Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-04 @ 3:20 PM
Study NCT ID:
NCT05440760
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2022-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2022-06-20', 'studyFirstSubmitQcDate': '2022-06-27', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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subjects who enroll onto the study.', 'timeFrame': '3 weeks'}, {'measure': 'The number of subjects who withdraw or are withdrawn from the study.', 'timeFrame': '3 weeks'}, {'measure': 'The number of subjects who successfully complete the study questionnaires for satisfaction, procedural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'}], 'secondaryOutcomes': [{'measure': 'Determination of VR distraction during brachytherapy treatment for cervical cancer pain', 'timeFrame': '3 weeks', 'description': "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."}, {'measure': 'Determination of VR distraction during brachytherapy treatment for cervical cancer on anxiety.', 'timeFrame': '3 weeks', 'description': "Compare the subject's procedural anxiety scores (using a VAS pre- and post-procedure) between sessions with VR and sessions without VR."}, {'measure': 'Opiod dose', 'timeFrame': '3 weeks', 'description': 'Compare the dose(s) of opioid pain medication per session (using morphine milligram equivalents \\[MMEs\\]) between sessions with VR and sessions without VR.'}, {'measure': 'Benzodiazepine dose', 'timeFrame': '3 weeks', 'description': 'Compare the dose(s) of benzodiazepine anxiolytics per session (using a benzodiazepine conversion calculator) between sessions with VR and sessions without VR'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Brachytherapy', 'Virtual Reality'], 'conditions': ['Endocervical Cancer']}, 'descriptionModule': {'briefSummary': "The primary objective is to demonstrate the feasibility of incorporating VR distraction into the brachytherapy and radiotherapy clinical workflow.\n\nThe 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.", 'detailedDescription': '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.\n\nThe 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:\n\n* Sequence Group A will be treated according to schedule VVNN.\n* Sequence Group B will be treated according to schedule VNNV.\n* Sequence Group C will be treated according to schedule NNVV.\n* Sequence Group D will be treated according to schedule NVVN.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, ≥ 18 years of age\n* Histopathologic diagnosis of gynecologic cancer (endometrial, cervical, vaginal, vulvar) that requires intracavitary brachytherapy with a tandem or interstitial brachytherapy\n* Able to provide written consent\n\nExclusion Criteria:\n\n* 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\n* History of seizure disorder, severe motion sickness, dizziness, or migraine headaches precipitated by visual auras\n* Known history of elevated intraocular pressure\n* Claustrophobia, thalassophobia, cleithrophobia or similar phobias\n* 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'}, 'identificationModule': {'nctId': 'NCT05440760', 'briefTitle': 'Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy', 'orgStudyIdInfo': {'id': '261231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence Group A', 'description': 'VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4.', 'interventionNames': ['Device: The Oculus Quest 2 Virtual Reality Headset']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence Group B', 'description': 'VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3.', 'interventionNames': ['Device: The Oculus Quest 2 Virtual Reality Headset']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence Group C', 'description': 'VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2.', 'interventionNames': ['Device: The Oculus Quest 2 Virtual Reality Headset']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence Group D', 'description': 'VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4.', 'interventionNames': ['Device: The Oculus Quest 2 Virtual Reality Headset']}], 'interventions': [{'name': 'The Oculus Quest 2 Virtual Reality Headset', 'type': 'DEVICE', 'description': '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):\n\n* Titans of Space® PLUS developed by Drash VR, LLC (Murrieta, CA, USA)\n* TRIPP® developed by TRIPP, Inc. (Los Angeles, CA, USA)\n* Nature Treks VR published by Greener Games (Ironbridge, England, UK)', 'armGroupLabels': ['Sequence Group A', 'Sequence Group B', 'Sequence Group C', 'Sequence Group D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph A Holley', 'role': 'CONTACT', 'email': 'jaholley@uams.edu', 'phone': '501-686-8274'}, {'name': 'Matthew R Kovak', 'role': 'CONTACT', 'email': 'mrkovak@uams.edu', 'phone': '501-686-8274'}], 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'centralContacts': [{'name': 'Joseph A Holley', 'role': 'CONTACT', 'email': 'jaholley@uams.edu', 'phone': '501-686-8274'}, {'name': 'Matthew R Kovak', 'role': 'CONTACT', 'email': 'mrkovak@uams.edu', 'phone': '501-686-8274'}], 'overallOfficials': [{'name': 'Gary Lewis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}