N/A
N=782
Reducing Colorectal Cancer Death Through Mailed Outreach Screening
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02584998 ↗Enrolled (actual)
782
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: The Number of Participants Who Completed the Mailed FIT Test Screening Within 6 Months — 0; 0; 62 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mailed-FIT (Other); Screening invitation-reminder (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Who Completed the Mailed FIT Test Screening Within 6 Months |
0; 0; 62 | — |
| SECONDARY The Number of Participants Who Received Any Colorectal Cancer Screening Test in the 6-month Period After Enrollment Into the Study. |
15; 20; 68 | <0.001 sig |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02584998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.