Study to Increase Colorectal Screening

NCT02870049 | Completed Results

• 2 other identifiers: 20153270U54132379
• Study Type: interventional
• Target: 673
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Keywords

early detection

Outcome Measures

Primary Outcomes (1)

• Screening Completion Rate

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

  23 months

Study Arms (4)

Inreach strategy

EXPERIMENTAL

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

Outreach strategy

EXPERIMENTAL

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

Behavioral: Outreach strategy

Both Inreach and Outreach strategies

EXPERIMENTAL

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

Behavioral: Both Inreach and Outreach strategies

Usual care

ACTIVE COMPARATOR

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

Behavioral: Usual care

Interventions

Inreach strategy BEHAVIORAL

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

Inreach strategy

Outreach strategy BEHAVIORAL

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

Outreach strategy

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

Both Inreach and Outreach strategies

Usual care BEHAVIORAL

Usual care: FIT kit delivery as part of usual care

Usual care

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals age 50 to 75 years,
• One or more SYHC visits in the last year,
• Not uptodate with CRC screening

You may not qualify if:

• Individuals with personal history of CRC or colorectal polyps

Sponsors & Collaborators

• University of California, San Diego: lead
• San Diego State University: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Samir Gupta, MD
• Organization: UC San Diego

s1gupta@health.ucsd.edu

07/09/2018

Study Officials

• Samir Gupta, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Sheila Castaneda, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 17, 2016
• Study Start: August 1, 2016
• Primary Completion: July 9, 2018
• Study Completion: August 30, 2019
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share