影響病人參與癌症臨床試驗之因素探討－系統性文獻回顧

背景：癌症為臺灣十大死因之首，癌症藥物研發需經過臨床試驗過程以確保藥物安全性與療效。暸解癌症病人參與臨床試驗的因素，有助試驗團隊瞭解病人面對癌症臨床試驗的動機與考量，進一步在知情同意過程強化病人對臨床試驗的瞭解及維護自主權。目的：以系統性文獻回顧探討影響病人參與癌症臨床試驗之因素。方法：採系統性文獻回顧法，收錄發表於Cochrane Library、Embase、PubMed、CINAHLE、Scopus五個資料庫之實證文獻，設立關鍵字與同義字為癌症、臨床試驗、參與、因素或動機、醫療決策等，發行年限由2011至2021年1月，共搜出9,353篇，經篩選、刪除重複及評讀，納入40篇符合主題文章進行分析。以安娜布里格斯學會（Joanna Briggs Institute, JBI）出版的評讀工具評析文獻品質，再依據JBI證據等級將所有文獻歸類，並萃取實證證據。結果：將影響癌症病人參與癌症臨床試驗之因素分為動機與阻礙，動機部分包含：（一）對醫療人員的信任；（二）期待治療益處；（三）沒有其他治療選擇；（四）利他；（五）得到醫療團隊詳盡的檢查與照護；（六）家人的支持；（七）重要他人或自身過去的癌症治療經驗；（八）其他與人口學因素。阻礙部分包括：（一）擔心試驗的未知副作用與治療效果；（二）無法掌握試驗的隨機分配；（三）擔心家庭經濟負擔變重；（四）無法維持生活品質；（五）因疾病歷程或變化不符合臨床試驗資格；（六）自己已有治療偏好；（七）醫療團隊對臨床試驗的負面態度；（八）家人不支持參與臨床試驗；（九）告知試驗訊息的時機不合適。結論／實務應用：本系統性文獻回顧歸納出八項參與臨床試驗動機與九項阻礙因素；顯示病人在決定是否參與癌症臨床試驗時，除了考量個人與決策情境因素，亦會考量家人與醫療團隊等因素。分析結果可幫助試驗團隊進一步在知情同意過程強化病人對臨床試驗的暸解以及病人的自主決策。

關鍵字

癌症；臨床試驗；動機；阻礙；系統性文獻回顧

並列摘要

Background: Cancer is the top cause of death in Taiwan. Cancer clinical trials are crucial for developing new treatments. Understanding the motivations and barriers related to the factors of influence on patient decisions regarding participation in cancer clinical trials may help clinical researchers improve patients' understanding of clinical trials and improve their ability to make autonomous decisions regarding informed consent. Purpose: This study was designed to explore the factors affecting patient decisions regarding cancer clinical trial participation using a systematic review of the literature. Methods: A systematic review was used. Articles were retrieved from electronic databases including Cochrane Library, Embase, PubMed, CINAHLE, and Scopus. The following keywords and MeSH terms were used to search for articles on cancer, clinical trials, participation, factors or motivations, and decision making. A total of 9353 articles published from 2011 to January 2021 that matched the search criteria were extracted. After screening the topics, deleting repetitions, and doing critical appraisals, 40 articles were selected for analysis. Research quality was assessed using Joanna Briggs Institute Levels of Evidence criteria. Results: Eight motivations and nine barriers were found to significantly influence patient participation in cancer clinical trials. These motivations were: (1) trust in health professionals, (2) hope for therapeutic benefits, (3) the last treatment option, (4) altruism, (5) family support, (6) extra care, (7) patients' or others' past therapy experience, and (8) other demographic factors. The barriers to participation identified were: (1) fear of side effects or treatment efficacy, (2) concerns about trial requirements and randomization, (3) heavy financial burden, (4) inability to maintain quality of life, (5) inability to participate due to disease progression, (6) having treatment preferences, (7) health professionals' negative attitudes toward clinical trials, (8) family opposition, and (9) providing trial information at an inappropriate time. Conclusions / Implications for Practice: Eight motivational factors and nine barriers influencing patient decisions regarding cancer clinical trial participation were extracted from the selected articles. In addition to personal and situational factors, family and health professionals were found to influence patient decisions regarding cancer clinical trial participation. The authors hope that the findings of this study help clinical researchers further improve patient understanding of clinical trials and help patients make autonomous decisions with regard to informed consent.

並列關鍵字

cancer ； clinical trials ； motivation ； barrier ； systematic review

參考文獻

Ayodele, O., Akhtar, M., Konenko, A., Keegan, N., Calacsan, F., Duggan, L., O’Connor, M., Calvert, P., Townsley, C. A., & Horgan, A. M. (2016). Comparing attitudes of younger and older patients towards cancer clinical trials. Journal of Geriatric Oncology, 7(3), 162–168.

Bell, J. A. H., & Balneaves, L. G. (2015). Cancer patient decision making related to clinical trial participation: An integrative review with implications for patients’ relational autonomy. Supportive Care in Cancer, 23(4), 1169–1196.

Bidad, N., MacDonald, L., Winters, Z. E., Edwards, S. J. L., Emson, M., Griffin, C. L., Bliss, J., & Horne, R. (2016). How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (quality of life after mastectomy and breast reconstruction). Trials, 17(1), Article 431.

Biedrzycki, B. A. (2010). Decision making for cancer clinical trial participation: A systematic review. Oncology Nursing Forum, 37(6), E387–E399.

Biedrzycki, B. A. (2011). Factors and outcomes of decision making for cancer clinical trial participation. Oncology Nursing Forum, 38(5), 542–552.

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影響病人參與癌症臨床試驗之因素探討－系統性文獻回顧

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