Immersive Virtual Reality for Enabling Patient Experience and Enrollment in Oncology Clinical Trials: A Feasibility...

Background/Objectives: Informed consent is a crucial part of the clinical trial enrollment process in which patients are asked to understand and provide approval for medical interventions. Consent forms can be complex and hinder patient comprehension, highlighting the need for novel tools to improve the patient enrollment experience. This feasibility study aimed to develop an immersive technology to enroll human subjects in oncology clinical trials and provide 3D avatar-based informed consent in a virtual reality (VR) environment. Methods: Clinical feasibility and the effects of head-mounted VR devices on motion sickness and educational quality were evaluated in adult oncology patients enrolled in an intravenous (IV) port placement intervention study. Participants received before- and after-questionnaires to measure their understanding of the information received in VR. A follow-up questionnaire was given four weeks post-consent to measure knowledge retention. Results: Clinical staff reported that VR technology was manageable to use. Among 16 adult participants, all reported that VR was well tolerated with no motion sickness. The mean pre-intervention knowledge score was 64.6%, with an immediate post-intervention knowledge score of 97.9%. A mean knowledge score of 93.3% four-weeks post-consent was observed among 10/16 participants who completed a follow-up questionnaire. Conclusions: These findings support that VR is well tolerated and effective at delivering information during the informed consent process for oncology clinical trials. Key limitations include the small sample size and single clinical population. Further trials are warranted to compare efficacy over traditional consenting mechanisms and include more diverse clinical populations among a wider participant pool.