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

NCT04301089 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2026-03-11

Study results available
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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.

Conditions

Interventions

DEVICE

Pico G2 4K Headset with Applied VR software

Headset used for 4 weeks while on study.

OTHER

Patient Reported Questionnaires

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).

BIOLOGICAL

Saliva sample collection (hormones)

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Tito R Mendoza, Ph.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-18
Primary Completion
2025-02-04
Completion
2025-02-04

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04301089 on ClinicalTrials.gov