This clinical trial studies the use of a mailed colorectal cancer screening program called SCORE to improve colorectal cancer (CRC) screening completion in vulnerable populations. The mailed outreach program may increase colorectal cancer screening rates and reduce colorectal cancer burden in vulnerable and marginalized populations.
Additional locations may be listed on ClinicalTrials.gov for NCT04406714.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To assess the effectiveness of a mailed FIT outreach program on CRC screening completion in a community health center context in both northeastern and western North Carolina. (Aim 1)
SECONDARY OBJECTIVES:
I. To assess implementation determinants and outcomes to inform plans for sustaining and scaling the CRC screening program.
II. Assess the logistical feasibility and patient and provider acceptability of the mailed FIT outreach program (Arm 2). (Aim 2)
III. Estimate the cost and cost-effectiveness per person screened in each arm, as well as the level of resource investment required to scale-up the program statewide. (Aim 3)
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: (USUAL CARE): Patents receive usual care.
ARM II (MAILED FIT OUTREACH): Patients receive a mailed FIT kit and complete FIT. Patients with a positive (abnormal) FIT result are offered patient navigation to facilitate follow-up colonoscopy.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorDaniel Reuland