- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05646355
Flatbush FHC Proactive Colorectal Cancer Screening and Navigation
Colorectal Cancer Screening Through Proactive Outreach and Navigation in a Federally Qualified Health Care Center in Brooklyn
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aasma Shaukat
- Phone Number: 212-686-7500
- Email: Aasma.Shaukat@nyulangone.org
Study Locations
-
-
New York
-
Brooklyn, New York, United States, 11220
- NYU Brooklyn Family Health Centers
-
Principal Investigator:
- Aasma Shaukat
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Receiving medical care at Flatbush FHC
- Due or overdue for CRC screening
Exclusion Criteria:
- Age younger than 45 years old or greater than 75 years old
- Up-to-date with colorectal cancer screening (FIT within 1 year or colonoscopy within 10 years)
- History of colorectal cancer, inflammatory bowel disease or colorectal polyps
- No address or phone number on file
- FIT test ordered within 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 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.
|
Active Comparator: Usual Care
Individuals in the usual care group will not be approached or notified of their enrollment in the study.
|
Participants will not receive additional outreach from the study team regarding CRC screening.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants who Complete Initial FIT at 6 Months
Time Frame: Up to Month 6
|
Up to Month 6
|
Number of Participants who Completed Colonoscopy at 6 Months
Time Frame: Up to Month 6
|
Up to Month 6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Positive FIT Test who Complete Colonoscopy at 6 Months
Time Frame: Up to Month 6
|
Up to Month 6
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aasma Shaukat, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-00730
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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