Trial Outcomes & Findings for Immersive Virtual Reality (VR) at the Time of Clinical Evaluation to Improve Psychological Distress and Anxiety in Primary Brain Tumor (PBT) Patients (NCT NCT04301089)

Immersive Virtual Reality (VR) at the Time of Clinical Evaluation to Improve Psychological Distress and Anxiety in Primary Brain Tumor (PBT) Patients

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.

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.

The proportion of eligible participants contacted by phone or email to participate in the study who enrolled in the virtual reality (VR) intervention study.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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."