Status:
COMPLETED
Adherence to Minimally Invasive Testing
Lead Sponsor:
Epigenomics, Inc
Conditions:
Colorectal Cancer
Eligibility:
All Genders
50-76 years
Brief Summary
Colorectal cancer (CRC) screening has been demonstrated to reduce long term disease burden and costs. Unfortunately, less than 65 % of age-eligible persons in the US are actually screened for CRC. The...
Eligibility Criteria
Inclusion
- 50 years of age or greater, but less than 76 years old
- Has not completed recommended screening for colonoscopy or FIT
- No colonoscopy in previous 10 years
- No fecal occult blood test (FOBT) or FIT in previous year and/or \> 13 months late FIT
- No flexible sigmoidoscopy in previous 5 years
- Verifiable offer of screening recommendation according to health system standard in at least two independent interactions and a verifiable lack of adherence for two most recent
- Verifiable lack of adherence for \>3 months following last screening recommendation
- Primary Care Provider (PCP) has agreed to refer patients for consideration of enrollment in the study
- Subject able to understand and sign written informed consent (IC)
Exclusion
- Family history of CRC in a first-degree relative
- Personal history of colonic adenomatous polyps, CRC or inflammatory bowel disease
- Symptoms for which colonoscopy or sigmoidoscopy would otherwise be performed (hematochezia, new onset diarrhea or constipation, abdominal pain)
- Comorbid illness precluding endoscopic evaluation (coronary artery disease with myocardial infarction within 6 months, unstable angina or congestive heart failure, chronic obstructive pulmonary disease requiring home oxygen, other diseases that limit life expectancy to less than 10 years)
- Chronic gastritis, pregnancy, cancer(s) other than colorectal
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT02251782
Start Date
October 1 2014
End Date
June 1 2015
Last Update
June 30 2015
Active Locations (2)
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1
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
2
Geisinger Clinic
Danville, Pennsylvania, United States, 17822