2732 - Real-Time Monitoring of Patient Centered Outcomes in Patients Undergoing Pelvic Radiation - A Randomized Controlled Trial

Purpose/Objective(s): PROs are widely accepted as a critical component of cancer treatment capturing the patient’s experience of side effects and overall quality of life. PROs have been widely incorporated in clinical trials for new treatments, but their use in a routine clinical workflow during radiation treatment has not been rigorously tested. Our hypothesis was that real time review of PROs in a radiation oncology clinic would improve management of treatment related side effects at the end of treatment

Materials/Methods: We conducted a randomized controlled trial with the primary endpoint of decline in bowel and urinary function at the end of treatment for patients receiving pelvic radiation. All patients completed weekly EPIC-26 surveys and were randomized to real-time physician review of PROs (weekly on treatment visits) or standard of care (SOC, per primary MD practice, no access to study PROs). Independent t-tests and Mann Whitney U tests were used to compare the change in urinary and bowel QOL scores from baseline to end of treatment between study arms. To account for multiple comparisons a Bonferroni correction was applied and significance was defined as alpha = 0.006. Target accrual was 126 patients; the study was terminated early due to slow accrual.

Results: A total of 78 patients were enrolled and randomized between 2022-2025. 61 patients (31 real time PROs, 30 SOC) had complete surveys for the primary endpoint. The median age was 70 years (interquartile range 63-75) and the majority of participants were white (85%), and male (89%). Overall, urinary and bowel scores declined over treatment (table). The primary endpoint did not reach statistical significant after correction for multiple comparisons, but there was a trend towards improved bowel scores in the real time PRO group (p=0.025, table).

Conclusion: Implementation of real-time physician review of PROs in radiation oncology is feasible and shows promise for improving symptoms management. Further analysis of long-term results and subgroup analyses may further inform the clinical implementation of PROs during radiation treatments.