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NCT04301089 · ClinicalTrials.gov registry record · Phase 2
Immersive Virtual Reality (VR) at the Time of Clinical Evaluation to Improve Psychological Distress and Anxiety in Primary Brain Tumor (PBT) Patients
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT04301089: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT04301089 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 61 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04301089, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Pico G2 4K Headset with Applied VR software
- OTHER Patient Reported Questionnaires
- BIOLOGICAL Saliva sample collection (hormones)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2021-03-18 |
| Est. Completion | 2025-02-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04301089
The ClinicalTrials.gov registry entry for NCT04301089 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pico G2 4K Headset with Applied VR software is the first listed.
NCT04301089 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04301089 about?
NCT04301089 is a clinical study titled "Immersive Virtual Reality (VR) at the Time of Clinical Evaluation to Improve Psychological Distress and Anxiety in Primary Brain Tumor (PBT) Patients". 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 str...
What is the current status of trial NCT04301089?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2021-03-18. Estimated completion is 2025-02-04.
What interventions are being tested in trial NCT04301089?
The interventions under investigation include: Pico G2 4K Headset with Applied VR software (DEVICE), Patient Reported Questionnaires (OTHER), Saliva sample collection (hormones) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04301089?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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