%0 Journal Article
%T Evaluating stress, satisfaction and the associated influencing factors of participants in cancer clinical trials: a cross-sectional study in China
%A Bo Lan
%A Bo Zhang
%A Dawei Wu
%A Hong Fang
%A Hongnan Mo
%A Jianliang Yang
%A Jianping Xu
%A Le Tang
%A Lin Gui
%A Peng Liu
%A Puyuan Xing
%A Sheng Yang
%A Shengyu Zhou
%A Shiyu Jiang
%A Yan Qin
%A Yan Sun
%A Yongkun Sun
%A Yuankai Shi
%J -
%D 2019
%R 10.1136/bmjopen-2018-028589
%X Objectives 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.

Design Cross-sectional analysis done by a questionnaire after informed consent.

Setting Cancer Hospital, Chinese Academy of Medical Sciences.

Participants 199 CCT participants. Primary and secondary outcome measures self-assessed stress and satisfaction in CCT.

Results 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 ¡Ý9/10; 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).

Conclusions Our study addressed factors influencing CCT participants¡¯ stress and satisfaction. We suggested measures to improve patients¡¯ experiences in CCT.

Trial registration number [NCT03412344][1]; Pre-results.

 [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03412344&atom=%2Fbmjopen%2F9%2F5%2Fe028589.ato
%U https://bmjopen.bmj.com/content/9/5/e028589