Proactive Outreach With FIT
PROOF
A Randomized, Multi-site Trial to Boost Colorectal Cancer Screening Rates Through Proactive Outreach and Navigation in Federally Qualified Health Centers in Brooklyn
1 other identifier
interventional
3,000
1 country
2
Brief Summary
The purpose of the study is to boost colorectal cancer (CRC) screening rates in an underserved population in Brooklyn through organized, proactive outreach of mailed Fecal Immunochemical Tests (FIT), utilizing evidence-based interventions tailored to the needs of the population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Mar 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2024
CompletedFirst Posted
Study publicly available on registry
February 21, 2024
CompletedStudy Start
First participant enrolled
March 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedDecember 2, 2025
December 1, 2025
1.8 years
February 14, 2024
December 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Participants who Complete FIT Test by Month 6
Up to Month 6
Secondary Outcomes (1)
Proportion of Participants with Positive FIT who Complete Colonoscopy by Month 6
Up to Month 6
Study Arms (2)
Proactive Screening Outreach
EXPERIMENTALParticipants assigned to the interventional arm will receive proactive outreach of mailed Fecal Immunochemical Tests (FIT) to screen for colorectal cancer.
Standard of Care
NO INTERVENTIONParticipants assigned to the standard of care group will receive usual care (i.e., opportunistic screening for colorectal cancer).
Interventions
Individuals in the interventional arm will receive an information letter, followed by mailed FIT kit. Individuals that do not respond will receive reminder phone calls. Individuals that do respond will receive navigation to assist with completion of FIT and the colonoscopy if FIT is abnormal. Clinic processes will be closely followed and the primary care provider will be informed of the program.
Eligibility Criteria
You may qualify if:
- Patients
- Men and women aged 45-75
- Receiving medical care at NYULH Flatbush FHC and CHN Crown Heights, East New York, East New York Health Hub, Williamsburg clinic sites.
- Due or overdue for CRC screening.
- Medical visit of any type at clinic in past year.
- Providers
- Physicians or primary care givers at Flatbush FHC or CHN Crown Heights, East New York, East New York Health Hub, Williamsburg clinic sites (CHN employees)
- Provide care to CRC screen-eligible patients
You may not qualify if:
- Age younger than 45 years old or greater than 75 years old
- Up-to-date with colorectal cancer screening:
- History of colorectal cancer, inflammatory bowel disease, colorectal polyps, or total colectomy
- In hospice care
- Patients 66 years or older living long-term in an institution or with advanced illness
- No address or phone number on file
- Providers
- No longer employed at an included clinic site
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
NYU Langone Health
Brooklyn, New York, 11203, United States
Community Health Care Network of New York
Brooklyn, New York, 11206, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aasma Shaukat
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2024
First Posted
February 21, 2024
Study Start
March 13, 2024
Primary Completion
December 15, 2025
Study Completion
April 30, 2026
Last Updated
December 2, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Aasma.Shaukat@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Aasma.Shaukat@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.