Evaluating stress, satisfaction and the associated influencing factors of participants in cancer clinical trials: a cross-sectional study in China. Issue 5 (1st June 2019)

• Record Type: Journal Article
• Authors: Jiang, Shiyu; Liu, Peng; Yang, Sheng; Yang, Jianliang; Wu, Dawei; Fang, Hong; Qin, Yan; Zhou, Shengyu; Xu, Jianping; Sun, Yongkun; Mo, Hongnan; Gui, Lin; Xing, Puyuan; Lan, Bo; Zhang, Bo; Tang, Le; Sun, Yan; Shi, Yuankai
• Is Part Of: BMJ open. Volume 9:Issue 5(2019)
• Publication Date: 2019-06-01
• Subjects: cancer -- clinical trials -- patient satisfaction -- stress; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2018-028589
• Languages: English
• ISSNs: 2044-6055

Abstract

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.