Expanding access to colorectal cancer screening through community pharmacies: Study protocol for the PharmFIT™ randomized controlled trial.

BACKGROUND: Colorectal cancer (CRC) is a leading cause of cancer death. Fecal immunochemical test (FIT) screening remains underused, particularly in underserved communities. Community pharmacies are highly accessible and increasingly deliver preventive care, yet pharmacy-based CRC screening has not been tested in a large pragmatic randomized trial with concurrent implementation and economic evaluation. This protocol describes a pragmatic trial testing a pharmacy-based CRC screening intervention using FIT, called PharmFIT™, which integrates community pharmacies into CRC screening pathways for primary care patients due for screening. METHODS: PharmFIT™ is a two-arm, pragmatic, hybrid type 1 effectiveness-implementation trial in two geographically disparate states (Washington and North Carolina). Adults aged 45-75 years, due for CRC screening, are randomized (n = 1200) to PharmFIT™ or usual care. In the intervention arm, clinics recommend CRC screening and refer participants to partner pharmacies, and pharmacists counsel participants, dispense FIT kits, and support kit return and follow-up. The primary outcome is completion of any United States Preventive Services Task Force-recommended CRC screening test within 6 months. Secondary outcomes include reach, timeliness of FIT completion and follow-up colonoscopy, and screening differences across participant subgroups. Implementation outcomes (acceptability, appropriateness, feasibility, fidelity, cost) are assessed using mixed methods, and economic analyses estimate intervention implementation costs, incremental cost per additional participant screened, and budget impact conducted from pharmacy and societal perspectives. CONCLUSIONS: PharmFIT™ will provide effectiveness, implementation, and cost evidence for pharmacy-based CRC screening, informing the scalability of pharmacist-led cancer prevention within primary care. TRIAL REGISTRATION: ClinicalTrials.gov (NCT06656936).