Trial Outcomes & Findings for Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE) (NCT NCT04406714)
NCT ID: NCT04406714
Last Updated: 2026-05-15
Results Overview
"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."
COMPLETED
NA
4318 participants
Up to 6 months after randomization
2026-05-15
Participant Flow
Subjects were enrolled between 07/07/2020 - 02/28/2022 in one center in North Carolina.
Participant milestones
| Measure |
Experimental: Trial Mailed FIT - 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 the two study sites. This arm receives a mailed FIT and up to two reminder letters.
|
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 the two study sites. This arm receives the usual care.
|
Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope
Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one study site. This arm receives a mailed FIT in an enhanced mailing envelope and up to two reminder letters.
|
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 study site. This arm receives a mailed FIT in a plain envelope and up to two reminder letters.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2001
|
2001
|
158
|
158
|
|
Overall Study
COMPLETED
|
2001
|
2001
|
158
|
158
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE)
Baseline characteristics by cohort
| Measure |
Experimental: Trial Mailed FIT - Age Group 50-75
n=2001 Participants
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 the two study sites. This arm receives a mailed FIT and up to two reminder letters.
|
No Intervention: Trial Usual Care - Age Group 50-75
n=2001 Participants
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 the two study sites. This arm receives the usual care.
|
Experimental: Sub-study Mailed FIT Age Group 45-49 Enhanced Envelope
n=158 Participants
Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one study site. This arm receives a mailed FIT in an enhanced mailing envelope and up to two reminder letters.
|
Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49
n=158 Participants
Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one study site. This arm receives a mailed FIT in a plain envelope and up to two reminder letters.
|
Total
n=4318 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1487 Participants
n=11 Participants
|
1496 Participants
n=9 Participants
|
158 Participants
n=20 Participants
|
158 Participants
n=186 Participants
|
3299 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
514 Participants
n=11 Participants
|
505 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
1019 Participants
n=12 Participants
|
|
Sex: Female, Male
Female
|
1135 Participants
n=11 Participants
|
1121 Participants
n=9 Participants
|
84 Participants
n=20 Participants
|
97 Participants
n=186 Participants
|
2437 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
866 Participants
n=11 Participants
|
880 Participants
n=9 Participants
|
74 Participants
n=20 Participants
|
61 Participants
n=186 Participants
|
1881 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
185 Participants
n=11 Participants
|
179 Participants
n=9 Participants
|
13 Participants
n=20 Participants
|
12 Participants
n=186 Participants
|
389 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1687 Participants
n=11 Participants
|
1679 Participants
n=9 Participants
|
141 Participants
n=20 Participants
|
145 Participants
n=186 Participants
|
3652 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
129 Participants
n=11 Participants
|
143 Participants
n=9 Participants
|
4 Participants
n=20 Participants
|
1 Participants
n=186 Participants
|
277 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=11 Participants
|
8 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=186 Participants
|
15 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=11 Participants
|
10 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=186 Participants
|
30 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
5 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
549 Participants
n=11 Participants
|
536 Participants
n=9 Participants
|
88 Participants
n=20 Participants
|
96 Participants
n=186 Participants
|
1269 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
1272 Participants
n=11 Participants
|
1295 Participants
n=9 Participants
|
50 Participants
n=20 Participants
|
44 Participants
n=186 Participants
|
2661 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
156 Participants
n=11 Participants
|
151 Participants
n=9 Participants
|
18 Participants
n=20 Participants
|
13 Participants
n=186 Participants
|
338 Participants
n=12 Participants
|
|
Region of Enrollment
United States
|
2001 Participants
n=11 Participants
|
2001 Participants
n=9 Participants
|
158 Participants
n=20 Participants
|
158 Participants
n=186 Participants
|
4318 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months after randomizationPopulation: Subjects who actively receive health care from the study sites, aged between 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."
Outcome measures
| Measure |
Completed 1 Annual FIT Screening Only in Year 1
n=2001 Participants
Completed 1 Annual FIT Screening Only in Year 1
|
Completed 1 Annual FIT Screening Only in Year 2
Completed 1 Annual FIT Screening Only in Year 2
|
Completed 2 Annual FIT Screenings in Year 1 and Year 2
Completed 2 Annual FIT Screenings in Year 1 and Year 2
|
Trial Mailed FIT Intervention - Age Group 50-75
n=2001 Participants
Subjects who are between 50-75 years of age and received study intervention.
