Colorectal Cancer (CRC) Screening
Conditions
Keywords
blood-based screening test, cancer risk, colorectal cancer risk, circulating tumor DNA, cell-free DNA, colorectal cancer screening
Brief summary
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.
Interventions
OTHEREducational Information via Smartphone App
The 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.
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Patients testing positive via BBST will be randomized based on clinic location such that half of the patients receive the intervention and the other half do not.
Eligibility
Sex/Gender
ALL
Age
45 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * Must have been seen in HTPN clinic within the past 24 months from study activation * Must have active MyBSW app portal account and/or establish account during study recruitment
Exclusion criteria
* 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 * Patients with any known medical condition which, in the opinion of the investigator, should preclude enrollment into the study * Have a recorded up to date CRC screening in the EMR (within 1 year for FIT, 3 years for mt-sDNA, 10 years for colonoscopy) * Patients with a previous abnormal colonoscopy finding who are due for surveillance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood-Based Screening Test (BBST) Follow-Up | 1 year after initial result | Assess the number of patients with a negative BBST result who accept and complete a follow-up BBST. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Screening Test Preference | 1 year | Assess patient preference rates and test completion rates for stool tests, colonoscopy, and blood-based CRC screening modalities. |
| Screening Rates | 1 year | 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 | 1 year | 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. |
Countries
United States
Contacts
CONTACTPage E Blas, MA
Outcome results
None listed