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Flatbush FHC Proactive Colorectal Cancer Screening and Navigation

Primary Purpose

Colorectal Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proactive CRC Screening Outreach
Usual Care
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • NYU Brooklyn Family Health Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Proactive Screening Outreach

Usual Care

Arm 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.

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

Outcomes

Primary Outcome Measures

Number of Participants who Complete Initial FIT at 6 Months
Number of Participants who Completed Colonoscopy at 6 Months

Secondary Outcome Measures

Number of Participants with Positive FIT Test who Complete Colonoscopy at 6 Months

Full Information

First Posted
December 2, 2022
Last Updated
May 2, 2023
Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05646355
Brief Title
Flatbush FHC Proactive Colorectal Cancer Screening and Navigation
Official Title
Colorectal Cancer Screening Through Proactive Outreach and Navigation in a Federally Qualified Health Care Center in Brooklyn
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proactive Screening Outreach
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Individuals in the usual care group will not be approached or notified of their enrollment in the study.
Intervention Type
Behavioral
Intervention Name(s)
Proactive CRC Screening Outreach
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Participants will not receive additional outreach from the study team regarding CRC screening.
Primary Outcome Measure Information:
Title
Number of Participants who Complete Initial FIT at 6 Months
Time Frame
Up to Month 6
Title
Number of Participants who Completed Colonoscopy at 6 Months
Time Frame
Up to Month 6
Secondary Outcome Measure Information:
Title
Number of Participants with Positive FIT Test who Complete Colonoscopy at 6 Months
Time Frame
Up to Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aasma Shaukat
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Brooklyn Family Health Centers
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Flatbush FHC Proactive Colorectal Cancer Screening and Navigation

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