Offering a Blood-Based Screening Option to Improve Colorectal Cancer Screening Uptake in Under-screened Individuals

Status: active

This clinical trial tests whether offering a blood-based screening option improves the uptake of colorectal cancer (CRC) screening in under-screening individuals. CRC is the second leading cause of cancer deaths in the United States. Most CRCs arise from precursor adenomatous polyps and early detection and removal of these polyps can reduce the risk of developing CRC and is the mainstay of CRC prevention. Despite its effectiveness, screening uptake remains low. Offering a blood-based screening option alongside the standard screening options (stool- or endoscopy-based screening) may improve CRC screening uptake for under-screened individuals.

Inclusion Criteria

Adults 45 – 85 years of age at average risk and able to provide informed consent
Patients overdue for a screening colonoscopy or stool-based test that was ordered by their University of Miami (UM) clinician

Exclusion Criteria

Impaired decision-making capability/unable to provide informed consent
Patients with high-risk conditions: * Personal history of CRC, adenomas, or other cancers * Those who had a positive result on another CRC screening method within the last six months, an abnormal stool test that found blood in your stool within the last 12 months, or abnormal Cologuard (fecal immunochemical test [FIT]-deoxyribonucleic acid [DNA] test) in the last 3 years * Those with inflammatory bowel disease (IBD), chronic ulcerative colitis (CUC), Crohn’s disease * Those who have a family history of colorectal cancer (in a parent, brother, sister, or child) * Genetic predisposition requiring more frequent screening (such as Lynch syndrome, IBD, history of colectomy, etc.) * Symptoms like rectal bleeding, weight loss, or other signs for which your doctor ordered a colonoscopy – not simply as a screening tool

PRIMARY OBJECTIVES:

I. To evaluate and compare adherence to different options for CRC screening.

II. To determine whether offering an additional blood-based test increases overall screening participation.

SECONDARY OBJECTIVE:

I. To explore uptake by country of origin, race/ethnicity, socioeconomic status, and insurance type/payor in each arm.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive a standard CRC screening reminder via mailed letter or patient portal.

ARM II: Participants receive a CRC screening reminder with the additional option of completing a blood-based screening test via mailed letter or patient portal. Participants who express interest in the blood-based screening option undergo collection of a blood sample for testing.

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Offering a Blood-Based Screening Option to Improve Colorectal Cancer Screening Uptake in Under-screened Individuals

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