search
Back to results

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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRC screening reminder
CRC Reminder & Short message
CRC Reminder and Navigation Program
CRC Reminder & CRC education
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Health Screening

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cornell Scott Hill Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

CRC screening reminder

CRC Reminder & Short message

CRC Reminder and Navigation Program

CRC Reminder & CRC education

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 12, 2021
Last Updated
March 2, 2023
Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04848051
Brief Title
Implementing Fit Kit Colorectal Cancer (CRC) Screening in High Risk Populations
Official Title
Implementing Fit Kit Colorectal Cancer (CRC) Screening in High Risk Populations
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
November 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Health Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRC screening reminder
Arm Type
Experimental
Arm Description
Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening
Arm Title
CRC Reminder & Short message
Arm Type
Experimental
Arm Description
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
Arm Title
CRC Reminder and Navigation Program
Arm Type
Experimental
Arm Description
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
Arm Title
CRC Reminder & CRC education
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
CRC screening reminder
Intervention Description
Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening
Intervention Type
Behavioral
Intervention Name(s)
CRC Reminder & Short message
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
CRC Reminder and Navigation Program
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
CRC Reminder & CRC education
Intervention Description
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 Outcome Measure Information:
Title
Total number of participants who completed their colorectal cancer screening
Description
The total number of participants that completed their colorectal cancer screening will be measured between the different arms
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Time to engagement
Description
The time to engagement will be measured as the days between reminder or reminder + intervention and days to screening among the 4 arms
Time Frame
18 months
Title
Screening outcomes: results of screening
Description
Screening outcomes will be defined as the following: descriptive summaries of the result of screening among the 4 arms.
Time Frame
18 months
Title
Screening outcomes: follow up
Description
Screening outcomes will be defined as the following: descriptive summaries of need and completion of follow up among the 4 arms.
Time Frame
18 months
Title
Screening outcomes: biopsy results
Description
Screening outcomes will be defined as the following: descriptive summaries of biopsy results (if needed) among the 4 arms.
Time Frame
18 months
Title
Screening outcomes: diagnostic results
Description
Screening outcomes will be defined as the following: descriptive summaries of the diagnostic result(s) among the 4 arms.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Jones
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cornell Scott Hill Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs