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 anti-cancer 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 time-consuming 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 anti-cancer 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.