Study to Increase Colorectal Screening

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02870049
• Other study ID #: 20153270
• Secondary ID: U54132379
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 673
• Est. completion date: August 2019
• Est. primary completion date: July 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Inreach strategy
Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit
• Outreach strategy
Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders
• Both Inreach and Outreach strategies
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
Usual care: FIT kit delivery as part of usual care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	San Diego State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening completion rate	Completion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy)	up to 24 months