CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
Saliva sample collection (hormones) +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04301089
NCT04301089Phase 2Completed

A Phase II Feasibility Trial Using Immersive Virtual Reality (VR) at the Time of Clinical Evaluation to Improve Psychological Distress and Anxiety in Primary Brain Tumor (PBT) Patients

National Cancer Institute (NCI)·interventional·Posted Mar 9, 2020·Updated Mar 11, 2026

In Brief

A Phase 2 clinical trial evaluating Pico G2 4K Headset with Applied VR software, Patient Reported Questionnaires, and 1 other intervention for Anxiety. Completed, enrolled 61 participants across 1 site.

Detailed Summary

Background: Distress, anxiety, and other psychological disorders may be more common in people with primary brain tumors (PBTs). PBTs can affect their symptoms, quality of life, and their tolerance of cancer treatments. Researchers want to learn if virtual reality (VR) technology can help reduce stress and improve mood. VR uses computer technology to make fake experiences and environments that look real. This allows people to escape from their lives and experience more positive thoughts and emotions. Objective: To learn if it is feasible to use a VR relaxation intervention in people with PBTs. Eligibility: Adults 18 and older who have a brain tumor and have recently reported psychological distress during their participation in the Natural History Study (NHS), protocol #16C0151 Design: The VR intervention and all patient-reported outcome measures (PROs) will be done remotely using telehealth. Participants will be mailed a VR headset. This headset looks like a thick pair of goggles that is worn over the eyes. Participants will view computer-generated environments on this VR headset. Participants will fill out symptom questionnaires at 4 different times points during participation in this study, including questionnaires for the NHS as well as 4 questionnaires unique to this study. There are also optional saliva samples that are collected at 2 of the timepoints. The 4 timepoints are: * Baseline (before the VR intervention) * Immediate post-VR (right after the VR intervention) * 1 week later * 4 weeks later Participants will also have a phone interview 4 weeks after the initial VR intervention, which will last 10 to 15 minutes. Participation lasts 4 to 6 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnxiety
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMar 9, 2020
Enrollment StartMar 18, 2021
Primary CompletionFeb 4, 2025
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 6.3 years ago

Interventions

Pico G2 4K Headset with Applied VR softwaredevice

Headset used for 4 weeks while on study.

Patient Reported Questionnairesother

Patient reported questionnaires completed at baseline, post virtual reality (VR) within 1 hour, post VR 1 week later (+/- 3 days), and/or post VR 1 month later (+/- 7 days).

Saliva sample collection (hormones)biological

Optional (per principal investigator and participant discretion). Saliva taken at baseline and post virtual reality (VR) (within 1 hour).