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

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

    • California
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center

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
EXPERIMENTAL: Experimental patient education document
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.
ACTIVE_COMPARATOR: Traditional patient education document
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.

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)
Immediately after receiving randomly assigned study intervention (that same day)

Secondary Outcome Measures

Outcome Measure
Time Frame
Colorectal cancer screening knowledge
Time Frame: Immediately after receiving randomly assigned study intervention (that same day)
Immediately after receiving randomly assigned study intervention (that same day)
Self-efficacy for 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)
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.

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

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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