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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
  Purpose

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 Intervention
Colorectal Cancer Screening
 Other: Patient navigation
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Randomized Controlled Trial of Patient Navigation to Increase Colorectal Cancer Screening Rates Among Community Health Center Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cambridge Health Alliance:

Primary Outcome Measures:
  • completion of colorectal cancer screening [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of detection of polyps and cancers in intervention vs. control groups [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 465
Study Start Date: September 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Other: Patient navigation
Letter and Colorectal Cancer Screening Brochure mailed to patients. Telephone outreach by Patient Navigators.
No Intervention: 2 Other: Usual care
Usual care

  Eligibility

Ages Eligible for Study:   52 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141114

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Karen E. Lasser, MD, MPH, Cambridge Health Alliance/Harvard Medical School
ClinicalTrials.gov Identifier: NCT01141114     History of Changes
Other Study ID Numbers: MRSGT-05-007-01-CPPB
Study First Received: June 9, 2010
Last Updated: June 9, 2010
Health Authority: United States: Institutional Review Board

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
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 16, 2013