Study to Increase Colorectal Screening

NCT ID: NCT02870049

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 673 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-08-30

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Inreach strategy

This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders.

Group Type: EXPERIMENTAL

Inreach strategy

Intervention Type: BEHAVIORAL

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

Outreach strategy

This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders.

Group Type: EXPERIMENTAL

Outreach strategy

Intervention Type: BEHAVIORAL

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

Both Inreach and Outreach strategies

This is a combination of the above two strategies: Inreach and Outreach combined.

Group Type: EXPERIMENTAL

Both Inreach and Outreach strategies

Intervention Type: 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

Usual care in the clinic using the fecal immunochemical test (FIT) kit.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

Usual care: FIT kit delivery as part of usual care

Interventions

Inreach strategy

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

Intervention Type: BEHAVIORAL

Outreach strategy

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Usual care

Usual care: FIT kit delivery as part of usual care

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Diego State University

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Samir Gupta

Associate Professor of Clinical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samir Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Sheila Castaneda, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U54132379

Identifier Type: OTHER

Identifier Source: secondary_id

20153270

Identifier Type: -

Identifier Source: org_study_id