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

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ClinicalTrials.gov Identifier: NCT00476970
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : September 21, 2016
Information provided by (Responsible Party):
Sanja Percac-Lima, MD, Massachusetts General Hospital

May 21, 2007
May 22, 2007
September 21, 2016
September 2007
September 2008   (Final data collection date for primary outcome measure)
Percentage of Eligible Patients In Study and Control Groups Who Undergo CRC Screening [ Time Frame: 18 Months ]
percentage of eligible patients in study and control groups who undergo CRC screening during the study period [ Time Frame: 18 Months ]
Complete list of historical versions of study NCT00476970 on ClinicalTrials.gov Archive Site
  • Type of CRC Screening Test Performed in Study vs Control Groups [ Time Frame: 18 Months ]
  • Number of Polyps and Cancers per 100 Patients in the Study vs Control Group [ Time Frame: 18 Months ]
- 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 ]
Not Provided
Not Provided
Colorectal Cancer Screening Navigator Program for Low Income and Non-English Speaking Populations
Improving Colorectal Cancer Screening Rates by Lowering Barriers in Low Income and Non-English Speaking Populations: The Chelsea Colorectal Cancer Screening Project

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

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.
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Colorectal Cancer
Behavioral: Patient Navigation
Patient navigators will perform an initial interview with participants to identify and explore barriers, work with patients to overcome barriers, educate patients about CRC screening, motivate and coach patients, and schedule and accompany patients to colonoscopy testing
  • Experimental: Patient Navigation Intervention
    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.
    Intervention: Behavioral: Patient Navigation
  • No Intervention: Usual Care
    Participants randomized to this arm will receive no additional navigation beyond the usual care for the duration of the 9-month intervention. Participants will be offered navigation services after the completion of the intervention period.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2008
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
52 Years to 79 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
2006P 002254
Not Provided
Plan to Share IPD: No
Sanja Percac-Lima, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Sanja Percac-Lima, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP