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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Endocervical Cancer

Intervention / Treatment
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* Device: The Oculus Quest 2 Virtual Reality Headset


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence Group A<br>VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4. | Device: The Oculus Quest 2 Virtual Reality Headset<br>* 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)<br>|
| Experimental: Sequence Group B<br>VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3. | Device: The Oculus Quest 2 Virtual Reality Headset<br>* 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)<br>|
| Experimental: Sequence Group C<br>VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2. | Device: The Oculus Quest 2 Virtual Reality Headset<br>* 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)<br>|
| Experimental: Sequence Group D<br>VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4. | Device: The Oculus Quest 2 Virtual Reality Headset<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brachytherapy, Virtual Reality