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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Patient Navigation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
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

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.

Primary Outcome Measures :
  1. Percentage of Eligible Patients In Study and Control Groups Who Undergo CRC Screening [ Time Frame: 18 Months ]

Secondary Outcome Measures :
  1. Type of CRC Screening Test Performed in Study vs Control Groups [ Time Frame: 18 Months ]
  2. Number of Polyps and Cancers per 100 Patients in the Study vs Control Group [ Time Frame: 18 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   52 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00476970

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United States, Massachusetts
MGH Chelsea Health Center
Chelsea, Massachusetts, United States, 02150
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Sanja Percac-Lima, MD, PhD Massachusetts General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sanja Percac-Lima, MD, Principal Investigator, Massachusetts General Hospital Identifier: NCT00476970    
Other Study ID Numbers: 2006P 002254
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sanja Percac-Lima, MD, Massachusetts General Hospital:
Colorectal Cancer
Cancer Screening
Patient Navigation
Low English Proficiency
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases