AnxietyPhase 2NCT04301089
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 testing Pico G2 4K Headset with Applied VR software, Patient Reported Questionnaires and Saliva sample collection (hormones) in people with Anxiety, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Pico G2 4K Headset with Applied VR software, Patient Reported Questionnaires and Saliva sample collection (hormones)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to 4 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Background
- Psychological distress is a common concern for patients across the cancer trajectory, which has been associated with worse clinical outcomes in terms of quality of life, adherence to treatment regimens, satisfaction with care, and poorer survival in past research.
- Virtual reality (VR) has the potential to alleviate some of the negative aspects of illness by allowing individuals to escape from their lives and experience more positive thoughts and emotions, which can be accomplished using mindfulness, breathing techniques and distraction (all of which can improve psychological symptoms).
- Past VR research has shown promising improvements in anxiety, pain, distress and distraction through use of immersive VR interventions, though there is scant evidence in primary brain tumors (PBTs) population, particularly in the time period surrounding their neuroimaging and clinical appointments when distress and anxiety can be highest.
- Recent evidence has demonstrated that the coronavirus disease 2019 (COVID-19) pandemic and associated mitigation procedures introduce additional stress for cancer patients, with higher levels of anxiety, depression, loneliness, and financial toxicity being reported during this time.
- The purpose of this phase II clinical trial is to determine the feasibility of implementing an immersive VR relaxation intervention in a PBT population and to assess the efficacy of the intervention to improve psychological distress and anxiety at the time of clinical evaluation. VR is an innovative delivery approach to teach our patients validated breathing and mindfulness techniques that can improve their psychological symptoms and their ability to self-manage these symptoms.
Objectives
-To describe the feasibility of implementing a VR intervention in a PBT population, including eligibility, accrual, compliance, device-related adverse effects, study completion, and participant satisfaction with the intervention
Eligibility
- PBT patients enrolled on the Natural History Study (NHS) trial in the Neuro-Oncology Branch (NOB) (all tumor types and grades eligible)
- Patients can be newly diagnosed, receiving active treatment, or on surveillance
- Adults (greater than or equal to 18 years of age) who are English-speaking and able to self-report symptoms
- Active corticosteroid therapy is permissible
- Participants have reported greater than or equal to 1 on distress item from MD Anderson Symptom Inventory (MDASI) Brain Tumor (MDASI-BT) prior to past clinic appointment
- Exclude patients without tissue diagnosis, recent cranial surgery (less than or equal to 2 weeks), scalp wound healing issues, or seizures within the last 6 weeks
- Exclude patients who have a hypersensitivity to motion, severe nausea, or significant visual field deficits that might interfere with VR experience (including hemianopsia, diplopia, and agnosia)
- Exclude patients with a current diagnosis of generalized anxiety disorder (GAD), post-traumatic stress disorder (PTSD), claustrophobia, or panic disorder
Design
- This is a phase II feasibility clinical trial with a single arm experimental design. The VR intervention and all patient-reported outcome measures (PROs) will be done remotely using telehealth.
- Study will include collection of self-reported PROs for distress, anxiety, mood disturbance, symptom burden/interference, quality of life, cognitive function, loneliness, and financial toxicity, as well as optional salivary stress biomarkers. These measures will be collected at baseline and immediately after a brief VR relaxation intervention to determine acute effects on distress, anxiety, and biological stress measures. Repeat post-intervention assessments will be done approximately 1 week and 1 month following the initial intervention to determine sub-acute effects on distress and anxiety, as well as impact on other symptoms. A semi-structured qualitative interview will also be conducted 1 month after the initial intervention to assess participant satisfaction with the intervention and how the pandemic has affected their psychological symptoms.
- Descriptive statistics, T-tests, Wilcoxon rank sum tests, and multiple logistic regression models will be used to evaluate the feasibility of the VR intervention. Linear mixed models and effect size calculations will be used to evaluate the acute and sub-acute effects of the VR intervention on self- reported PRO's. Pearson or Spearman correlations will be used to evaluate the relationship between the biological stress measures and self-reported PRO's.
