抗肿瘤新药Ⅰ期临床试验受试者对临床试验的认知和满意度调查

Investigation on cognition, evaluation and satisfaction of phase Ⅰ cancer clinical trial subjects

目的:受试者对临床试验的认知评价和满意度会直接影响临床试验是否能够顺利开展。本研究探讨受试者对抗肿瘤新药I期临床试验的认知和满意度的影响因素,为抗肿瘤新药Ⅰ期临床试验受试者招募和试验依从管理、提高试验效率提供参考。方法:2017年7月至2019年5月对在中国医学科学院肿瘤医院参加抗肿瘤新药Ⅰ期临床试验的恶性肿瘤患者进行横断面问卷调查,对调查结果进行统计学分析。采用Cronbach’s α系数估计内部一致性。使用有序Logistic回归模型分析对影响受试者认知及评价的相关因素进行分析。结果:本研究的Cronbach’s α值为0.67,问卷内部一致性可接受。在参加抗肿瘤新药Ⅰ期临床试验的患者中,不耗时组的患者对试验评价最正向[非常耗时组vs.不耗时组:优势比(odds ratio,OR)为0.07,P<0.001;一般耗时组vs.不耗时组:OR=0.17,P=0.008]。受教育程度较高的群体较偏低组对试验的整体评价更正向(教育程度偏低组vs.教育程度较高组:OR=0.29,P=0.008;教育程度中等组vs.教育程度较高组:OR=0.78,P=0.611)。参与试验过程中不耗时组满意度高(非常耗时组vs.不耗时组:OR=0.09,P=0.005);获取信息渠道充足的满意度高(OR=8.20,P<0.001)。相比经济补偿充足的人群,经济补偿居中的人群满意度更低(补偿不足组vs.补偿充足组:OR=3.32,P=0.092;补偿一般组vs.补偿充足组:OR=0.26,P=0.032)。不耗时组的受试者压力最小(非常耗时组vs.不耗时组:OR=5.76,P=0.001;一般耗时组vs.不耗时组:OR=5.92,P=0.001)。参加试验前思考时间仓促的受试者较思考时间充分的受试者在试验过程中感受到更大压力(思考时间不足组vs.思考时间充足组:OR=0.12,P=0.001)。结论:运用现代信息通讯手段提供更广泛、更便捷的临床试验咨询,减少抗肿瘤新药Ⅰ期临床试验受试者在试验过程中的时间消耗;充分考虑受试者的经济补偿;在入组前给予受试者充分的思考时间、对其进行合适的心理疏导,会减少受试者参加临床试验的心理压力、提高患者满意度和对临床试验的整体评价。

Objective: Patients’ cognition, evaluation, and satisfaction concerning cancer clinical trials may affect study accrual and quality. This study aimed to evaluate the cognition, evaluation, and other influencing factors in patients participating in phase Ⅰ anticancer clinical trials. Methods: From July 2017 to May 2019, a cross-sectional questionnaire survey was performed among phase Ⅰ clinical trial subjects after acquiring informed consent from the National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, a tertiary hospital in China, and the data was statistically analyzed. Results: Cronbach’s α value was determined to assess the internal consistency of the questionnaire. In this study, the Cronbach’s α value was 0.67, which is generally considered acceptable. Patients in the non-time-consuming group had the most positive evaluation of the trial(much time-consuming vs. non-time-consuming group:OR=0.07, P<0.001;general time-consuming group vs. non-time consuming group: OR=0.17, P=0.008);and the higher educational level of the subjects was associated with a favorable evaluation of the trial(low education level vs. high education level: OR=0.29, P=0.008;medium education group vs. high education group: OR=0.78, P=0.611). The non-time-consuming group had higher satisfaction with the study(much timeconsuming group vs. non-time-consuming group: OR=0.09, P=0.005). Phase I trial participants with adequate clinical trial information had higher satisfaction(OR=8.20, P<0.001). People in the middle group of economic compensation had the lowest satisfaction(under-compensation group vs. adequate compensation group: OR=3.32, P=0.092;moderate compensation group vs. adequate compensation group:OR=0.26, P=0.032). Subjects in the non-time-consuming group had the least stress(very time-consuming vs. non-time-consuming: OR=5.76,P=0.001;general time-consuming group vs. non-time-consuming group: OR=5.92, P=0.001). Subjects who spent less time to think before participating in the phase Ⅰ clinical trial were more likely to experience stress than subjects who had sufficient time to think(insufficient time vs. sufficient time: OR=0.12, P=0.001). Conclusions: Several strategies can reduce patients’ stress when participating in phase Ⅰ anticancer clinical trials. Examples include reducing time consumption in phase I clinical trials, applying modern information and communication approaches to optimize clinical trial consultation, more financial compensation, sufficient time to think before enrollment, and optimal psychological management of subjects. This will improve personal satisfaction and the overall evaluation of the trial.