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NCT05440760 | RECRUITING | Endocervical Cancer

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

University of Arkansas

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.

Condition or disease

Endocervical Cancer

Intervention/treatment

The Oculus Quest 2 Virtual Reality Headset

Phase

NA

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
Estimated Enrollment : 20 participants
Masking : SINGLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy
Actual Study Start Date : 2022-08-08
Estimated Primary Completion Date : 2026-07
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy

Location Details

NCT05440760

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How to Participate

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Locations

RECRUITING

United States, Arkansa

University of Arkansas for Medical Sciences

Little Rock, Arkansa, United States, 72205