Abstract
Purpose
The purpose of this study was to investigate the perception and satisfaction of cancer patients participating in clinical trials of anticancer drugs and the factors affecting their satisfaction.
Methods
The participants were cancer patients who participated in more than two cycles of clinical trials at a tertiary hospital in Seoul, Korea. Questionnaires were used to assess the perception and satisfaction of clinical trials of anticancer drugs.
Results
A total of 106 patients participated. The average perception and satisfaction regarding clinical trials among patients on a 5 point scale was 3.99±0.45 and 4.09±0.55 respectively. There was a significant difference in the correlation among participants' perception and their satisfaction (r =.67, p<.001). Regression analysis revealed that satisfaction was explained by, perception of clinical trials (β =.67, p<.001), participation period 30~59 days (β =.21, p=.009), and participation period over 60 days (β=.20, p=.013). These variables explained 48.7% of the variance of clinical trial satisfaction.
Conclusion
The results of this study suggest that changes in perceptions of clinical trials are needed to improve satisfaction of anticancer drug clinical trials. This can be used as a basis for improving the quality of clinical trials and education programs for cancer patients participating in clinical trials.
References
1. National Cancer Information Center (KR). Understanding clinical trial [Internet]. Accessed January 10, 2019. Available from: http://www.cancer.go.kr/lay1/S1T303C304/contents.do.
2. Ministry of Food and Drug Safety (KR). Results of clinical trial approval in 2017 [Internet]. Accessed January 10, 2019. Available from: http://www.mfds.go.kr/brd/m_99/view.do?seq=41107.
3. Korea CLinical trials Information Center. Clinical trial [Internet]. Accessed January 10, 2019. Available from: http://www.koreaclinicaltrials.org/kr/contents/datainfo_data_01_tab02/view.do.
4. Paik SS. Affecting factors on satisfaction of clinical trial subjects [master's thesis]. Gimhae: Inje Univ.;2010.
5. We KC. A study on the protection of trial subjects in clinical trials of investigational new drug. Korean Soc Law Med. 2012; 13:79–113.
6. Kim HY. Experience of patients with cancer participating in a clinical trial for the development of a new drug. J Korean Oncol Nurs. 2006; 6:121–132.
7. Kim JW, Kim SJ, Chung YH, Kwon JH, Lee HJ, Chung YJ, et al. Cancer patients' awareness of clinical trials, perceptions on the benefit and willingness to participate: Korean perspectives. Br J Cancer. 2008; 99:1593–1599.
8. Lim Y, Lim JM, Jeong WJ, Lee KH, Keam B, Kim TY, et al. Korean cancer patients' awareness of clinical trials, perceptions on the benefit and willingness to participate. Cancer Res Treat. 2017; 49:1033–1043.
9. Mun HR, Kim HK, Lee KS, Kang BK, Song HH. A survey of the cognition on clinical trial and informed consent of cancer patients and their families. J Korean Soc Clin Pharmacol Ther. 1995; 3:141–153.
10. Mills EJ, Seely D, Rachlis B, Griffith L, Wu P, Wilson K, et al. Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. Lancet Oncol. 2006; 7:141–148.
11. Hussain-Gambles M. South Asian patients' views and experiences of clinical trial participation. Fam Pract. 2004; 21:636–642.
12. Kim KH, Hwang BY, Son GM. Factors associated with willingness to participate in clinical trials for cancer patients: an exploratory narrative review. J Acupunct Res. 2016; 33:145–152.
13. Kim H, Lee M. Anxiety, depression and uncertainty in cancer patients participating in clinical trials of anticancer drugs. Korean J Adult Nurs. 2013; 25:53–61.
14. Bos A, Vosselman N, Hoogstraten J, Prahl-Andersen B. Patient compliance: a determinant of patient satisfaction? Angle Orthod. 2005; 75:526–531.
15. Kim YH. A survey of the cognition on informed consent in clinical trials with patients who participating to cancer clinical trials [master's thesis]. Seoul: Yonsei Univ.;2008.
16. Kim JY, Yi SY, Lee HR. Analysis of the degree of cancer patients' awareness on clinical trials: a view of subject's protection. Korean J Med Ethics. 2013; 16:346–360.
18. Jung HJ, Park JE, Kim AR, Liu Y, Lee MH, Kim JE, et al. A survey on motivation and satisfaction of subjects in acupuncture & moxibustion clinical trial. J Acupunct Res. 2013; 30:109–115.
19. Ryu BE. Understanding and satisfaction of clinical trial participants [master's thesis]. Seoul: Ewha Womans Univ.;2009.
20. Asan Medical Center. Clinical trials [Internet]. Accessed January 10, 2019. Available from: http://www.amc.seoul.kr/asan/healthtv/video/videoDetail.do?videoId=653.
21. Yun EH, Kim JS, Jeong IS. Understanding of informed consent and decisional regret among participants in cardiology clinical trials. Korean J Med Ethics. 2014; 17:237–252.
22. National Comprehensive Cancer Network. Kidney cancer [Internet]. Accessed January 10, 2019. Available from: https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf.
23. Cainap C, Qin S, Huang WT, Chung IJ, Pan H, Cheng Y, et al. Linifanib versus Sorafenib in patients with advanced hepatocellular carcinoma: results of a randomized phase III trial. J Clin Oncol. 2015; 33:172–179.
24. Cheng AL, Kang YK, Lin DY, Park JW, Kudo M, Qin S, et al. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clin Oncol. 2013; 31:4067–4075.
25. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001; 358:1772–1777.
26. Kang HS, Kim WO, Jeong IS, Baik JM. The working conditions and clinical trial practice of research nurses. Clin Nurs Res. 2004; 9:42–55.
27. Ellis PM. Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature. Ann Oncol. 2000; 11:939–945.