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がん治療の健康結果(アウトカム)評価法の確立と臨床応用

癌症治疗健康结局评价方法的建立及临床应用

基本信息

批准号：
11672248
负责人：
下妻晃二郎
金额：
$ 1.34万
依托单位：
Kawasaki Medical School
依托单位国家：
日本
项目类别：
Grant-in-Aid for Scientific Research (C)
财政年份：
1999
资助国家：
日本
起止时间：
1999 至 2002
项目状态：
已结题

来源：
https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-11672248/
关键词：
癌治療 Quality of life(QOL)Health outcome research サイコオンコロジー QOL-ACD EORTCQLQ Functional Assessment of Cancer Therapy EQ-5D EORTC QLQ 健康指標効用

项目摘要

1国際共同臨床研究用に適したプロファイル型QOL調査票の確立(1) FACIT(Functional Assessment of Chronic Illness Therapy)scaleあるいはFACT(Functional Assessment of Cancer Therapy)scaleの治療・症状別追加尺度のうち、FACT-Pal(緩和医療用)の日本語版を完成。(2)乳癌術後患者を対象としたEORTC QLQ-C30とQOL-ACDの信頼性・妥当性試験を施行。2000年の米国臨床腫瘍学会で発表(ASCO Proc2000)。それに加えてEORTC QLQ-BR23、FACT-B(乳癌用追加尺度)などの結果を2000年国際QOL学会(Quality Life Res9,2000)、にて発表。FACT-Taxane(Taxane毒性用追加尺度),FACIT-SP(霊性用追加尺度)の信頼性・妥当性検証は実施中。(3) QOL scoreの予後予測因子としての意義Surg Today30,20002乳癌術後患者のQOL/心理的苦痛/治療関連症状調査とQOL予測因子の解析2000年1月末現在130例集積終了。200例集積を目標として、術後1,6,12ヶ月における縦断調査を進行中。3医療経済評価とアウトカム統合指標の作成と応用-乳癌治療のrisk/benefit studyがん特異的尺度としてのEORTC QLQとFACT、包括的尺度としてのEuroQol(EQ)-5Dをsecondary endpointに用いた乳癌補助療法臨床試験が本年7月開始予定。

1. Establishment of QOL questionnaire for international joint clinical research (1) Japanese version of FACT (Functional Assessment of Chronic Illness Therapy)scale and FACT (Functional Assessment of Cancer Therapy) scale for additional scales of treatment and symptoms. (2)The reliability and appropriateness of the EORTC QLQ-C30 and QOL-ACD were tested on patients after breast cancer surgery. ASCO Proc2000. EORTC QLQ-BR23 and FACT-B(Additional Scale for Breast Cancer) were added to the results of the 2000 International QOL Society (Quality Life Res9,2000). FACT-Taxane(additional scale for toxicity of Taxane),FACIT-SP(additional scale for toxicity of Taxane) reliability and suitability evaluation are in operation. (3)The significance of QOL score and its predictive factors Surg Today30,20002 QOL/psychological pain/treatment-related symptoms survey and analysis of QOL predictive factors in breast cancer patients after operation. 200 cases were collected and investigated at 1, 6 and 12 months after operation. 3. Clinical trials of breast cancer adjuvant therapy began in July this year with the establishment of an integrated index of medical evaluation and use-risk/benefit study of breast cancer treatment-specific criteria including EORTC QLQ and FACT-secondary endpoint.