Trial Outcomes & Findings for Colonoscopy Outreach for Rural Communities Aim 2 (NCT NCT05453630)
NCT ID: NCT05453630
Last Updated: 2026-07-15
Results Overview
Number of participants who received a colonoscopy within 12 months (365 days) of their referral for the procedure. Electronic health record documentation of the procedure (e.g., procedure report, pathology report, results letter) or self-report was used to determine whether the patient received the colonoscopy.
COMPLETED
NA
527 participants
1 year
2026-07-15
Participant Flow
Six partner primary care organizations identified potentially eligible patients. The research team recruited participants over 21 months between June 2022 to February 2024. Recruitment outreach occurred via phone, text, and email with enrollment over the phone.
Participant milestones
| Measure |
Patient Navigation Intervention
Participants received the CORC Patient Navigation program: Language-concordant patient navigation from a trained, lay navigator, over the phone and via text and email, to assist participants to complete colonoscopy to screen for colorectal cancer. The navigator was employed by a community-based organization and delivered the program to participants across 3 states.
|
Standard of Care Control
Participants received an educational brochure about colonoscopy to screen for colorectal cancer.
|
|---|---|---|
|
Overall Study
STARTED
|
263
|
264
|
|
Overall Study
COMPLETED
|
260
|
263
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Patient Navigation Intervention
Participants received the CORC Patient Navigation program: Language-concordant patient navigation from a trained, lay navigator, over the phone and via text and email, to assist participants to complete colonoscopy to screen for colorectal cancer. The navigator was employed by a community-based organization and delivered the program to participants across 3 states.
|
Standard of Care Control
Participants received an educational brochure about colonoscopy to screen for colorectal cancer.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Participants who provided a response to this question on the baseline survey
Baseline characteristics by cohort
| Measure |
Patient Navigation Intervention
n=263 Participants
Participants received the CORC Patient Navigation program: Language-concordant patient navigation from a trained, lay navigator, over the phone and via text and email, to assist participants to complete colonoscopy to screen for colorectal cancer
|
Standard of Care Control
n=264 Participants
Participants received an educational brochure about colonoscopy to screen for colorectal cancer
|
Total
n=527 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, categorical · ≤ 18 years
|
0 Participants
n=263 Participants
|
0 Participants
n=264 Participants
|
0 Participants
n=527 Participants
|
|
Age, Customized
Age, categorical · 19 years to 64 years
|
181 Participants
n=263 Participants
|
179 Participants
n=264 Participants
|
360 Participants
n=527 Participants
|
|
Age, Customized
Age, categorical · ≥ 65 years
|
81 Participants
n=263 Participants
|
84 Participants
n=264 Participants
|
165 Participants
n=527 Participants
|
|
Age, Customized
Age, categorical · Unknown
|
1 Participants
n=263 Participants
|
1 Participants
n=264 Participants
|
2 Participants
n=527 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
123 Participants
n=263 Participants
|
114 Participants
n=264 Participants
|
237 Participants
n=527 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
139 Participants
n=263 Participants
|
149 Participants
n=264 Participants
|
288 Participants
n=527 Participants
|
|
Sex/Gender, Customized
Gender · Unknown
|
1 Participants
n=263 Participants
|
1 Participants
n=264 Participants
|
2 Participants
n=527 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=263 Participants
|
3 Participants
n=264 Participants
|
10 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=263 Participants
|
0 Participants
n=264 Participants
|
2 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=263 Participants
|
0 Participants
n=264 Participants
|
0 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=263 Participants
|
1 Participants
n=264 Participants
|
3 Participants
n=527 Participants
|
|
Race (NIH/OMB)
White
|
243 Participants
n=263 Participants
|
255 Participants
n=264 Participants
|
498 Participants
n=527 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=263 Participants
|
3 Participants
n=264 Participants
|
8 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=263 Participants
|
2 Participants
n=264 Participants
|
6 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=263 Participants
|
44 Participants
n=264 Participants
|
88 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
217 Participants
n=263 Participants
|
217 Participants
n=264 Participants
|
434 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=263 Participants
|
3 Participants
n=264 Participants
|
5 Participants
n=527 Participants
|
|
Region of Enrollment
United States
|
263 Participants
n=263 Participants
|
264 Participants
n=264 Participants
|
527 Participants
n=527 Participants
|
|
Rurality
Rural
|
199 Participants
n=263 Participants
|
195 Participants
n=264 Participants
|
394 Participants
n=527 Participants
|
|
Rurality
Urban
|
64 Participants
n=263 Participants
|
69 Participants
n=264 Participants
|
133 Participants
n=527 Participants
|
|
Insurance type
Private
|
124 Participants
n=263 Participants
|
125 Participants
n=264 Participants
|
249 Participants
n=527 Participants
|
|
Insurance type
Medicare
|
71 Participants
n=263 Participants
|
78 Participants
n=264 Participants
|
149 Participants
n=527 Participants
|
|
Insurance type
Medicaid
|
58 Participants
n=263 Participants
|
51 Participants
n=264 Participants
|
109 Participants
n=527 Participants
|
|
Insurance type
Other insurance
|
3 Participants
n=263 Participants
|
2 Participants
n=264 Participants
|
5 Participants
n=527 Participants
|
|
Insurance type
Uninsured
|
6 Participants
n=263 Participants
|
7 Participants
n=264 Participants
|
13 Participants
n=527 Participants
|
|
Insurance type
Unknown
|
1 Participants
n=263 Participants
|
1 Participants
n=264 Participants
|
2 Participants
n=527 Participants
|
|
Primary language
English
|
235 Participants
n=263 Participants
|
235 Participants
n=264 Participants
|
470 Participants
n=527 Participants
|
|
Primary language
Spanish
|
28 Participants
n=263 Participants
|
29 Participants
n=264 Participants
|
57 Participants
n=527 Participants
|
|
Education
Less than high school degree or GED
|
32 Participants
n=258 Participants • Participants who provided a response to this question on the baseline survey
|
38 Participants
n=255 Participants • Participants who provided a response to this question on the baseline survey
|
70 Participants
n=513 Participants • Participants who provided a response to this question on the baseline survey
|
|
Education
High school graduate or GED
|
55 Participants
n=258 Participants • Participants who provided a response to this question on the baseline survey
|
63 Participants
n=255 Participants • Participants who provided a response to this question on the baseline survey
|
118 Participants
n=513 Participants • Participants who provided a response to this question on the baseline survey
|
|
Education
Some college or Associate's degree
|
86 Participants
n=258 Participants • Participants who provided a response to this question on the baseline survey
|
77 Participants
n=255 Participants • Participants who provided a response to this question on the baseline survey
|
163 Participants
n=513 Participants • Participants who provided a response to this question on the baseline survey
|
|
Education
Bachelor's degree or higher
|
85 Participants
n=258 Participants • Participants who provided a response to this question on the baseline survey
|
77 Participants
n=255 Participants • Participants who provided a response to this question on the baseline survey
|
162 Participants
n=513 Participants • Participants who provided a response to this question on the baseline survey
|
|
Prior colonoscopy
Yes
|
134 Participants
n=256 Participants • Participants who provided a response to this question on the baseline survey
|
148 Participants
n=254 Participants • Participants who provided a response to this question on the baseline survey
|
282 Participants
n=510 Participants • Participants who provided a response to this question on the baseline survey
|
|
Prior colonoscopy
No
|
122 Participants
n=256 Participants • Participants who provided a response to this question on the baseline survey
|
106 Participants
n=254 Participants • Participants who provided a response to this question on the baseline survey
|
228 Participants
n=510 Participants • Participants who provided a response to this question on the baseline survey
|
|
Family history of CRC
Yes
|
31 Participants
n=249 Participants • Participants who provided a response to this question on the baseline survey
|
31 Participants
n=251 Participants • Participants who provided a response to this question on the baseline survey
|
62 Participants
n=500 Participants • Participants who provided a response to this question on the baseline survey
|
|
Family history of CRC
No
|
218 Participants
n=249 Participants • Participants who provided a response to this question on the baseline survey
|
220 Participants
n=251 Participants • Participants who provided a response to this question on the baseline survey
|
438 Participants
n=500 Participants • Participants who provided a response to this question on the baseline survey
|
|
General health
Excellent or very good
|
104 Participants
n=259 Participants • Participants who provided a response to this question on the baseline survey
|
99 Participants
n=256 Participants • Participants who provided a response to this question on the baseline survey
|
203 Participants
n=515 Participants • Participants who provided a response to this question on the baseline survey
|
|
General health
Good
|
99 Participants
n=259 Participants • Participants who provided a response to this question on the baseline survey
|
103 Participants
n=256 Participants • Participants who provided a response to this question on the baseline survey
|
202 Participants
n=515 Participants • Participants who provided a response to this question on the baseline survey
|
|
General health
Fair or poor
|
56 Participants
n=259 Participants • Participants who provided a response to this question on the baseline survey
|
54 Participants
n=256 Participants • Participants who provided a response to this question on the baseline survey
|
110 Participants
n=515 Participants • Participants who provided a response to this question on the baseline survey
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All enrolled participants (intention to treat analysis).
Number of participants who received a colonoscopy within 12 months (365 days) of their referral for the procedure. Electronic health record documentation of the procedure (e.g., procedure report, pathology report, results letter) or self-report was used to determine whether the patient received the colonoscopy.
Outcome measures
| Measure |
Standard of Care Control
n=264 Participants
Participants received an educational brochure about colonoscopy to screen for colorectal cancer
|
Patient Navigation Intervention
n=263 Participants
Participants received the CORC Patient Navigation program: Language-concordant patient navigation from a trained, lay navigator, over the phone and via text and email, to assist participants to complete colonoscopy to screen for colorectal cancer
|
|---|---|---|
|
Number of Participants Who Complete Colonoscopy Within 1 Year of the Colonoscopy Referral
|
184 Participants
|
196 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: All enrolled participants (intention to treat analysis).
Number of participants who received a colonoscopy within 9 months (274 days) of their referral for the procedure. Electronic health record documentation of the procedure (e.g., procedure report, pathology report, results letter) or self-report was used to determine whether the patient received the colonoscopy.
Outcome measures
| Measure |
Standard of Care Control
n=264 Participants
Participants received an educational brochure about colonoscopy to screen for colorectal cancer
|
Patient Navigation Intervention
n=263 Participants
Participants received the CORC Patient Navigation program: Language-concordant patient navigation from a trained, lay navigator, over the phone and via text and email, to assist participants to complete colonoscopy to screen for colorectal cancer
|
|---|---|---|
|
Number of Participants Who Complete Colonoscopy Within 9 Months of the Colonoscopy Referral
|
175 Participants
|
187 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All enrolled participants (intention to treat analysis).
Number of participants who received a colonoscopy within 6 months (183 days) of their referral for the procedure. Electronic health record documentation of the procedure (e.g., procedure report, pathology report, results letter) or self-report was used to determine whether the patient received the colonoscopy.
Outcome measures
| Measure |
Standard of Care Control
n=264 Participants
Participants received an educational brochure about colonoscopy to screen for colorectal cancer
|
Patient Navigation Intervention
n=263 Participants
Participants received the CORC Patient Navigation program: Language-concordant patient navigation from a trained, lay navigator, over the phone and via text and email, to assist participants to complete colonoscopy to screen for colorectal cancer
|
|---|---|---|
|
Number of Participants Who Complete Colonoscopy Within 6 Months of the Colonoscopy Referral
|
151 Participants
|
166 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All enrolled participants (intention to treat analysis).
Kaplan-Meier estimated median days to completion. Based on the number of days to colonoscopy completion or end of the 12 month (365 day) follow-up period, from the participant's referral for the procedure. Electronic health record documentation of the procedure (e.g., procedure report, pathology report, results letter) or self-report was used to determine whether the patient received the colonoscopy.
Outcome measures
| Measure |
Standard of Care Control
n=264 Participants
Participants received an educational brochure about colonoscopy to screen for colorectal cancer
|
Patient Navigation Intervention
n=263 Participants
Participants received the CORC Patient Navigation program: Language-concordant patient navigation from a trained, lay navigator, over the phone and via text and email, to assist participants to complete colonoscopy to screen for colorectal cancer
|
|---|---|---|
|
Time to Completion of Colonoscopy or End of Follow-up After the Colonoscopy Referral
|
159 Days
Interval 140.0 to 180.0
|
129 Days
Interval 118.0 to 142.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants who received a colonoscopy within 12 months and had colonoscopy procedure information describing prep in their electronic health record.
Number of participants who received a colonoscopy within 12 months of their referral who had documentation of adequate bowel preparation in their electronic health record. Adequate bowel preparation was defined as a subjective rating of fair, adequate, good, or excellent; or a Boston Bowel Preparation Score (BBPS) total of 6 or higher. The BBPS scale ranges from 0-9 with higher values indicating better preparation.
Outcome measures
| Measure |
Standard of Care Control
n=175 Participants
Participants received an educational brochure about colonoscopy to screen for colorectal cancer
|
Patient Navigation Intervention
n=187 Participants
Participants received the CORC Patient Navigation program: Language-concordant patient navigation from a trained, lay navigator, over the phone and via text and email, to assist participants to complete colonoscopy to screen for colorectal cancer
|
|---|---|---|
|
Number of Participants Who Have Completed Colonoscopies With Adequate Preparation
|
170 Participants
|
182 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants who received a colonoscopy within 12 months, did not have an obstruction due to cancer, and had procedure information in their electronic health record.
Number of participants who received a colonoscopy within 12 months of their referral who had documentation of cecal intubation in their electronic health record. Cecal intubation was considered achieved if there was text documenting reaching the cecum or photographic documentation labeled with cecal landmarks in the procedure information.
Outcome measures
| Measure |
Standard of Care Control
n=175 Participants
Participants received an educational brochure about colonoscopy to screen for colorectal cancer
|
Patient Navigation Intervention
n=189 Participants
Participants received the CORC Patient Navigation program: Language-concordant patient navigation from a trained, lay navigator, over the phone and via text and email, to assist participants to complete colonoscopy to screen for colorectal cancer
|
|---|---|---|
|
Number of Participants Who Have Colonoscopies With Cecal Intubation
|
172 Participants
|
185 Participants
|
Adverse Events
Patient Navigation Intervention
Standard of Care Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place