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Randomized Controlled Trial of Patient Navigation to Increase Colorectal Cancer Screening Rates Among Community Health Center Patients


N/A
52 Years
75 Years
Not Enrolling
Both
Colorectal Cancer Screening

Thank you

Trial Information

Randomized Controlled Trial of Patient Navigation to Increase Colorectal Cancer Screening Rates Among Community Health Center Patients


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Outcome Measure:

completion of colorectal cancer screening

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Karen E Lasser, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cambridge Health Alliance/Harvard Medical School

Authority:

United States: Institutional Review Board

Study ID:

MRSGT-05-007-01-CPPB

NCT ID:

NCT01141114

Start Date:

September 2008

Completion Date:

March 2010

Related Keywords:

  • Colorectal Cancer Screening
  • community health centers
  • colorectal cancer screening
  • urban health
  • Colorectal Neoplasms

Name

Location

Cambridge Health AllianceCambridge, Massachusetts  02139