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Flatbush FHC Proactive Colorectal Cancer Screening and Navigation

NCT ID: NCT05646355

Last Updated: 2024-12-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2023-12-11

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Proactive 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.

Group Type EXPERIMENTAL

Proactive CRC Screening Outreach

Intervention Type BEHAVIORAL

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

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Participants will not receive additional outreach from the study team regarding CRC screening.

Interventions

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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.

Intervention Type BEHAVIORAL

Usual Care

Participants will not receive additional outreach from the study team regarding CRC screening.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aasma Shaukat

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Brooklyn Family Health Centers

Brooklyn, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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22-00730

Identifier Type: -

Identifier Source: org_study_id