Colorectal Cancer Screening Navigator Program for Low Income and Non-English Speaking Populations

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Patient Navigation

• Registration Number: NCT00476970
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The goal of this study is to implement and in a controlled randomised trial test a program to identify and overcome barriers to CRC screening and thus improve CRC screening rates at MGH Chelsea HC.

Our hypothesis is that a bilingual navigator program, enhanced by using trained interpreting staff will improve CRC screening rates at MGH Chelsea HC overall, and decrease disparities between patients with limited English proficiency and English speakers

Detailed Description

We developed a training program for five health center interpreters fluent in eight different languages. Patients randomly assigned to the study intervention receive an introductory letter in their native language. During the initial contact the navigator educates patients about CRC screening and explores patients' barriers to CRC screening. Based on results from a qualitative study conducted at in 2006, we developed interventions to overcome individual barriers to CRC screening tailored to each individual patient. Specific interventions include elucidation of culturally-specific health beliefs; teaching about cancer risk, colonoscopy, and colon prep administration; and help with appointment-making and transport.

Study Timeline

• Study First Submitted: 2007-05-21
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-22
• Study Start: 2007-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1223

Inclusion Criteria

• Between 52-79 years of age
• Have not had a colonoscopy within the last 10 years
• Have not had a sigmoidoscopy/barium enema within the past 5 years
• Have not had a home fecal occult blood testing within the past year.

Exclusion Criteria

• Acutely ill
• Dementia
• Metastatic cancer
• Schizophrenia
• Any end stage disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Navigation Intervention	Patient Navigation	Participants randomized to this arm will receive language-concordant patient navigation in the form of an introductory letter with educational material followed by phone or in-person contact to provide individually tailored interventions.

Primary Outcome Measures

Name	Time	Method
Percentage of Eligible Patients In Study and Control Groups Who Undergo CRC Screening	18 Months

Secondary Outcome Measures

Name	Time	Method
Type of CRC Screening Test Performed in Study vs Control Groups	18 Months
Number of Polyps and Cancers per 100 Patients in the Study vs Control Group	18 Months

Trial Locations

Locations (1)

MGH Chelsea Health Center; 🇺🇸 Chelsea, Massachusetts, United States