- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00965965
Comprehensibility of Colorectal Cancer Screening Educational Materials: Effects on Patient Knowledge and Motivation
April 26, 2012 updated by: University of California, Davis
Effects of Comprehensibility of Colorectal Cancer Screening Educational Materials on Patient Knowledge and Motivation: A Randomized Controlled Trial
The purpose of this study is to determine whether a newly developed patient education document concerning colorectal cancer screening will be better understood and have greater effects on patient knowledge of and motivation for screening than a standard educational document.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
60
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
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California
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Sacramento, California, United States, 95817
- University of California Davis Medical Center
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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 to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Receive primary care at one of the participating outpatient offices
- Age 50-75
- Able to read and speak English
- Adequate vision, hearing, and hand function to read printed documents, communicate with research staff, answer questionnaires, and otherwise participate
- Not up to date for colorectal cancer screening (defined as fecal occult blood test within 1 year, flexible sigmoidoscopy within 5 years, or colonoscopy within 10 years)
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: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Experimental patient education document
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The newly developed educational document was created accounting for health behavioral models (such as the Expanded Health Behavior Model, Social Cognitive Theory, and the Transtheoretical Model) and related research studies indicating the factors that most strongly and positively influence patients' cognitions regarding colorectal cancer screening and are, in turn, predictive of actual colorectal cancer screening behavior.
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ACTIVE_COMPARATOR: Traditional patient education document
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The traditional educational document is a slightly edited version of materials freely available on the National Cancer Institute (NCI) web site, used in this study with the permission of the NCI.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Comprehension of randomly assigned educational document
Time Frame: Immediately after receiving randomly assigned study intervention (that same day)
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Immediately after receiving randomly assigned study intervention (that same day)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Colorectal cancer screening knowledge
Time Frame: Immediately after receiving randomly assigned study intervention (that same day)
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Immediately after receiving randomly assigned study intervention (that same day)
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Self-efficacy for undergoing colorectal cancer screening
Time Frame: Immediately after receiving randomly assigned study intervention (that same day)
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Immediately after receiving randomly assigned study intervention (that same day)
|
|
Perceived barriers to undergoing colorectal cancer screening
Time Frame: Immediately after receiving randomly assigned study intervention (that same day)
|
Immediately after receiving randomly assigned study intervention (that same day)
|
|
Readiness to undergo colorectal cancer screening
Time Frame: Immediately after receiving randomly assigned study intervention (that same day)
|
Immediately after receiving randomly assigned study intervention (that same day)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tonantzin Rodriguez, MPH, University of California, Davis
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
August 1, 2009
Primary Completion (ACTUAL)
April 1, 2010
Study Completion (ACTUAL)
April 1, 2010
Study Registration Dates
First Submitted
August 20, 2009
First Submitted That Met QC Criteria
August 24, 2009
First Posted (ESTIMATE)
August 26, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
April 27, 2012
Last Update Submitted That Met QC Criteria
April 26, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200917361-1
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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