Clinical trial NCT00476970: Colorectal Cancer Screening Navigator Program for Low Income and Non-English Speaking Populations
Official title: Improving Colorectal Cancer Screening Rates by Lowering Barriers in Low Income and Non-English Speaking Populations: The Chelsea Colorectal Cancer Screening Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Cancer Screening
Patient Navigation
Low English Proficiency
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2007-05-22
Enrollment: 1223
Sex: ALL
Minimum age (years): 52
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Eligible Patients In Study and Control Groups Who Undergo CRC Screening
timeFrame: 18 Months
Secondary outcomes:
measure: Type of CRC Screening Test Performed in Study vs Control Groups
timeFrame: 18 Months
measure: Number of Polyps and Cancers per 100 Patients in the Study vs Control Group
timeFrame: 18 Months
Other outcomes:
Locations:
city: Chelsea
country: United States
facility: MGH Chelsea Health Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sanja Percac-Lima, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Percac-Lima S, Grant RW, Green AR, Ashburner JM, Gamba G, Oo S, Richter JM, Atlas SJ. A culturally tailored navigator program for colorectal cancer screening in a community health center: a randomized, controlled trial. J Gen Intern Med. 2009 Feb;24(2):211-7. doi: 10.1007/s11606-008-0864-x.