Trial Outcomes & Findings for Interventions to Improve Colorectal Cancer Screening (NCT NCT00692211)
NCT ID: NCT00692211
Last Updated: 2015-05-13
Results Overview
Completing fecal blood test within 90 days of enrolling
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
404 participants
Primary outcome timeframe
3 months
Results posted on
2015-05-13
Participant Flow
Participant milestones
| Measure |
Arm 1: Fecal Immunochemical Tests
Mailed fecal immunochemical tests
Fecal immunochemical testing: Stool blood test
|
Arm 2: Fecal Occult Blood Tests
Mailed fecal occult blood tests
Fecal occult blood test: Stool blood test
|
|---|---|---|
|
Overall Study
STARTED
|
202
|
202
|
|
Overall Study
COMPLETED
|
202
|
202
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interventions to Improve Colorectal Cancer Screening
Baseline characteristics by cohort
| Measure |
Arm 1: Fecal Immunochemical Tests
n=202 Participants
Mailed fecal immunochemical tests
Fecal immunochemical testing: Stool blood test
|
Arm 2: Fecal Occult Blood Tests
n=202 Participants
Mailed fecal occult blood tests
Fecal occult blood test: Stool blood test
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
128 Participants
n=99 Participants
|
131 Participants
n=107 Participants
|
259 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
74 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
145 Participants
n=206 Participants
|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 7.3 • n=99 Participants
|
63.9 years
STANDARD_DEVIATION 8.1 • n=107 Participants
|
63.9 years
STANDARD_DEVIATION 7.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
199 Participants
n=99 Participants
|
193 Participants
n=107 Participants
|
392 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
202 participants
n=99 Participants
|
202 participants
n=107 Participants
|
404 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsCompleting fecal blood test within 90 days of enrolling
Outcome measures
| Measure |
Arm 1: Fecal Immunochemical Tests
n=202 Participants
Mailed fecal immunochemical tests
Fecal immunochemical testing: Stool blood test
|
Arm 2: Fecal Occult Blood Tests
n=202 Participants
Mailed fecal occult blood tests
Fecal occult blood test: Stool blood test
|
|---|---|---|
|
Colorectal Cancer Screening
|
127 participants
|
112 participants
|
Adverse Events
Arm 1: Fecal Immunochemical Tests
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Fecal Occult Blood Tests
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