Multicenter, open-label, randomized, controlled study to test the utility of electronic patient-reported outcome (ePRO) monitoring in patients with unresectable advanced cancers or metastatic/recurrent solid tumors

Background: Electronic patient-reported outcome (ePRO) monitoring for patients undergoing cancer chemotherapy may provide qualified and early detection of adverse events or disease-related symptoms, leading to improved patient care. The aim of this study is to examine whether addition of ePRO monitoring to routine medical care contributes to improved overall survival and quality of life of cancer patients undergoing chemotherapy. Methods: Patients with unresectable advanced cancers or metastatic/recurrent solid tumors receiving systemic chemotherapy will be randomized to an ePRO monitoring group and a usual care group. The ePRO group will conduct weekly symptom monitoring using an electronic device after study enrollment until the end of the study. Monitoring items were extracted for each cancer type from the Patient-Reported Outcome-Common Terminology Criteria for Adverse Events. Monitoring results will be returned to medical personnel and used as information for patient care. In addition, a threshold for high severity is predefined for each symptom, and any report in excess of the threshold will be sent to the medical personnel as an alert notification. Upon receiving the notification, the personnel will assess the notification and take the appropriate action. The primary endpoints are overall survival and health related quality of life, and the secondary endpoints are quality adjusted life years, time from the last drug therapy to death, number of unscheduled visits, relative dose intensity of drug therapy, number of drug therapy regimens, incremental cost-effectiveness ratio, and patient-healthcare provider communication. The target sample size is 500 cases. Discussion: Timely access to information on adverse events that occur at home through ePRO monitoring during therapy may lead to proper management of clinically relevant adverse events and early detection of disease progression. If the usefulness of new communication tools between patients and medical staff using information technology is proved, the quality of cancer treatment will progress greatly. Trial registration: ClinicalTrials.gov Identifier: NCT05931445. First Posted: July 5, 2023. University Hospital Medical Information Network: UMIN ID000042447. First Posted: November 13, 2020.