Effectiveness Study of a Computer-Based Colorectal Cancer Screening Decision Aid (InfoPC)

August 7, 2018 updated by: Wake Forest University Health Sciences

Overcoming Literacy Barriers in Colorectal Cancer Screening

The purpose of this study is to determine whether a multimedia educational computer program can increase colorectal cancer screening rates in low and adequate literacy patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Results will be stratified by low/marginal and adequate literacy as determined by the Rapid Estimate of Adult Literacy in Medicine instrument.

Study Type

Interventional

Enrollment (Actual)

264

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

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27101
        • Wake Forest University Baptist Medical Center; Downtown Health Plaza

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English-speaking
  • Scheduled to see an internal medicine provider
  • No recent colorectal cancer screening

Exclusion Criteria:

  • Personal history of colorectal cancer
  • Family history of colorectal cancer
  • Blood seen in stools within last month
  • Obvious cognitive or physical impairment that would prevent participation

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Behavioral: CHOICE decision aid
computer-based patient decision aid about colorectal cancer screening delivered immediately before a healthcare provider visit
Other Names:
  • CHOICE
Placebo Comparator: Placebo group
Behavioral: YourMeds patient education program
computer-based patient education program about prescription drug safety seen immediately before a healthcare provider visit
Other Names:
  • YourMeds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Receipt of colorectal cancer screening
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in participants' readiness to be screened (Stage of Change)
Time Frame: Day 1
Day 1
Self-reported intent to discuss colorectal cancer screening with healthcare provider
Time Frame: Day 1
Day 1
Provider ordering a colorectal cancer screening test
Time Frame: Day 1
Day 1
Participant completion of computer program without assistance
Time Frame: Day 1
Day 1
Participant acceptance of computer program
Time Frame: Day 1
Day 1
Number of polyps and cancers found by screening tests performed
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

University of North Carolina, Chapel Hill
American Cancer Society, Inc.

Investigators

  • Principal Investigator: David P Miller, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

November 13, 2007

First Submitted That Met QC Criteria

November 13, 2007

First Posted (Estimate)

November 14, 2007

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCCDA-05-162-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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