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Colorectal Cancer Screening Intervention in UWPN Clinics

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ClinicalTrials.gov Identifier: NCT00161460
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 13, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Cynthia Ko, University of Washington

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE June 2005
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2007)
Colorectal cancer screening test utilization [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
Colorectal cancer screening test utilization within 6 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2007)
  • Knowledge about colorectal cancer screening tests [ Time Frame: 2 months ]
  • Cancer worry score [ Time Frame: 2 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • Knowledge about colorectal cancer screening tests
  • Cancer worry score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colorectal Cancer Screening Intervention in UWPN Clinics
Official Title  ICMJE Colorectal Cancer Screening Intervention in UWPN Clinics
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Neoplasia
Intervention  ICMJE Behavioral: colorectal cancer screening intervention
Enrolled subjects receive tailored education from a registered nurse who also facilitates ordering and completion of screening tests
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: colorectal cancer screening intervention
  • No Intervention: 2
    Patients who do not enroll receive usual care from their primary care providers.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2014)
80
Original Enrollment  ICMJE
 (submitted: September 8, 2005)
500
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00161460
Other Study ID Numbers  ICMJE 26840-J
1R21CA107157 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cynthia Ko, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Cynthia Ko, MD University of Washington
PRS Account University of Washington
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP