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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanja Percac-Lima, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00476970
First received: May 21, 2007
Last updated: September 20, 2016
Last verified: September 2016
  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
Colorectal Cancer
Behavioral: Patient Navigation

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:


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 [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Type of CRC Screening Test Performed in Study vs Control Groups [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
  • Number of Polyps and Cancers per 100 Patients in the Study vs Control Group [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Enrollment: 1223
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476970

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanja Percac-Lima, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00476970     History of Changes
Other Study ID Numbers: 2006P 002254 
Study First Received: May 21, 2007
Last Updated: September 20, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Massachusetts General Hospital:
Colorectal Cancer
Cancer Screening
Patient Navigation
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 September 28, 2016