This trial studies how well an enhanced prevention program works in increasing screening in participants at high risk for colorectal cancer. An enhanced prevention program, including self-test kit, educational materials and outreach, and reminders may help participants to understand the benefit of early detection of colorectal cancer, and may help to increase the attendance of annual colorectal cancer screening.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02882620.
PRIMARY OBJECTIVES:
I. Finalize and evaluate (using a three-arm randomized controlled trial design and mixed methods) the efficacy of serially implemented interventions of graded intensity for increasing annual colorectal cancer (CRC) screening uptake.
II. Determine (using qualitative methods) promoters and barriers to enhancing CRC screening practices from the perspective of (a) participants who were “largely adherent’ (completed fecal immunochemical test [FIT] two or three of three times) and those who were “not adherent” (never completed or completed FIT only one of three times) to CRC screening guidelines; (b) navigators; and, (c) health care providers and medical directors at Indian Health Service [IHS] health facilities.
III. Conduct process evaluation (using mixed-methods) to: (a) determine the costs of completing CRC screening (and appropriate follow-up diagnostic and treatment services, as needed); (b) determine fidelity of study implementation (e.g., recruitment, intervention delivery, barriers); and (c) develop program sustainability and scalability plans.
OUTLINE:
QUALITATIVE RESEARCH: Participants attend 3 focus groups to finalize the intervention and data collection materials.
QUANTITATIVE RESEARCH: Patients are randomized to 1 of 3 groups.
GROUP I: Participants receive mailed FIT kit and educational material at 1, 13, and 25 months, 4 in-depth education outreach (telephone or home visits) sessions between months 1-28, and follow-up mailed reminders.
GROUP II: Participants receive mailed FIT kit and education material at 1, 13, and 25 months and follow-up mailed reminders.
GROUP III: Participants receive usual care.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationUniversity of New Mexico Cancer Center
Principal InvestigatorShiraz Mishra
