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完整後設資料紀錄
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.advisor | 胡文郁(Hu Wen-Yu) | |
dc.contributor.author | Ming-Tzu Wu | en |
dc.contributor.author | 吳明姿 | zh_TW |
dc.date.accessioned | 2021-06-15T04:05:17Z | - |
dc.date.available | 2016-10-07 | |
dc.date.copyright | 2011-10-07 | |
dc.date.issued | 2011 | |
dc.date.submitted | 2011-08-17 | |
dc.identifier.citation | 王蘭香(2008)˙癌症病人參加臨床試驗的意願、需求與期望之探討˙未發表碩士論文,台北:長庚大學護理學研究所。
行政院衛生署(2005,01月06日修正)˙藥品優良臨床試驗準則˙ 2010年5月22日取自:http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDAT0201.asp 行政院衛生署(2009,10月1日)˙97年度死因統計記者會發布資料-死因統計結果分析˙2010年5月22日取自: http://www.doh.gov.tw/CHT2006/DisplayStatisticFile.aspx?d=71700&s=1 行政院衛生署食品藥物管理局(2002)˙癌症治療藥品臨床試驗基準˙2010年5月27日取自:http://www.vghks.gov.tw/erli/IRB/%E6%B3%95%E8%A6%8F/%E7%99%8C%E7%97%87%E6%B2%BB%E7%99%82%E8%97%A5%E5%93%81%E8%87%A8%E5%BA%8A%E8%A9%A6%E9%A9%97%E5%9F%BA%E6%BA%96.pdf 行政院中央健康保險局(2008,4月25日)˙修正「全民健康保險藥品給付規定—第9章抗癌瘤藥物Antineoplastics drugs 9.29. erlotinib(如Tarceva)」給付規定˙2010年3月26日取自: http://www.nhi.gov.tw/webdata/AttachFiles/Attach_11492_1_W0970024485-附件.doc 吳彥慧(2009)˙晚期非小細胞肺癌得細胞毒性抗癌藥物回顧˙臨床試驗中英文季刊,4(1),26-34。 林勇良(2006)˙癌症藥物Phase III臨床試驗˙臨床試驗中英文季刊,1,35-38。 熊佩韋. 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dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/45120 | - |
dc.description.abstract | 癌症自1982年起即位居國人死因之首位,影響國人健康甚鉅,然而現階段多數癌症的治療仍有其無法突破之瓶頸,癌症病人為了尋求治療與生存的機會,接觸臨床試驗藥物的機會越來越多。病人對臨床試驗的認知與態度將影響其參與臨床試驗的意願,以及後續的治療遵從性,尤其病人是否在相當的知情同意基礎下,充分衡量試驗的利弊風險,進而做出參加臨床試驗的決策,需要醫護團隊對此議題與族群進行關切。
本研究以橫斷式描述性相關性研究,採立意取樣,在2011年2月至2011年6期間針對半年內曾經受邀參加治療性臨床試驗並決策的癌症病人,以結構式問卷為訪談工具,探討病人對臨床試驗的認知、態度以及決策行為意向。本研究工具包含:基本屬性、隨機臨床試驗認知與態度量表、共享決策程度量表(SDM-Q-9)、以及決策滿意度(SWD-scale) 與決策反悔程度量表(DRS),經徵求量表原作者之授權同意後進行翻譯與回覆翻譯,五份量表皆具有良好信效度表現(Cronbach’s alpha, 0.82~0.89),並於北部某醫學中心申請倫理委員會審查通過後,始於腫瘤科門診、內科門診、早期臨床試驗病房與化學治療室等進行資料收集。 結果共有117位肺癌與肝癌病人願意參加本研究,但6位因體力關係未完成問卷填寫,因此共111份個案資料進入本研究分析。整體而言癌症病人對於參與臨床試驗的行為意向偏高,約74.8%之受訪者表示可能或非常有可能考慮參加。整體癌症病人對臨床試驗的認知程度答對率僅達58%,在隨機臨床試驗相關的推論概念較薄弱,此外癌症病人對臨床試驗的態度整體為趨近正向(平均分數=3.55;S.D = 0.36),主要以「對醫師信任感」次概念量表得分最高(平均為4.07;SD = 0.41),且多數個案表示與試驗團隊共享決策程度良好(86.5%; S.D= 11.97)、對決策過程之滿意度感受良好(4.15, S.D = 0.54)、決策反悔程度屬於偏低(26.53%, S.D = 15.45)。而本研究進一步以多元線性迴歸分析探討影響病人參與臨床試驗行為意向的重要預測因子為:性別/男性、教育程度/大專學以上、決策滿意度以及對臨床試驗態度,可解釋癌症病人參與臨床試驗行為意向變異量達35.9% ( Adjusted R2 = 0.335, p < 0.000),臨床試驗認知程度與共享決策程度兩個變項對行為意向的預測力雖未達顯著,但經過中介變項之檢定,發現乃透過影響態度與決策滿意度進而間接影響病人對參與臨床試驗行為意向,其中影響態度與決策滿意度所共同存在的預測因子為共享決策程度,顯示試驗團隊在受試者同意書的溝通解釋議題具有相當大的重要性。 因此本研究建議未來試驗醫療團隊可加強解釋受試者同意書過程中,針對病人的替代選擇治療作完整評估及說明,以及提升癌症病人對隨機分派的過程與目的或重要性的認知,藉以提升與病人之間的共享決策程度與決策滿意度,同時降低決策反悔的感受,使癌症病人於試驗期間能在自主意願的基礎下有更好的遵從性、滿意度等感受,同時對試驗人員來說也能期許使臨床試驗之推展工作更加順利。 | zh_TW |
