Colorectal Neoplasms Clinical Trial
Official title:
Center for Advancing Equity in Clinical Preventive Services Project 1: Improving Rates of Repeat Colorectal Cancer Screening
The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC)
screening using fecal occult blood testing (FOBT), sigmoidoscopy, or colonoscopy in adults,
beginning at age 50 and continuing until age 75. However, rates of CRC screening remain
inadequate. In 2006, only 60.8% of adults 50 or older reported recent CRC screening.
Screening rates are even lower among Black and Hispanic populations and in areas with higher
poverty rates. Annual or biennial FOBT testing over many years is essential for FOBT to be
effective. Few studies have examined the rate of repeat FOBT testing; to the investigators
knowledge, none have been conducted in populations with high prevalence of barriers to
screening (e.g., low literacy, varied cultural norms, and transportation difficulties). The
assumption that FOBT is an effective CRC screening strategy presumes it will be done at
least biennially, and cost-effectiveness studies of CRC screening strategies have found that
the results are sensitive to the rate of adherence. The investigators study will provide
critical information for providers and policymakers as they consider optimal strategies to
increase CRC screening among vulnerable populations.
Overall Study Goal: Improve colorectal cancer screening by increasing rates of repeat fecal
occult blood testing (FOBT).
Aim 1: Test if a multifaceted intervention increases repeat FOBT testing adherence over a
30-month period
Hypothesis 1: Compared to usual care, the intervention will increase the proportion of
patients who complete a repeat annual FOBT within 6 months of their due date.
Hypothesis 2: Compared to usual care, the intervention will increase the proportion of
patients who complete 2 additional FOBTs over the 30-month intervention period.
Aim 2: Explore perceived barriers to screening among patients who received the intervention
but did not complete repeat FOBT testing within 18 months
Aim 3: Assess the costs of the intervention and the costs per additional repeat screening
compared to patients who received usual care.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening
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