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Systems Intervention to Promote Colorectal Cancer (CRC) Screening

This study is currently recruiting participants.
Verified September 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT01299493
First Posted: February 18, 2011
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
Colorectal cancer is the second leading cause of cancer death and one of the most commonly diagnosed malignancies. Screening is effective at reducing incidence and mortality from colorectal cancer. This study will evaluate the effectiveness of implementing systems-changes in community health centers that facilitate screening.

Condition Intervention
Carcinoma Other: Systems-level intervention to promote colon cancer screening

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Systems Intervention to Promote Colorectal Cancer Screening/ Program for the Elimination of Cancer Disparities

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Practice-level colon cancer screening rate [ Time Frame: 12-months post baseline ]
    Colorectal cancer screening will be assessed as the proportion of screening-eligible patients who are adherent to national screening guidelines for colorectal cancer.


Estimated Enrollment: 3186
Actual Study Start Date: June 19, 2012
Estimated Study Completion Date: August 31, 2018
Estimated Primary Completion Date: August 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventional
Access to systems-level interventions to increase colorectal cancer screening.
Other: Systems-level intervention to promote colon cancer screening
Intervention practices will receive access to, and assistance in implementing, evidence-based strategies for increasing colorectal cancer screening rates.
No Intervention: Usual Care
Practices will receive access to intervention components after outcomes data collection is complete.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Community health center in the Saint Louis Metropolitan Area, including Southern Illinois
  • Participant in Partnership Planning Process
  • Affiliated with the Washington University Program for the Elimination of Cancer Disparities

Exclusion Criteria:

  • Primary patient population has private health insurance.
  • Not in an medically underserved area.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299493


Contacts
Contact: Aimee S James, Ph.D., MPH 314-454-8300 aimeejames@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Aimee S James, PhD, MPH    314-454-8300    aimeejames@wustl.edu   
Principal Investigator: Aimee S James, Ph.D., MPH         
Sub-Investigator: Jean Wang, MD         
Sub-Investigator: Yan Yan, PhD         
Sub-Investigator: Graham A Colditz, M.D., DrPH         
Sponsors and Collaborators
Washington University School of Medicine
National Cancer Institute (NCI)
Investigators
Principal Investigator: Aimee S James, PhD, MPH Washington University School of Medicine
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01299493     History of Changes
Other Study ID Numbers: 10-1131 / 201110005
U54CA153460 ( U.S. NIH Grant/Contract )
First Submitted: February 16, 2011
First Posted: February 18, 2011
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
carcinoma
colorectal cancer
community health centers
cluster-randomized
health behavior

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