dc.description.abstract | Since present anti-cancer therapies still have their limitation, nowadays more and more cancer patients would be invited or suggested to consider participating in clinical trial. This study was aim to explore the knowledge, attitudes, behavior intention, and decision making process towards clinical trials on cancer patients in Taiwan (R.O.C.). A cross-sectional, observational, and co-relational study has conducted during 2011 February to 2011 June in a medical center located in north Taiwan. The information was collected using structured questionnaires which was composed of following 5 scales: (1) Clinical trial Knowledge scale, (2) Attitude toward randomized clinical trials scale, (3) Shared Decision Making (SDM-Q-9), (4) Satisfaction with Decision (SWD-scale), and (5) Decision Regret scale (DRS). All of these scales have the permission of translation and showed great reliability (Cronbach’s alpha, 0.82~0.89) in this study. A total number of 117 lung cancer and liver cancer patients, who have experienced the treatment clinical trials' informed consent process in 6 months, were recruited. But 6 did not complete the questionnaire due to physical reason. Therefore 111 data from patient were be analyzed in our study.
Result: Among 111 cancer patients sampled, most of them show great attitude, shared decision making level and high satisfaction, as well as low decisional regret feeling. Meanwhile, they show high behavior intention (74.8%) to consider participating in clinical trials. In addition, our study demonstrated the fact that patients who are more likely to participate in cancer clinical trials would have following predictors: male, high educational level, great attitudes toward clinical trial, and high satisfaction with decision making about whether to participate in trials( Adjusted R2 = 0.335, p < 0.000). However, patients who had more experience on participating clinical trials would have both higher level of decisional regret perception (x2=2.58, p=0.01) and lower level of satisfaction with decision. Our study suggested that clinical trials medical workers can reinforce the level of shared decision making and satisfaction with decisions through taking some steps in following aspects: provide the alternative treatments options and the process or purpose about randomized allocation in necessary, as well as discuss the whole medical condition with patients and try to understand patients’ preference. So that medical worker would improved patients' autonomy, satisfaction with the decision making and communication process between patients and medical professors whenever cancer patients consider participating in clinical trials. | en |
