Phase 2
Completed N=61
Immersive Virtual Reality (VR) at the Time of Clinical Evaluation to Improve Psychological Distress and Anxiety in Primary Brain Tumor (PBT) Patients
Anxiety
Source: ClinicalTrials.gov NCT04301089 ↗
Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Number of Participants Who Completed Patient-Reported Outcomes (PROs) Questionnaires — 61; 61; 61; 61 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Completed Patient-Reported Outcomes (PROs) Questionnaires |
61; 61; 61; 61; 61; 61 | — |
| PRIMARY Number of Participants Compliant With Virtual Reality (VR) Headset Use |
61; 61; 61; 61 | — |
| PRIMARY Proportion of Eligible Participants Approached to be Screened for Study Eligibility Prior to Enrollment Who Enrolled in the Virtual Reality (VR) Intervention Study |
1.00 | — |
| PRIMARY Proportion of Participants Who Reported Symptoms Measured by the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire |
0.26; 0.28; 0.23; 0.88; 1.00; 1.00 | — |
| SECONDARY Self-reported Mood Disturbance as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Short Form |
53.6; 53.4; 51.3 | — |
| SECONDARY Self-reported Mood Disturbance as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Short-Form |
52.2; 49.1; 48.3 | — |
| SECONDARY Proportion of Participants With High (Moderate/Severe) Distress (Based on Distress Thermometer (DT) Cut-off Score of Greater Than or Equal to 5) Compared to Those With Low Distress (Based on DT Scores of 0-.4) on the 0-10 Numeric Scale |
0.38; 0.41; 0.30; 0.34; 0.62; 0.59 | — |
| SECONDARY Effect Sizes of Acute and Subacute Distress That Indicate Moderate-Severe Distress as Measured by the National Comprehensive Cancer Network (NCCN) Distress Thermometer |
0.01; 0.17; 0.23 | — |
| SECONDARY Proportion of Participants Reporting Any Moderate to Severe (≥5) Symptoms on the 0-10 Numeric Rating Scale as Measured by the MD Anderson Symptom Inventory-Brain Tumor [MDASI-BT]) |
0.61; 0.57; 0.57 | — |
| SECONDARY Symptom Burden and Interference As Measured by the MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) |
1.7; 1.5; 1.4; 2.5; 2.2; 1.9 | — |
| SECONDARY Self-Reported Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory, 6-item Short Form (STAI-6) |
41.8; 35.4; 39.7; 37.4 | — |
| SECONDARY Change in Distress and Anxiety T-score at Baseline and Immediate Post-use of Virtual Reality (VR) for Participants on Systemic Corticosteroids (CS) Compared to Those Who Are Not |
— | — |
| SECONDARY Number of Participants Satisfied With the Virtual Reality (VR) Experience as Measured by the Was it Worth it (WIWI) Questionnaire |
38; 21; 36; 38; 21; 34 | — |
| SECONDARY Number of Participants Who Participated in the Virtual Reality (VR) Qualitative Interview |
60 | — |
Eligibility Criteria
- INCLUSION CRITERIA:
- Primary brain tumor (PBT) patients enrolled on the Natural History Study (NHS) trial (16C0151) in the Neuro-Oncology Branch (NOB) who have an upcoming scan and clinical appointment
- Participants can be newly diagnosed, receiving active treatment, or on surveillance
- Concurrent enrollment in other NOB trials is permissible
- Adults (greater than or equal to 18 years of age) who are English-speaking
- Participants must be able to reliably self-report symptoms, based on clinician assessment
- Participants report greater than or equal to 1 on distress item from MD Anderson Symptom Inventory (MDASI) Brain Tumor (MDASI-BT) prior to clinic appointment
- Active corticosteroid therapy is permissible
- Ability of subject to understand and the willingness to sign a written informed consent document
EXCLUSION CRITERIA
- Participants who do not have a tissue diagnosis (no past surgery or biopsy to confirm diagnosis)
- Cranial surgery less than or equal to 2 weeks prior to initiation of study intervention
- Scalp wound healing issues that might interfere with comfortable virtual reality (VR) headset use
- Those who have epilepsy or have had a seizure in the last 6 weeks
- Participants with a current diagnosis of generalized anxiety disorder (GAD), post-traumatic stress disorder (PTSD), claustrophobia, or panic disorder
- Participants who have a hypersensitivity to motion or severe nausea, which could make the VR experience uncomfortable
- Those with visual deficits that might interfere with the VR experience, including hemianopsia, diplopia, and agnosia based on their most recent clinical assessment
Data sourced from ClinicalTrials.gov (NCT04301089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.