癌症病人對臨床試驗之認知、態度與決策行為意向之探討

The study of the knowledge, attitudes, and decision making towards clinical trials in cancer patients

吳明姿(Ming-Tzu Wu)

指導教授 ： 胡文郁

國立臺灣大學/醫學院/護理學研究所/碩士(2011年)

https://doi.org/10.6342/NTU.2011.01680

摘要

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。

關鍵字

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

並列摘要

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.

並列關鍵字

shared decision making ； clinical trials ； attitude and knowledge towards ； clinical trial ； behavior intention ； Decision Regret

參考文獻

熊佩韋. (2010). 癌症治療的新突破. 聲洋防癌之聲, 129, 25-29.

金詠興、賴裕和、吳智珠、魏德芝、劉滄梧、彭汪嘉康（2004）˙腫瘤護士在臨床試驗中之角色與功能˙腫瘤護理雜誌，4(2)，15-23。

許姿婷、洪慧君、詹佩珊、黃心怡、黃佩茹、蔡素珍（2009）˙台灣與美國居家安寧療護之比較˙長庚科技學刊，10，123-136。

陳錫杰、蘇慧芳、李中一、賴美淑、謝碧晴（2010）˙醫師的遵循行為可促進病患的存活嗎？以台灣非小細胞肺癌病患為例˙台灣公共衛生雜誌，29(2)，118-130。

熊佩韋（2010）˙癌症治療的新突破˙聲洋防癌之聲，(129)，25-29。