Development Program for the Japanese Version of the PRO-CTCAE

• 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
• Project Status: Completed (Fiscal Year 2014)
• Budget Amount: ¥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)
• 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

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.

Research Products

• [Journal Article] Randomized study of orally administered fluorinated pyrimidines (capecitabine versus S-1) in women with metastatic or recurrent breast cancer: Japan Breast Cancer Research Network 05 Trial (2015)
  • Author(s): Daigo Yamamoto, Satoru Iwase,Yu Tsubota, Keisuke Ariyoshi, Takashi Kawaguchi, Tempei Miyaji, Noriko Sueoka, Chizuko Yamamoto, Seiichi Teramoto, Hiroki Odagiri, Kaoru Kitamura, Yoshinori Nagumo, Takuhiro Yamaguchi
  • Journal Title: Cancer Chemotherapy and Pharmacology Volume: (accepted for publication) Issue: 6 Pages: 1183-1189
  • DOI: 10.1007/s00280-015-2738-3
  • Peer Reviewed
• [Journal Article] Oral nutritional support can shorten the duration of parenteral hydration in end-of-life cancer patients: a randomized controlled trial (2015)
  • Author(s): Hiroto Ishiki, Satoru Iwase, Yasuyuki Gyoda, Yoshiaki Kanai, Keisuke Ariyoshi, Tempei Miyaji, Yukiko Tahara, Takashi Kawaguchi, Mieko Chinzei, Takuhiro Yamaguchi
  • Journal Title: Nutr Cancer Volume: Volume 67, Issue 1 Issue: 1 Pages: 105-111
  • DOI: 10.1080/01635581.2015.976312
  • Peer Reviewed
• [Journal Article] Development Program for the Japanese Version of the PRO-CTCAE (2013)
  • Author(s): Takuhiro Yamaguchi PhD, Satoru Iwase MD, Yasushi Goto MD, Masahiro Tsuboi MD, Daigo Yamamoto MD, Hiroki Odagiri MD, Yu Tsubota MD, Yukiko Iioka PhD, Takashi Kawaguchi, Natsumi Anzai, Tempei Miyaji, Tetsuya Hamaguchi MD, Yuto Takatsu, Yasuhiro Shimada MD, Sandra Mitchell PhD, Ethan Basch MD
  • Journal Title: 日本臨床試験研究会雑誌 薬理と治療 (JPT) JAPANESE PHARMACOLOGY & THERAPEUTICS Volume: 6号 vol.41 Pages: 79-82
• [Presentation] 抗癌剤と分子標的薬によってコントロールされている肝転移症例 (2015)
  • Author(s): 小田桐弘毅
  • Organizer: 第１２回日本乳癌学会東北地方会
  • Place of Presentation: 仙台国際センター（宮城県仙台市）
  • Year and Date: 2015-03-07
• [Presentation] がん患者の倦怠感と疼痛、QOLに関する観察研究 (2014)
  • Author(s): 岩瀬哲，川口崇，金井良晃，所昭宏，山田公人，松田能宣，大熊加恵，稲田修士，柏谷優子，畝崎榮，山口拓洋
  • Organizer: 第19回日本緩和医療学会学術大会
  • Place of Presentation: 神戸国際展示場、神戸ポートピアホテル(兵庫県神戸市)
  • Year and Date: 2014-06-20
• [Presentation] Patient preference trial comparing capecitabine and S-1 in metastatic breast cancer patients. (2014)
  • Author(s): D. Yamamoto, S. Iwase, T. Yamaguchi, Y. Tsubota, T. Kawaguchi, H. Odagiri, K. Ariyoshi, K. Kitamura
  • Organizer: 2014 ASCO Annual meeting
  • Place of Presentation: McCormick Place(Chicago, U.S.A.)
  • Year and Date: 2014-05-30 – 2014-06-03
• [Presentation] PRO-CTCAE日本語版の開発計画と進捗状況
  • Author(s): 山口拓洋他
  • Organizer: 第10回日本臨床腫瘍学会学術集会
  • Place of Presentation: 大阪国際会議場（グランキューブ大阪）
• [Presentation] PRO-CTCAEの日本語版開発
  • Author(s): 山口拓洋
  • Organizer: 第4回日本臨床試験研究会学術集会総会
  • Place of Presentation: 北海道大学クラーク会館