Proactive Outreach With FIT

Colorectal Cancer Clinical Trial

— PROOF  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06269744
• Other study ID #: 23-01032
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3000
• Est. completion date: April 30, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Proactive 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.

Locations

Country	Name	City	State
United States	Community Health Care Network of New York	Brooklyn	New York
United States	NYU Langone Health	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants who Complete FIT Test by Month 6		Up to Month 6
Secondary	Proportion of Participants with Positive FIT who Complete Colonoscopy by Month 6		Up to Month 6