Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT04406714

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

Sponsor: UNC Lineberger Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

4318

Start Date

2020-07-07

Completion Date

2024-09-02

Last Updated

2026-05-15

Healthy Volunteers

Yes

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.

Inclusion Criteria: * Age 45-75 years * At average risk for CRC ("average risk" is defined as those patients who do not have any of the following: documented history of CRC, colorectal neoplasms, colorectal polyps, colonic adenomas, family history of CRC among first degree relative \[father, mother, sister, brother\], or diagnosis of inflammatory bowel disease) * No record of fecal occult blood test (FOBT)/FIT within the past 12 months or colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date * No record of any CRC diagnosis or total colectomy * No record of comorbidities or screening contraindications, including dementia, hospice care, assisted living, end-stage renal disease, and other cancers (glioblastoma, pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer, mesothelioma) * Has a complete North Carolina mailing address in the EHR * Active patient of the clinic (seen within the past 18 months) at the time of randomization * No record of a positive (abnormal) FIT result in the first study round (Trial Ages 50-75 only) Exclusion Criteria: * Age younger than 45 years or older than 75 years * Not at average risk for CRC ("average risk" is defined as those patients who do not have any of the following: documented history of CRC, colorectal neoplasms, colorectal polyps, colonic adenomas, family history of CRC among first degree relative \[father, mother, sister, brother\], or diagnosis of inflammatory bowel disease) * Record of FOBT/FIT within the past 12 months or colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or CT colonography within 10 years of the EHR query date * Record of any CRC diagnosis or total colectomy * Record of comorbidities or screening contraindications, including dementia, hospice care, assisted living, end-stage renal disease, and other cancers (glioblastoma, pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer, mesothelioma) * Does not have a complete North Carolina mailing address in the EHR * Not an active patient of the clinic (not seen within the past 18 months) at the time of randomization * Record of a positive (abnormal) FIT result reported during the first study round (Trial Ages 50-75)

Locations (2)

Roanoke Chowan Community Health Center

Ahoskie, North Carolina, United States

Blue Ridge Health

Hendersonville, North Carolina, United States

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (2)