Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE)

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.

Conditions

• Colorectal Cancer

Interventions

BEHAVIORAL

Trial Mailed FIT Intervention - Age Group 50-75

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.

BEHAVIORAL

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

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.

BEHAVIORAL

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

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• East Carolina University

  collaborator OTHER

• UNC Lineberger Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Daniel S Reuland, MD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-07-07

Primary Completion

2023-03-31

Completion

2024-09-02

Countries

• United States

Study Locations