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Virtual Reality for Cervical Cancer Comfort During Brachytherapy

N/A
Recruiting
Led By Gary Lewis, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histopathologic diagnosis of gynecologic cancer (endometrial, cervical, vaginal, vulvar) that requires intracavitary brachytherapy with a tandem or interstitial brachytherapy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing if VR can help people during cancer treatment by distracting them from the pain and making them more comfortable.

Who is the study for?
This trial is for women aged 18 or older with a confirmed diagnosis of gynecologic cancer (like cervical cancer) that requires brachytherapy. Participants must be able to give written consent. It's not suitable for those with certain phobias, severe vision or hearing issues, history of seizures or motion sickness due to visual triggers, or any condition that would interfere with wearing a VR headset.Check my eligibility
What is being tested?
The study tests if using the Oculus Quest 2 Virtual Reality Headset during brachytherapy can improve patient satisfaction and reduce pain and the need for painkillers or anxiety medication. The goal is also to see how well VR technology fits into the clinical routine.See study design
What are the potential side effects?
While not directly related to treatment side effects, using VR may cause discomfort such as dizziness, nausea, eye strain, headaches in some individuals—especially those prone to motion sickness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a gynecologic cancer that needs specific radiation therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of eligible subjects who enroll onto the study.
The number of subjects who successfully complete the study questionnaires for satisfaction, procedural pain, and anxiety.
The number of subjects who withdraw or are withdrawn from the study.
+1 more
Secondary outcome measures
Benzodiazepine dose
Determination of VR distraction during brachytherapy treatment for cervical cancer on anxiety
Determination of VR distraction during brachytherapy treatment for cervical cancer pain
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Sequence Group DExperimental Treatment1 Intervention
VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4.
Group II: Sequence Group CExperimental Treatment1 Intervention
VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2.
Group III: Sequence Group BExperimental Treatment1 Intervention
VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3.
Group IV: Sequence Group AExperimental Treatment1 Intervention
VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4.

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
481 Previous Clinical Trials
148,215 Total Patients Enrolled
Gary Lewis, MDPrincipal InvestigatorUniversity of Arkansas
5 Previous Clinical Trials
110 Total Patients Enrolled

Media Library

Cervical Cancer Research Study Groups: Sequence Group A, Sequence Group B, Sequence Group C, Sequence Group D

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still accepting participants for this experiment?

"This medical experiment, which was first advertised on August 8th 2022, is currently recruiting patients. The record for the trial has been revised as recently as August 31st of this same year."

Answered by AI

How many volunteers has this trial enrolled thus far?

"That is accurate. The clinicaltrials.gov page highlights that this medical trial was first announced on August 8th 2022 and has since been modified as recently as the 31st of the same month. 20 volunteers are needed from a single location for enrollment into the study."

Answered by AI

What is the primary objective of this investigation?

"Over a 3-week period, the primary assessment of this trial will be tracking the number of participants who abandon or are removed from it. Secondary outcomes encompass benzodiazepine dose comparison between sessions with/without virtual reality (VR), evaluation of VR's ability to distract patients during brachytherapy treatment for cervical cancer and its effect on anxiety levels, as well as opioid dose comparisons."

Answered by AI
~4 spots leftby Jul 2024