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

  • STATUS
    Recruiting
  • End date
    Sep 18, 2023
  • participants needed
    4400
  • sponsor
    UNC Lineberger Comprehensive Cancer Center
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Updated on 7 October 2022
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adenoma
blood test
fecal immunochemical test
Accepts healthy volunteers

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.

Description

Trial (Age Group 50-75) This randomized controlled trial assesses the effectiveness, feasibility, acceptability, and cost-effectiveness of mailing FITs from a central location to patients served by FQHCs. Subjects are randomly selected and assigned to receive either a mailed FIT intervention (Arm 1: Trial Mailed FIT Intervention - Age Group 50-75) or usual care (Arm 2: Trial Usual Care - Age Group 50-75). To assess United States Preventive Services Task Force recommendations for annual screening, we will mail subjects one round of FIT per year for up to two years.

Sub-study (Age Group 45-49) A sub-study assesses the effectiveness of mailing FITs from a central location to patients who are 45-49 years of age and newly eligible for CRC screening. The sub-study also assesses the impact of varying the appearance of the FIT packet mailing envelope on FIT return. All eligible patients from one FQHC clinic site are randomly assigned to receive either a mailed FIT intervention that includes an enhanced mailing envelope (Arm 3: Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) or a plain envelope (Arm 4: Sub-study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49).

The Trial (Age Group 50-75) and the Sub-study (Age Group 45-49) also assess the effectiveness of delivering patient navigation from a central location to facilitate follow up colonoscopy for patients with a positive (abnormal) FIT result.

Details
Condition Colorectal Cancer
Treatment Mailed FIT Outreach, Trial Mailed FIT Intervention - Age Group 50-75, Sub-Study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49, Sub-Study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49
Clinical Study IdentifierNCT04406714
SponsorUNC Lineberger Comprehensive Cancer Center
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

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
Record of any CRC diagnosis or total colectomy
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 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)
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