Trial Outcomes & Findings for Stool DNA to Improve Colorectal Cancer Screening Among Alaska Native People (NCT NCT04336397)
NCT ID: NCT04336397
Last Updated: 2025-11-19
Results Overview
Incident CRC screening episode defined as having at least one of the following within 1 year of follow-up after randomization and intervention: colonoscopy; MT-sDNA with a negative result; or MT-sDNA with a positive result followed by a colonoscopy within 1 year.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2029 participants
Primary outcome timeframe
1 year
Results posted on
2025-11-19
Participant Flow
Unit of analysis: Community
Participant milestones
| Measure |
High Intensity
Navigated tribal health worker telephone outreach up to 5 telephone calls and 1 mailed culturally appropriate educational material describing CRC screening options available. If MT-sDNA selected, sent a MT-sDNA kit and follow-up reminders.
|
Medium Intensity
1 mailed culturally appropriate educational material describing CRC screening options available and 1 telephone call from a tribal health worker. If MT-sDNA selected, sent a MT-sDNA kit and follow-up reminders.
|
Usual Care
Usual care (i.e., opportunistic screening recommendation at a clinic visit)
|
|---|---|---|---|
|
Overall Study
STARTED
|
746 16
|
696 16
|
587 14
|
|
Overall Study
COMPLETED
|
746 16
|
696 16
|
587 14
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
At baseline, no participants had chosen a colorectal cancer screening test.
Baseline characteristics by cohort
| Measure |
High Intensity
n=746 Participants
Navigated tribal health worker telephone outreach up to 5 telephone calls and 1 mailed culturally appropriate educational material describing CRC screening options available. If MT-sDNA selected, sent a MT-sDNA kit and follow-up reminders.
|
Medium Intensity
n=696 Participants
1 mailed culturally appropriate educational material describing CRC screening options available and 1 telephone call from a tribal health worker. If MT-sDNA selected, sent a MT-sDNA kit and follow-up reminders.
|
Usual Care
n=587 Participants
Usual care (i.e., opportunistic screening recommendation at a clinic visit)
|
Total
n=2029 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
45-54
|
338 Participants
n=746 Participants
|
321 Participants
n=696 Participants
|
311 Participants
n=587 Participants
|
970 Participants
n=2029 Participants
|
|
Age, Customized
55-64
|
267 Participants
n=746 Participants
|
242 Participants
n=696 Participants
|
178 Participants
n=587 Participants
|
687 Participants
n=2029 Participants
|
|
Age, Customized
65-75
|
141 Participants
n=746 Participants
|
133 Participants
n=696 Participants
|
98 Participants
n=587 Participants
|
372 Participants
n=2029 Participants
|
|
Sex: Female, Male
Female
|
303 Participants
n=746 Participants
|
274 Participants
n=696 Participants
|
239 Participants
n=587 Participants
|
816 Participants
n=2029 Participants
|
|
Sex: Female, Male
Male
|
443 Participants
n=746 Participants
|
422 Participants
n=696 Participants
|
348 Participants
n=587 Participants
|
1213 Participants
n=2029 Participants
|
|
Race/Ethnicity, Customized
Alaska Native
|
746 Participants
n=746 Participants
|
696 Participants
n=696 Participants
|
587 Participants
n=587 Participants
|
2029 Participants
n=2029 Participants
|
|
Region of Enrollment
United States
|
746 participants
n=746 Participants
|
696 participants
n=696 Participants
|
587 participants
n=587 Participants
|
2029 participants
n=2029 Participants
|
|
CRC screening test requested
MT-sDNA
|
0 Participants
At baseline, no participants had chosen a colorectal cancer screening test.
|
0 Participants
At baseline, no participants had chosen a colorectal cancer screening test.
|
0 Participants
At baseline, no participants had chosen a colorectal cancer screening test.
|
0 Participants
At baseline, no participants had chosen a colorectal cancer screening test.
