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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04848051
• Other study ID #: 2000030006
• Secondary ID: 2P30CA016359-39
• Status: Completed
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: November 21, 2022

Study information

• Verified date: March 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3127
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Cornell Scott Hill Health Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of participants who completed their colorectal cancer screening	The total number of participants that completed their colorectal cancer screening will be measured between the different arms	18 months
Secondary	Time to engagement	The time to engagement will be measured as the days between reminder or reminder + intervention and days to screening among the 4 arms	18 months
Secondary	Screening outcomes: results of screening	Screening outcomes will be defined as the following: descriptive summaries of the result of screening among the 4 arms.	18 months
Secondary	Screening outcomes: follow up	Screening outcomes will be defined as the following: descriptive summaries of need and completion of follow up among the 4 arms.	18 months
Secondary	Screening outcomes: biopsy results	Screening outcomes will be defined as the following: descriptive summaries of biopsy results (if needed) among the 4 arms.	18 months
Secondary	Screening outcomes: diagnostic results	Screening outcomes will be defined as the following: descriptive summaries of the diagnostic result(s) among the 4 arms.	18 months