Trial Mailed FIT Intervention: 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.
|
|---|---|---|---|---|
|
Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75)
|
192 Participants
|
—
|
—
|
598 Participants
|
SECONDARY outcome
Timeframe: Up to 60 days after randomizationPopulation: Subjects who actively receive health care from the study sites, aged between 50-75.
The proportion of subjects who received study Intervention (Age Group - 50-75) and returned a completed FIT per electronic health record review.
Outcome measures
| Measure |
Completed 1 Annual FIT Screening Only in Year 1
Completed 1 Annual FIT Screening Only in Year 1
|
Completed 1 Annual FIT Screening Only in Year 2
Completed 1 Annual FIT Screening Only in Year 2
|
Completed 2 Annual FIT Screenings in Year 1 and Year 2
Completed 2 Annual FIT Screenings in Year 1 and Year 2
|
Trial Mailed FIT Intervention - Age Group 50-75
n=2001 Participants
Subjects who are between 50-75 years of age and received study intervention.
Trial Mailed FIT Intervention: 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.
|
|---|---|---|---|---|
|
Proportion of Subjects Who Returned a Completed Mailed FIT at 60 Days
|
—
|
—
|
—
|
409 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months after diagnostic colonoscopy referral datePopulation: Subjects who started the study and were assessed for colon carcinoma within 6 months.
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.
Outcome measures
| Measure |
Completed 1 Annual FIT Screening Only in Year 1
n=26 Participants
Completed 1 Annual FIT Screening Only in Year 1
|
Completed 1 Annual FIT Screening Only in Year 2
Completed 1 Annual FIT Screening Only in Year 2
|
Completed 2 Annual FIT Screenings in Year 1 and Year 2
Completed 2 Annual FIT Screenings in Year 1 and Year 2
|
Trial Mailed FIT Intervention - Age Group 50-75
n=81 Participants
Subjects who are between 50-75 years of age and received study intervention.
Trial Mailed FIT Intervention: 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.
|
|---|---|---|---|---|
|
Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy
Abnormal FIT
|
18 Participants
|
—
|
—
|
48 Participants
|
|
Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy
Completed colonoscopy
|
8 Participants
|
—
|
—
|
33 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months after screening or diagnostic colonoscopy result datePopulation: Subjects who participated to the study and were diagnosed with colorectal carcinoma.
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.
Outcome measures
| Measure |
Completed 1 Annual FIT Screening Only in Year 1
n=192 Participants
Completed 1 Annual FIT Screening Only in Year 1
|
Completed 1 Annual FIT Screening Only in Year 2
Completed 1 Annual FIT Screening Only in Year 2
|
Completed 2 Annual FIT Screenings in Year 1 and Year 2
Completed 2 Annual FIT Screenings in Year 1 and Year 2
|
Trial Mailed FIT Intervention - Age Group 50-75
n=598 Participants
Subjects who are between 50-75 years of age and received study intervention.
Trial Mailed FIT Intervention: 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.
|
|---|---|---|---|---|
|
Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months
|
8 Participants
|
—
|
—
|
22 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months after CRC diagnosisPopulation: 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.
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.
Outcome measures
| Measure |
Completed 1 Annual FIT Screening Only in Year 1
n=2 Participants
Completed 1 Annual FIT Screening Only in Year 1
|
Completed 1 Annual FIT Screening Only in Year 2
Completed 1 Annual FIT Screening Only in Year 2
|
Completed 2 Annual FIT Screenings in Year 1 and Year 2
Completed 2 Annual FIT Screenings in Year 1 and Year 2
|
Trial Mailed FIT Intervention - Age Group 50-75
n=5 Participants
Subjects who are between 50-75 years of age and received study intervention.
Trial Mailed FIT Intervention: 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.
|
|---|---|---|---|---|
|
Number of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment
|
0 days
Interval 0.0 to 0.0
|
—
|
—
|
3.25 days
Interval 0.0 to 13.0
|
SECONDARY outcome
Timeframe: Up to 6 months after cancer diagnosis datePopulation: Subjects who received a 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.
Outcome measures
| Measure |
Completed 1 Annual FIT Screening Only in Year 1
n=2 Participants
Completed 1 Annual FIT Screening Only in Year 1
|
Completed 1 Annual FIT Screening Only in Year 2
Completed 1 Annual FIT Screening Only in Year 2
|
Completed 2 Annual FIT Screenings in Year 1 and Year 2
Completed 2 Annual FIT Screenings in Year 1 and Year 2
|
Trial Mailed FIT Intervention - Age Group 50-75
n=5 Participants
Subjects who are between 50-75 years of age and received study intervention.
