Data management and monitoring
ADVERSE EFFECTS, EVENT
The PROs data from the questionnaires was collected via the Scribe electronic interface using links emailed to participants at the 4 study timepoints (baseline, immediate post-VR intervention, 1 week post-VR intervention, and 1 month post-VR intervention). All trial data was exported into a password-protected internal database and audited for errors by trained data analysts. To protect confidentiality, patient identifiers are stored in a separate location from the research data and only the key study personnel have access to identifying information.Device-related AEs were assessed via the PRO-CTCAE questionnaires and through patient report during weekly check-ins with the study team. In the event that the participant reported any adverse effects, either during the intervention or with ongoing VR use at home, they were instructed to remove the VR headset and allow time to recover from the symptoms. If their symptoms persisted despite a break from using the device, their clinical team was notified, VR use was discontinued, and they completed follow-up PROs assessments, per investigator and clinician discretion.