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OpenTrials
Completed

NCT Number: NCT04848051

Implementing Fit Kit Colorectal Cancer (CRC) Screening in High Risk Populations

The purpose of this study is to understand best strategies for engaging high risk populations in a primary care setting to improved adherence to colorectal cancer screening guidelines. The results will be used to identify best practices that are scalable to other high-risk populations who are due or overdue for colorectal cancer (CRC) screening.

Completed

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Key information

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cornell Scott Hill Health Center

New Haven, Connecticut, 06519, United States

About this study

This is a prospective implementation science study that will test 4 different approaches to increase colorectal cancer screening in a local primary care setting that provides services to individuals who are under-resourced. The interventions will include reminders from primary care providers with and without additional information and/or services to help complete colorectal cancer screening. A review of electronic medical records will be used to identify baseline information assessing risk factors and personal and family CRC history. For arm 3 of the study, participants may elect to enroll in our existing health navigation program. If so, additional baseline information will be collected, including information on Social Determinants of Health (SDOH). For arm 4 of the study, a questionnaire will be used to assess knowledge about colorectal cancer screening. The questionnaire will be repeated after the intervention (informational video). For all arms of the study, the primary outcome (engagement on CRC screening, receipt of CRC screening, results of CRC screening) will be collected through EPIC.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • be 50-74 years of old at the time of enrollment
  • have one valid medical encounter with CSHHC Columbus Ave. location or Dixwell location between the dates of 11/01/2019 and 11/30/2020

Exclusion criteria

  • Documented history of colorectal cancer

Treatment and study plan

CRC screening reminder

Behavioral

Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening

CRC Reminder & Short message

Behavioral

Participants randomized to the CRC Reminder & short message arm will receive reminder that they are due/overdue for CRC screening and short message to encourage screening

CRC Reminder and Navigation Program

Behavioral

Participants randomized to the CRC reminder and navigation program arm will receive reminder that they are due/overdue for CRC screening and short message to participate in the health navigation program that will connect participants to individually tailored resources and assistance

CRC Reminder & CRC education

Behavioral

Participants randomized to the CRC reminder and CRC education program arm will receive reminder that they are due/overdue for CRC screening and offered short educational program conducted online

Primary outcomes

  1. Total number of participants who completed their colorectal cancer screening

    Time frame: 18 months

    The total number of participants that completed their colorectal cancer screening will be measured between the different arms

Secondary outcomes

  1. Time to engagement

    Time frame: 18 months

    The time to engagement will be measured as the days between reminder or reminder + intervention and days to screening among the 4 arms

  2. Screening outcomes: results of screening

    Time frame: 18 months

    Screening outcomes will be defined as the following: descriptive summaries of the result of screening among the 4 arms.

  3. Screening outcomes: follow up

    Time frame: 18 months

    Screening outcomes will be defined as the following: descriptive summaries of need and completion of follow up among the 4 arms.

  4. Screening outcomes: biopsy results

    Time frame: 18 months

    Screening outcomes will be defined as the following: descriptive summaries of biopsy results (if needed) among the 4 arms.

  5. Screening outcomes: diagnostic results

    Time frame: 18 months

    Screening outcomes will be defined as the following: descriptive summaries of the diagnostic result(s) among the 4 arms.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2021
Registry last updated
Mar 3, 2023

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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