Implementing Fit Kit Colorectal Cancer (CRC) Screening in High Risk Populations
2 other identifiers
interventional
3,127
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Oct 2021
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2021
CompletedFirst Posted
Study publicly available on registry
April 19, 2021
CompletedStudy Start
First participant enrolled
October 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2022
CompletedMarch 3, 2023
March 1, 2023
1.1 years
April 12, 2021
March 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Time to engagement
18 months
Screening outcomes: results of screening
18 months
Screening outcomes: follow up
18 months
Screening outcomes: biopsy results
18 months
Screening outcomes: diagnostic results
18 months
Study Arms (4)
CRC screening reminder
EXPERIMENTALParticipants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening
CRC Reminder & Short message
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Documented history of colorectal cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Cornell Scott Hill Health Center
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beth Jones
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2021
First Posted
April 19, 2021
Study Start
October 12, 2021
Primary Completion
November 21, 2022
Study Completion
November 21, 2022
Last Updated
March 3, 2023
Record last verified: 2023-03