Flatbush FHC Proactive Colorectal Cancer Screening and Navigation

Colorectal Cancer Clinical Trial

Official title:

Colorectal Cancer Screening Through Proactive Outreach and Navigation in a Federally Qualified Health Care Center in Brooklyn

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05646355
• Other study ID #: 22-00730
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: December 11, 2023

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Proactive CRC Screening Outreach
Proactive approach that incorporates a mailed outreach invitation to screen with fecal immunochemical testing (FIT), followed by active assistance to colonoscopy completion if preferred or indicated by FIT test result.
• Usual Care
Participants will not receive additional outreach from the study team regarding CRC screening.

Locations

Country	Name	City	State
United States	NYU Brooklyn Family Health Centers	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who Complete Initial FIT at 6 Months		Up to Month 6
Primary	Number of Participants who Completed Colonoscopy at 6 Months		Up to Month 6
Secondary	Number of Participants with Positive FIT Test who Complete Colonoscopy at 6 Months		Up to Month 6