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Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities (Get Screened)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00818857
First received: January 6, 2009
Last updated: November 9, 2011
Last verified: January 2009
History of Changes
  Purpose

The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients


Condition Intervention
Preventive Measures
 Behavioral: Early Intervention
Behavioral: Delayed intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome. [ Time Frame: End of project, 12/2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: January 2009
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Early intervention.
 Behavioral: Early Intervention
At the point of randomization the early group will receive increasingly intensive reminders to complete specific cancer screening tests.
Active Comparator: 2
Delayed intervention
 Behavioral: Delayed intervention
One year from the point of randomization patients will begin to receive increasingly intensive reminders to complete specific cancer screening tests.

Detailed Description:

This project is designed to implement and rigorously evaluate a cancer screening quality improvement project within a practice serving underserved patients. The project involves use of a patient registry coupled with patient reminders,recall and outreach.All unscreened patients will receive the benefit of this intervention, though some sooner than others for the purpose of evaluation.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men age 50-75 yrs.
  • Women age 40-75 yrs
  • One primary care visit in past 2 years.

Exclusion Criteria:

  • High risk for colorectal or breast cancer.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818857

Sponsors and Collaborators
University of Rochester
American Cancer Society, Inc.
Investigators
Principal Investigator: Kevin Fiscella, MD, MPH University of Rochester
  More Information

No publications provided by University of Rochester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kevin Fiscella, MD MPH, Associate Professor of Family Medicine, University of Rochester Medical Center
ClinicalTrials.gov Identifier: NCT00818857     History of Changes
Other Study ID Numbers: RSRB 00025557
Study First Received: January 6, 2009
Last Updated: November 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
cancer screening
screening disparities
underserved populations

ClinicalTrials.gov processed this record on May 16, 2013