Proactive Outreach With FIT

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Health Care Network of New York, Brooklyn, New York, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proactive Screening Outreach

Behavioral

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.

Primary outcomes

Proportion of Participants who Complete FIT Test by Month 6

Time frame: Up to Month 6

Secondary outcomes

Proportion of Participants with Positive FIT who Complete Colonoscopy by Month 6

Time frame: Up to Month 6

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Acronym: PROOF

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Feb 21, 2024
Registry last updated: Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by Invitation