"Uninformed consent" in clinical trials with cancer patients: A qualitative analysis of patients' and support persons' communication experiences and needs.

Objective: Cancer patients are often overwhelmed when being informed about clinical trials. However, there is a lack of evidence-based strategies to improve physician-patient communication in this area. This study assessed the experiences and needs of cancer patients and their support persons (SPs) during the informed consent (IC) process prior to participation in clinical trials.

Methods: 17 semi-structured interviews with cancer patients and their SP were conducted and analysed using a framework analysis.

Results: Most respondents reported feeling well informed about the clinical trial. However, core aspects of the study were often not understood highlighting a dissonance between perceived and actual recall and understanding. Many participants trusted that the trial recommended was the best available care and only skimmed the consent form or did not read it at all.

Conclusions: This is the first German study to analyse both cancer patients' and SPs' perspectives on IC processes. Although many feel well informed, our results suggest a significant gap in recall and understanding of core components of clinical trials which hinders IC.

Practice Implications: Further interventional research is required to improve the consent processes prior to clinical trials in order to provide optimal, patient-centred care.