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

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: Colorectal Cancer; Health Literacy
• Intervention / Treatment: Behavioral: CHOICE decision aid; Behavioral: YourMeds patient education program

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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	24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

General Publications

• Miller DP Jr, Spangler JG, Case LD, Goff DC Jr, Singh S, Pignone MP. Effectiveness of a web-based colorectal cancer screening patient decision aid: a randomized controlled trial in a mixed-literacy population. Am J Prev Med. 2011 Jun;40(6):608-15. doi: 10.1016/j.amepre.2011.02.019.

Study record dates

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: Colorectal cancer; Screening; Patient education; Health literacy; Computer assisted instruction
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• 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