Flatbush FHC Proactive Colorectal Cancer Screening and Navigation

NYU Langone Health

Status: Completed

Conditions: Colorectal Cancer

Treatments: Behavioral: Proactive CRC Screening Outreach; Behavioral: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05646355

22-00730

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

Proactive Screening Outreach

Experimental group

Description:

Participants will receive a letter from their clinic explaining CRC screening options (fecal immunochemical test (FIT) vs colonoscopy) including a FIT kit with completion and return instructions. The letter will also include information for navigation to a screening colonoscopy instead of FIT testing, if deemed to be the participant's preference. Approximately 10-14 days after mailing the FIT kit, participants who have not completed screening will receive a telephone call (with voice message left) and text message, querying whether the FIT kit was received and reminding the participant to complete the test or request a new kit, if needed. If the FIT kit has not been submitted after about two weeks from the reminder call/text message, the study team will mail a final letter to the participant on behalf of the clinic, reminding them to complete and return the FIT kit.

Treatment:

Behavioral: Proactive CRC Screening Outreach

Usual Care

Active Comparator group

Description:

Individuals in the usual care group will not be approached or notified of their enrollment in the study.

Treatment:

Behavioral: Usual Care