Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
National GCP Center for Anticancer Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
BMJ Open. 2019 Jun 1;9(5):e028589. doi: 10.1136/bmjopen-2018-028589.
Patients' stress and satisfaction concerning cancer clinical trials (CCT) may affect study accrual and quality. Our study aimed to evaluate stress and satisfaction in CCT and the influencing factors.
Cross-sectional analysis done by a questionnaire after informed consent.
Cancer Hospital, Chinese Academy of Medical Sciences.
199 CCT participants. Primary and secondary outcome measures self-assessed stress and satisfaction in CCT.
Among 199 participants, 83.9% would join CCT again; 72.9% had enough time to decide on trial participation; 73.9% claimed complete awareness of CCT; 3.5% doubted CCT's significance and scientific quality; 33.2% deemed CCT time-consuming; 73.9% scored satisfaction ≥9/10; and 25.6% claimed moderate to severe stress. Positive factors for satisfaction were enough decision time (OR=0.36, p=0.0003), better impressions of doctors (OR=0.41, p=0.047) and less time-consuming trials (OR=0.43, p<0.0001). Individuals with more prior uninsured medical expenses (OR=1.23, p=0.026), less time consumption (OR=2.35, p<0.0001) and more tests in CCT (OR=0.64, p=0.035) were less likely to experience stress. Phase III study participants bore less stress than phase II (OR=0.29, p=0.032) but more than phase I (OR=1.18, p=0.009).
Our study addressed factors influencing CCT participants' stress and satisfaction. We suggested measures to improve patients' experiences in CCT.
NCT03412344; Pre-results.
患者对癌症临床试验（CCT）的压力和满意度可能会影响研究入组和质量。本研究旨在评估 CCT 中的压力和满意度及其影响因素。
知情同意后通过问卷进行的横断面分析。
中国医学科学院肿瘤医院。
199 名 CCT 参与者。主要和次要结局指标是 CCT 中的自我评估压力和满意度。
在 199 名参与者中，83.9%会再次参加 CCT；72.9%有足够的时间决定参加试验；73.9%表示完全了解 CCT；3.5%怀疑 CCT 的意义和科学质量；33.2%认为 CCT 耗时；73.9%的满意度得分为≥9/10；25.6%的人表示有中度至重度压力。满意度的积极因素是有足够的决策时间（OR=0.36，p=0.0003）、对医生的印象更好（OR=0.41，p=0.047）和试验耗时更少（OR=0.43，p<0.0001）。既往未参保医疗费用较高者（OR=1.23，p=0.026）、耗时较少者（OR=2.35，p<0.0001）和 CCT 中检查较多者（OR=0.64，p=0.035）发生压力的可能性较小。III 期研究参与者的压力小于 II 期（OR=0.29，p=0.032），但大于 I 期（OR=1.18，p=0.009）。
本研究探讨了影响 CCT 参与者压力和满意度的因素。我们提出了改善患者 CCT 体验的措施。
NCT03412344；预注册。
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