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Systems Intervention to Promote Colorectal Cancer Screening/ Program for the Elimination of Cancer Disparities

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Trial Information

Systems Intervention to Promote Colorectal Cancer Screening/ Program for the Elimination of Cancer Disparities

Colorectal cancer (CRC) is one of the cancers that our community partners have identified as
a priority. It is the second leading cause of cancer death in the United States, and one
with significant disparities in screening, stage of diagnosis, and survival. Underinsured
and uninsured adults are less likely to be screened, more likely to have their cancer
diagnosed at a late stage, and less likely to survive CRC. In this project we will work
with "safety-net" health centers serving Medicaid and uninsured patients in St. Louis City
and St. Louis County in Missouri, and in East St. Louis/St. Clair County in Illinois.
Working with our Colorectal Cancer Community Partnership we planned a cluster-randomized
delayed start trial to test the effectiveness of offering community health centers a "Menu"
of evidence-based systems interventions for increasing rates of CRC screening. The
strategies included in the Menu will be drawn from evidence-based interventions. The
control condition will be usual care, but in concordance with our partners' wishes, we will
offer all participating health centers access to state-of-the-art evidence-based patient
education materials. The primary outcome will be CRC screening adherence as measured by
self-report surveys of a random sample of health center patients. Our evaluation will also
be informed by a chart audit to assess screening referral and completion, surveys of
physicians and staff at intervention sites to assess implementation outcomes, and exit
interviews with administration of intervention health centers to assess maintenance of the
intervention strategies. We developed and will conduct our study adhering to the principles
of community-based participatory research (CBPR). The specific aims are: (1) Working with
community partners, we will select and refine the evidence-based intervention strategies for
the trial; (2) Using a CBPR approach, we will collaborate with our partners to implement and
evaluate the systems-level intervention for its effectiveness in increasing CRC screening
rates. (3) Using the RE-AIM framework, we will work with our partners to evaluate
implementation and maintenance of systems changes by intervention health centers and
adoption of the changes by control centers. Compared to traditional clinics and healthcare
providers, safety-net health centers face additional challenges in implementing
evidence-based strategies for increase screening uptake; yet rigorously testing such
strategies in this context is novel. Allowing health centers to select from a menu of
strategies will provide a practical test of effectiveness, and will increase buy-in and
representativeness of participating health centers. As a practical clinical trial with good
external validity, this project has the potential for significant impact on CRC screening
rates with promise for substantial impact on disparities in CRC burden. This study is
responsive to community concerns about CRC and about no-intervention control groups, and is
responsive to the RFA by proposing a CBPR randomized controlled trial to increase access to
and utilization of CRC screening procedures.

Inclusion Criteria:

- Community health center in the Saint Louis Metropolitan Area, including Southern

- Participant in Partnership Planning Process

- Affiliated with the Washington University Program for the Elimination of Cancer

Exclusion Criteria:

- Primary patient population has private health insurance.

- Not in an medically underserved area.

Type of Study:


Study Design:

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

Outcome Measure:

Practice-level colon cancer screening rate

Outcome Description:

Colorectal cancer screening will be assessed as the proportion of screening-eligible patients who are adherent to national screening guidelines for colorectal cancer.

Outcome Time Frame:

12-months post baseline

Safety Issue:


Principal Investigator

Aimee S James, PhD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Federal Government

Study ID:




Start Date:

June 2012

Completion Date:

August 2015

Related Keywords:

  • Carcinoma
  • carcinoma
  • colorectal cancer
  • community health centers
  • cluster-randomized
  • health behavior
  • Carcinoma
  • Colorectal Neoplasms



Washington University School of MedicineSaint Louis, Missouri  63110