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OpenTrials
Completed

NCT Number: NCT02870049

Study to Increase Colorectal Screening

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inreach strategy

Behavioral

Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit

Outreach strategy

Behavioral

Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders

Both Inreach and Outreach strategies

Behavioral

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

Usual Care

Behavioral

Usual care: FIT kit delivery as part of usual care

Primary outcomes

  1. Screening Completion Rate

    Time frame: 23 months

    Completion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy)

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • San Diego State University

Registry information

Official study title

A RCT of Outreach and Inreach Strategies for Boosting CRC Screening in a Federally-Qualified Health Center

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Aug 17, 2016
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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