| Project/Area Number |
24590595
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical sociology
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| Research Institution | Tohoku University |
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Principal Investigator |
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| 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)
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| Project Period (FY) |
2012-04-01 – 2015-03-31
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| Project Status |
Completed (Fiscal Year 2014)
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| Budget Amount *help |
¥5,330,000 (Direct Cost: ¥4,100,000、Indirect Cost: ¥1,230,000)
Fiscal Year 2014: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2013: ¥2,600,000 (Direct Cost: ¥2,000,000、Indirect Cost: ¥600,000)
Fiscal Year 2012: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
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| 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 / 患者報告にもとづくアウトカム(PRO) / 医療の質 / がん |
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| 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.
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