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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: CRC screening reminder; Behavioral: CRC Reminder & Short message; Behavioral: CRC Reminder and Navigation Program; Behavioral: CRC Reminder & CRC education

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.

• Study Type: Interventional
• Enrollment (Actual): 3127
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beth Jones, PhD, MPH; Phone Number: +1 (203) 764-7207; Email: beth.jones@yale.edu
• Study Contact Backup: Name: Sally Alsup; Email: sarah.alsup@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Cornell Scott Hill Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRC screening reminder; Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening	Behavioral: CRC screening reminder; Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening
Experimental: 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	Behavioral: 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
Experimental: 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	Behavioral: 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
Experimental: 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	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Beth Jones, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Actual): November 21, 2022
• Study Completion (Actual): November 21, 2022

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Health Screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2000030006; 2P30CA016359-39 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No