Colorectal Cancer Screening Intervention in UWPN Clinics

May 11, 2016 updated by: Cynthia Ko, University of Washington
The purpose of this study is to determine if a prototype colorectal cancer screening program with the services of a cancer prevention specialist will increase utilization of appropriate colorectal cancer screening tests.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colorectal cancer is the second leading cause of cancer death in the United States. Colorectal cancer screening is widely recommended, but generally under-utilized. Previous studies have shown that only a minority of people over the age of 50 are screened for colorectal cancer with either fecal occult blood testing or flexible sigmoidoscopy. Barriers to screening include patient and provider-related factors. An innovative program to support primary care providers in providing necessary education about colorectal cancer screening, to provide reminders when screening tests are due, and to facilitate requesting and follow-up of screening tests may help address some of these barriers to providing screening services.

In this proposal, we will develop and implement a primary care based-colorectal cancer screening program to supplement clinical services provided in a primary care practice network. This network uses an electronic medical record and has established referral patterns for gastrointestinal endoscopy services, radiology, and pathology. In the proposed screening program, we will develop a colorectal cancer screening module to supplement the existing electronic medical record. This module will enable providers to review risk factors for colorectal cancer, prior screening history, and need for future screening in one easily accessible location. The information provided by this module will be supplemented by the services of a cancer prevention specialist. This person will oversee enrollment of patients into the program, provide patient education about colorectal cancer screening, and facilitate ordering or referral for screening or follow-up tests.

Outcome measures will include utilization of screening rates, patient knowledge about screening tests, and provider acceptance of the program. If successful, this program may be useful to other large primary care practices, and may also help to improve utilization of other types of cancer prevention services.

Study Type

Interventional

Enrollment (Actual)

80

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

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 50 years and over, enrolled for medical care in the UWPN clinics

Exclusion Criteria:

  • Primary care physicians feel they would not benefit from colorectal cancer screening, unwilling or unable to complete study procedures

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Study nurse contacts subjects who enroll in the intervention to provide detailed education about screening tests, to assess their risk for colorectal cancer, and to facilitate screening.
Behavioral: colorectal cancer screening intervention
Enrolled subjects receive tailored education from a registered nurse who also facilitates ordering and completion of screening tests
No Intervention: 2
Patients who do not enroll receive usual care from their primary care providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Colorectal cancer screening test utilization
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Knowledge about colorectal cancer screening tests
Time Frame: 2 months
2 months
Cancer worry score
Time Frame: 2 months
2 months

Collaborators and Investigators

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

Sponsor

University of Washington

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Cynthia Ko, MD, University of Washington

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

June 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26840-J
  • 1R21CA107157 (U.S. NIH Grant/Contract)

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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