- A total of 120 PBT patients will participate in this study.
- Conditions
- Anxiety
- Being tested
- Pico G2 4K Headset with Applied VR software, Patient Reported Questionnaires, Saliva sample collection (hormones)
- Keywords
- Virtual Reality, Scanxiety, Distress, Brain Tumors
- Medical subject headings
- Anxiety Disorders, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pico G2 4K Headset with Applied VR softwareDevice
Also called Pico G2 4K Headset with Applied virtual reality (VR) software
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Virtual Reality (VR) Intervention, Survey/Questionnaire Completion & Sample Submission | Experimental | 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. Receives: Device: Pico G2 4K Headset with Applied VR software; Other: Patient Reported Questionnaires; Biological: Saliva sample collection (hormones) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed Patient-Reported Outcomes (PROs) Questionnaires
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.
Measured: Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
Number of Participants Compliant With Virtual Reality (VR) Headset Use
Participants are fitted with a Pico G2 4K headset and instructed by trained Research staff how to put on the headset, adjust the headset, navigate the main virtual interface, select different scenarios and proper use of the remote for the first time. If a participant was able to do the above, then they are compliant for the timepoint.
Measured: Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days).
Proportion of Eligible Participants Approached to be Screened for Study Eligibility Prior to Enrollment Who Enrolled in the Virtual Reality (VR) Intervention Study
The proportion of eligible participants contacted by phone or email to participate in the study who enrolled in the virtual reality (VR) intervention study.
Measured: Screening, up to 6 months prior to study enrollment.
Proportion of Participants Who Reported Symptoms Measured by the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire
PRO-CTCAE measures symptomatic toxicities on a 5-point scale. Each symptomatic toxicity may have up to 3 attributes: frequency, severity, and interference. Higher ratings indicate more frequency, severity, or interference. The symptomatic toxicities chosen were nausea, vomiting, dizziness, and headache.
Measured: Baseline, immediate post-use virtual reality (VR (within 1 hour), and/or 1-month post-use VR (+/- 7 days).
Secondary outcomes (10)
Self-reported Mood Disturbance as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Short Form
The Patient-Reported Outcomes Measurement Symptom (PROMIS)-Emotional Distress-Anxiety Short Form 8a measures symptoms of anxiety with 8 items rated on 5-point scale from "Never" (1) to "Always" (5). A T-score is calculated via scale algorithm with p. Possible T-scores ranging from 37.1 to 83.1. A T-score of 50.0 represents an average person in the United States. Higher T-scores indicate more anxiety symptoms.
Measured: Baseline, 1-week post-use virtual reality (VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
Self-reported Mood Disturbance as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Short-Form
Patient-Reported Outcomes Measurement System (PROMISs)-Emotional Distress-Depression Short Form 8a measures symptoms of depression with 8 items rated on a 5-point scale from "Never" (1) to "Always" (5). T-scores are calculated via scale algorithm with possible T-scores ranging from 38.2 to 81.3. A T-score of 50.0 represents an average person in the United States. Higher T-scores indicate more depression symptoms.
Measured: Baseline, 1-week post-use virtual reality (VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
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
The DT measures distress in the past week with is a one item on a scale of 0 (No distress) to 10 (Extreme distress). Higher score on the DT indicates more distress.
Measured: Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
Effect Sizes of Acute and Subacute Distress That Indicate Moderate-Severe Distress as Measured by the National Comprehensive Cancer Network (NCCN) Distress Thermometer
To assess the effects of a virtual reality (VR) intervention on self-reported acute and subacute distress (as measured by the NCCN Distress Thermometer [DT]) in Primary Brain Tumor (PBT) Participants. The DT measures distress in the past week with one item on a scale of 0 (No distress) to 10 (Extreme distress). Acute distress is quantified by the change from baseline DT score to immediate post-use DT score. Subacute distress is quantified by 1) the change from baseline DT score to week 1 DT score and 2) from baseline DT score to week 4 DT score. The effect size is Hedge's g and ranges from 0 to 1, with larger values indicating larger effect size. Baseline should not be included in the table because all numbers reflect a change from baseline.
