PROGRESS: Implementing a hybrid decentralized clinical trial to advance precision oncology and improve cancer care quality and equity across North Carolina oncology practices.

Abstract

70 Background: Rates of comprehensive molecular profiling (CMP), use of evidence-based genome-informed therapy (GIT), and clinical trial participation remain low despite being markers of high-quality cancer care. PROGRESS is an interventional study evaluating the impact of a centralized precision oncology navigator and pharmacist-led expert CMP review on GIT ordering and cancer outcomes across an academic medical center (AMC) and community practice locations (CPLs) in North Carolina. Using hybrid decentralized clinical trial (hDCT) methods, the study was designed to increase access while minimizing clinician burden. We describe key operational challenges and solutions. Methods: PROGRESS was operationalized as an hDCT in which CPL providers were not considered research-engaged because all assessments performed locally were standard of care. Regulatory oversight remained at the AMC. Pre-launch meetings assessed CPL interest and workflow integration. AMC-led launch meetings included CPL providers, investigators, study coordinators (SC), and regulatory staff. An AMC-based SC identified potential subjects via the shared electronic health record (EHR), obtained remote electronic consent, and coordinated expert CMP reviews documented in the EHR. Follow up data were collected via medical record abstraction. Descriptive qualitative and process-level metrics were used to identify barriers and guide workflow adaptations. Results: In addition to the AMC, 3 CPLs approached were onboarded with n = 100 subjects enrolled over 11 months. Key facilitators included: a local study champion, integrating into existing workflows, and addressing remote consent concerns. Post-launch enrollment barriers included: heterogeneous CMP vendor use, limited multidisciplinary support, participant language and health-literacy challenges, subject research-fatigue, and inefficient prescreening tools. Implementation challenges highlighted opportunities to standardize biomarker testing pathways, provide CMP financial assistance counseling, and monitor demographics to support equitable participation. Post-implementation adaptations included monthly newsletters, a protocol amendment accommodating CMP ordering workflows, removal of burdensome surveys, translated consent forms, and an EHR-based prescreening report minimizing clinician involvement. Following these changes, enrollment increased by 116.1% in the second 6 months versus the first six months. Accrual is ongoing and primary study endpoint results will be reported separately. Conclusions: The implementation of PROGRESS using hDCT methodology generated practical insights to strengthen partnerships with CPLs and identify scalable approaches to improve cancer care quality via precision medicine support and local clinical research opportunities. Clinical trial information: NCT06896162 .