CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 782 enrolled
Drug / intervention
Mailed-FIT +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02584998
NCT02584998N/ACompleted

Reducing Colorectal Cancer Death Through Mailed Outreach Screening

VA Office of Research and Development·interventional·Posted Oct 23, 2015·Updated Dec 24, 2018

In Brief

A clinical study evaluating Mailed-FIT and Screening invitation-reminder for Colorectal Cancer. Completed, enrolled 782 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 23, 2015
Enrollment StartJan 1, 2017
Primary CompletionJun 12, 2017
Study CompletionDec 30, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.7 years ago

Interventions

Mailed-FITother

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.

Screening invitation-reminderother

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