Measured: Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
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])
The MD Anderson Symptom Inventory-Brain Tumor questionnaire measures severity of 23 symptoms (e.g., fatigue, pain) on a scale of 0 to 10. Higher ratings indicate more severity. A rating of 5 or greater is considered moderate to severe.
Measured: Baseline, 1-week post-use virtual reality (VR (+/- 3 days), and 1-month post-use VR (+/- 7 days)
Symptom Burden and Interference As Measured by the MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT)
Symptom Burden and Interference as measured by the MD Anderson Symptom Inventory for brain tumor (MDASI-BT). The MDASI-BT questionnaire contains 23 symptoms and 6 interference items. Symptom burden is the mean of the 23 symptoms and ranges from 0 to 10. Symptom interference is the mean of the 6 interference items and ranges from 0 to 10. Higher scores indicate worse symptoms or worse interference.
Measured: Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
Self-Reported Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory, 6-item Short Form (STAI-6)
The Spielberger State-Trait Anxiety Inventory, 6-item, Short Form (STAI-6) is a questionnaire that measures how anxious one feels in the moment rated on a 4-point Likert Scale, from "Not at all" (1) to "Very much" (4). The STAI-6 score is the sum of the 6 items and ranges from 20-80, with higher scores indicating more anxiety in the moment.
Measured: Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
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
To determine if the effects VR has on distress and anxiety are more pronounced in those individuals not on systemic corticosteroids (CS) compared to those who are. Measurement and comparison of distress and anxiety on those on systemic corticosteroids will be performed by calculating the difference in scores in distress and anxiety. And a t-test will be performed on the distress difference scores based on participants who or are not on steroids.
Measured: Baseline and immediate post-use VR (within 1 hour)
Number of Participants Satisfied With the Virtual Reality (VR) Experience as Measured by the Was it Worth it (WIWI) Questionnaire
The Was it worth it (WIWI) questionnaire asks participants 4 yes or no questions to determine participants satisfaction with the VR experience collected electronically via Scribe.
Measured: Immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
Number of Participants Who Participated in the Virtual Reality (VR) Qualitative Interview
Participants will be interviewed by trained Research staff using the semi-structured phone interview with pre-defined prompts. The purpose of the interview is to allow the participants to share their experiences with VR.
Measured: 1-month post-use VR (+/- 7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start18 Mar 2021
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Tito Mendoza, National Cancer Institute (NCI)
- Investigators
- Tito R Mendoza, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301089
- Sponsor's protocol ID
- 200065
- Other IDs
- 20-C-0065
- Status last verified
- Feb 2026
- First submitted
- 6 Mar 2020
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Biomedical Translational Research Information System (BTRIS): All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
Publications
Lin 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.
PubMed 23661311Maples-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.
PubMed 28475502Niki 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.
PubMed 30676847King 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.
PubMed 36944930King 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.
PubMed 36884201King 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.
PubMed 36865245King AL, Roche KN, Leeper HE, Vera E, Mendoza T, Mentges K, Acquaye AA, Adegbesan K, 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 M, 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. Res Sq [Preprint]. 2023 Jan 31:rs.3.rs-2522094. doi: 10.21203/rs.3.rs-2522094/v1.
PubMed 36789426
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04301089
- Acronym / sponsor ID
- 200065
- Conditions
- Anxiety
- Keywords
- Virtual Reality, Scanxiety, Distress, Brain Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Posted 11 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
- Psychological distress is a common concern for patients across the cancer trajectory, which has been associated with worse clinical outcomes in terms of quality of life, adherence to treatment regimens, satisfaction with care, and poorer survival in past research.
- Virtual reality (VR) has the potential to alleviate some of the negative aspects of illness by allowing individuals to escape from their lives and experience more positive thoughts and emotions, which can be accomplished using mindfulness, breathing techniques and distraction (all of which can improve psychological symptoms).
