CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4,318 enrolled
Drug / intervention
Trial Mailed FIT Intervention - Age Group 50-75 +2 morebehavioral
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/NCT04406714
NCT04406714N/ACompleted

Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE): A State-Level Program to Reduce Colorectal Cancer Burden in Vulnerable Populations

UNC Lineberger Comprehensive Cancer Center·interventional·Posted May 28, 2020·Updated May 15, 2026

In Brief

A clinical study evaluating Trial Mailed FIT Intervention - Age Group 50-75, Sub-Study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49, and 1 other intervention for Colorectal Cancer. Completed, enrolled 4,318 participants across 2 sites.

Detailed Summary

This study will test the effectiveness of mailing fecal immunochemical tests (FITs) in increasing colorectal cancer (CRC) screening rates in U.S. adults ages 45-75. We are implementing this study in two age groups, 45-49 years and 50-75 years.

Study Details

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

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 28, 2020
Enrollment StartJul 7, 2020
Primary CompletionMar 31, 2023
Study CompletionSep 2, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.1 years ago

Interventions

Trial Mailed FIT Intervention - Age Group 50-75behavioral

Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in an envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.

Sub-Study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49behavioral

Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in an enhanced envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. The enhanced envelope is a yellow padded envelope with a USPS tracking label and sticker message: "Important information from your doctor". Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.

Sub-Study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49behavioral

Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in plain envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. The plain envelope is a white envelope without a USPS tracking label or sticker message. Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.