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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

Brief Summary:
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.

Condition or disease Intervention/treatment
Colorectal Cancer Screening Other: Patient navigation Other: Usual care

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Randomized Controlled Trial of Patient Navigation to Increase Colorectal Cancer Screening Rates Among Community Health Center Patients
Study Start Date : September 2008
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Use of a Patient Navigator Other: Patient navigation
Letter and Colorectal Cancer Screening Brochure mailed to patients. Telephone outreach by Patient Navigators.
Usual Care
No Intervention - usual care
Other: Usual care
Usual care

Primary Outcome Measures :
  1. completion of colorectal cancer screening [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Comparison of detection of polyps and cancers in intervention vs. control groups [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   52 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01141114

United States, Massachusetts
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Cambridge Health Alliance
American Cancer Society, Inc.
Harvard Medical School
Principal Investigator: Karen E Lasser, MD, MPH Cambridge Health Alliance/Harvard Medical School

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cambridge Health Alliance Identifier: NCT01141114     History of Changes
Other Study ID Numbers: MRSGT-05-007-01-CPPB
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017

Keywords provided by Cambridge Health Alliance:
community health centers
colorectal cancer screening
urban health

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