- Past VR research has shown promising improvements in anxiety, pain, distress and distraction through use of immersive VR interventions, though there is scant evidence in primary brain tumors (PBTs) population, particularly in the time period surrounding their neuroimaging and clinical appointments when distress and anxiety can be highest.
- Recent evidence has demonstrated that the coronavirus disease 2019 (COVID-19) pandemic and associated mitigation procedures introduce additional stress for cancer patients, with higher levels of anxiety, depression, loneliness, and financial toxicity being reported during this time.
- The purpose of this phase II clinical trial is to determine the feasibility of implementing an immersive VR relaxation intervention in a PBT population and to assess the efficacy of the intervention to improve psychological distress and anxiety at the time of clinical evaluation. VR is an innovative delivery approach to teach our patients validated breathing and mindfulness techniques that can improve their psychological symptoms and their ability to self-manage these symptoms.
Objectives
-To describe the feasibility of implementing a VR intervention in a PBT population, including eligibility, accrual, compliance, device-related adverse effects, study completion, and participant satisfaction with the intervention
Eligibility
- PBT patients enrolled on the Natural History Study (NHS) trial in the Neuro-Oncology Branch (NOB) (all tumor types and grades eligible)
- Patients can be newly diagnosed, receiving active treatment, or on surveillance
- Adults (greater than or equal to 18 years of age) who are English-speaking and able to self-report symptoms
- Active corticosteroid therapy is permissible
- Participants have reported greater than or equal to 1 on distress item from MD Anderson Symptom Inventory (MDASI) Brain Tumor (MDASI-BT) prior to past clinic appointment
- Exclude patients without tissue diagnosis, recent cranial surgery (less than or equal to 2 weeks), scalp wound healing issues, or seizures within the last 6 weeks
- Exclude patients who have a hypersensitivity to motion, severe nausea, or significant visual field deficits that might interfere with VR experience (including hemianopsia, diplopia, and agnosia)
- Exclude patients with a current diagnosis of generalized anxiety disorder (GAD), post-traumatic stress disorder (PTSD), claustrophobia, or panic disorder
Design
- This is a phase II feasibility clinical trial with a single arm experimental design. The VR intervention and all patient-reported outcome measures (PROs) will be done remotely using telehealth.
- Study will include collection of self-reported PROs for distress, anxiety, mood disturbance, symptom burden/interference, quality of life, cognitive function, loneliness, and financial toxicity, as well as optional salivary stress biomarkers. These measures will be collected at baseline and immediately after a brief VR relaxation intervention to determine acute effects on distress, anxiety, and biological stress measures. Repeat post-intervention assessments will be done approximately 1 week and 1 month following the initial intervention to determine sub-acute effects on distress and anxiety, as well as impact on other symptoms. A semi-structured qualitative interview will also be conducted 1 month after the initial intervention to assess participant satisfaction with the intervention and how the pandemic has affected their psychological symptoms.
- Descriptive statistics, T-tests, Wilcoxon rank sum tests, and multiple logistic regression models will be used to evaluate the feasibility of the VR intervention. Linear mixed models and effect size calculations will be used to evaluate the acute and sub-acute effects of the VR intervention on self- reported PRO's. Pearson or Spearman correlations will be used to evaluate the relationship between the biological stress measures and self-reported PRO's.
- A total of 120 PBT patients will participate in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Virtual Reality (VR) Intervention, Survey/Questionnaire Completion & Sample Submission | Experimental | Device: Pico G2 4K Headset with Applied VR software, Other: Patient Reported Questionnaires, Biological: Saliva sample collection (hormones)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pico G2 4K Headset with Applied VR softwareAlso: Pico G2 4K Headset with Applied virtual reality (VR) softwareHeadset used for 4 weeks while on study. | Device | Experimental Virtual Reality (VR) Intervention, Survey/Questionnaire Completion & Sample Submission |
| Patient Reported QuestionnairesPatient 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). | Other | Experimental Virtual Reality (VR) Intervention, Survey/Questionnaire Completion & Sample Submission |
| Saliva sample collection (hormones)Optional (per principal investigator and participant discretion). Saliva taken at baseline and post virtual reality (VR) (within 1 hour). | Biological | Experimental Virtual Reality (VR) Intervention, Survey/Questionnaire Completion & Sample Submission |
Primary outcome
Number of Participants Who Completed Patient-Reported Outcomes (PROs) Questionnaires
Time frame: Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
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.
