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Evaluating stress, satisfaction and the associated influencing factors of participants in cancer clinical trials: a cross-sectional study in China.


ABSTRACT: 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 ?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). CONCLUSIONS:Our study addressed factors influencing CCT participants' stress and satisfaction. We suggested measures to improve patients' experiences in CCT. TRIAL REGISTRATION NUMBER:NCT03412344; Pre-results.

SUBMITTER: Jiang S 

PROVIDER: S-EPMC6549607 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Evaluating stress, satisfaction and the associated influencing factors of participants in cancer clinical trials: a cross-sectional study in China.

Jiang Shiyu S   Liu Peng P   Yang Sheng S   Yang Jianliang J   Wu Dawei D   Fang Hong H   Qin Yan Y   Zhou Shengyu S   Xu Jianping J   Sun Yongkun Y   Mo Hongnan H   Gui Lin L   Xing Puyuan P   Lan Bo B   Zhang Bo B   Tang Le L   Sun Yan Y   Shi Yuankai Y  

BMJ open 20190601 5


<h4>Objectives</h4>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.<h4>Design</h4>Cross-sectional analysis done by a questionnaire after informed consent.<h4>Setting</h4>Cancer Hospital, Chinese Academy of Medical Sciences.<h4>Participants</h4>199 CCT participants. Primary and secondary outcome measures self-assessed stress and satisfaction in CCT  ...[more]

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