Trial · NCT04406714
Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE)
NCT04406714, Not applicable, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2024-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE). Trials, record NCT04406714. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04406714
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE)
- NCT number
- NCT04406714
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 4,318 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Colorectal Cancer
- Interventions
- 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
- First posted
- 2020-05-28
- Last updated
- 2026-05-15
- Results first posted
- 2024-06-25
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75) | Up to 6 months after randomization | "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." |
| Secondary | Proportion of Subjects Who Returned a Completed Mailed FIT at 60 Days | Up to 60 days after randomization | The proportion of subjects who received study Intervention (Age Group - 50-75) and returned a completed FIT per electronic health record review. |
| Secondary | Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy | Up to 6 months after diagnostic colonoscopy referral date | 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. |
| Secondary | 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 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. |
| Secondary | Number of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment | Up to 12 months after CRC diagnosis | 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. |
| Secondary | Number of Subjects Who Received Referral for Cancer Treatment | Up to 6 months after cancer diagnosis date | 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. |
| Secondary | Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach | Round 1 time frame: at 6 months after randomization; Round 2 time frame: at 6 months after determining eligibility for Round 2 | "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. |
| Secondary | Incremental Cost of Each Additional Patient Screened in the Intervention Arm Compared to Usual Care (Trial - Age Group 50-75) | Through study completion, up to 36 months after randomization | 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. |
| Secondary | The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening | Up to 6 months after randomization | 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. |
| Secondary | Proportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days | 60 days after randomization | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75) | Up to 6 months after randomization | Subjects who actively receive health care from the study sites, aged between 50-75. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects Who Returned a Completed Mailed FIT at 60 Days | Up to 60 days after randomization | Subjects who actively receive health care from the study sites, aged between 50-75. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy | Up to 6 months after diagnostic colonoscopy referral date | Subjects who started the study and were assessed for colon carcinoma within 6 months. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months | Up to 12 months after screening or diagnostic colonoscopy result date | Subjects who participated to the study and were diagnosed with colorectal carcinoma. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment | Up to 12 months after CRC diagnosis | Participants were diagnosed with CRC ever during Round 1. Five subjects from Trial Mailed FIT Intervention - Age Group 50-75 and 2 subjects from Trial Usual Care - Age Group 50-75 were evaluated for treatment. | days | MEAN |
| SECONDARY | Number of Subjects Who Received Referral for Cancer Treatment | Up to 6 months after cancer diagnosis date | Subjects who received a referral for cancer treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach | Round 1 time frame: at 6 months after randomization; Round 2 time frame: at 6 months after determining eligibility for Round 2 | Subjects who are 50-75 years old received study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incremental Cost of Each Additional Patient Screened in the Intervention Arm Compared to Usual Care (Trial - Age Group 50-75) | Through study completion, up to 36 months after randomization | |||
| SECONDARY | The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening | Up to 6 months after randomization | Screening-eligible population, aged 45-49 years old. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days | 60 days after randomization | Subjects who are between 45-49 old completed mailed FIT at 60 days | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75) | Trial Mailed FIT Intervention - Age Group 50-75 | 598 | Participants | ||
| Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75) | Trial Usual Care - Age Group 50-75 | 192 | Participants | ||
| Proportion of Subjects Who Returned a Completed Mailed FIT at 60 Days | Trial Mailed FIT Intervention - Age Group 50-75 | 409 | Participants | ||
| Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy | Trial Mailed FIT Intervention - Age Group 50-75 | Abnormal FIT | 48 | Participants | |
| Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy | Trial Usual Care - Age Group 50-75 | Abnormal FIT | 18 | Participants | |
| Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy | Trial Mailed FIT Intervention - Age Group 50-75 | Completed colonoscopy | 33 | Participants | |
| Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy | Trial Usual Care - Age Group 50-75 | Completed colonoscopy | 8 | Participants | |
| Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months | Trial Mailed FIT Intervention - Age Group 50-75 | 22 | Participants | ||
| Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months | Trial Usual Care - Age Group 50-75 | 8 | Participants | ||
| Number of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment | Trial Mailed FIT Intervention - Age Group 50-75 | 3.25 | Full Range 0 to 13 | days |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental: Trial Mailed FIT - Age Group 50-75 | 2,001 | |
| Overall Study | STARTED | No Intervention: Trial Usual Care - Age Group 50-75 | 2,001 | |
| Overall Study | STARTED | Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope | 158 | |
| Overall Study | STARTED | Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49 | 158 | |
| Overall Study | COMPLETED | Experimental: Trial Mailed FIT - Age Group 50-75 | 2,001 | |
| Overall Study | COMPLETED | No Intervention: Trial Usual Care - Age Group 50-75 | 2,001 | |
| Overall Study | COMPLETED | Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope | 158 | |
| Overall Study | COMPLETED | Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49 | 158 | |
| Overall Study | NOT COMPLETED | Experimental: Trial Mailed FIT - Age Group 50-75 | 0 | |
| Overall Study | NOT COMPLETED | No Intervention: Trial Usual Care - Age Group 50-75 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental: Trial Mailed FIT - Age Group 50-75 | 0 | 0 |
| Total, all-cause mortality | No Intervention: Trial Usual Care - Age Group 50-75 | 0 | 0 |
| Total, all-cause mortality | Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope | 0 | 0 |
| Total, all-cause mortality | Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49 | 0 | 0 |
| Total, other adverse events | Experimental: Trial Mailed FIT - Age Group 50-75 | 0 | 0 |
| Total, other adverse events | No Intervention: Trial Usual Care - Age Group 50-75 | 0 | 0 |
| Total, other adverse events | Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope | 0 | 0 |
| Total, other adverse events | Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49 | 0 | 0 |
| Total, serious adverse events | Experimental: Trial Mailed FIT - Age Group 50-75 | 0 | 0 |
| Total, serious adverse events | No Intervention: Trial Usual Care - Age Group 50-75 | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers15
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UH3CA233251 | Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE): A State-Level Program to Reduce Colorectal Cancer Burden in Vulnerable Populations | REULAND, DANIEL S. | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL CANCER INSTITUTE | 2019 to 2023 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Trial Mailed FIT Intervention - Age Group 50-75 vs Trial Usual Care - Age Group 50-75: Number of Subjects Who Received Referral for Cancer Treatment | Trial comparisons |
| Trial Mailed FIT Intervention - Age Group 50-75 vs Trial Usual Care - Age Group 50-75: Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75) | Trial comparisons |
| Trial Mailed FIT Intervention - Age Group 45-49 vs Trial Usual Care - Age Group 45-49: Proportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days | Trial comparisons |
| Trial Mailed FIT Intervention - Age Group 50-75 vs Trial Usual Care - Age Group 50-75: Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04406714
GET https://conductscience.org/api/trials/v1/NCT04406714/results?page=2