Clinical trial · Interventional
Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System
NCT02613260CI-TRIAL-00039981completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Uptake of colorectal cancer (CRC) screening is suboptimal in the San Francisco Health Network and access to care may be limited so novel models of health care delivery are warranted. The objective of this study is to examine whether a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses.
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 |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FIT Outreach | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Patients in this study arm will receive usual care from their primary care clinic.
- type
- EXPERIMENTAL
- label
- FIT Outreach + Usual Care
- description
- Patients in this study arm will receive usual care at their primary care clinic and the intervention.
- interventionNames
- Behavioral: FIT Outreach
Primary outcomes (1)
- measure
- Completion of FIT- one year
- timeFrame
- One year
- description
- The primary outcome is the completion rate for CRC screening one-year after randomization between mailed FIT outreach and usual care.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Asymptomatic men and women * 50 to 75 years of age Exclusion Criteria: * Personal history of polyps requiring colonoscopic surveillance * Homeless * Severe co-morbidities limiting life expectancy e.g., advanced stage cancer
References
Publications (3)
- DERIVEDMcClellan SP, Canchola AJ, Potter MB, Gomez SL, Somsouk M. Neighborhood socioeconomic status and the effectiveness of colorectal cancer screening outreach with mailed fecal immunochemical tests within a safety net healthcare system in San Francisco, CA: A subgroup analysis of a randomized controlled trial. Prev Med. 2023 Feb;167:107388. doi: 10.1016/j.ypmed.2022.107388. Epub 2022 Dec 14. PMID 36528113
- DERIVEDLee B, Keyes E, Rachocki C, Grimes B, Chen E, Vittinghoff E, Ladabaum U, Somsouk M. Increased Colorectal Cancer Screening Sustained with Mailed Fecal Immunochemical Test Outreach. Clin Gastroenterol Hepatol. 2022 Jun;20(6):1326-1333.e4. doi: 10.1016/j.cgh.2021.07.022. Epub 2021 Jul 16. PMID 34280552
- DERIVEDWang A, Rachocki C, Shapiro JA, Issaka RB, Somsouk M. Low Literacy Level Instructions and Reminder Calls Improve Patient Handling of Fecal Immunochemical Test Samples. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1822-1828. doi: 10.1016/j.cgh.2018.11.050. Epub 2018 Nov 29. PMID 30503967