Number of Participants Compliant With Virtual Reality (VR) Headset Use
Time frame: Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days).
Participants are fitted with a Pico G2 4K headset and instructed by trained Research staff how to put on the headset, adjust the headset, navigate the main virtual interface, select different scenarios and proper use of the remote for the first time. If a participant was able to do the above, then they are compliant for the timepoint.
Proportion of Eligible Participants Approached to be Screened for Study Eligibility Prior to Enrollment Who Enrolled in the Virtual Reality (VR) Intervention Study
Time frame: Screening, up to 6 months prior to study enrollment.
The proportion of eligible participants contacted by phone or email to participate in the study who enrolled in the virtual reality (VR) intervention study.
Proportion of Participants Who Reported Symptoms Measured by the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire
Time frame: Baseline, immediate post-use virtual reality (VR (within 1 hour), and/or 1-month post-use VR (+/- 7 days).
PRO-CTCAE measures symptomatic toxicities on a 5-point scale. Each symptomatic toxicity may have up to 3 attributes: frequency, severity, and interference. Higher ratings indicate more frequency, severity, or interference. The symptomatic toxicities chosen were nausea, vomiting, dizziness, and headache.
10 secondary outcomes
Self-reported Mood Disturbance as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Short Form
Time frame: Baseline, 1-week post-use virtual reality (VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
Self-reported Mood Disturbance as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Short-Form
Time frame: Baseline, 1-week post-use virtual reality (VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
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
Time frame: Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
Effect Sizes of Acute and Subacute Distress That Indicate Moderate-Severe Distress as Measured by the National Comprehensive Cancer Network (NCCN) Distress Thermometer
Time frame: Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
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])
Time frame: Baseline, 1-week post-use virtual reality (VR (+/- 3 days), and 1-month post-use VR (+/- 7 days)
Symptom Burden and Interference As Measured by the MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT)
Time frame: Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
Self-Reported Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory, 6-item Short Form (STAI-6)
Time frame: Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
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
Time frame: Baseline and immediate post-use VR (within 1 hour)
Number of Participants Satisfied With the Virtual Reality (VR) Experience as Measured by the Was it Worth it (WIWI) Questionnaire
Time frame: Immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)
Number of Participants Who Participated in the Virtual Reality (VR) Qualitative Interview
Time frame: 1-month post-use VR (+/- 7 days).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23661311Lin 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.
- Background: PubMed 28475502Maples-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.
- Background: PubMed 30676847Niki 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.
- Derived from this study: PubMed 36944930King 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.
- Derived from this study: PubMed 36884201King 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.
- Derived from this study: PubMed 36865245King 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.
- Derived from this study: PubMed 36789426King AL, Roche KN, Leeper HE, Vera E, Mendoza T, Mentges K, Acquaye AA, Adegbesan K, 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 M, 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. Res Sq [Preprint]. 2023 Jan 31:rs.3.rs-2522094. doi: 10.21203/rs.3.rs-2522094/v1.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Biomedical Translational Research Information System (BTRIS): All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tito R Mendoza, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pico G2 4K Headset with Applied VR software, Patient Reported Questionnaires and Saliva sample collection (hormones) in people with Anxiety, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Completed Patient-Reported Outcomes (PROs) Questionnaires (time frame: Baseline, immediate post-use VR (within 1 hour), 1-week post-use VR (+/- 3 days), and/or 1-month post-use VR (+/- 7 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04301089, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.