Clinical trial · Interventional
Predicting and Addressing Colonoscopy in Safety Net Settings
- 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 prospective cohort study will evaluate the effectiveness of patient navigation in community health center settings. The investigators will collaborate with the advisory board, composed of key clinicians and patients, researchers, and policymakers, to establish a procedure to conduct and evaluate a patient navigation program that aims to increase rates of follow-up colonoscopy among diverse patient populations served by safety net clinics. Phase 1 will be a milestone-driven planning process in which the investigators will validate the risk prediction model and apply the risk prediction model to stratify the patients and adapt patient navigation materials for the local context. Phase II will be a large-scale, patient randomized-controlled trial that will include 1200 patients at a large 34-clinic community health center in Washington State.
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 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient navigation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Patient Navigation
- description
- Patients randomized to this arm will receive patient navigation with the goal of completing a follow-up colonoscopy within 12 months of a positive FIT result.
- interventionNames
- Behavioral: Patient navigation
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Patients will receive usual care screening opportunities
Primary outcomes (1)
- measure
- Rate of follow-up colonoscopy
- timeFrame
- 12 months
- description
- Receipt of colonoscopy within 1 year of abnormal Fecal Immunochemical Test (FIT) result
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Positive FIT test Exclusion Criteria: * Prior colorectal cancer * Dialysis patient
References
Publications (3)
- DERIVEDCoronado GD, Petrik AF, Thompson JH, Leo MC, Slaughter M, Gautom P, Hussain SA, Mosso L, Gibbs J, Yadav N, Mummadi RR, Johnson ES, Jimenez R. Patient Navigation to Improve Colonoscopy Completion After an Abnormal Stool Test Result : A Randomized Controlled Trial. Ann Intern Med. 2025 May;178(5):645-654. doi: 10.7326/ANNALS-24-01885. Epub 2025 Apr 1. PMID 40163863
- DERIVEDCoronado GD, Kihn-Stang A, Slaughter MT, Petrik AF, Thompson JH, Rivelli JS, Jimenez R, Gibbs J, Yadav N, Mummadi RR. Follow-up colonoscopy after an abnormal stool-based colorectal cancer screening result: analysis of steps in the colonoscopy completion process. BMC Gastroenterol. 2021 Sep 28;21(1):356. doi: 10.1186/s12876-021-01923-1. PMID 34583638
- DERIVEDCoronado GD, Johnson ES, Leo MC, Schneider JL, Smith D, Mummadi R, Petrik AF, Thompson JH, Jimenez R. Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers. Contemp Clin Trials. 2020 Feb;89:105920. doi: 10.1016/j.cct.2019.105920. Epub 2019 Dec 24. PMID 31881390