Flatbush FHC Proactive Colorectal Cancer Screening and Navigation
- Conditions
- Colorectal Cancer
- Interventions
- Behavioral: Usual CareBehavioral: Proactive CRC Screening Outreach
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
- Receiving medical care at Flatbush FHC
- Due or overdue for CRC screening
- 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
- Arm && Interventions
Group Intervention Description Usual Care Usual Care Individuals in the usual care group will not be approached or notified of their enrollment in the study. Proactive Screening Outreach Proactive CRC Screening Outreach 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.
- 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