CompletedNCT04406714SCOREUpdated May 15, 2026Results posted

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

An interventional study of Trial Mailed FIT Intervention - Age Group 50-75 and Sub-Study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49 in Colorectal Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 2 sites in United States. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Health services research

Phase: Not applicable
Study type: Interventional
Enrollment: 4,318
Allocation: Randomized
Ages: 45 Years to 75 Years
Sex: All

Study 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.

Read the detailed 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.

Conditions studied

Colorectal Cancer

Browse trials for

Colorectal Neoplasms 5,599

Keywords

Cancer Screening
Colonoscopy
Community Health Centers
Implementation Science
Patient Navigation

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 4,318 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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)

Study design

Phase: Not applicable
Primary purpose: Health services research
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 4,318 participants (actual)

Study arms

Experimental
Trial Mailed FIT Intervention - Age Group 50-75
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
No intervention
Trial Usual Care - Age Group 50-75
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.
Experimental
Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49
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
Active comparator
Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49
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

BehavioralTrial 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.
BehavioralSub-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.
BehavioralSub-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.

What researchers measure

Primary outcomes

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."
Time frame: Up to 6 months after randomization

Secondary outcomes

Proportion of Subjects Who Returned a Completed Mailed FIT at 60 Days
The proportion of subjects who received study Intervention (Age Group - 50-75) and returned a completed FIT per electronic health record review.
Time frame: Up to 60 days after randomization
Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy
The proportion of subjects who received study Intervention (Age Group 50-75) and did not receive study information (Usual Care only - Age Group 50-75), who had a positive (abnormal) FIT/FOBT result, and for whom colonoscopy was deemed to be clinically appropriate by the subject's provider, who completed follow-up (diagnostic) colonoscopy per electronic health record review.
Time frame: Up to 6 months after diagnostic colonoscopy referral date
Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months
Number of CRCs and advanced adenomas detected among subjects who received study Intervention (Age Group 50-75) and subjects who did not receive study intervention (Usual Care only - Age Group 50-75) per electronic health record review.
Time frame: 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
Number of days from CRC diagnosis to the date of evaluation for CRC treatment among subjects who received study Intervention (Age Group 50-75) and subjects who did not receive study intervention (Usual Care - Age Group 50-75) using electronic health record data to ascertain the dates of CRC diagnosis and evaluation for CRC treatment.
Time frame: Up to 12 months after CRC diagnosis
Number of Subjects Who Received Referral for Cancer Treatment
Number of subjects who received study Intervention (Age Group 50-75) and did not receive intervention (Age Group 50-75) who received referral for cancer treatment among individuals diagnosed with CRC per electronic health record review.
Time frame: Up to 6 months after cancer diagnosis date
Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach
"Number of annual FIT screenings completed (0, 1, or 2) by subjects who received Intervention (Age Group 50-75) after two annual rounds of mailed FIT outreach per electronic health record review.
Time frame: Round 1 time frame: at 6 months after randomization; Round 2 time frame: at 6 months after determining eligibility for Round 2
Incremental Cost of Each Additional Patient Screened in the Intervention Arm Compared to Usual Care (Trial - Age Group 50-75)
Comparison of the programmatic costs incurred and number of subjects screened in Arm 1(Trial Mailed FIT Intervention - Age Group 50-75) compared to Arm 2 (Trial Usual Care - Age Group 50-75), measured as cost of intervention minus the cost of usual care, divided by the number screened in Arm 1 minus the number screened in Arm 2. Intervention costs will be assessed using periodic episodes of direct observation of mailed FIT outreach activities, time logs maintained by the intervention team, and assembly of administrative data capturing non-personnel/non-labor expenditures, such as costs associated with materials printing, FIT processing, and mailing costs. Usual care costs will be assessed using a combination of clinic observations and interviews with staff.
Time frame: Through study completion, up to 36 months after randomization
The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening
The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Envelope - Age Group 45-49) who are current with any CRC screening compared to baseline, using any of the screening modalities recommended by the United States Preventive Services Task Force (FIT, fecal occult blood test \[FOBT\], FIT-DNA, colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, CT colonography) per electronic health record review.
Time frame: Up to 6 months after randomization
Proportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days
The proportion of subjects in Arm 3 (Intervention Enhanced Envelope - Age Group 45-49) compared to subjects in Arm 4 (Intervention Active Comparator Envelope - Age Group 45-49) who returned a completed FIT.
Time frame: 60 days after randomization
Proportion of Subjects Who Completed a Follow up (Diagnostic) Colonoscopy
The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Plain Envelope - Age Group 45-40) with a positive (abnormal) FIT/FOBT result for whom colonoscopy is deemed to be clinically appropriate by the subject's provider who completes a follow-up (diagnostic) colonoscopy per electronic health record review.
Time frame: Up to 6 months after abnormal FIT result date

Results

Posted Jun 25, 2024

Participant flow

Participant flow — Overall Study
Milestone	Experimental: Trial Mailed FIT - Age Group 50-75	No Intervention: Trial Usual Care - Age Group 50-75	Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope	Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49
Started	2001	2001	158	158
Completed	2001	2001	158	158
Not completed	0	0	0	0

Outcome measures

PrimaryProportion 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."

Time frame:: Up to 6 months after randomization
Reported as:: Count of participants · Participants

Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75)
Participants	Trial Mailed FIT Intervention - Age Group 50-75	Trial Usual Care - Age Group 50-75
Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75)	598	192

SecondaryProportion of Subjects Who Returned a Completed Mailed FIT at 60 Days

The proportion of subjects who received study Intervention (Age Group - 50-75) and returned a completed FIT per electronic health record review.

Time frame:: Up to 60 days after randomization
Reported as:: Count of participants · Participants

Proportion of Subjects Who Returned a Completed Mailed FIT at 60 Days
Participants	Trial Mailed FIT Intervention - Age Group 50-75
Proportion of Subjects Who Returned a Completed Mailed FIT at 60 Days	409

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

The proportion of subjects who received study Intervention (Age Group 50-75) and did not receive study information (Usual Care only - Age Group 50-75), who had a positive (abnormal) FIT/FOBT result, and for whom colonoscopy was deemed to be clinically appropriate by the subject's provider, who completed follow-up (diagnostic) colonoscopy per electronic health record review.

Time frame:: Up to 6 months after diagnostic colonoscopy referral date
Reported as:: Count of participants · Participants

Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy
Participants	Trial Mailed FIT Intervention - Age Group 50-75	Trial Usual Care - Age Group 50-75
Abnormal FIT	48	18
Completed colonoscopy	33	8

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

Number of CRCs and advanced adenomas detected among subjects who received study Intervention (Age Group 50-75) and subjects who did not receive study intervention (Usual Care only - Age Group 50-75) per electronic health record review.

Time frame:: Up to 12 months after screening or diagnostic colonoscopy result date
Reported as:: Count of participants · Participants

Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months
Participants	Trial Mailed FIT Intervention - Age Group 50-75	Trial Usual Care - Age Group 50-75
Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months	22	8

SecondaryNumber of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment

Number of days from CRC diagnosis to the date of evaluation for CRC treatment among subjects who received study Intervention (Age Group 50-75) and subjects who did not receive study intervention (Usual Care - Age Group 50-75) using electronic health record data to ascertain the dates of CRC diagnosis and evaluation for CRC treatment.

Time frame:: Up to 12 months after CRC diagnosis
Reported as:: Mean · days

Number of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment
days	Trial Mailed FIT Intervention - Age Group 50-75	Trial Usual Care - Age Group 50-75
Number of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment	3.25 (0 to 13)	0 (0 to 0)

SecondaryNumber of Subjects Who Received Referral for Cancer Treatment

Number of subjects who received study Intervention (Age Group 50-75) and did not receive intervention (Age Group 50-75) who received referral for cancer treatment among individuals diagnosed with CRC per electronic health record review.

Time frame:: Up to 6 months after cancer diagnosis date
Reported as:: Count of participants · Participants

Number of Subjects Who Received Referral for Cancer Treatment
Participants	Trial Mailed FIT Intervention - Age Group 50-75	Trial Usual Care - Age Group 50-75
Number of Subjects Who Received Referral for Cancer Treatment	4	2

SecondaryNumber of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach

"Number of annual FIT screenings completed (0, 1, or 2) by subjects who received Intervention (Age Group 50-75) after two annual rounds of mailed FIT outreach per electronic health record review.

Time frame:: Round 1 time frame: at 6 months after randomization; Round 2 time frame: at 6 months after determining eligibility for Round 2
Reported as:: Count of participants · Participants

Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach
Participants	Completed 0 Annual FITs	Completed 1 Annual FIT Screening Only in Year 1	Completed 1 Annual FIT Screening Only in Year 2	Completed 2 Annual FIT Screenings in Year 1 and Year 2
Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach	1372	261	116	252

SecondaryIncremental Cost of Each Additional Patient Screened in the Intervention Arm Compared to Usual Care (Trial - Age Group 50-75)

Comparison of the programmatic costs incurred and number of subjects screened in Arm 1(Trial Mailed FIT Intervention - Age Group 50-75) compared to Arm 2 (Trial Usual Care - Age Group 50-75), measured as cost of intervention minus the cost of usual care, divided by the number screened in Arm 1 minus the number screened in Arm 2. Intervention costs will be assessed using periodic episodes of direct observation of mailed FIT outreach activities, time logs maintained by the intervention team, and assembly of administrative data capturing non-personnel/non-labor expenditures, such as costs associated with materials printing, FIT processing, and mailing costs. Usual care costs will be assessed using a combination of clinic observations and interviews with staff.

Time frame:: Through study completion, up to 36 months after randomization

Results for this outcome have not been posted.

