Study of Patient Navigation to Promote Colon Cancer Screening

This study has been completed.
Sponsor:
Collaborators:
American Cancer Society, Inc.
Harvard University
Information provided by:
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT01141114
First received: June 9, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted

June 9, 2010
June 9, 2010
September 2008
March 2010   (final data collection date for primary outcome measure)
completion of colorectal cancer screening [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Comparison of detection of polyps and cancers in intervention vs. control groups [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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: 1
    Intervention: Other: Patient navigation
  • No Intervention: 2
    Intervention: Other: Usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
465
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
Both
52 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01141114
MRSGT-05-007-01-CPPB
No
Karen E. Lasser, MD, MPH, Cambridge Health Alliance/Harvard Medical School
Cambridge Health Alliance
  • American Cancer Society, Inc.
  • Harvard University
Principal Investigator: Karen E Lasser, MD, MPH Cambridge Health Alliance/Harvard Medical School
Cambridge Health Alliance
June 2010

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