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Comprehensibility of Colorectal Cancer Screening Educational Materials: Effects on Patient Knowledge and Motivation

This study has been completed.
Sponsor:
Collaborator:
California Academy of Family Physicians
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00965965
First received: August 20, 2009
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Colorectal Neoplasms
 Behavioral: New colorectal cancer screening patient education document
Behavioral: Traditional colorectal cancer screening education document

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effects of Comprehensibility of Colorectal Cancer Screening Educational Materials on Patient Knowledge and Motivation: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Comprehension of randomly assigned educational document [ Time Frame: Immediately after receiving randomly assigned study intervention (that same day) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Colorectal cancer screening knowledge [ Time Frame: Immediately after receiving randomly assigned study intervention (that same day) ] [ Designated as safety issue: No ]
  • Self-efficacy for undergoing colorectal cancer screening [ Time Frame: Immediately after receiving randomly assigned study intervention (that same day) ] [ Designated as safety issue: No ]
  • Perceived barriers to undergoing colorectal cancer screening [ Time Frame: Immediately after receiving randomly assigned study intervention (that same day) ] [ Designated as safety issue: No ]
  • Readiness to undergo colorectal cancer screening [ Time Frame: Immediately after receiving randomly assigned study intervention (that same day) ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: August 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental patient education document Behavioral: New colorectal cancer screening 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 Behavioral: Traditional colorectal cancer screening 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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965965

Locations
United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
California Academy of Family Physicians
Investigators
Principal Investigator: Tonantzin Rodriguez, MPH University of California, Davis
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00965965     History of Changes
Other Study ID Numbers: 200917361-1
Study First Received: August 20, 2009
Last Updated: April 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
health behavior
randomized controlled trials
self-efficacy
patient education
 comprehension
mass screening
prevention and control

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 16, 2013