Engaging Patients And Stakeholders In The Process Of Designing A Clinical Trial And Patient Education Platform

63 Background: Patient engagement during the initiation, development, and implementation of a study has been shown to improve the ethical nature of research and the appropriateness of treatment methods, and insights into how best to partner with patients are needed. We describe our patient engagement experience in developing a clinical trial for non-metastatic pancreatic cancer (PCA).A team of patient research partners (PRPs) was consulted to design a multi-institutional study to evaluate the efficacy of chemotherapy, stereotactic body radiation therapy, and early palliative care (EPC) in patients with PCA who are typically ineligible for clinical trials due to advanced age, poor performance status, or preexisting comorbidities. PRPs included patients, caregivers, clinical researchers, patient advocacy organizations, and pharmaceutical companies. A 22-item initial survey on personal interests and a 5-item follow-up survey on study design were anonymously completed after two in-person meetings.Of 15 PRPs involved, 9 completed the initial survey and 10 completed the follow-up survey. PRPs were most interested in improving quality of life (QOL, 89%), care coordination (78%), symptom management (67%), stress/anxiety (56%), and survival (56%). Confidence in the care team, hope, QOL, education and understanding, dignity, and pain management were reported to be the most important factors throughout the cancer experience. The majority (89%) requested that study participants have access to the study protocol and research publications supporting the study design. Because all PRPs suggested that a personal website be used to provide information to study participants and to disseminate the results of the study, an online patient education platform was adopted and customized for patients (and caregivers). Furthermore, integration of EPC into the treatment regimen was unanimously endorsed.Engaging PRPs in the process of designing a clinical trial for PCA appears to be feasible and valuable in identifying the study objectives most important to patients. PRPs conveyed that maintaining a good QOL is essential, and adoption of EPC in these patients should be considered.