This clinical trial tests how well using pharmacy based fecal immunochemical tests (FIT) works to improve the rates of colorectal cancer screening for patients. The FIT tests works by using a small fecal sample, collected at home and then returned for testing, to screen for colorectal cancer. Colorectal cancer screening is traditionally delivered as part of a medical visit. However, due to short visit times and competing demands among providers and patients alike, patients who regularly attend medical visits may still miss out on screening, putting them at a higher risk of serious disease. Pharmacies are the most accessible healthcare setting in the US and therefore providing pharmacy based FIT tests may improve colorectal cancer screening for patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06656936.
Locations matching your search criteria
United States
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer CenterStatus: Approved
Contact: Alison Brenner
Phone: 919-914-0979
PRIMARY OBJECTIVES:
I. Evaluate the effectiveness of the PharmFIT intervention.
II. Assess the implementation of the PharmFIT intervention.
III. Assess the cost of the PharmFIT intervention.
OUTLINE: Patients are randomized to arm I or arm II. Pharmacy and clinic staff are assigned to arm III.
ARM I: Patients receive a referral to the participating pharmacy. Four days after the referral, patients receive a notification to pick up their FIT. Patients may receive additional notifications at 7 and 14 days after the referral if the FIT has not been picked up. Patients receive the FIT and counseling from the pharmacist regarding how to complete and return the FIT, how results are distributed and receive an instruction sheet on how to complete the test. Patients receive reminders to complete the FIT at 7 and 14 days after receiving the kit. Patients with negative results receive notification via email or letter. Patients with positive results receive notification from the pharmacist via phone, in person meeting or virtual counseling, and receive patient navigation support to aid in coordinating additional care. All patients have their results sent to their primary care provider.
ARM II: Patients receive screening services through standard of care methods at their primary care facility.
ARM III: Primary care provider clinic staff and pharmacy staff complete surveys and an interview on study.
After completion of study intervention, patients are followed up at 6 months.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorAlison Brenner
