Flatbush FHC Proactive Colorectal Cancer Screening and Navigation

Not Applicable

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT05646355
• Lead Sponsor: NYU Langone Health

Brief Summary

The proposed study is a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice.

Detailed Description

The proposed study is a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice, which provides free and subsidized health services to underrepresented minorities. The investigators will randomize patients to the proactive screening outreach arm which will include mailed letters providing patients with information regarding their eligibility for and instructions for performing colorectal cancer screening with FIT testing or colonoscopy. Colorectal cancer screening rates via FIT testing or colonoscopy will be compared in the proactive outreach group and the usual care group. The investigators hypothesize that rates of colorectal cancer screening will improve in underserved populations with the implementation of a proactive approach that incorporates a mailed outreach invitation to screen, followed by active assistance to a colonoscopy completion if preferred or indicated.

Study Timeline

• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-12
• Study Start: 2023-03-15
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11
• Results First Submitted: 2024-11-25
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Results First Posted: 2024-12-27
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• Receiving medical care at Flatbush FHC
• Due or overdue for CRC screening

Exclusion Criteria

• Age younger than 45 years old or greater than 75 years old
• Up-to-date with colorectal cancer screening (FIT within 1 year or colonoscopy within 10 years)
• History of colorectal cancer, inflammatory bowel disease or colorectal polyps
• No address or phone number on file
• FIT test ordered within 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months	Up to Month 6	Number of Participants who completed CRC screening via FIT by 6 months past the start of intervention
Number of Participants Who Completed Colonoscopy at 6 Months	Up to Month 6	Number of Participants who underwent colonoscopy by 6 months past the start of intervention

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Positive FIT Test Who Complete Colonoscopy at 6 Months	Up to Month 6	Number of Participants who underwent colonoscopy after a positive FIT result by 6 months past the start of intervention

Trial Locations

Locations (1)

NYU Brooklyn Family Health Centers; 🇺🇸 Brooklyn, New York, United States