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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01141114

Enrollment

465

Registered

2010-06-10

Start date

2008-09-30

Completion date

2010-03-31

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Screening

Keywords

community health centers, colorectal cancer screening, urban health

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.

Interventions

OTHERPatient navigation

Letter and Colorectal Cancer Screening Brochure mailed to patients. Telephone outreach by Patient Navigators.

OTHERUsual care

Usual care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

52 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
completion of colorectal cancer screening	1 year

Secondary

Measure	Time frame
Comparison of detection of polyps and cancers in intervention vs. control groups	1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026