SecondaryThe Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening

The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Envelope - Age Group 45-49) who are current with any CRC screening compared to baseline, using any of the screening modalities recommended by the United States Preventive Services Task Force (FIT, fecal occult blood test \[FOBT\], FIT-DNA, colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, CT colonography) per electronic health record review.

Time frame:: Up to 6 months after randomization
Reported as:: Count of participants · Participants

The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening
Participants	Experimental: Mailed FIT Intervention Enhanced Envelope - Age Group 45-49 Enhanced Envelope	Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49
Screening-eligible population, aged 45-49 years old	158	158
Count of screened participants	53	45

SecondaryProportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days

The proportion of subjects in Arm 3 (Intervention Enhanced Envelope - Age Group 45-49) compared to subjects in Arm 4 (Intervention Active Comparator Envelope - Age Group 45-49) who returned a completed FIT.

Time frame:: 60 days after randomization
Reported as:: Count of participants · Participants

Proportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days
Participants	Trial Mailed FIT Intervention - Age Group 45-49	Trial Usual Care - Age Group 45-49
Proportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days	34	20

SecondaryProportion of Subjects Who Completed a Follow up (Diagnostic) Colonoscopy

The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Plain Envelope - Age Group 45-40) with a positive (abnormal) FIT/FOBT result for whom colonoscopy is deemed to be clinically appropriate by the subject's provider who completes a follow-up (diagnostic) colonoscopy per electronic health record review.

Time frame:: Up to 6 months after abnormal FIT result date
Reported as:: Count of participants · Participants

Proportion of Subjects Who Completed a Follow up (Diagnostic) Colonoscopy
Participants	Trial Mailed FIT Intervention - Age Group 45-49	Trial Usual Care - Age Group 45-49
positive (abnormal) FIT/FOBT result	2	1
completed a follow-up colonoscopy	2	1

Adverse events

Collected over Up to 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Experimental: Trial Mailed FIT - Age Group 50-75	—	—	—
No Intervention: Trial Usual Care - Age Group 50-75	—	—	—
Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope	—	—	—
Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49	—	—	—

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Experimental: Trial Mailed FIT - Age Group 50-75	No Intervention: Trial Usual Care - Age Group 50-75	Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope	Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	1487	1496	158	158	3299
>=65 years	514	505	0	0	1019

Sex: Female, Male
Sex: Female, Male(Participants)	Experimental: Trial Mailed FIT - Age Group 50-75	No Intervention: Trial Usual Care - Age Group 50-75	Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope	Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49	Total
Female	1135	1121	84	97	2437
Male	866	880	74	61	1881

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Experimental: Trial Mailed FIT - Age Group 50-75	No Intervention: Trial Usual Care - Age Group 50-75	Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope	Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49	Total
Hispanic or Latino	185	179	13	12	389
Not Hispanic or Latino	1687	1679	141	145	3652
Unknown or Not Reported	129	143	4	1	277

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Experimental: Trial Mailed FIT - Age Group 50-75	No Intervention: Trial Usual Care - Age Group 50-75	Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope	Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49	Total
American Indian or Alaska Native	4	8	1	2	15
Asian	17	10	0	3	30
Native Hawaiian or Other Pacific Islander	3	1	1	0	5
Black or African American	549	536	88	96	1269
White	1272	1295	50	44	2661
More than one race	0	0	0	0	0
Unknown or Not Reported	156	151	18	13	338

Region of Enrollment
Region of Enrollment(Participants)	Experimental: Trial Mailed FIT - Age Group 50-75	No Intervention: Trial Usual Care - Age Group 50-75	Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope	Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49	Total
United States	2001	2001	158	158	4318

Study locations

2 sites

Roanoke Chowan Community Health Center
Ahoskie, North Carolina 27910, United States
Blue Ridge Health
Hendersonville, North Carolina 28792, United States

References and documents

Publications

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. PubMed 24196665 ↗
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. PubMed 15150305 ↗
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. PubMed 20127156 ↗
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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. PubMed 41549310 ↗
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. PubMed 39585696 ↗
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. PubMed 37300632 ↗
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. PubMed 34620250 ↗

Study documents

Protocol and statistical analysis plan · Dec 3, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — As outlined in the Notice of Award, each study site must make its Limited Data Set (LDS) accessible to other sites in the ACCSIS consortium. Information Management Services (IMS) will serve as the repository and have responsibility for creating a Limited Consolidated Data Set (LCDS) for analytic use of researchers both within and external to the ACCSIS consortium. Dataset Items in the LDS are defined by the Common Data Elements. There also will be a "public use data set" that consists of the Common Data Elements, available to external researchers. IMS will use a systematic process to remove identifiers. In addition, all data that underlie results in publications will be available per Cancer Moonshot Notice of Award.

Supporting information: Study protocol

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04406714
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI), East Carolina University
Responsible party: Sponsor
First posted: May 28, 2020
Start date: Jul 7, 2020
Primary completion: Mar 31, 2023
Completion: Sep 2, 2024
Results posted: Jun 25, 2024
Last update: May 15, 2026

Study contacts

Daniel S Reuland, MD

principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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