Clinical trial NCT05440760: Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy
Official title: Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endocervical Cancer
Keywords: Brachytherapy
Virtual Reality
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The number of eligible subjects who enroll onto the study.
timeFrame: 3 weeks
measure: The number of subjects who withdraw or are withdrawn from the study.
timeFrame: 3 weeks
measure: The number of subjects who successfully complete the study questionnaires for satisfaction, procedural pain, and anxiety.
timeFrame: 3 weeks
measure: The number of times a technical problem occurs with the VR distraction
timeFrame: 3 weeks
Secondary outcomes:
measure: Determination of VR distraction during brachytherapy treatment for cervical cancer pain
timeFrame: 3 weeks
measure: Determination of VR distraction during brachytherapy treatment for cervical cancer on anxiety.
timeFrame: 3 weeks
measure: Opiod dose
timeFrame: 3 weeks
measure: Benzodiazepine dose
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Gary Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References: