Trial Outcomes & Findings for Study to Increase Colorectal Screening (NCT NCT02870049)
NCT ID: NCT02870049
Last Updated: 2025-09-04
Results Overview
Completion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
673 participants
Primary outcome timeframe
23 months
Results posted on
2025-09-04
Participant Flow
Participant milestones
| Measure |
Inreach Strategy
This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders.
Inreach strategy: Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit
|
Outreach Strategy
This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders.
Outreach strategy: Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders
|
Both Inreach and Outreach Strategies
This is a combination of the above two strategies: Inreach and Outreach combined.
Both Inreach and Outreach strategies: Both Inreach and Outreach strategies: Both In clinic education and delivery of fecal immunochemical test (FIT) kit and Mailed fecal immunochemical test (FIT) kit and telephone reminders
|
Usual Care
Usual care in the clinic using the fecal immunochemical test (FIT) kit.
Usual care: Usual care: FIT kit delivery as part of usual care
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
168
|
171
|
167
|
167
|
|
Overall Study
COMPLETED
|
167
|
171
|
166
|
167
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Increase Colorectal Screening
Baseline characteristics by cohort
| Measure |
Inreach Strategy
n=167 Participants
This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders.
Inreach strategy: Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit
|
Outreach Strategy
n=171 Participants
This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders.
Outreach strategy: Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders
|
Both Inreach and Outreach Strategies
n=166 Participants
This is a combination of the above two strategies: Inreach and Outreach combined.
Both Inreach and Outreach strategies: Both Inreach and Outreach strategies: Both In clinic education and delivery of fecal immunochemical test (FIT) kit and Mailed fecal immunochemical test (FIT) kit and telephone reminders
|
Usual Care
n=167 Participants
Usual care in the clinic using the fecal immunochemical test (FIT) kit.
Usual care: Usual care: FIT kit delivery as part of usual care
|
Total
n=671 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
59.9 years
STANDARD_DEVIATION 6.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
343 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
328 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
167 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
671 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
167 participants
n=5 Participants
|
171 participants
n=7 Participants
|
166 participants
n=5 Participants
|
167 participants
n=4 Participants
|
671 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 23 monthsCompletion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy)
Outcome measures
| Measure |
Inreach Strategy
n=167 Participants
This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders.
Inreach strategy: Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit
|
Outreach Strategy
n=171 Participants
This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders.
Outreach strategy: Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders
|
Both Inreach and Outreach Strategies
n=166 Participants
This is a combination of the above two strategies: Inreach and Outreach combined.
Both Inreach and Outreach strategies: Both Inreach and Outreach strategies: Both In clinic education and delivery of fecal immunochemical test (FIT) kit and Mailed fecal immunochemical test (FIT) kit and telephone reminders
|
Usual Care
n=167 Participants
Usual care in the clinic using the fecal immunochemical test (FIT) kit.
Usual care: Usual care: FIT kit delivery as part of usual care
|
|---|---|---|---|---|
|
Screening Completion Rate
|
46 Participants
|
88 Participants
|
132 Participants
|
131 Participants
|
Adverse Events
Inreach Strategy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Outreach Strategy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Both Inreach and Outreach Strategies
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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