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OpenTrials
Completed

NCT Number: NCT05646355

Flatbush FHC Proactive Colorectal Cancer Screening and Navigation

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Brooklyn Family Health Centers

Brooklyn, New York, 11220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proactive CRC Screening Outreach

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

Behavioral

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

Primary outcomes

  1. Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months

    Time frame: Up to Month 6

    Number of Participants who completed CRC screening via FIT by 6 months past the start of intervention

  2. Number of Participants Who Completed Colonoscopy at 6 Months

    Time frame: Up to Month 6

    Number of Participants who underwent colonoscopy by 6 months past the start of intervention

Secondary outcomes

  1. Number of Participants With Positive FIT Test Who Complete Colonoscopy at 6 Months

    Time frame: Up to Month 6

    Number of Participants who underwent colonoscopy after a positive FIT result by 6 months past the start of intervention

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Colorectal Cancer Screening Through Proactive Outreach and Navigation in a Federally Qualified Health Care Center in Brooklyn

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2022
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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