The goal of this prospective implementation study is to understand the impact of a blood-based screening test (BBST) for colorectal cancer (CRC) on patient acceptability of and adherence to CRC screening as well as the rate of follow-up BBST in those with negative BBST at a 1-year interval.
Additional aims include assessing the impact of digital patient navigation intervention on the rate of follow-up colonoscopy in individuals with positive BBST. Patients will be randomized into the non-intervention arm or the intervention with an app arm.
patients aged 45-84 years of age
Considered by health-care providers to be "average risk" for CRC as determined by USPSTF guidelines
If a patient opts for BBST, they are able and willing to provide blood samples per protocol
Ability to understand and the willingness to participate in the study
Patients with a personal history of CRC
Patients with a known high-risk family history of CRC precluding the patient from being average risk
Patients with known diagnosis of inflammatory bowel disease or history of polyps
Patients who are currently symptomatic for CRC such as: blood in the stool
Parallel
Educational Information via Smartphone App
Other interventionThe educational messages will include information about the meaning of a positive test result, the patient's chances of having a CRC detected on colonoscopy, and the importance of early CRC detection.
Blood-Based Screening Test (BBST) Follow-Up
Assess the number of patients with a negative BBST result who accept and complete a follow-up BBST.
Patient Screening Test Preference
Assess patient preference rates and test completion rates for stool tests, colonoscopy, and blood-based CRC screening modalities.
Screening Rates
Compare the overall screening rates in the study population to a historical cohort in which blood-based testing was not offered as an option.
Intervention Efficacy
Assess whether use of a digital patient navigation tool +/- traditional patient navigation leads to an increased rate of completion of colonoscopy in those with a positive blood or stool test.
Baseline BBST Results
Number of positive and negative BBST results at baseline testing.
Follow-Up BBST Results
Number of positive and negative BBST results at follow-up test
BBST+ Follow-Up
Number of BBST positives who received follow-up colonoscopy
BBST+/Colonoscopy- Follow-Up
Percentage of BBST-positive/colonoscopy-negative patients who accept and complete the follow-up BBST after negative colonoscopy.
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This trial is not recruiting at the moment. You can still explore other options:
