulvar) that requires intracavitary brachytherapy with a tandem or interstitial brachytherapy
• Able to provide written consent

Exclusion Criteria:

• Severe vision or hearing problems that may hinder the ability to see or hear clearly through the VR headset or other condition that may interfere with the placement of the VR headset such as a head, ear or facial wound
• History of seizure disorder, severe motion sickness, dizziness, or migraine headaches precipitated by visual auras
• Known history of elevated intraocular pressure
• Claustrophobia, thalassophobia, cleithrophobia or similar phobias
• Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence Group A; VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4.	Device: The Oculus Quest 2 Virtual Reality Headset; The hardware includes the wireless headset with integrated headphones which will block the sight and sounds of the clinical setting as well as the hand controllers for the interactive VR experience, which will be delivered through any of three VR software options (subject may choose one or more from the following options): Titans of Space® PLUS developed by Drash VR, LLC (Murrieta, CA, USA); TRIPP® developed by TRIPP, Inc. (Los Angeles, CA, USA); Nature Treks VR published by Greener Games (Ironbridge, England, UK)
Experimental: Sequence Group B; VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3.	Device: The Oculus Quest 2 Virtual Reality Headset; The hardware includes the wireless headset with integrated headphones which will block the sight and sounds of the clinical setting as well as the hand controllers for the interactive VR experience, which will be delivered through any of three VR software options (subject may choose one or more from the following options): Titans of Space® PLUS developed by Drash VR, LLC (Murrieta, CA, USA); TRIPP® developed by TRIPP, Inc. (Los Angeles, CA, USA); Nature Treks VR published by Greener Games (Ironbridge, England, UK)
Experimental: Sequence Group C; VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2.	Device: The Oculus Quest 2 Virtual Reality Headset; The hardware includes the wireless headset with integrated headphones which will block the sight and sounds of the clinical setting as well as the hand controllers for the interactive VR experience, which will be delivered through any of three VR software options (subject may choose one or more from the following options): Titans of Space® PLUS developed by Drash VR, LLC (Murrieta, CA, USA); TRIPP® developed by TRIPP, Inc. (Los Angeles, CA, USA); Nature Treks VR published by Greener Games (Ironbridge, England, UK)
Experimental: Sequence Group D; VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4.	Device: The Oculus Quest 2 Virtual Reality Headset; The hardware includes the wireless headset with integrated headphones which will block the sight and sounds of the clinical setting as well as the hand controllers for the interactive VR experience, which will be delivered through any of three VR software options (subject may choose one or more from the following options): Titans of Space® PLUS developed by Drash VR, LLC (Murrieta, CA, USA); TRIPP® developed by TRIPP, Inc. (Los Angeles, CA, USA); Nature Treks VR published by Greener Games (Ironbridge, England, UK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of eligible subjects who enroll onto the study.	3 weeks
The number of subjects who withdraw or are withdrawn from the study.	3 weeks
The number of subjects who successfully complete the study questionnaires for satisfaction, procedural pain, and anxiety.	3 weeks
The number of times a technical problem occurs with the VR distraction	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of VR distraction during brachytherapy treatment for cervical cancer pain	Compare the subject's procedural pain scores (using a visual analog scale [VAS] pre- and post-procedure) between sessions with VR and sessions without VR.	3 weeks
Determination of VR distraction during brachytherapy treatment for cervical cancer on anxiety	Compare the subject's procedural anxiety scores (using a VAS pre- and post-procedure) between sessions with VR and sessions without VR.	3 weeks
Opiod dose	Compare the dose(s) of opioid pain medication per session (using morphine milligram equivalents [MMEs]) between sessions with VR and sessions without VR.	3 weeks
Benzodiazepine dose	Compare the dose(s) of benzodiazepine anxiolytics per session (using a benzodiazepine conversion calculator) between sessions with VR and sessions without VR	3 weeks

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Gary Lewis, MD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Virtual Reality; Brachytherapy
• Other Study ID Numbers: 261231

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No