Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Educational Information via Smartphone App.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer (CRC) Screening. Basic parameters: 45 years — 84 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other Educational 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.
Primary outcome measures
- Blood-Based Screening Test (BBST) Follow-Up [Time frame: 1 year after initial result]
Secondary outcome measures (3)
- Patient Screening Test Preference [Time frame: 1 year]
- Screening Rates [Time frame: 1 year]
- Intervention Efficacy [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Baylor University Medical Center, Baylor Charles A Sammons Cancer Center — Dallas
Identifiers
NCT: NCT07398456 · IRB TBD