Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-84
SponsorBaylor Research Institute

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Educational Information via Smartphone App

Treatment groups

5,500 Participants
are divided into 2 treatment groups

Sponsors and collaborators