OBJECTIVES: In oncology trials, PROM endpoints provide a valuable complement to endpoints such as tumour response and are central to the patient’s understanding of treatment benefits. The burden of regular PROM completion is poorly understood, yet invaluable in informing PROM selection and scheduling strategies. We examine completion times, often seen as an indicator of burden, for commonly used PROMs in oncology to better understand how measure selection translates to patient time investment in clinical trials.

METHODS: PROM completion times were examined for 2386 patients recruited into 7 global ongoing studies in Breast Cancer and Non-Small Cell Lung Cancer. PROMs were completed electronically with a tablet device at clinics, using a single item per screen presentation. Completion time was estimated from the PROM start and completion electronic timestamps at baseline (BL) and end of treatment (EoT) assessments.

RESULTS: Across visits, per item completion times (seconds) were greater for the single-item side-effect impact measure (BL: median:16s, IQR:15s; EoT: median:12s, IQR:13s). Shorter but similar per item completion times were found for EORTC QLQ-C30 (BL: median:9s, IQR:6s; EoT: median:6s, IQR:6s), EORTC QLQ-BR23 (BL: median:8s, IQR:5s; EoT: median:6s, IQR:4s), EORTC QLQ-LC13 (BL: median:7s, IQR:5s; EOT: median:8s, IQR:9s), and PRO-CTCAE (BL: median:7s IQR:6s; EoT: median:6s, IQR:5s). The EoT assessment for all measures except the QLQ-LC13 was completed quicker, likely due to increased patient familiarity.

CONCLUSIONS: Careful PROM selection and scheduling in oncology trials are essential for the management of patient time investment and PROM completion burden. Core PROM measurement sets for oncology may require greater use of PROM subscales, and at-home assessments. Based on our EoT data, the estimated completion time for the QLQ-C30 physical function subscale, along with selected PRO-CTCAE items and the side-effect impact measure is approximately 120s. This provides confidence that an optimized measurement strategy utilizing core PROM sets may not be over-burdensome to patients.