|
|
CRC screening test requested
Colonoscopy
|
0 Participants
At baseline, no participants had chosen a colorectal cancer screening test.
|
0 Participants
At baseline, no participants had chosen a colorectal cancer screening test.
|
0 Participants
At baseline, no participants had chosen a colorectal cancer screening test.
|
0 Participants
At baseline, no participants had chosen a colorectal cancer screening test.
|
|
CRC screening test requested
Unable to contact/Refused
|
0 Participants
At baseline, no participants had chosen a colorectal cancer screening test.
|
0 Participants
At baseline, no participants had chosen a colorectal cancer screening test.
|
0 Participants
At baseline, no participants had chosen a colorectal cancer screening test.
|
0 Participants
At baseline, no participants had chosen a colorectal cancer screening test.
|
PRIMARY outcome
Timeframe: 1 yearIncident CRC screening episode defined as having at least one of the following within 1 year of follow-up after randomization and intervention: colonoscopy; MT-sDNA with a negative result; or MT-sDNA with a positive result followed by a colonoscopy within 1 year.
Outcome measures
| Measure |
High Intensity
n=746 Participants
Navigated tribal health worker telephone outreach up to 5 telephone calls and 1 mailed culturally appropriate educational material describing CRC screening options available. If MT-sDNA selected, sent a MT-sDNA kit and follow-up reminders.
|
Medium Intensity
n=696 Participants
1 mailed culturally appropriate educational material describing CRC screening options available and 1 telephone call from a tribal health worker. If MT-sDNA selected, sent a MT-sDNA kit and follow-up reminders.
|
Usual Care
n=587 Participants
Usual care (i.e., opportunistic screening recommendation at a clinic visit)
|
|---|---|---|---|
|
Colorectal Cancer Screening by Study Arm
|
205 Participants
|
165 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 1 yearTest requested (MT-sDNA or colonoscopy) by intervention participants
Outcome measures
| Measure |
High Intensity
n=539 Participants
Navigated tribal health worker telephone outreach up to 5 telephone calls and 1 mailed culturally appropriate educational material describing CRC screening options available. If MT-sDNA selected, sent a MT-sDNA kit and follow-up reminders.
|
Medium Intensity
n=410 Participants
1 mailed culturally appropriate educational material describing CRC screening options available and 1 telephone call from a tribal health worker. If MT-sDNA selected, sent a MT-sDNA kit and follow-up reminders.
|
Usual Care
Usual care (i.e., opportunistic screening recommendation at a clinic visit)
|
|---|---|---|---|
|
Test Requested (MT-sDNA or Colonoscopy)
MT-sDNA
|
384 Participants
|
277 Participants
|
—
|
|
Test Requested (MT-sDNA or Colonoscopy)
Colonoscopy
|
155 Participants
|
133 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: This measure only includes participants who had an abnormal MT-sDNA test in either the high- and medium-intensity intervention arms and whether they received a follow-up colonoscopy. Usual care arm was not offered MT-sDNA and so is not included in this secondary outcome measure.
Rate of positive MT-sDNA test follow up to diagnostic colonoscopy
Outcome measures
| Measure |
High Intensity
n=37 Participants
Navigated tribal health worker telephone outreach up to 5 telephone calls and 1 mailed culturally appropriate educational material describing CRC screening options available. If MT-sDNA selected, sent a MT-sDNA kit and follow-up reminders.
|
Medium Intensity
n=20 Participants
1 mailed culturally appropriate educational material describing CRC screening options available and 1 telephone call from a tribal health worker. If MT-sDNA selected, sent a MT-sDNA kit and follow-up reminders.
|
Usual Care
Usual care (i.e., opportunistic screening recommendation at a clinic visit)
|
|---|---|---|---|
|
MT-sDNA Diagnostic Follow-up
|
29 Participants
|
20 Participants
|
—
|
Adverse Events
High Intensity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medium Intensity
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
Dr. Diana Redwood
Alaska Native Tribal Health Consortium
Phone: 907-729-3959
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place