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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
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring early detection

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 8, 2016
    Last Updated
    August 19, 2019
    Sponsor
    University of California, San Diego
    Collaborators
    San Diego State University
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    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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