Study of Patient Navigation to Promote Colon Cancer Screening

April 17, 2017 updated by: Cambridge Health Alliance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

465

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • Cambridge Health Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

52 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Other: Usual Care
No Intervention - usual care
Other: Usual care
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
completion of colorectal cancer screening
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge Health Alliance

Collaborators

Harvard Medical School (HMS and HSDM)
American Cancer Society, Inc.

Investigators

  • Principal Investigator: Karen E Lasser, MD, MPH, Cambridge Health Alliance/Harvard Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 9, 2010

First Submitted That Met QC Criteria

June 9, 2010

First Posted (Estimate)

June 10, 2010

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 17, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRSGT-05-007-01-CPPB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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