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Public health
Research
Evaluating stress, satisfaction and the associated influencing factors of participants in cancer clinical trials: a cross-sectional study in China
  1. Shiyu Jiang1,
  2. Peng Liu1,
  3. Sheng Yang1,
  4. Jianliang Yang1,
  5. Dawei Wu1,2,
  6. Hong Fang2,
  7. Yan Qin1,
  8. Shengyu Zhou1,
  9. Jianping Xu1,
  10. Yongkun Sun1,
  11. Hongnan Mo1,
  12. Lin Gui1,
  13. Puyuan Xing1,
  14. Bo Lan1,
  15. Bo Zhang1,
  16. Le Tang1,
  17. Yan Sun1,2,
  18. Yuankai Shi1,2
  1. 1 Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
  2. 2 National GCP Center for Anticancer Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
  1. Correspondence to Professor Yuankai Shi; syuankai{at}cicams.ac.cn

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.

  • cancer
  • clinical trials
  • patient satisfaction
  • stress

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-028589

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    Footnotes

    • Contributors YKShi and SYJ conceptualised and designed the study. YKShi, SYJ, PL, SY, JLY, DWW, HF, YQ, SYZ, JPX, YKSun, HNM, LG, PYX, BL, BZ and LT reviewed the literature, collected data and interpreted the findings. SYJ and YKShi performed statistical analysis and drafted the manuscript. All authors critically reviewed the manuscript and approved the final manuscript.

    • Funding This study was was supported by the grants from Chinese National Major Project for New Drug Innovation(2017ZX09304015).

    • Disclaimer The authors express sincere gratitude to the patients, their families and all investigators who participated in the study.

    • Competing interests None declared.

    • Ethics approval Ethical approval was obtained from the Institutional Review Board of National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Dataset is available upon requirement.

    • Patient consent for publication Obtained.