Evaluating the effectiveness of immersive virtual reality in reducing distress in patients with cancer receiving chemotherapy: A prospective randomized trial.

11052 Background: Patients diagnosed with cancer commonly face high levels of distress, anxiety, and depressive symptoms along with discomfort or pain, that can be exacerbated during chemotherapy treatment. Immersive Virtual Reality (VR) has not been evaluated in patients with cancer as an intervention to relieve psychological and physical symptoms. In this randomized trial, we sought to assess the effect of a unique immersive type of VR on reducing distress compared to standard of care (SOC). Methods: This is a two-arm, prospective controlled randomized trial. Eligibility criteria included patients diagnosed with any type of cancer at any stage, with an NCCN Distress Thermometer Score ≥ 5, and actively receiving chemotherapy. Participants were randomized in a 1:1 ratio to receive either the intervention (VR) or the control group (SOC). Questionnaires, available in English and Spanish, were administered to both groups before and after the intervention. The primary outcome was to evaluate the effectiveness of VR in reducing distress levels while receiving chemotherapy infusion (NCCN Distress Thermometer) compared to SOC. Secondary outcomes included evaluating the effectiveness in reducing anxiety levels (GAD-7); pain (Universal Pain Assessment Tool) and improving overall wellbeing (Cleveland Clinic 4 Visual Analog Scale - CCVAS). Changes in questionnaire scores were assessed using a two-sample t-test for both arms. All data analyses were conducted using SAS version 9.4. Results: A total of N=70 participants meeting the eligibility criteria are expected to be enrolled in this study. To date, N=41 participants have been enrolled and were included in this preliminary analysis, with n=19 assigned to the intervention group (VR) and n=22 assigned to the control group (SOC). A significant difference was observed for the primary outcome, where the intervention group (VR) demonstrated a mean score reduction in NCCN distress thermometer of 3.9 points (SD± 3.3) compared to 1.0 points (SD± 2.0) for the control group (p = 0.0017). In addition, the VR group showed an improvement in overall wellbeing symptoms measured by decreased CCVAS of 1.7 (SD±2.2) vs. 0.2 (SD±1.4) points in the control group (p=0.0160). No significant difference was observed for anxiety and pain. Conclusions: VR is an innovative immersive experience with the potential to relieve distress and improve wellbeing during chemotherapy sessions in patients diagnosed with cancer.The study is currently ongoing, and final results will be reported upon completion. Comparison of test changes between pre- and post-intervention. Virtual Reality(n=19) SOC(n=22) p-value Primary Outcome, mean ±SD NCCN Distress Thermometer 3.9 ± 3.3 1.0 ± 2.0 0.0017 Secondary Outcomes, mean ±SD GAD-7 0.4 ± 1.6 0.6 ± 1.7 0.7096 CCVAS 1.7 ± 2.2 0.2 ± 1.4 0.0160 Universal Pain Assessment Tool 1.2 ± 3.0 -0.2 ± 2.9 0.1404