Proactive Outreach With FIT (PROOF)

NYU Langone Health

Status: Invitation-only

Conditions: Colorectal Cancer

Treatments: Behavioral: Proactive Screening Outreach

Study type: Interventional

Funder types: Other

Identifiers

NCT06269744

23-01032

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,000 participants in 2 patient groups

Proactive Screening Outreach

Experimental group

Description:

Participants assigned to the interventional arm will receive proactive outreach of mailed Fecal Immunochemical Tests (FIT) to screen for colorectal cancer.

Treatment:

Behavioral: Proactive Screening Outreach

Standard of Care

No Intervention group

Description:

Participants assigned to the standard of care group will receive usual care (i.e., opportunistic screening for colorectal cancer).