Trial Outcomes & Findings for Flatbush FHC Proactive Colorectal Cancer Screening and Navigation (NCT NCT05646355)
NCT ID: NCT05646355
Last Updated: 2024-12-27
Results Overview
Number of Participants who completed CRC screening via FIT by 6 months past the start of intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
Up to Month 6
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Proactive Screening Outreach
Participants will receive a letter from their clinic explaining CRC screening options (fecal immunochemical test (FIT) vs colonoscopy) including a FIT kit with completion and return instructions. The letter will also include information for navigation to a screening colonoscopy instead of FIT testing, if deemed to be the participant's preference.
Approximately 10-14 days after mailing the FIT kit, participants who have not completed screening will receive a telephone call (with voice message left) and text message, querying whether the FIT kit was received and reminding the participant to complete the test or request a new kit, if needed.
If the FIT kit has not been submitted after about two weeks from the reminder call/text message, the study team will mail a final letter to the participant on behalf of the clinic, reminding them to complete and return the FIT kit.
Proactive CRC Screening Outreach: Proactive approach that incorporates a mailed outreach invitation to screen with fecal immunochemical testing (FIT), followed by active assistance to colonoscopy completion if preferred or indicated by FIT test result.
|
Usual Care
Individuals in the usual care group will not be approached or notified of their enrollment in the study.
Usual Care: Participants will not receive additional outreach from the study team regarding CRC screening.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
9
|
0
|
Reasons for withdrawal
| Measure |
Proactive Screening Outreach
Participants will receive a letter from their clinic explaining CRC screening options (fecal immunochemical test (FIT) vs colonoscopy) including a FIT kit with completion and return instructions. The letter will also include information for navigation to a screening colonoscopy instead of FIT testing, if deemed to be the participant's preference.
Approximately 10-14 days after mailing the FIT kit, participants who have not completed screening will receive a telephone call (with voice message left) and text message, querying whether the FIT kit was received and reminding the participant to complete the test or request a new kit, if needed.
If the FIT kit has not been submitted after about two weeks from the reminder call/text message, the study team will mail a final letter to the participant on behalf of the clinic, reminding them to complete and return the FIT kit.
Proactive CRC Screening Outreach: Proactive approach that incorporates a mailed outreach invitation to screen with fecal immunochemical testing (FIT), followed by active assistance to colonoscopy completion if preferred or indicated by FIT test result.
|
Usual Care
Individuals in the usual care group will not be approached or notified of their enrollment in the study.
Usual Care: Participants will not receive additional outreach from the study team regarding CRC screening.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
translated materials not available for pilot
|
2
|
0
|
|
Overall Study
no longer screen eligible (completed screening prior to intervention)
|
6
|
0
|
Baseline Characteristics
Flatbush FHC Proactive Colorectal Cancer Screening and Navigation
Baseline characteristics by cohort
| Measure |
Proactive Screening Outreach
n=50 Participants
Participants will receive a letter from their clinic explaining CRC screening options (fecal immunochemical test (FIT) vs colonoscopy) including a FIT kit with completion and return instructions. The letter will also include information for navigation to a screening colonoscopy instead of FIT testing, if deemed to be the participant's preference.
Approximately 10-14 days after mailing the FIT kit, participants who have not completed screening will receive a telephone call (with voice message left) and text message, querying whether the FIT kit was received and reminding the participant to complete the test or request a new kit, if needed.
If the FIT kit has not been submitted after about two weeks from the reminder call/text message, the study team will mail a final letter to the participant on behalf of the clinic, reminding them to complete and return the FIT kit.
Proactive CRC Screening Outreach: Proactive approach that incorporates a mailed outreach invitation to screen with fecal immunochemical testing (FIT), followed by active assistance to colonoscopy completion if preferred or indicated by FIT test result.
|
Usual Care
n=50 Participants
Individuals in the usual care group will not be approached or notified of their enrollment in the study.
