O1-011 - Introduction and Current Status of the Development Program for a Japanese Version of the NCI PRO-CTCAE

Abstract

ABSTRACT Background The U.S. National Cancer Institute (NCI)-Common Toxicity Criteria for Adverse Events (CTCAE) is a long-standing empirically developed ‘dictionary’ or lexicon, designed for the use in clinical trials to aid clinicians in detecting and documenting an array of adverse events (AEs) commonly encountered in oncology. There is growing awareness that collecting symptom data directly from patients using patient-reported outcome (PRO) tools can improve the accuracy and efficiency of symptomatic AE data collection. The purpose of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) project is to develop an electronic-based system for patient self-reporting of symptom adverse events listed in the CTCAE in an effort to improve the accuracy and precision of grading of this class of AEs. The accurate reporting of AEs that in clinical trials is a federal requirement that facilitates evaluation of new therapies. To develop a translation of the PRO-CTCAE to Japanese would serve important role to collect subjective symptom in the clinical oncology setting. Methods and Results Forward and back translations were carried out and an independent review was carried out by the Japan Clinical Oncology Group (JCOG) Executive Committee. These items were designated as PRO-CTCAE-Japanese Version 1.0 by Tohoku University/The University of Tokyo/JCOG. We are now conducting cognitive interviews in a range of treatment settings among diverse groups of cancer patients. Participants are asked to self-complete the PRO-CTCAE and then are interviewed to determine when items are difficult to comprehend and/or not relevant to their symptoms. Conclusion and next steps We developed a Japanese version of the PRO-CTCAE and will now assess the level of comprehension and cognitive equivalence of the translation via cognitive interviews. In 2012, we will perform a validation study and examine the reliability and validity of the Japanese version. In addition, in a multicenter clinical trial, JCOG1018, a subset of PRO-CTCAE items related to the expected adverse events in this trial, will be administered. An electronic-based system will be developed to provide interfaces to investigators, clinicians, and patients to collect and report patient-reported symptom data.