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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04848051
Enrollment
3127
Registered
2021-04-19
Start date
2021-10-12
Completion date
2022-11-21
Last updated
2023-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Health Screening

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALCRC screening reminder

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

BEHAVIORALCRC Reminder & Short message

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

BEHAVIORALCRC Reminder and Navigation Program

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

BEHAVIORALCRC Reminder & CRC education

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Total number of participants who completed their colorectal cancer screening18 monthsThe total number of participants that completed their colorectal cancer screening will be measured between the different arms

Secondary

MeasureTime frameDescription
Time to engagement18 monthsThe time to engagement will be measured as the days between reminder or reminder + intervention and days to screening among the 4 arms
Screening outcomes: results of screening18 monthsScreening outcomes will be defined as the following: descriptive summaries of the result of screening among the 4 arms.
Screening outcomes: follow up18 monthsScreening outcomes will be defined as the following: descriptive summaries of need and completion of follow up among the 4 arms.
Screening outcomes: biopsy results18 monthsScreening outcomes will be defined as the following: descriptive summaries of biopsy results (if needed) among the 4 arms.
Screening outcomes: diagnostic results18 monthsScreening outcomes will be defined as the following: descriptive summaries of the diagnostic result(s) among the 4 arms.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026