Flatbush FHC Proactive Colorectal Cancer Screening and Navigation
Colorectal Cancer Screening Through Proactive Outreach and Navigation in a Federally Qualified Health Care Center in Brooklyn
1 other identifier
interventional
109
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Mar 2023
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2022
CompletedFirst Posted
Study publicly available on registry
December 12, 2022
CompletedStudy Start
First participant enrolled
March 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2023
CompletedResults Posted
Study results publicly available
December 27, 2024
CompletedDecember 27, 2024
December 1, 2024
9 months
December 2, 2022
November 25, 2024
December 19, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months
Number of Participants who completed CRC screening via FIT by 6 months past the start of intervention
Up to Month 6
Number of Participants Who Completed Colonoscopy at 6 Months
Number of Participants who underwent colonoscopy by 6 months past the start of intervention
Up to Month 6
Secondary Outcomes (1)
Number of Participants With Positive FIT Test Who Complete Colonoscopy at 6 Months
Up to Month 6
Study Arms (2)
Proactive Screening Outreach
EXPERIMENTALParticipants 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.
Usual Care
ACTIVE COMPARATORIndividuals in the usual care group will not be approached or notified of their enrollment in the study.
Interventions
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.
Participants will not receive additional outreach from the study team regarding CRC screening.
Eligibility Criteria
You may qualify if:
- Receiving medical care at Flatbush FHC
- Due or overdue for CRC screening
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
NYU Brooklyn Family Health Centers
Brooklyn, New York, 11220, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Aasma Shaukat
- Organization
- NYU Langone Health
Study Officials
- PRINCIPAL INVESTIGATOR
Aasma Shaukat
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2022
First Posted
December 12, 2022
Study Start
March 15, 2023
Primary Completion
December 11, 2023
Study Completion
December 11, 2023
Last Updated
December 27, 2024
Results First Posted
December 27, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Aasma.Shaukat@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Aasma.Shaukat@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.