Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Colorectal Cancer
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Using a randomized controlled trial study design, our study team will assign patients to one of two arms: mailed FIT plus up to two reminder letters (intervention) or usual care (control). We will randomize participants 1:1 at baseline and participants will remain in their assigned arm for the duration of the study.Masking: Single (Outcomes Assessor)Primary Purpose: Screening

Participation Requirements

Age
Between 50 years and 75 years
Gender
Both males and females

Description

Effectiveness and feasibility: As part of this randomized controlled trial, our study team will work with two FQHCs in North Carolina to identify patients who are eligible and due for CRC screening according to the clinics' electronic health records. We will randomly select and assign eligible patie...

Effectiveness and feasibility: As part of this randomized controlled trial, our study team will work with two FQHCs in North Carolina to identify patients who are eligible and due for CRC screening according to the clinics' electronic health records. We will randomly select and assign eligible patients to receive either the mailed FIT intervention or usual care in waves, rather than defining the patient cohort at the beginning of the study, to more closely align with a pragmatic approach that would occur in clinical practice. Among patients who return a completed FIT and have a positive (abnormal) FIT result, a patient navigator will call the patient to assess and resolve barriers to follow-up (diagnostic) colonoscopy. The study team will conduct another round of mailings the following year. Participants will remain in their originally assigned study arms. Participants in the intervention arm who remain eligible for the study will be mailed another FIT and, if the FIT result is positive (abnormal), will be offered navigation to follow-up (diagnostic) colonoscopy. Implementation assessment: We will survey FQHC providers to assess their perceptions of the appropriateness, feasibility, and fit of the program. We also will administer a brief survey to representatives of each FQHC to assess organizational climate, culture, and communication patterns that may affect the implementation of the project. Following the survey, we will conduct interviews with providers to better understand contextual factors that may affect adoption, maintenance, and scalability of the SCORE CRC screening program. Also, we will interview patients in the Mailed FIT (intervention) arm patients to better understand factors that affect completion of a follow-up colonoscopy following a positive (abnormal) FIT result. Cost and cost-effectiveness: We will assess total cost (sum of fixed and variable costs) and the incremental cost-effectiveness of the Mailed FIT (intervention) arm versus the usual care arm, measured in cost per person screened for CRC. We will document all fixed and variable costs associated with implementing the intervention, based upon personnel time tracking, invoices, receipts paid, test kit and processing costs, postage and other mailing costs, and other means.

Tracking Information

NCT #
NCT04406714
Collaborators
  • National Cancer Institute (NCI)
  • East Carolina University
Investigators
Principal Investigator: Daniel S Reuland, MD University of North Carolina, Chapel Hill