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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00818857
First Posted: January 8, 2009
Last Update Posted: June 20, 2016
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. Read our disclaimer for details.
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Kevin Fiscella, University of Rochester
  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
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities

Further study details as provided by Kevin Fiscella, 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 ]

Enrollment: 1072
Study Start Date: January 2009
Study Completion Date: February 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00818857


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kevin Fiscella, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT00818857     History of Changes
Other Study ID Numbers: RSRB 00025557
First Submitted: January 6, 2009
First Posted: January 8, 2009
Last Update Posted: June 20, 2016
Last Verified: June 2016

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