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

Abstract

Purpose: Cancer patients experience distress and anxiety when undergoing imaging studies to monitor disease status, yet these symptoms are not always appropriately identified or well-managed. This interim analysis of a phase 2 clinical trial explored feasibility and acceptability of a virtual reality relaxation (VR) intervention for primary brain tumor (PBT) patients at the time of clinical evaluation. Methods: English speaking, adult PBT patients with previous reports of distress and upcoming neuroimaging were recruited between March of 2021 and March 2022. A brief VR session was done within 2 weeks prior to neuroimaging with patient-reported outcomes (PROs) collected before and immediately post-intervention. Self-directed VR use over the next 1 month was encouraged with additional PROs assessments at 1 and 4 weeks. Feasibility metrics included enrollment, eligibility, attrition, and device-related adverse effects with satisfaction measured with qualitative phone interviews. Results: 55 patients were approached via email, 40 (73%) responded and 20 (50%) enrolled (9 declines, 11 screen fails). 65% of participants were ≤ 50 years, 50% were male, 90% were White/non-Hispanic, 85% had good KPS (≥ 90), and most were on active treatment. All patients completed the VR intervention, PROs questionnaires, weekly check-ins, and qualitative interview. Most (90%) reported frequent VR use and high satisfaction and only 7 mild AEs were recorded (headache, dizziness, nausea, neck pain). Conclusion: This interim analysis confirmed feasibility and acceptability of a novel VR intervention to target psychological symptoms for PBT patients. Trial enrollment will continue to assess for intervention efficacy. Trial Registration: NCT04301089 registered on 3/9/2020.

Figure 1.. AppliedVR^™ virtual scenarios on Pico G2 4K headset.

The dynamic breathing scenarios, which make use of a breath shield attachment, guide the participant to take slow, deep breaths in order to slow the heart rate and induce relaxation as the environment seen changes based on the breathing pattern. Guided relaxation scenarios are meditative in nature and promote mindfulness and bringing attention to unhelpful thoughts and emotions that participants might be experiencing. Instant escape scenarios allow distraction through exploration of immersive environments, including ocean-based experiences, travel to various locations around the world, and interactive games.

Figure 2.. Consort diagram.

A total of 55 PBT patients were recruited for participation in this trial (46 via email, 9 in clinic) with 15 patients not responding to the reach-out and 9 patients declined participation (reasons listed above). There were 31 patients who were interested in participating and were screened for eligibility with a total of 11 screen fails (reasons outlined above). Ultimately, 20 patients were eligible and consented to the trial. All enrolled patients completed baseline assessments, the VR intervention, all post-intervention assessments, weekly check-ins with the study team, as well as the qualitative phone interview.