Study to Increase Colorectal Screening

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Inreach strategy; Behavioral: Outreach strategy; Behavioral: Both Inreach and Outreach strategies; Behavioral: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 673
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Inreach strategy; Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit
Experimental: Outreach strategy; This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders.	Behavioral: Outreach strategy; Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders
Experimental: Both Inreach and Outreach strategies; This is a combination of the above two strategies: Inreach and Outreach combined.	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
Active Comparator: Usual care; Usual care in the clinic using the fecal immunochemical test (FIT) kit.	Behavioral: Usual care; Usual care: FIT kit delivery as part of usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening Completion Rate	Completion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy)	23 months

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: San Diego State University
• Investigators: Principal Investigator: Samir Gupta, MD, University of California, San Diego; Principal Investigator: Sheila Castaneda, PhD, San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): July 9, 2018
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimated): August 17, 2016

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 30, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: early detection
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 20153270; U54132379 (Other Identifier: NCI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO