The influence of patient engagement on the design and implementation of a clinical trial to improve cancer care delivery.

223 Background: We have engaged 10 patient partners in the development and implementation of S1415CD, a five-year pragmatic clinical trial currently in year 3 assessing the effectiveness of a guideline-based colony stimulating factor standing order intervention (NCT02728596). Patient partners serve as part of a 21-person External Stakeholder Advisory Group (ESAG), which also includes providers, payers and guidelines experts. This abstract explores the influence of patient partners on the design, tools and implementation of S1415CD Methods: Patient partners advise the study team on protocol development, patient-facing materials and implementation challenges over four teleconferences each year, annual in-person meetings and targeted email communication. All patient partner input from 2014-2017 was tracked, collected and reviewed for impact on the trial. Results: Input from patient partners led to the refinement of the study’s patient-reported outcome (PRO) survey questions, the creation of a highly utilized patient brochure, and the formation of talking points for clinic staff to help explain the study. Patient partners in conjunction with high performing sites helped develop strategies for sites with lower patient accrual to optimize the approach and consent of study participants. Conclusions: The sustained engagement of patient partners in S1415CD ensured patient-centeredness in trial design and guided the development of PRO surveys and relevant, high quality patient-facing materials. Drawing on experiential knowledge and insights from their roles as caregivers and advocates, patient partners provided valuable feedback that influenced patient approach and engagement in the study. Embedding patient partners in the research continuum has catalyzed critical discussions and problem solving among the patient partners and study team, which has led to patient-centered solutions to study challenges. Clinical trial information: NCT02728596.

Duke Scholars

Author Gary Herbert Lyman Medicine, Medical Oncology