Knowledge and Attitudes Towards Clinical Trials Among Women with Ovarian Cancer: Results of The Acto Study

Abstract

BackgroundAlthough there are several initiatives by research groups, regulatory authorities, and scientific associations to engage citizens/patients in clinical research, there are still obstacles to participation. Among the main discouraging aspects are incomplete understanding of the concepts related to the clinical trial, and the scant, sometimes confused, explanations given. The aim of this observational, cross-sectional multicenter study is to investigate knowledge, attitudes and trust in clinical research.We conducted a survey among women with ovarian cancer at their first follow-up visit or first therapy session, treated in centers belonging to the Mario Negri Gynecologic Oncology (MaNGO) and Multicenter Italian Trials in Ovarian Cancer (MITO) groups. A questionnaire on knowledge, attitudes and experience was assembled ad hoc after a literature review and a validation process involving patients of the Alliance against Ovarian Cancer (ACTO).ResultsFrom 25 centers 348 questionnaire were collected; 73.5% of responders were 56 years or older, 54.8% had a high level of education, more than 80% had no experience of trial participation. Among participants 59% knew what clinical trials are and 71% what the informed consent is. However more than half did not know the meaning of the term randomization. More than half (56%) were in favor of participating in a clinical trial, but 35% were not certain. Almost all responders acknowledged the doctor’s important role in decision-making. Patients associations were recognized as playing a powerful role in the design and planning of clinical trials. ConclusionsThis study helps depict the knowledge and attitudes of women with ovarian cancer in relation to clinical trial, suggesting initiatives aimed at improving trials’ culture, literacy and compliance, and fresh ways of communication between doctors and patients.