Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00476970
First received: May 21, 2007
Last updated: April 30, 2010
Last verified: April 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Colorectal Cancer Screening
 Behavioral: multilingual navigator
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Improving Colorectal Cancer Screening Rates by Lowering Barriers in Low Income and Non-English Speaking Populations: The Chelsea Colorectal Cancer Screening Project

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • percentage of eligible patients in study and control groups who undergo CRC screening during the study period [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • - type of CRC screening test performed in study vs control groups - CRC screening stratified by English language proficiency and navigator contact - Identify barriers to screening and interventions used to achieve CRC screening goals [ Time Frame: 18 months ]

Estimated Enrollment: 1400
Study Start Date: September 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   52 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • acutely ill, currently receiving cancer treatment, or cognitively impaired
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476970

Contacts
Contact: Sanja Percac-Lima, MD, PhD 617 889 8580 spercaclima@partners.org

Locations
United States, Massachusetts
MGH Chelsea Health Center Recruiting
Chelsea, Massachusetts, United States, 02150
Principal Investigator: Sanja Percac-Lima, MD PhD            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Sanja Percac-Lima, MD, PhD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanja Percac-Lima, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00476970     History of Changes
Other Study ID Numbers: 2006P 002254
Study First Received: May 21, 2007
Last Updated: April 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
colorectal cancer
cancer screening
navigator
low English proficiency

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013