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N/A N=450 Randomized Double-blind Screening

Improving Rates of Repeat Colorectal Cancer Screening

Colorectal Neoplasms

Enrolled (actual)
450
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Completion of a Fecal Occult Blood Test (FOBT) — 185; 84 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Reminder and Outreach Intervention (Behavioral)
Age
Adult, Older Adult · 51+ yrs
Sex
All
Sponsor
Northwestern University
Primary completion
Aug 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Completion of a Fecal Occult Blood Test (FOBT)
185; 84

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • Fecal occult blood test (FOBT) completed in the past year
  • Age 51-75
  • Preferred language English or Spanish

Exclusion Criteria

  • Any of the following: (1) Colonoscopy within 10 years (2) Flexible sigmoidoscopy within 5 years or (3) A clinician order or referral for FOBT prior to the due date
  • Documentation of medical conditions suggesting colorectal cancer (CRC) screening through FOBT may be inappropriate including: chronic diarrhea, inflammatory bowel disease, iron deficiency, previous colonic polyp, use of medications in the previous 1 month that elevate the risk of a false-positive FOBT
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01453894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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