dc.description.provenance | Made available in DSpace on 2021-06-15T04:05:17Z (GMT). No. of bitstreams: 1 ntu-100-R98426005-1.pdf: 2398743 bytes, checksum: 3d6769c1a20afaf43c65ceb037c4c3d6 (MD5) Previous issue date: 2011 | en |
dc.description.tableofcontents | 誌謝.... ii
摘要.... iv Abstract....... vi 表目錄... xi 圖目錄... xiii 第一章 緒論..... 1 第一節 研究動機與重要性.. 1 第二節 研究目的. .3 第三節 研究假設.. 4 第四節 名詞定義.. 5 第二章 文獻查證.. 6 第一節 癌症治療.. 6 第二節 臨床試驗相關概念.. 8 第三節 理性行動理論於癌症病人對參與臨床試驗行為意向之應用...... 11 第四節 影響癌症病人參與臨床試驗行為決策之相關因素..... 13 第五節 共享決策之相關概念........ 17 第六節 概念架構......... 20 第三章 研究方法......... 22 第一節 研究設計......... 22 第二節 研究對象選樣與場所. 23 第三節 樣本數........... 24 第四節 研究工具......... 26 第五節 研究工具的信效度檢定....... 30 第六節 研究資料收集過程.......... 31 第七節 資料統計及分析.... 32 第八節 倫理考量......... 33 第四章 研究結果......... 34 第一節 個案基本屬性與臨床試驗參與經驗之現況.. 35 第二節 研究工具之信效度建置....... 43 第三節 癌症病人對參與臨床試驗的行為意向..... 58 第四節 癌症病人對臨床試驗之認知與態度...... 61 第五節 癌症病人對臨床試驗之共享決策程度、主觀規範與決策評價之現況 66 第六節 影響癌症病人對臨床試驗認知與態度的相關因素..... 77 第七節 影響癌症病人對參與臨床試驗共享決策、主觀規範與決策評價之相關因素 89 第八節 影響參加臨床試驗行為意向之相關因素.... 105 第九節 影響個案參與臨床試驗行為意向之重要預測因子..... 117 第五章 討論.... 130 第一節 癌症病人對參與臨床試驗的行為意向............. 131 第二節 影響癌症病人參與臨床試驗行為意向之主要預測因子.. 134 第三節 癌症病人對參與臨床試驗的認知、態度與行為意向的關係...... 138 第四節 癌症病人對參與臨床試驗的共享決策程度、決策滿意度與行為意向的關係 139 第六章 結論、建議與研究限制....... 144 第一節 結論........144 第二節 臨床應用......... 146 第三節 研究限制及未來研究之建議.... 148 參考文獻 ..149 中文文獻 149 英文文獻 151 附錄.... 157 附錄一 Dr. Peter.Ellis同意授權翻譯原版臨床試驗認知與態度量表之e-mail 紀錄 157 附錄二 Professor Martin Harter同意授權翻譯原版德文SDM-Q-9之e-mail 紀錄 158 附錄三 Professor Margaret HolmesRovner同意授權翻譯原版SDW e-mail 紀錄 159 附錄四 Professor Jamie C. Brehaut同意授權使用DRS 之e-mail 紀錄 160 附錄五 專家效度名單 161 附錄六 專家效度計分表 162 附錄七 臨床試驗認知量表(Clinical trial Knowledge scale 7-item)原始版本與反翻譯對照版 166 附錄八 臨床試驗態度量表(Attitude toward randomized clinical trials) 原始版本與反翻譯對照版 167 附錄九【共享決策程度量表】SDM-Q-9兩位獨立譯者德翻中版本 170 附錄十 專家建議之問卷效度修改內容 171 附錄十一【決策滿意度量表】-SWD原始版本與反翻譯對照版 172 附錄十二【決策反悔量表】-DRS原始版本與反翻譯對照版 173 附錄十三 臨床試驗認知量表難度鑑別度評分表 174 附錄十四 癌症病人對臨床試驗認知、態度與決策行為意向之結構式問卷 175 附錄十五 倫理委員會審查通過核准函文 183 | |
dc.language.iso | zh-TW | |
dc.title | 癌症病人對臨床試驗之認知、態度與決策行為意向之探討 | zh_TW |
dc.title | The study of the knowledge, attitudes, and decision making towards clinical trials in cancer patients | en |
dc.type | Thesis | |
dc.date.schoolyear | 99-2 | |
dc.description.degree | 碩士 | |
dc.contributor.oralexamcommittee | 許駿(Chiun Hsu),張啟仁(Chee-Jen Chang) | |
dc.subject.keyword | 肺癌,臨床試驗,決策,共享決策,行為意向,認知,態度,決策滿意度,決策反悔, | zh_TW |
dc.subject.keyword | shared decision making,clinical trials,attitude and knowledge towards,clinical trial,behavior intention,Decision Regret, | en |
dc.relation.page | 184 | |
dc.rights.note | 有償授權 | |
dc.date.accepted | 2011-08-17 | |
dc.contributor.author-college | 醫學院 | zh_TW |
dc.contributor.author-dept | 護理學研究所 | zh_TW |
顯示於系所單位: | 護理學系所 |
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