28: A Three-Arm Randomized Multicenter Phase II Trial Comparing Patient-Reported Outcome (PRO) Monitoring in Cabozantinib Treatment in Patients with Advanced Renal Cell Carcinoma: ePRO vs paper-PRO, or usual care (Trial in Progress)
Lecturer Department of Renal And Genitourinary Surgery Hokkaido University Graduate School of Medicine, Sapporo, Japan Sapporo, Hokkaido, Japan
Background: The use of patient reported outcome (PRO) has been proposed as an effective method of adverse event (AE) management based on the results of previous clinical trials. Appropriate AE management helps maintain good health-related quality of life (HRQOL) and continuous dosing of drugs, which may lead to improved patient survival. In particular, electronic PRO (ePRO) can prompt intervention in response to AEs with the alert system in a timely manner. Therefore, ePRO is expected to be a useful alternative to paper-PRO. This study aims to investigate the benefit of ePRO use during cabozantinib treatment in patients with advanced renal cell carcinoma (RCC) in terms of AE management.
Trial
Design: A total of 105 patients with advanced RCC who had prior immune-checkpoint inhibitor will be enrolled in this three-arm randomized phase II study (jRCTs011210055): ePRO monitoring, paper-PRO monitoring, and usual care (35 patients each). The registration has started in December 2021. Patients will receive cabozantinib 60 mg once daily and will be followed for up to 24 weeks after treatment initiation. Patient’s daily conditions including dosing status, body weight, temperature, blood pressure, and PRO-CTCAE will be recorded in both the ePRO and the paper-PRO monitoring groups. Patients and physicians in the ePRO monitoring group will be alerted when AEs exceeding the prespecified threshold are entered to the smartphone application. Patients in the paper-PRO group will record their status daily using paper-PRO and those in the usual care group will be managed in routine practice. The primary endpoint is the proportion of clinically meaningful deterioration of the Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index-19, defined as a ≥ 5 score decrease from baseline.