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

June 16, 2016 updated by: Kevin Fiscella, University of Rochester
The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1072

Phase

  • Not Applicable

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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
End of project, 12/2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Kevin Fiscella, MD, MPH, University of Rochester

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.

General Publications

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

January 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 6, 2009

First Submitted That Met QC Criteria

January 7, 2009

First Posted (Estimate)

January 8, 2009

Study Record Updates

Last Update Posted (Estimate)

June 20, 2016

Last Update Submitted That Met QC Criteria

June 16, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RSRB 00025557

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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