Clinical trial · Interventional
Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (CRC) Screening | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational Information via Smartphone App | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- App Intervention
- description
- Patients on the app intervention arm will receive educational messages via their healthcare portal smartphone app.
- interventionNames
- Other: Educational Information via Smartphone App
- type
- NO_INTERVENTION
- label
- Standard Support
- description
- Patients on the standard support arm who receive a positive blood test result and either do not access their healthcare portal smartphone app and/or do not schedule a colonoscopy within 2 weeks of the blood test result will receive the standard patient navigation support offered which typically includes explanation and education regarding their positive test result and referral to a gastroenterologist or other proceduralist for a colonoscopy.
Primary outcomes (1)
- measure
- Blood-Based Screening Test (BBST) Follow-Up
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 84 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available