Article Text
Abstract
Introduction/Background Although there are several initiatives by research groups, regulatory authorities, scientific associations to engage citizens/patients on clinical research, obstacles still prevent people from participating. Among the main discouraging aspects, the incomplete understanding of the concepts related to the proposed study, and the scarce, sometimes confused, explanations received.
This study aims to investigate knowledge and understanding, trust in clinical research, obstacles and motivation in participation, satisfaction with the information received and involvement of ovarian cancer patients on clinical trials.
Methodology Ricerca In-Acto is a prospective, multicentre study using self-administered questionnaires. After the signature of inform consent, the first questionnaire is delivered by the physician of the participating centre to eligible ovarian cancer women during the first follow-up visit or during the first therapy session. A follow-up questionnaire is mailed after 3 months.
The questionnaire has been developed starting from a research of literature, and through a validation process that involved researchers, clinicians and ACTO regional groups (Bari, Campania Lombardia, Piemonte, Roma).
The study will be carried out in 39 centres of the MaNGO (Mario Negri Gynecologic Oncology) and MITO (Multicenter Italians Trials in Ovarian Cancer) groups, and coordinated by Mario Negri Institute. A recruitment period of 6 months is expected allowing to involve about 400–500 women.
Results During 2018 the protocol and the questionnaires have been finalised, as well the submission to the competent ethics committees. Currently eight centres started the recruitment after approval from ethics committee.
Conclusion A large number of clinical centres participate in this research showing the great interested in this issue. Results of this study will contribute to figure out knowledge, and attitude of women with a history of ovarian cancer in relation to clinical studies suggesting initiatives aimed at improving the culture of clinical studies and compliance as well new ways of communication between doctor and patient.
Disclosure This research is funded by ACTO Onlus - Alleanza contro il tumore ovarico Both authors Nicoletta Cerana and Paola Mosconi have no conflict of interest to declare.