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Real-world registry studies to develop clinical evidence for difficult symptoms in patients with far-advanced cancer

Research Project

Project/Area Number 16H06239
Research Category

Grant-in-Aid for Young Scientists (A)

Allocation TypeSingle-year Grants
Research Field Epidemiology and preventive medicine
Research InstitutionSeirei Christopher University (2017-2019)
Osaka City University (2016)

Principal Investigator

Maeda Isseki  聖隷クリストファー大学, 看護学研究科, 臨床講師 (70706639)

Project Period (FY) 2016-04-01 – 2020-03-31
Project Status Completed (Fiscal Year 2019)
Budget Amount *help
¥24,830,000 (Direct Cost: ¥19,100,000、Indirect Cost: ¥5,730,000)
Fiscal Year 2019: ¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Fiscal Year 2018: ¥7,280,000 (Direct Cost: ¥5,600,000、Indirect Cost: ¥1,680,000)
Fiscal Year 2017: ¥7,540,000 (Direct Cost: ¥5,800,000、Indirect Cost: ¥1,740,000)
Fiscal Year 2016: ¥5,330,000 (Direct Cost: ¥4,100,000、Indirect Cost: ¥1,230,000)
Keywordsレジストリ研究 / 終末期がん患者 / 症状緩和 / 緩和医療 / リアル・ワールドデータ / レジストリ / 臨床
Outline of Final Research Achievements

Far-advanced or terminally-ill cancer patients frequently experience difficult symptoms including terminal delirium, refractory pain, nausea and vomiting. However, high-quality clinical evidence for these symptoms are scarce. In this real-world registry study, we indicated safety and effectiveness of the following pharmacological interventions for vulnerable patients with advanced cancer who received palliative care through inpatient palliative care teams, palliative care units, or psycho-oncology services: anti-psychotics administration for terminal delirium; olanzapine for nausea and vomiting; and naldemedine for opioid-induced constipation.

Academic Significance and Societal Importance of the Research Achievements

本研究は、実施可能性や倫理的な観点からランダム化比較試験の実施が困難な終末期がん患者の重大症状に関する薬物治療のエビデンスを創出する試みである。本研究の成果は診療ガイドライン等への反映を通じ患者の終末期ケアの質の向上に貢献するものとなると共に、本研究を通じて国内の緩和ケア施設のネットワーク構築および多施設共同によるレジストリ研究の実施基盤が形成され、今後のこの分野でのエビデンス創出基盤が整備されたと言える。

Report

(5 results)
  • 2019 Annual Research Report   Final Research Report ( PDF )
  • 2018 Annual Research Report
  • 2017 Annual Research Report
  • 2016 Annual Research Report
  • Research Products

    (7 results)

All 2019 2018

All Journal Article (3 results) (of which Int'l Joint Research: 2 results,  Peer Reviewed: 3 results,  Open Access: 2 results) Presentation (4 results) (of which Int'l Joint Research: 1 results,  Invited: 2 results)

  • [Journal Article] Reversibility of delirium in Ill-hospitalized cancer patients: Does underlying etiology matter?2019

    • Author(s)
      Matsuda Y, Fujisawa D, et al.
    • Journal Title

      Cancer Med

      Volume: 9 (1) Issue: 1 Pages: 19-26

    • DOI

      10.1002/cam4.2669

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Journal Article] Current Pharmacotherapy Does Not Improve Severity of Hypoactive Delirium in Patients with Advanced Cancer: Pharmacological Audit Study of Safety and Efficacy in Real World (Phase‐R).[Epub ahead of print]2019

    • Author(s)
      Okuyama Toru、Yoshiuchi Kazuhiro、Ogawa Asao、Iwase Satoru、Yokomichi Naosuke、Sakashita Akihiro、Tagami Keita、Uemura Keiichi、Nakahara Rika、Akechi Tatsuo、on behalf of Phase‐R Delirium Study Group
    • Journal Title

      The Oncologist

      Volume: - Issue: 7 Pages: e574-e582

    • DOI

      10.1634/theoncologist.2018-0242

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Journal Article] Current Pharmacotherapy Does Not Improve Severity of Hypoactive Delirium in Patients with Advanced Cancer: Pharmacological Audit Study of Safety and Efficacy in Real World (Phase-R).2019

    • Author(s)
      Okuyama T, Yoshiuchi K, Ogawa A, Iwase S, Yokomichi N, Sakashita A, Tagami K, Uemura K, Nakahara R, Akechi T; Phase‐R Delirium Study Group.
    • Journal Title

      Oncologist

      Volume: 印刷中

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed
  • [Presentation] リアルワールドでのせん妄治療:多施設前向き観察研究を実施して2019

    • Author(s)
      前田一石
    • Organizer
      第24回日本緩和医療学会学術大会
    • Related Report
      2019 Annual Research Report
    • Invited
  • [Presentation] Naldemedine for opioid-induced constipation in patients receiving palliative care: A real-world registry study (Phase-R OIC Study)2019

    • Author(s)
      Masaki Shimizu, Takaomi Kessoku, Hiroto Ishiki, Tetsuya Matsuura, Yusuke Hiratsuka, Yoshinobu Matsuda, Takaaki Hasegawa, Kengo Imai, Isseki Maeda, Shunsuke Oyamada, Eriko Satomi
    • Organizer
      ASCO 2019 annual meeting
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] 進行がん患者のせん妄に対する抗精神病薬の有効性・安全性の検討:全国大規模多施設レジストリ研究2018

    • Author(s)
      前田一石、森田達也、小山田隼佑、小川朝生、吉内一浩、岩瀬哲
    • Organizer
      第23回日本緩和医療学会
    • Related Report
      2017 Annual Research Report
  • [Presentation] Up-to-date in Important palliative and end-of-life care issues: prognostication, difficult symptoms, and palliative sedation2018

    • Author(s)
      前田一石
    • Organizer
      第16回日本臨床腫瘍学会学術集会
    • Related Report
      2017 Annual Research Report
    • Invited

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Published: 2016-04-21   Modified: 2021-02-19  

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