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Completed

NCT Number: NCT04301089

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.

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.

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Key information

Conditions

Anxiety Anxiety Disorders Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Pico G2 4K Headset with Applied VR software

Device

Headset used for 4 weeks while on study.

Other names: Pico G2 4K Headset with Applied virtual reality (VR) software

Patient Reported Questionnaires

Other

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. 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)

    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.

  4. 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)

    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.

  5. 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)

    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.

  6. 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)

    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.

  7. 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)

    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.

  8. 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)

    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.

  9. 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)

    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.

  10. Number of Participants Who Participated in the Virtual Reality (VR) Qualitative Interview

    Time frame: 1-month post-use VR (+/- 7 days).

    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.

Other outcomes

  1. Number of Participants Analyzed for Symptomatic Adverse Events Measured by the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

    Time frame: Baseline, immediate post-use Virtual Reality (VR) (within 1 hour) and 1-month post-use VR

    Here is the number of participants analyzed for the reporting of a symptomatic adverse events measured by the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). PRO-CTCAE is a patient reported outcome measurement system to record symptomatic events experienced by participants using virtual reality headsets on this trial.

  2. Number of Participants With Symptomatic Adverse Events Measured by the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Reported by Term

    Time frame: Baseline, immediate post-virtual reality (VR (within 1 hour), and/or post-VR 1 month later (+/- 7 days)

    Here is the number of participants with symptomatic adverse events measured by the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) reported by term. PRO-CTCAE is a participant reported outcome measurement system to record symptomatic events experienced by participants using virtual reality headsets on this trial. Symptoms are rated using Frequency (F), Severity (S) and Interference (I). Frequency ranges from "not at all" to "almost constantly." Severity ranges from "not at all" to "very severe." And Interference ranges from "not at all" to "very much."

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 9, 2020
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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