An interventional study of Mailed-FIT and Screening invitation-reminder in Colorectal Cancer, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 50 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-24.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Screening
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.
This study seeks to establish the foundation to systematically study and improve the delivery and effectiveness of colorectal cancer (CRC) screening in the VA by developing, implementing and disseminating a pilot mailed-FIT screening outreach program that does not rely on having a clinical office visit. The investigators specifically address the need to identify and remediate potential failures to identify and offer screening to eligible Veterans through multilevel interventions. The investigators will also create electronic data linkages to, in future studies, enable evaluation of FIT performance characteristics and help close critical evidence gaps for optimizing screening among Veterans. As this is a pilot study, the focus is to assess feasibility of a population-based screening outreach approach through the development, implementation and dissemination of a mailed FIT outreach program in the Philadelphia VA Medical Center that does not rely on having an office visit.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's enrollment of 782 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Have any known gastrointestinal symptoms such as:
The investigators will also exclude Veterans:
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).
Other: Screening invitation-reminder
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).
Other: Mailed-FIT
The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample. Specimens will be analyzed according to manufacturer's instructions to minimize potential degradation of hemoglobin. Results are provided as positive if the hemoglobin concentration is 100ng/dL. The machine records (but does not report) the quantitative results of the hemoglobin concentration in the sample, which we will seek to obtain from the laboratory for future studies.
Also known as: Fecal Immunochemical Test
These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm
The Number of Participants Who Completed the Mailed FIT Test Screening Within 6 Months
The completion rate of mailed FIT test within 6 months of the mailing of the screening invitation. The absence of FIT result in the electronic medical record (CRPS) will be considered a failure to complete the FIT test
Time frame: 6 months
The Number of Participants Who Received Any Colorectal Cancer Screening Test in the 6-month Period After Enrollment Into the Study.
The receipt of any colorectal cancer screening test in the 6-month period after enrollment into the study. For patients in the usual care arm, 6 months was counted from the date of mailed letter to arms 2 and 3 within that block of participants.
Time frame: 6 months
| Milestone | Usual Care | Screening Invitation-reminder | Mailed-FIT |
|---|---|---|---|
| Started | 260 | 261 | 261 |
| Completed | 260 | 261 | 261 |
| Not completed | 0 | 0 | 0 |
The completion rate of mailed FIT test within 6 months of the mailing of the screening invitation. The absence of FIT result in the electronic medical record (CRPS) will be considered a failure to complete the FIT test
| Participants | Usual Care | Screening Invitation-reminder | Mailed-FIT |
|---|---|---|---|
| The Number of Participants Who Completed the Mailed FIT Test Screening Within 6 Months | 0 | 0 | 62 |
The receipt of any colorectal cancer screening test in the 6-month period after enrollment into the study. For patients in the usual care arm, 6 months was counted from the date of mailed letter to arms 2 and 3 within that block of participants.
| Participants | Usual Care | Screening Invitation-reminder | Mailed-FIT |
|---|---|---|---|
| The Number of Participants Who Received Any Colorectal Cancer Screening Test in the 6-month Period After Enrollment Into the Study. | 15 | 20 | 68 |
Collected over Adverse events were collected during the same time frame as the primary outcome, which was 6 months from the time of the mailed screening invitation in arms 2 and 3.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | 1/260 (0.4%) | 0/260 (0%) | 0/260 (0%) |
| Screening Invitation-reminder | 0/261 (0%) | 0/261 (0%) | 0/261 (0%) |
| Mailed-FIT | 0/261 (0%) | 0/261 (0%) | 0/261 (0%) |
| Age, Continuous(years) | Usual Care | Screening Invitation-reminder | Mailed-FIT | Total |
|---|---|---|---|---|
| Mean | 61 ± 7.0 | 60 ± 7.0 | 61 ± 6.5 | 61 ± 6.8 |
| Sex: Female, Male(Participants) | Usual Care | Screening Invitation-reminder | Mailed-FIT | Total |
|---|---|---|---|---|
| Female | 8 | 7 | 7 | 22 |
| Male | 252 | 254 | 254 | 760 |
| Race/Ethnicity, Customized(Participants) | Usual Care | Screening Invitation-reminder | Mailed-FIT | Total |
|---|---|---|---|---|
| Race — Black | 162 | 149 | 160 | 471 |
| Race — White | 85 | 97 | 88 | 270 |
| Race — Other | 3 | 4 | 5 | 12 |
| Race — Unknown | 10 | 11 | 8 | 29 |
| Region of Enrollment(Participants) | Usual Care | Screening Invitation-reminder | Mailed-FIT | Total |
|---|---|---|---|---|
| United States | 260 | 261 | 261 | 782 |
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Plan to share: No
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