Reducing Colorectal Cancer Death Through Mailed Outreach Screening
Colorectal Cancer

About this trial
This is an interventional screening trial for Colorectal Cancer
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.
Sites / Locations
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Active Comparator
Active Comparator
Usual care
Screening invitation-reminder
Mailed-FIT
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.
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).
Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (plus a screening invitation) followed by the kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update their contact information. They will be informed that a telephone reminder will follow 4 weeks from notification letter if screening is not completed. Participants who do not return their kit within 4 weeks after their pre-notification letter was mailed will receive a live telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero).