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

NCT04406714 | Completed Results DMC

• 2 other identifiers: LCCC20564UH3CA233251-02
• Study Type: interventional
• Target: 4,318
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Cancer Screening; Colonoscopy; Community Health Centers; Implementation Science; Patient Navigation

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75)

  "The proportion of subjects who received study Intervention (Age Group 50-75) and did not receive study intervention (Usual Care - Age Group 50-75 who completed CRC screening using any of the screening modalities recommended by the United States Preventive Services Task Force per electronic health record review. Fecal immunochemical test (FIT), fecal occult blood test \[FOBT\], fecal immunochemical test - deoxyribonucleic acid (FIT-DNA), colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, Computerized Tomography colonography."

  Up to 6 months after randomization

Secondary Outcomes (10)

• Proportion of Subjects Who Returned a Completed Mailed FIT at 60 Days

  Up to 60 days after randomization

• Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy

  Up to 6 months after diagnostic colonoscopy referral date

• Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months

  Up to 12 months after screening or diagnostic colonoscopy result date

• Number of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment

  Up to 12 months after CRC diagnosis

• Number of Subjects Who Received Referral for Cancer Treatment

  Up to 6 months after cancer diagnosis date

Study Arms (4)

Trial Mailed FIT Intervention - Age Group 50-75

EXPERIMENTAL

Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of two FQHCs. Only subjects who are 50-75 years of age are randomized to this arm. Subjects who are 50-75 cannot be randomized to Arm 3 or Arm 4.

Behavioral: Trial Mailed FIT Intervention - Age Group 50-75

Trial Usual Care - Age Group 50-75

NO INTERVENTION

Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of two FQHCs. Only subjects who are 50-75 years of age are randomized to this arm. Subjects who are 50-75 cannot be randomized to Arm 3 or Arm 4.

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

EXPERIMENTAL

Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one FQHC. Only subjects who are 45-49 years of age are randomized to this arm. Subjects who are 45-49 years of age cannot be randomized to Arm 1 or Arm 2 of the main trial.

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

Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49

ACTIVE COMPARATOR

Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one FQHC. Only subjects who are 45-49 years of age are randomized to this arm. Subjects who are 45-49 years of age cannot be randomized to Arm 1 or Arm 2 of the main trial.

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

Interventions

Trial Mailed FIT Intervention - Age Group 50-75 BEHAVIORAL

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.

Trial Mailed FIT Intervention - Age Group 50-75

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

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.

Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49

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

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 Intervention Enhanced Envelope - Age Group 45-49

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• East Carolina University: collaborator

Study Sites (2)

Roanoke Chowan Community Health Center

Ahoskie, North Carolina, 27910, United States

Location

Blue Ridge Health

Hendersonville, North Carolina, 28792, United States

Location

Related Publications (15)

• Centers for Disease Control and Prevention (CDC). Vital signs: colorectal cancer screening test use--United States, 2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 8;62(44):881-8.

  PMID: 24196665 BACKGROUND

• Church TR, Yeazel MW, Jones RM, Kochevar LK, Watt GD, Mongin SJ, Cordes JE, Engelhard D. A randomized trial of direct mailing of fecal occult blood tests to increase colorectal cancer screening. J Natl Cancer Inst. 2004 May 19;96(10):770-80. doi: 10.1093/jnci/djh134.

  PMID: 15150305 BACKGROUND

• Daly JM, Levy BT, Merchant ML, Wilbur J. Mailed fecal-immunochemical test for colon cancer screening. J Community Health. 2010 Jun;35(3):235-9. doi: 10.1007/s10900-010-9227-8.

  PMID: 20127156 BACKGROUND

• Gupta S, Halm EA, Rockey DC, Hammons M, Koch M, Carter E, Valdez L, Tong L, Ahn C, Kashner M, Argenbright K, Tiro J, Geng Z, Pruitt S, Skinner CS. Comparative effectiveness of fecal immunochemical test outreach, colonoscopy outreach, and usual care for boosting colorectal cancer screening among the underserved: a randomized clinical trial. JAMA Intern Med. 2013 Oct 14;173(18):1725-32. doi: 10.1001/jamainternmed.2013.9294.

  PMID: 23921906 BACKGROUND

• Jonas DE, Russell LB, Sandler RS, Chou J, Pignone M. Value of patient time invested in the colonoscopy screening process: time requirements for colonoscopy study. Med Decis Making. 2008 Jan-Feb;28(1):56-65. doi: 10.1177/0272989X07309643.

  PMID: 18263561 BACKGROUND

• Kempe KL, Shetterly SM, France EK, Levin TR. Automated phone and mail population outreach to promote colorectal cancer screening. Am J Manag Care. 2012 Jul;18(7):370-8.

  PMID: 22823531 BACKGROUND

• Levy BT, Daly JM, Xu Y, Ely JW. Mailed fecal immunochemical tests plus educational materials to improve colon cancer screening rates in Iowa Research Network (IRENE) practices. J Am Board Fam Med. 2012 Jan-Feb;25(1):73-82. doi: 10.3122/jabfm.2012.01.110055.

  PMID: 22218627 BACKGROUND

• Sabatino SA, Lawrence B, Elder R, Mercer SL, Wilson KM, DeVinney B, Melillo S, Carvalho M, Taplin S, Bastani R, Rimer BK, Vernon SW, Melvin CL, Taylor V, Fernandez M, Glanz K; Community Preventive Services Task Force. Effectiveness of interventions to increase screening for breast, cervical, and colorectal cancers: nine updated systematic reviews for the guide to community preventive services. Am J Prev Med. 2012 Jul;43(1):97-118. doi: 10.1016/j.amepre.2012.04.009.

