Development Program for the Japanese Version of the PRO-CTCAE

2014 Fiscal Year Final Research Report

• Project/Area Number: 24590595
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Medical sociology
• Research Institution: Tohoku University
• Principal Investigator: YAMAGUCHI Takuhiro 東北大学, 医学(系)研究科(研究院), 教授 (50313101)
• Co-Investigator(Kenkyū-buntansha): IWASE Satoru 東京大学, 医科学研究所, 特任講師 (60372372) ; GOTO Yasushi 国立がん研究センター中央病院, 呼吸器内科, 医員 (20596374) ; YAMAMOTO Daigo 関西医科大学, 医学部附属病院, 講師 (10340738) ; ODAGIRI Hiroki 弘前大学, 医学研究科, 客員研究員 (60250601) ; TSUBOI Masahiro 国立がん研究センター東病院, 呼吸器外科, 科長 (90297309) ; KAWAGUCHI Takashi 東京薬科大学, 薬学部, 助手 (60548486)
• Project Period (FY): 2012-04-01 – 2015-03-31
• Keywords: Patient Reported Outcome / NCI PRO-CTCAE 日本語版 / バリデーション研究 / ePRO / 有害事象評価

Outline of Final Research Achievements

We analyzed results of cognitive interviews conducted in a range of treatment settings among diverse groups of cancer patients. Participants were asked to self-complete the Japanese version of the PRO-CTCAE (PRO-CTCAE-J) and then were interviewed using semi-structured scripts and predetermined probes to determine whether any items were difficult to comprehend and/or not relevant to their symptoms. The PRO-CTCAE-J was planned to being administered in JCOG1018 trial. Before it opened, we conducted a feasibility evaluation in 16 patients, to assure that patients were willing and able to report this information in a timely manner. There were no missing data and feasibility of the measurement was confirmed. We planned a validation study to examine the reliability and validity of the PRO-CTCAE-J and it’s now under registration. An electronic-based system with iPad was developed to provide interfaces to investigators, clinicians, and patients to collect and report PRO data.

Free Research Field

医学統計学