Clinical trial · Interventional
Reducing Colorectal Cancer Death Through Mailed Outreach Screening
NCT02584998CI-TRIAL-00036261completedN/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)
The main study aim is to develop, implement and disseminate a pilot population-based mailed FIT outreach screening program in the Philadelphia VA Medical Center that does not rely on having an office visit, by conducting a proof-of-concept 3-arm parallel-design pragmatic randomized trial to (1) Compare the effects of usual care (UC), screening invitation + reminder (invitation-reminder), or screening invitation + mailed FIT kit + reminder (mailed-FIT); (2) Explore whether the FIT completion rate varies by age or race/ethnicity; and (3) Explore barriers to use of mailed outreach screening for Veterans.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mailed-FIT | Other | — | UNRESOLVED |
| Screening invitation-reminder | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Usual care
- description
- These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results.
- type
- ACTIVE_COMPARATOR
- label
- Screening invitation-reminder
- description
- Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero).
- interventionNames
- Other: Screening invitation-reminder
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * The pragmatic trial will include Veterans in southeastern Pennsylvania and Southern New Jersey who, during the funding year * 50 to 75 years old * Have received care at the Philadelphia VA Medical Center in the 18-48 months prior to selection for the study but who have not been seen by primary care in the past 18 months prior to selection * Due for screening * Are asymptomatic for CRC * This includes the period during which 3-sample testing was being regularly used at the Philadelphia VA Medical Center Exclusion Criteria: * Have any known gastrointestinal symptoms such as: * bleeding * unexplained weight loss * change in bowel habits * family history of CRC * inflammatory bowel disease (IBD) * colectomy using International Classification of Disease (9th and 10th edition) diagnostic code or by self-report. * The investigators will also exclude Veterans: * with evidence of prior colonoscopy within 10 years * sigmoidoscopy within 5 years * fecal occult blood test (FOBT)/FIT in the same calendar year * The information used to exclude patients will be derived from the electronic queries or chart audits.
References
Publications (1)
- DERIVEDGoldshore MA, Mehta SJ, Fletcher W, Tzanis G, Doubeni CA, Paulson EC. An RCT of Fecal Immunochemical Test Colorectal Cancer Screening in Veterans Without Recent Primary Care. Am J Prev Med. 2020 Jul;59(1):41-48. doi: 10.1016/j.amepre.2020.02.014. PMID 32564804