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

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04848051
Collaborator
National Cancer Institute (NCI) (NIH)
2,000
1
4
20.6
97.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CRC screening reminder
  • Behavioral: CRC Reminder & Short message
  • Behavioral: CRC Reminder and Navigation Program
  • Behavioral: CRC Reminder & CRC education
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Implementing Fit Kit Colorectal Cancer (CRC) Screening in High Risk Populations
Actual Study Start Date :
Oct 12, 2021
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Total number of participants who completed their colorectal cancer screening [18 months]

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

Secondary Outcome Measures

  1. Time to engagement [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 [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 [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 [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 [18 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 74 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cornell Scott Hill Health Center New Haven Connecticut United States 06519

Sponsors and Collaborators

  • Yale University
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Beth Jones, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT04848051
Other Study ID Numbers:
  • 2000030006
  • 2P30CA016359-39
First Posted:
Apr 19, 2021
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yale University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022