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

Primary Purpose

Colorectal Neoplasms

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

New colorectal cancer screening patient education document

Traditional colorectal cancer screening education document

About this trial

This is an interventional health services research trial for Colorectal Neoplasms focused on measuring health behavior, randomized controlled trials, self-efficacy, patient education, comprehension, mass screening, prevention and control

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

University of California Davis Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental patient education document

Traditional patient education document

Arm Description

Outcomes

Primary Outcome Measures

Comprehension of randomly assigned educational document

Secondary Outcome Measures

Colorectal cancer screening knowledge

Self-efficacy for undergoing colorectal cancer screening

Perceived barriers to undergoing colorectal cancer screening

Readiness to undergo colorectal cancer screening

Full Information

NCT ID

NCT00965965

First Posted

August 20, 2009

Last Updated

April 26, 2012

Sponsor

University of California, Davis

Collaborators

California Academy of Family Physicians

1. Study Identification

Unique Protocol Identification Number

NCT00965965

Brief Title

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

Official Title

Effects of Comprehensibility of Colorectal Cancer Screening Educational Materials on Patient Knowledge and Motivation: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

Collaborators

California Academy of Family Physicians

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms

Keywords

health behavior, randomized controlled trials, self-efficacy, patient education, comprehension, mass screening, prevention and control

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental patient education document

Arm Type

Experimental

Arm Title

Traditional patient education document

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

New colorectal cancer screening patient education document

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Traditional colorectal cancer screening education document

Intervention Description

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.

Primary Outcome Measure Information:

Title

Comprehension of randomly assigned educational document

Time Frame