  PMID: 22704754 BACKGROUND

• Siegel RL, Sahar L, Robbins A, Jemal A. Where can colorectal cancer screening interventions have the most impact? Cancer Epidemiol Biomarkers Prev. 2015 Aug;24(8):1151-6. doi: 10.1158/1055-9965.EPI-15-0082. Epub 2015 Jul 8.

  PMID: 26156973 BACKGROUND

• US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW Jr, Garcia FAR, Gillman MW, Harper DM, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Owens DK, Phillips WR, Phipps MG, Pignone MP, Siu AL. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jun 21;315(23):2564-2575. doi: 10.1001/jama.2016.5989.

  PMID: 27304597 BACKGROUND

• Ganguly AP, O'Leary MC, Crockett SD, Ferrari RM, Randolph CM, Stradtman LR, Moore AA, Su K, Tan X, Brenner AT, Reuland DS. Time to Follow-Up Colonoscopy After Positive Fecal Immunochemical Test with Centralized Patient Navigation: A Randomized Clinical Trial. J Gen Intern Med. 2026 May;41(6):1534-1544. doi: 10.1007/s11606-025-10151-2. Epub 2026 Feb 4.

  PMID: 41639370 DERIVED

• Ferrari RM, Randolph CM, O'Leary MC, Lich KH, Moore AA, Leeman J, Brenner AT, Wheeler SB, Crockett SD, Reuland DS. What makes patient navigation work? Identifying functions and forms and conducting causal loop diagramming to specify components of a successful colorectal cancer patient navigation program. Implement Sci Commun. 2026 Jan 19;7(1):32. doi: 10.1186/s43058-026-00858-6.

  PMID: 41549310 DERIVED

• Reuland DS, O'Leary MC, Crockett SD, Farr DE, Ferrari RM, Malo TL, Moore AA, Randolph CM, Ratner S, Stradtman LR, Stylianou C, Su K, Tan X, Tang V, Wheeler SB, Brenner AT. Centralized Colorectal Cancer Screening Outreach in Federally Qualified Health Centers: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2446693. doi: 10.1001/jamanetworkopen.2024.46693.

  PMID: 39585696 DERIVED

• O'Leary MC, Reuland DS, Correa SY, Moore AA, Malo TL, Tan X, Rohweder CL, Wheeler SB, Brenner AT. Uptake of colorectal cancer screening after mailed fecal immunochemical test (FIT) outreach in a newly eligible 45-49-year-old community health center population. Cancer Causes Control. 2023 Dec;34(Suppl 1):125-133. doi: 10.1007/s10552-023-01717-8. Epub 2023 Jun 10.

  PMID: 37300632 DERIVED

• Malo TL, Correa SY, Moore AA, Ferrari RM, Leeman J, Brenner AT, Wheeler SB, Tan X, Reuland DS; Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE) Study Protocol Consortium. Centralized colorectal cancer screening outreach and patient navigation for vulnerable populations in North Carolina: study protocol for the SCORE randomized controlled trial. Implement Sci Commun. 2021 Oct 7;2(1):113. doi: 10.1186/s43058-021-00194-x.

  PMID: 34620250 DERIVED

Related Links

• UNC Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Alexis Moore
• Organization: University of North Carolina Lineberger Comprehensive Cancer Center

alexis.moore@unc.edu

+1 919-962-5409

Study Officials

• Daniel S Reuland, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Trial (Age Group 50-75) Using a randomized controlled trial study design, subjects are assigned to one of two arms: Arm 1: Trial Mailed FIT Intervention; or Arm 2: Trial Usual Care. Arm 1 (intervention) receives a mailed FIT plus up to two reminder letters. Subjects are randomized 1:1 at baseline and remain in their assigned arm for the duration of the study (i.e., two annual rounds of mailed FIT). Sub-study (Age Group 45-49) Subjects, ages 45-49, are randomly assigned to one of two arms: Arm 3: Sub-Study Mailed FIT Intervention - Enhanced Envelope; or Arm 4: Sub-study Mailed FIT Active Comparator Plain Envelope. Subjects in both Arm 3 and Arm 4 receive mailed FIT plus up to two reminder letters. Subjects are randomized 1:1 at baseline and remain in their assigned arm for the duration of the sub-study (i.e., one annual round of mailed FIT).

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: July 7, 2020
• Primary Completion: March 31, 2023
• Study Completion: September 2, 2024
• Last Updated: May 15, 2026
• Results First Posted: June 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The IPD sharing time frame has not been defined at this time.
• Access Criteria: There are 2 classes of dataset requests: public use and special. Requests are submitted via the IMS website. Requestors electronically sign and submit necessary forms, including an agreement to acknowledge ACCSIS in publications and presentations. A public use dataset containing common data elements is made available to external researchers by application. IMS responds to public use dataset applications by sending the requestor one-time access to a data download link. External researchers may also request a more customized data set. Requestors must submit a brief concept form or ancillary studies form, for preliminary review by the ACCSIS Steering Committee (SC), before invitation to submit a full proposal. Full proposals receive administrative review by NCI and RTI before being sent to the SC for review and approval. Requestors report every 6 months and published articles or conference presentations to RTI. Requestors are encouraged to make articles available through PubMed Central.

Locations

US (2)