Clinical trial · Interventional
Evidence-Based Colorectal Cancer Screening for the Uninsured
NCT01946282CI-TRIAL-00044136completedN/AResults postedClinicalTrials.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)
Through this program, the investigators will test a systematic colon cancer screening outreach strategy for increasing screening completion among uninsured patients, not up-to-date with screening. The intervention will consist of mailed screening invitations, with processes such as phone reminders to promote screening and evidence based follow up. All patients will be randomly assigned to receive mailed invitations to complete a home fecal immunochemical test (FIT). Some patients will be randomly assigned to receive a small financial incentive on completion of FIT testing.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FIT Invitation Only | Other | — | UNRESOLVED |
| FIT plus $10 Incentive | Other | — | UNRESOLVED |
| FIT plus $5 Incentive | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- FIT Invitation Only
- description
- Fecal Immunochemical Test (FIT) mailed to patient homes free of charge. Intervention: Fecal Immunochemical Test (FIT) kits and an invitation letter to complete colorectal cancer screening are mailed to the homes of study eligible patients. A postage paid return mailer is included. Automated and "live" phone call reminders are made at the time of invitation and within one week of invitation. Up to two "live" phone call reminders are attempted 2 to 3 weeks post invitation. Follow up for patients who return a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3 consistent with guideline recommended annual FIT for colorectal cancer screening. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy.
- interventionNames
- Other: FIT Invitation Only
- type
- ACTIVE_COMPARATOR
- label
- FIT plus $5 Incentive
- description
- Fecal Immunochemical Test (FIT) mailed to patient homes, plus an incentive to complete the test. Intervention: FIT kits and invitation letter with a $5 gift card incentive to complete screening are mailed to the homes of 1000 randomly assigned eligible patients. A postage paid return mailer is included. Automated and "live" phone call reminders are made at the time of invitation and within one week of invitation. Up to two "live" phone call reminders are attempted 2 to 3 weeks post invitation. Follow up for patients who return a normal test in Year 1 will consist of repeat screening invitations in Year 2 and Year 3. Follow up for patients who return an abnormal test will consist of navigation to complete colonoscopy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Age 50-64. * Uninsured, but participants in John Peter Smith Health System (JPS) medical assistance program for the uninsured. * One or more visits to a JPS primary care clinic within a year. * Not up-to-date with colorectal cancer screening. Exclusion Criteria: * Patients with a history of Colorectal Cancer or colon resection, no address and/or phone number on file, or who are incarcerated will be excluded.
References
Publications (13)
- BACKGROUNDJemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010 Sep-Oct;60(5):277-300. doi: 10.3322/caac.20073. Epub 2010 Jul 7. PMID 20610543
- BACKGROUNDStatBite: National Costs for Cancer Care in 2010 in Billions of Dollars by Cancer Site. J Natl Cancer Inst. 2012 Jan 4;104(1):13. doi: 10.1093/jnci/djr534. Epub 2011 Dec 14. No abstract available. PMID 22173584
- BACKGROUNDWard E, Halpern M, Schrag N, Cokkinides V, DeSantis C, Bandi P, Siegel R, Stewart A, Jemal A. Association of insurance with cancer care utilization and outcomes. CA Cancer J Clin. 2008 Jan-Feb;58(1):9-31. doi: 10.3322/CA.2007.0011. Epub 2007 Dec 20. PMID 18096863
- BACKGROUNDHardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, James PD, Mangham CM. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet. 1996 Nov 30;348(9040):1472-7. doi: 10.1016/S0140-6736(96)03386-7. PMID 8942775
- BACKGROUNDMandel JS, Bond JH, Church TR, Snover DC, Bradley GM, Schuman LM, Ederer F. Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study. N Engl J Med. 1993 May 13;328(19):1365-71. doi: 10.1056/NEJM199305133281901. PMID 8474513
- BACKGROUNDKronborg O, Fenger C, Olsen J, Jorgensen OD, Sondergaard O. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet. 1996 Nov 30;348(9040):1467-71. doi: 10.1016/S0140-6736(96)03430-7. PMID 8942774
- BACKGROUNDFaivre J, Dancourt V, Lejeune C, Tazi MA, Lamour J, Gerard D, Dassonville F, Bonithon-Kopp C. Reduction in colorectal cancer mortality by fecal occult blood screening in a French controlled study. Gastroenterology. 2004 Jun;126(7):1674-80. doi: 10.1053/j.gastro.2004.02.018.