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Colorectal Cancer Screening Intervention in UWPN Clinics

Primary Purpose

Colorectal Neoplasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
colorectal cancer screening intervention
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Neoplasia focused on measuring Colorectal cancer, Mass screening

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

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.

Patients who do not enroll receive usual care from their primary care providers.

Outcomes

Primary Outcome Measures

Colorectal cancer screening test utilization

Secondary Outcome Measures

Knowledge about colorectal cancer screening tests
Cancer worry score

Full Information

First Posted
September 8, 2005
Last Updated
May 11, 2016
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00161460
Brief Title
Colorectal Cancer Screening Intervention in UWPN Clinics
Official Title
Colorectal Cancer Screening Intervention in UWPN Clinics
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasia
Keywords
Colorectal cancer, Mass screening

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
No Intervention
Arm Description
Patients who do not enroll receive usual care from their primary care providers.
Intervention Type
Behavioral
Intervention Name(s)
colorectal cancer screening intervention
Intervention Description
Enrolled subjects receive tailored education from a registered nurse who also facilitates ordering and completion of screening tests
Primary Outcome Measure Information:
Title
Colorectal cancer screening test utilization
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Knowledge about colorectal cancer screening tests
Time Frame
2 months
Title
Cancer worry score
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Ko, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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Colorectal Cancer Screening Intervention in UWPN Clinics

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