Trial Mailed FIT Intervention: 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.
|
|---|---|---|---|---|
|
Number of Subjects Who Received Referral for Cancer Treatment
|
2 Participants
|
—
|
—
|
4 Participants
|
SECONDARY outcome
Timeframe: Round 1 time frame: at 6 months after randomization; Round 2 time frame: at 6 months after determining eligibility for Round 2Population: Subjects who are 50-75 years old received study intervention.
"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.
Outcome measures
| Measure |
Completed 1 Annual FIT Screening Only in Year 1
n=2001 Participants
Completed 1 Annual FIT Screening Only in Year 1
|
Completed 1 Annual FIT Screening Only in Year 2
n=1624 Participants
Completed 1 Annual FIT Screening Only in Year 2
|
Completed 2 Annual FIT Screenings in Year 1 and Year 2
n=1624 Participants
Completed 2 Annual FIT Screenings in Year 1 and Year 2
|
Trial Mailed FIT Intervention - Age Group 50-75
n=2001 Participants
Subjects who are between 50-75 years of age and received study intervention.
Trial Mailed FIT Intervention: 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.
|
|---|---|---|---|---|
|
Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach
|
261 Participants
|
116 Participants
|
252 Participants
|
1372 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 36 months after randomizationComparison 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 months after randomizationPopulation: Screening-eligible population, aged 45-49 years old.
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.
Outcome measures
| Measure |
Completed 1 Annual FIT Screening Only in Year 1
n=158 Participants
Completed 1 Annual FIT Screening Only in Year 1
|
Completed 1 Annual FIT Screening Only in Year 2
Completed 1 Annual FIT Screening Only in Year 2
|
Completed 2 Annual FIT Screenings in Year 1 and Year 2
Completed 2 Annual FIT Screenings in Year 1 and Year 2
|
Trial Mailed FIT Intervention - Age Group 50-75
n=158 Participants
Subjects who are between 50-75 years of age and received study intervention.
Trial Mailed FIT Intervention: 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.
|
|---|---|---|---|---|
|
The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening
Screening-eligible population, aged 45-49 years old
|
158 Participants
|
—
|
—
|
158 Participants
|
|
The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening
Count of screened participants
|
45 Participants
|
—
|
—
|
53 Participants
|
SECONDARY outcome
Timeframe: 60 days after randomizationPopulation: Subjects who are between 45-49 old 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.
Outcome measures
| Measure |
Completed 1 Annual FIT Screening Only in Year 1
n=158 Participants
Completed 1 Annual FIT Screening Only in Year 1
|
Completed 1 Annual FIT Screening Only in Year 2
Completed 1 Annual FIT Screening Only in Year 2
|
Completed 2 Annual FIT Screenings in Year 1 and Year 2
Completed 2 Annual FIT Screenings in Year 1 and Year 2
|
Trial Mailed FIT Intervention - Age Group 50-75
n=158 Participants
Subjects who are between 50-75 years of age and received study intervention.
Trial Mailed FIT Intervention: 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.
|
|---|---|---|---|---|
|
Proportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days
|
20 Participants
|
—
|
—
|
34 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months after abnormal FIT result datePopulation: Subjects who are 45-49 years old completed study intervention.
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.
Outcome measures
| Measure |
Completed 1 Annual FIT Screening Only in Year 1
n=158 Participants
Completed 1 Annual FIT Screening Only in Year 1
|
Completed 1 Annual FIT Screening Only in Year 2
Completed 1 Annual FIT Screening Only in Year 2
|
Completed 2 Annual FIT Screenings in Year 1 and Year 2
Completed 2 Annual FIT Screenings in Year 1 and Year 2
|
Trial Mailed FIT Intervention - Age Group 50-75
n=158 Participants
Subjects who are between 50-75 years of age and received study intervention.
Trial Mailed FIT Intervention: 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.
|
|---|---|---|---|---|
|
Proportion of Subjects Who Completed a Follow up (Diagnostic) Colonoscopy
positive (abnormal) FIT/FOBT result
|
1 Participants
|
—
|
—
|
2 Participants
|
|
Proportion of Subjects Who Completed a Follow up (Diagnostic) Colonoscopy
completed a follow-up colonoscopy
|
1 Participants
|
—
|
—
|
2 Participants
|
Adverse Events
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
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alexis Moore
University of North Carolina Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place