Skip to content

Proactive Outreach With FIT

A Randomized, Multi-site Trial to Boost Colorectal Cancer Screening Rates Through Proactive Outreach and Navigation in Federally Qualified Health Centers in Brooklyn

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06269744
Acronym
PROOF
Enrollment
3000
Registered
2024-02-21
Start date
2024-03-13
Completion date
2026-04-30
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

BEHAVIORALProactive Screening Outreach

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.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Proportion of Participants who Complete FIT Test by Month 6Up to Month 6

Secondary

MeasureTime frame
Proportion of Participants with Positive FIT who Complete Colonoscopy by Month 6Up to Month 6

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026