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

University of Arkansas

Status: Enrolling

Conditions: Endocervical Cancer

Treatments: Device: The Oculus Quest 2 Virtual Reality Headset

Study type: Interventional

Funder types: Other

Identifiers

NCT05440760

261231

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 4 patient groups

Sequence Group A

Experimental group

Description:

VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4.

Treatment:

Device: The Oculus Quest 2 Virtual Reality Headset

Sequence Group B

Experimental group

Description:

VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3.

Treatment:

Device: The Oculus Quest 2 Virtual Reality Headset

Sequence Group C

Experimental group

Description:

VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2.

Treatment:

Device: The Oculus Quest 2 Virtual Reality Headset

Sequence Group D

Experimental group

Description:

VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4.

Treatment:

Device: The Oculus Quest 2 Virtual Reality Headset