Study to Increase Colorectal Screening
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inreach strategy
Outreach strategy
Both Inreach and Outreach strategies
Usual care
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring early detection
Eligibility Criteria
Inclusion Criteria:
- Individuals age 50 to 75 years,
- One or more SYHC visits in the last year,
- Not uptodate with CRC screening
Exclusion Criteria:
- Individuals with personal history of CRC or colorectal polyps
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Inreach strategy
Outreach strategy
Both Inreach and Outreach strategies
Usual care
Arm Description
This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders.
This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders.
This is a combination of the above two strategies: Inreach and Outreach combined.
Usual care in the clinic using the fecal immunochemical test (FIT) kit.
Outcomes
Primary Outcome Measures
Screening completion rate
Completion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy)
Secondary Outcome Measures
Full Information
NCT ID
NCT02870049
First Posted
August 8, 2016
Last Updated
August 19, 2019
Sponsor
University of California, San Diego
Collaborators
San Diego State University
1. Study Identification
Unique Protocol Identification Number
NCT02870049
Brief Title
Study to Increase Colorectal Screening
Official Title
A RCT of Outreach and Inreach Strategies for Boosting CRC Screening in a Federally-Qualified Health Center
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (Actual)
Primary Completion Date
July 9, 2018 (Actual)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
San Diego State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether inreach and outreach strategies will be superior to usual care, and combination of both will be superior to either strategy alone.
Detailed Description
Colorectal cancer (CRC) screening saves lives, but screening rates are low among underserved populations, particularly Latinos. The screening rate in the predominantly Latino population served by San Ysidro Health Center (SYHC, a Federally Qualified Health Center (FQHC)), is just 31%, similar to that reported for Latinos nationally, but lower than the overall national average of 65%. Previous research has demonstrated that inreach interventions at point of medical care such as patient navigation after screening referral, and outreach outside of usual medical care (such as with mailed invitations) can increase screening rates among underserved populations. However, since these have undergone limited evaluation among low income predominantly Spanish-speaking Latinos, it is unclear which approach is best, and whether implementing both approaches would be synergistic for optimizing screening rates. We hypothesize that two culturally and linguistically tailored interventions: a) an inreach strategy (IR, consisting of community health worker-delivered in clinic education regarding CRC screening and other components), and b) an outreach strategy (OS, consisting of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) and telephone reminders) can substantially increase screening, and further, that the two interventions together will be substantially better than either alone. To test these hypotheses, we propose a randomized trial comparing usual care, IR, OS, and IR+OS for CRC screening.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
early detection
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
673 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inreach strategy
Arm Type
Experimental
Arm Description
This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders.
Arm Title
Outreach strategy
Arm Type
Experimental
Arm Description
This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders.
Arm Title
Both Inreach and Outreach strategies
Arm Type
Experimental
Arm Description
This is a combination of the above two strategies: Inreach and Outreach combined.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care in the clinic using the fecal immunochemical test (FIT) kit.
Intervention Type
Behavioral
Intervention Name(s)
Inreach strategy
Intervention Description
Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit
Intervention Type
Behavioral
Intervention Name(s)
Outreach strategy
Intervention Description
Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders
Intervention Type
Behavioral
Intervention Name(s)
Both Inreach and Outreach strategies
Intervention Description
Both Inreach and Outreach strategies: Both In clinic education and delivery of fecal immunochemical test (FIT) kit and Mailed fecal immunochemical test (FIT) kit and telephone reminders
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Usual care: FIT kit delivery as part of usual care
Primary Outcome Measure Information:
Title
Screening completion rate
Description
Completion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy)
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals age 50 to 75 years,
One or more SYHC visits in the last year,
Not uptodate with CRC screening
Exclusion Criteria:
Individuals with personal history of CRC or colorectal polyps
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir Gupta, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheila Castaneda, PhD
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Increase Colorectal Screening
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