- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01299493
Systems Intervention to Promote Colorectal Cancer (CRC) Screening
July 11, 2018 updated by: Washington University School of Medicine
Systems Intervention to Promote Colorectal Cancer Screening/ Program for the Elimination of Cancer Disparities
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
490
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
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: Interventional
Access to systems-level interventions to increase colorectal 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12-months post baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Aimee S James, PhD, MPH, Washington University School of Medicine
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.
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 (Actual)
June 19, 2012
Primary Completion (Actual)
September 21, 2017
Study Completion (Actual)
September 21, 2017
Study Registration Dates
First Submitted
February 16, 2011
First Submitted That Met QC Criteria
February 17, 2011
First Posted (Estimate)
February 18, 2011
Study Record Updates
Last Update Posted (Actual)
July 12, 2018
Last Update Submitted That Met QC Criteria
July 11, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-1131 / 201110005
- U54CA153460 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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