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

This study has been completed.
Sponsor:
Collaborators:
American Cancer Society, Inc.
University of North Carolina, Chapel Hill
Information provided by:
Wake Forest University
ClinicalTrials.gov Identifier:
NCT00558233
First received: November 13, 2007
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention
Colorectal Cancer
Health Literacy
 Behavioral: CHOICE decision aid
Behavioral: YourMeds patient education program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Overcoming Literacy Barriers in Colorectal Cancer Screening

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wake Forest University:

Primary Outcome Measures:
  • Receipt of colorectal cancer screening [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in participants' readiness to be screened (Stage of Change) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Self-reported intent to discuss colorectal cancer screening with healthcare provider [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Provider ordering a colorectal cancer screening test [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Participant completion of computer program without assistance [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Participant acceptance of computer program [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of polyps and cancers found by screening tests performed [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: November 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group Behavioral: CHOICE decision aid
computer-based patient decision aid about colorectal cancer screening delivered immediately before a healthcare provider visit
Other Name: 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 Name: YourMeds

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558233

Locations
United States, North Carolina
Wake Forest University Baptist Medical Center; Downtown Health Plaza
Winston-Salem, North Carolina, United States, 27101
Sponsors and Collaborators
Wake Forest University
American Cancer Society, Inc.
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: David P Miller, MD Wake Forest University
  More Information

No publications provided by Wake Forest University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David P. Miller, MD / Principal Investigator, Wake Forest University School of Medicine
ClinicalTrials.gov Identifier: NCT00558233     History of Changes
Other Study ID Numbers: CCCDA-05-162-01
Study First Received: November 13, 2007
Last Updated: April 20, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest University:
Colorectal cancer
Screening
Health literacy
Patient education
Computer assisted instruction

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

ClinicalTrials.gov processed this record on May 22, 2013