This clinical trial tests a customizable multilevel intervention (MLI) to improve colorectal cancer (CRC) screening uptake, follow-up and referral-to-care among patients age 50-74 in 12 counties in Appalachian Kentucky (KY) and Ohio (OH). The MLI consists of both clinic-based in-reach and community-based outreach using an evidence-based intervention, to address the high burden of CRC in Appalachian KY and OH. A customizable MLI delivered at the community level, targeting residents and community organizations, and through clinical partners may promote CRC screening among underserved populations, thus, reducing cancer health disparities, saving lives, and reducing unnecessary health care costs.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04427527.
PRIMARY OBJECTIVES:
I. Pilot test, measure, and refine a MLI to increase rates of CRC screening, follow-up and referral-to-care in two counties in Appalachian KY and Appalachian OH. (Planning-Exploratory Phase [Phase 1])
II. Provide evidence supporting transition to the Implementation Phase (per National Cancer Institute [NCI] approval). (Planning-Exploratory Phase [Phase 1])
III. Test the revised, customizable MLI in a group randomized trial, delayed intervention to assess the impact of an MLI on increasing rates of CRC screening, follow-up, and referral-to-care in 12 Appalachian KY and Appalachian OH counties. (Implementation Phase [Phase 2])
IV. Assess the dissemination and sustainability of the intervention. (Implementation Phase [Phase 2])
OUTLINE:
PHASE 1: Community members, health clinic staff, clinicians and colonoscopy providers who accept referrals participate in interviews over 30-60 minutes to assess barriers to screening, norms about CRC and screening, and ways to facilitate screening/treatment by either fecal immunochemical test (FIT) or colonoscopy in the selected communities.
PHASE 2: Counties are randomized to 1 of 2 groups.
GROUP 1 (EARLY INTERVENTION): Beginning year 2, healthcare providers and staff may attend an educational session over 1 hour, and complete questionnaires that focus on CRC knowledge, beliefs, attitudes, and practices. Providers and staff receive the MLI over 12 months with assistance from the project personnel. Counties and health clinics then utilize the program without project personnel assistance for 24 additional months (i.e., a sustainability period).
GROUP 2 (DELAYED INTERVENTION): Beginning year 2, healthcare providers and staff may attend an educational session over 1 hour, and complete questionnaires that focus on CRC knowledge, beliefs, attitudes, and practices. Providers and staff receive usual care over 12 months, followed by MLI over 12 months with assistance from the project personnel. Counties and health clinics then remain in the sustainability period over 12 months.
In both groups, random samples of county residents aged 50-74 (n=100 per county) complete telephone surveys annually for 4 years. The survey collects socio-demographic data (e.g., sex, age, ethnicity/race, education, income, employment); access to health care, CRC screening (e.g., stool blood testing, colonoscopy and sigmoidoscopy, frequency since last CRC test), and barriers to CRC screening.
Lead OrganizationUniversity of Kentucky/Markey Cancer Center
Principal InvestigatorMark Dignan
