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Coordinated Endoscopic Colorectal Cancer Screening

Primary Purpose

Preventive Health Services

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Help with physician office and patient management
Tailored physician recommendation letter
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Preventive Health Services focused on measuring colorectal cancer screening, sigmoidoscopy, colonoscopy

Eligibility Criteria

50 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - Exclusion Criteria: history of colorectal cancer or polyps flexible sigmoidoscopy within five years of enrollment barium enema within five years of enrollment colonoscopy within five years of enrollment

Sites / Locations

  • University of Pittsburgh Cancer Institute

Outcomes

Primary Outcome Measures

Medical record verified flexible sigmoidoscopy or colonoscopy

Secondary Outcome Measures

Full Information

First Posted
May 16, 2006
Last Updated
February 18, 2011
Sponsor
University of Pittsburgh
Collaborators
Association of Schools of Public Health, Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00327457
Brief Title
Coordinated Endoscopic Colorectal Cancer Screening
Official Title
Coordinated Endoscopic Colorectal Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh
Collaborators
Association of Schools of Public Health, Centers for Disease Control and Prevention

4. Oversight

5. Study Description

Brief Summary
The investigators aim to use a randomized design to test the effects of 1) tailored physician recommendations, relative to non-specific recommendations, and 2) coordinated physician office management systems on patient adherence to colorectal cancer screening recommendations.
Detailed Description
The investigators aim to use a randomized design to test the effects of 1) tailored physician recommendations, relative to non-specific recommendations, and 2) coordinated physician office management systems on patient adherence to colorectal cancer screening recommendations. To accomplish these aims, the investigators propose 1) to use existing physician practice-based computerized patient registration systems to define populations of 50 to 79 year-old pri-mary care patients, 2) to use mailed questionnaires to determine colorectal cancer risk factor status and prior colorectal cancer screening history, 3) to use responses from mailed questionnaires to identify persons not adhering to colorectal cancer screening guidelines, 4) to use computer driven algorithms to help physicians prepare and deliver individually tailored and written colorectal cancer screening recommendations, and 5) to develop, implement, and evaluate a centralized service for delivering high quality screening flexible sigmoidoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preventive Health Services
Keywords
colorectal cancer screening, sigmoidoscopy, colonoscopy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
599 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Help with physician office and patient management
Intervention Type
Behavioral
Intervention Name(s)
Tailored physician recommendation letter
Primary Outcome Measure Information:
Title
Medical record verified flexible sigmoidoscopy or colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Exclusion Criteria: history of colorectal cancer or polyps flexible sigmoidoscopy within five years of enrollment barium enema within five years of enrollment colonoscopy within five years of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel L. Weissfeld, MD MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19139323
Citation
Ling BS, Schoen RE, Trauth JM, Wahed AS, Eury T, Simak DM, Solano FX, Weissfeld JL. Physicians encouraging colorectal screening: a randomized controlled trial of enhanced office and patient management on compliance with colorectal cancer screening. Arch Intern Med. 2009 Jan 12;169(1):47-55. doi: 10.1001/archinternmed.2008.519.
Results Reference
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Coordinated Endoscopic Colorectal Cancer Screening

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