Assessing the Effect of a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy Completion
Colorectal Cancer
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring colorectal cancer screening, septin 9
Eligibility Criteria
Inclusion Criteria:
- not up-to-date with colorectal cancer screening, defined as a colonoscopy in the past 10 years, a stool test (FOBT/FIT) in the past year, or a flexible sigmoidoscopy in the past 5 years.
- Declined colorectal cancer screening (both colonoscopy and FIT) in the previous 6 months, which must be documented in the electronic health record
Exclusion Criteria:
- Personal history of colonic adenomas (including sessile serrated adenomas), proximal hyperplastic polyps, CRC, inflammatory bowel disease, or hereditary gastrointestinal cancer syndrome
- First degree relative with CRC diagnosed at <60 years of age; family history of hereditary gastrointestinal cancer syndromes.
- Vulnerable populations
- Adult unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Sites / Locations
- VA New York Harbor Health Care System
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control
Septin9
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Patients who call will speak to a research assistant who is trained in patient navigation and can facilitate referrals for colonoscopy or FIT. Patients will receive a follow-up telephone call that reiterates information in the letter. Patients will also be asked to complete a questionnaire about their beliefs and attitudes regarding CRC screening. The questionnaire will be mailed with the invitation letter and will also be administered over the telephone by the research assistant.
Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Letters will also include an option to participate in the blood test, with instructions to call the study number to schedule the blood draw. This option will not appear in the letters sent to the control group. Patients will also receive a follow-up telephone call and a questionnaire. Participants who choose to the blood test (Septin9) will undergo phlebotomy. The blood sample will be run by an off-site commercial laboratory. The study team will notify patients and their primary care physicians of blood test results and will facilitate a colonoscopy referral for those with positive tests.