Patients' knowledge and perceived understanding – Associations with consenting to participate in cancer clinical trials

Abstract

Recruitment to clinical trials is essential. The aims of the study were to investigate associations between patients' informed consent to participate in a cancer clinical trial and knowledge and perceived understanding of the trial. Furthermore, associations between demographic factors and consent to participate and knowledge and perceived understanding of information about the trial were studied. Methods: The patients were recruited in connection to a visit at the oncology clinic for information about a drug trial. The Quality of Informed Consent questionnaire was mailed to the patients after they had decided about participation in the trial. The associations of demographic factors and “knowledge” and “perceived understanding” were analysed using linear regression models. Results: A total of 125 patients were included. Higher levels of “knowledge” and “understanding” were found to be associated with consent to participate in a clinical trial, both in the univariate and multivariate analyses (p = 0.001). None of the tested demographic factors were related to consent to participate. No statistically significant associations between any of the demographic factors and knowledge or perceived understanding scores were found. Conclusion: The results indicate that interventions that increase patients' knowledge and perceived understanding might improve participation rates in clinical trials.

Keywords

• Cancer clinical trial
• Informed consent
• Knowledge
• Understanding
• Recruitment
• Quality of informed consent