Abstract
PURPOSE:Adverse event (AE) reporting is essential in clinical trials. Clinician interpretation can result in under-reporting; therefore, the value of patient self-reporting has been recognized. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for direct patient AE reporting. A nonrandomized prospective cohort feasibility study aimed to explore the compliance and acceptability of an electronic (Internet or telephone) system for collecting patient self-reported AEs and quality of life (QOL).METHODS:Oncology patients undergoing treatment (chemotherapy, targeted agents, hormone therapy, radiotherapy, and/or surgery) at 2 hospitals were sent automated weekly reminders to complete PRO-CTCAE once a week and QOL (for a maximum of 12 weeks). Patients had to speak/understand English and have access to the Internet or a touch-tone telephone. Primary outcome was compliance (proportion of expected questionnaires), and recruitment rate, attrition, and patient/staff feedback were also explored.RESULTS:Of 520 patients, 249 consented (47.9%)—mean age was 62 years, 51% were male, and 70% were married—and 230 remained on the study at week 12. PRO-CTCAE was completed at 2,301 (74.9%) of 3,074 timepoints and QOL at 749 (79.1%) of 947 timepoints. Individual weekly/once every 4 weeks compliance reduced over time but was more than 60% throughout. Of 230 patients, 106 (46.1%) completed 13 or more PRO-CTCAE, and 136 (59.1%) of 230 patients completed 4 QOL questionnaires. Most were completed on the Internet (82.3%; mean age, 60.8 years), which was quicker, but older patients preferred the telephone option (mean age, 70.0 years). Positive feedback was received from patients and staff.CONCLUSION:Self-reporting of AEs and QOL using an electronic home-based system is feasible and acceptable. Implementation of this approach in cancer clinical trials may improve the precision and accuracy of AE reporting.
Highlights
As more cancer treatments with innovative modes of action are evaluated via clinical trials, the need to monitor and record adverse events (AEs)[1] increases to ensure safety and guide prescribing and patient information.[2]
The Common Terminology Criteria for Adverse Events (CTCAE)[3] is the standard method of reporting AEs, allowing clinicians to uniformly classify AEs and their severity, but its focus is on safety rather than exploring patient experiences.[4]
These treatments do not result in the acute severe AEs observed with chemotherapy, they often result in low- to moderate-grade prolonged symptoms that significantly impact patients’ lives and treatment adherence.[1,9]
Summary
As more cancer treatments with innovative modes of action are evaluated via clinical trials, the need to monitor and record adverse events (AEs)[1] increases to ensure safety and guide prescribing and patient information.[2]. The CTCAE system is suitable for acute AEs when patients receive regular oncologist review; many new treatments are outpatient-based oral therapies that require less frequent reviews. These treatments do not result in the acute severe AEs observed with chemotherapy, they often result in low- to moderate-grade prolonged symptoms that significantly impact patients’ lives and treatment adherence.[1,9] CTCAE is less appropriate for monitoring AEs during these treatments.[7]
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