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Systems Intervention to Promote Colorectal Cancer (CRC) Screening

Primary Purpose

Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Systems-level intervention to promote colon cancer screening
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Carcinoma focused on measuring carcinoma, colorectal cancer, community health centers, cluster-randomized, health behavior

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional

Usual Care

Arm Description

Access to systems-level interventions to increase colorectal cancer screening.

Practices will receive access to intervention components after outcomes data collection is complete.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 16, 2011
Last Updated
July 11, 2018
Sponsor
Washington University School of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01299493
Brief Title
Systems Intervention to Promote Colorectal Cancer (CRC) Screening
Official Title
Systems Intervention to Promote Colorectal Cancer Screening/ Program for the Elimination of Cancer Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 19, 2012 (Actual)
Primary Completion Date
September 21, 2017 (Actual)
Study Completion Date
September 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma
Keywords
carcinoma, colorectal cancer, community health centers, cluster-randomized, health behavior

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
Access to systems-level interventions to increase colorectal cancer screening.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Practices will receive access to intervention components after outcomes data collection is complete.
Intervention Type
Other
Intervention Name(s)
Systems-level intervention to promote colon cancer screening
Intervention Description
Intervention practices will receive access to, and assistance in implementing, evidence-based strategies for increasing colorectal cancer screening rates.
Primary Outcome Measure Information:
Title
Practice-level colon cancer screening rate
Description
Colorectal cancer screening will be assessed as the proportion of screening-eligible patients who are adherent to national screening guidelines for colorectal cancer.
Time Frame
12-months post baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee S James, PhD, MPH
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23731594
Citation
James AS, Richardson V, Wang JS, Proctor EK, Colditz GA. Systems intervention to promote colon cancer screening in safety net settings: protocol for a community-based participatory randomized controlled trial. Implement Sci. 2013 Jun 3;8:58. doi: 10.1186/1748-5908-8-58.
Results Reference
derived
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Systems Intervention to Promote Colorectal Cancer (CRC) Screening

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