Usual Care: Participants will not receive additional outreach from the study team regarding CRC screening.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.54 years
STANDARD_DEVIATION 8.53 • n=5 Participants
|
55.40 years
STANDARD_DEVIATION 8.42 • n=7 Participants
|
55.47 years
STANDARD_DEVIATION 8.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Month 6Number of Participants who completed CRC screening via FIT by 6 months past the start of intervention
Outcome measures
| Measure |
Proactive Screening Outreach
n=50 Participants
Participants will receive a letter from their clinic explaining CRC screening options (fecal immunochemical test (FIT) vs colonoscopy) including a FIT kit with completion and return instructions. The letter will also include information for navigation to a screening colonoscopy instead of FIT testing, if deemed to be the participant's preference.
Approximately 10-14 days after mailing the FIT kit, participants who have not completed screening will receive a telephone call (with voice message left) and text message, querying whether the FIT kit was received and reminding the participant to complete the test or request a new kit, if needed.
If the FIT kit has not been submitted after about two weeks from the reminder call/text message, the study team will mail a final letter to the participant on behalf of the clinic, reminding them to complete and return the FIT kit.
Proactive CRC Screening Outreach: Proactive approach that incorporates a mailed outreach invitation to screen with fecal immunochemical testing (FIT), followed by active assistance to colonoscopy completion if preferred or indicated by FIT test result.
|
Usual Care
n=50 Participants
Individuals in the usual care group will not be approached or notified of their enrollment in the study.
Usual Care: Participants will not receive additional outreach from the study team regarding CRC screening.
|
|---|---|---|
|
Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months
|
7 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Month 6Number of Participants who underwent colonoscopy by 6 months past the start of intervention
Outcome measures
| Measure |
Proactive Screening Outreach
n=50 Participants
Participants will receive a letter from their clinic explaining CRC screening options (fecal immunochemical test (FIT) vs colonoscopy) including a FIT kit with completion and return instructions. The letter will also include information for navigation to a screening colonoscopy instead of FIT testing, if deemed to be the participant's preference.
Approximately 10-14 days after mailing the FIT kit, participants who have not completed screening will receive a telephone call (with voice message left) and text message, querying whether the FIT kit was received and reminding the participant to complete the test or request a new kit, if needed.
If the FIT kit has not been submitted after about two weeks from the reminder call/text message, the study team will mail a final letter to the participant on behalf of the clinic, reminding them to complete and return the FIT kit.
Proactive CRC Screening Outreach: Proactive approach that incorporates a mailed outreach invitation to screen with fecal immunochemical testing (FIT), followed by active assistance to colonoscopy completion if preferred or indicated by FIT test result.
|
Usual Care
n=50 Participants
Individuals in the usual care group will not be approached or notified of their enrollment in the study.
Usual Care: Participants will not receive additional outreach from the study team regarding CRC screening.
|
|---|---|---|
|
Number of Participants Who Completed Colonoscopy at 6 Months
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Month 6Number of Participants who underwent colonoscopy after a positive FIT result by 6 months past the start of intervention
Outcome measures
| Measure |
Proactive Screening Outreach
n=50 Participants
Participants will receive a letter from their clinic explaining CRC screening options (fecal immunochemical test (FIT) vs colonoscopy) including a FIT kit with completion and return instructions. The letter will also include information for navigation to a screening colonoscopy instead of FIT testing, if deemed to be the participant's preference.
Approximately 10-14 days after mailing the FIT kit, participants who have not completed screening will receive a telephone call (with voice message left) and text message, querying whether the FIT kit was received and reminding the participant to complete the test or request a new kit, if needed.
If the FIT kit has not been submitted after about two weeks from the reminder call/text message, the study team will mail a final letter to the participant on behalf of the clinic, reminding them to complete and return the FIT kit.
Proactive CRC Screening Outreach: Proactive approach that incorporates a mailed outreach invitation to screen with fecal immunochemical testing (FIT), followed by active assistance to colonoscopy completion if preferred or indicated by FIT test result.
|
Usual Care
n=50 Participants
Individuals in the usual care group will not be approached or notified of their enrollment in the study.
Usual Care: Participants will not receive additional outreach from the study team regarding CRC screening.
|
|---|---|---|
|
Number of Participants With Positive FIT Test Who Complete Colonoscopy at 6 Months
|
0 Participants
|
0 Participants
|
Adverse Events
Proactive Screening Outreach
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