Clinical trial · Interventional
Immersive Virtual Reality (VR) at the Time of Clinical Evaluation to Improve Psychological Distress and Anxiety in Primary Brain Tumor (PBT) Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient Reported Questionnaires | Other | — | UNRESOLVED |
| Pico G2 4K Headset with Applied VR software | Device | — | UNRESOLVED |
| Saliva sample collection (hormones) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Virtual Reality (VR) Intervention, Survey/Questionnaire Completion & Sample Submission
- description
- Experimental Virtual Reality (VR) Intervention, Survey or Questionnaire Completion and Sample Submission. This is a single arm study where all participants were given the Applied VR device to potentially reduce distress and anxiety.
- interventionNames
- Device: Pico G2 4K Headset with Applied VR software
- Other: Patient Reported Questionnaires
- Biological: Saliva sample collection (hormones)
Primary outcomes (4)
- measure
- Number of Participants Who Completed Patient-Reported Outcomes (PROs) Questionnaires
- timeFrame
- Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
- description
- To report the feasibility of implementing a virtual reality (VR) intervention in a Primary Brain Tumor (PBT) population, the number of participants who completed the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT), Spielberger State-Trait Anxiety Inventory, 6-item Short-Form (STAI-6), Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE), MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT), Was It Worth It (WIWI), Patient-Reported Outcomes Measurement Information System (PROMIS)-Emotional Distress-Anxiety and -Emotional Distress-Depression, and EuroQol 5 Dimensions 3 Level (EQ-5D-3L) questionnaires will be reported.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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
References
Publications (7)
- BACKGROUNDLin L, Chiang HH, Acquaye AA, Vera-Bolanos E, Gilbert MR, Armstrong TS. Uncertainty, mood states, and symptom distress in patients with primary brain tumors: analysis of a conceptual model using structural equation modeling. Cancer. 2013 Aug 1;119(15):2796-806. doi: 10.1002/cncr.28121. Epub 2013 May 9. PMID 23661311
- BACKGROUNDMaples-Keller JL, Bunnell BE, Kim SJ, Rothbaum BO. The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Harv Rev Psychiatry. 2017 May/Jun;25(3):103-113. doi: 10.1097/HRP.0000000000000138. PMID 28475502
- BACKGROUNDNiki K, Okamoto Y, Maeda I, Mori I, Ishii R, Matsuda Y, Takagi T, Uejima E. A Novel Palliative Care Approach Using Virtual Reality for Improving Various Symptoms of Terminal Cancer Patients: A Preliminary Prospective, Multicenter Study. J Palliat Med. 2019 Jun;22(6):702-707. doi: 10.1089/jpm.2018.0527. Epub 2019 Jan 24. PMID 30676847
- DERIVEDKing AL, Acquaye-Mallory AA, Vera E, Mendoza T, Reyes J, Stockdill ML, Gilbert MR, Armstrong TS. Feasibility and preliminary efficacy of a virtual reality intervention targeting distress and anxiety in primary brain tumor patients at the time of clinical evaluation: Study protocol for a phase 2 clinical trial. BMC Cancer. 2023 Mar 21;23(1):262. doi: 10.1186/s12885-023-10671-2. PMID 36944930
- DERIVEDKing AL, Roche KN, Leeper HE, Vera E, Mendoza T, Mentges K, Acquaye-Mallory AA, Adegbesan KA, Boris L, Burton E, Choi A, Grajkowska E, Kunst T, Levine J, Lollo N, Miller H, Panzer M, Penas-Prado M, Pillai V, Polskin L, Reyes J, Sahebjam S, Stockdill ML, Theeler BJ, Wu J, Gilbert MR, Armstrong TS. Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial. J Neurooncol. 2023 Mar;162(1):137-145. doi: 10.1007/s11060-023-04271-0. Epub 2023 Mar 8. PMID 36884201
- DERIVEDKing AL, Acquaye AA, Mendoza T, Reyes J, Stockdill M, Gilbert MR, Armstrong TS, Vera E. Feasibility and preliminary efficacy of a virtual reality intervention targeting distress and anxiety in primary brain tumor patients at the time of clinical evaluation: Study protocol for a phase 2 clinical trial. Res Sq [Preprint]. 2023 Feb 16:rs.3.rs-2521990. doi: 10.21203/rs.3.rs-2521990/v1.