Study of Patient Navigation to Promote Colon Cancer Screening

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: NCT01141114
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : April 18, 2017
American Cancer Society, Inc.
Harvard Medical School
Information provided by (Responsible Party):
Cambridge Health Alliance

June 9, 2010
June 10, 2010
April 18, 2017
September 2008
March 2010   (Final data collection date for primary outcome measure)
completion of colorectal cancer screening [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01141114 on Archive Site
Comparison of detection of polyps and cancers in intervention vs. control groups [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
Study of Patient Navigation to Promote Colon Cancer Screening
Randomized Controlled Trial of Patient Navigation to Increase Colorectal Cancer Screening Rates Among Community Health Center Patients
This study will investigate whether patient navigation can increase rates of colorectal cancer screening among linguistically and culturally diverse disadvantaged patients served by urban community health centers.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Colorectal Cancer Screening
  • Other: Patient navigation
    Letter and Colorectal Cancer Screening Brochure mailed to patients. Telephone outreach by Patient Navigators.
  • Other: Usual care
    Usual care
  • Experimental: Use of a Patient Navigator
    Intervention: Other: Patient navigation
  • Usual Care
    No Intervention - usual care
    Intervention: Other: Usual care

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients aged 52-75 who had one visit to a primary care physician in a community health center in each of the 2 previous years and who have not received colorectal cancer screening based on HEDIS criteria.

Exclusion Criteria:

  • Current cancer diagnosis, undergoing treatment (or treatment completed within the past year)
  • Severe cardiac disease (high-risk CAD,9 valvular disease, NYHA Class III or IV CHF, EF < 35%)
  • Severe COPD (FEV1< 1liter or on home oxygen)
  • CVA with severe functional impairment (aphasia or hemiparesis)
  • MS with severe functional impairment
  • Renal failure with CrCl< 30 or on dialysis
  • Gastrointestinal symptoms (pain, bleeding, etc) within the past 6 months
  • Chronic active liver disease or cirrhosis, with albumin < 3 or elevated INR
  • Advanced HIV disease (CD4 count <200)
  • Severe lupus (with cerebritis or renal failure as defined above)
  • Severe complications of diabetes (blindness, amputations other than toes)
  • Advanced Dementia
  • Psychosis
  • Paranoia
  • Active substance abuse
  • Schizophrenia
  • Psychiatric hospitalization within the past year
Sexes Eligible for Study: All
52 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Cambridge Health Alliance
Cambridge Health Alliance
  • American Cancer Society, Inc.
  • Harvard Medical School
Principal Investigator: Karen E Lasser, MD, MPH Cambridge Health Alliance/Harvard Medical School
Cambridge Health Alliance
April 2017

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