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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00558233
First Posted: November 14, 2007
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
American Cancer Society, Inc.
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Overcoming Literacy Barriers in Colorectal Cancer Screening

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Receipt of colorectal cancer screening [ Time Frame: 24 weeks ]

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

Enrollment: 264
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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Health Sciences
American Cancer Society, Inc.
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: David P Miller, MD Wake Forest University Health Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00558233     History of Changes
Other Study ID Numbers: CCCDA-05-162-01
First Submitted: November 13, 2007
First Posted: November 14, 2007
Last Update Posted: November 8, 2017
Last Verified: February 2017

Keywords provided by Wake Forest University Health Sciences:
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