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

Primary Purpose

Colorectal Cancer, Health Literacy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHOICE decision aid
YourMeds patient education program
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring Colorectal cancer, Screening, Health literacy, Patient education, Computer assisted instruction

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Baptist Medical Center; Downtown Health Plaza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Placebo group

Arm Description

Outcomes

Primary Outcome Measures

Receipt of colorectal cancer screening

Secondary Outcome Measures

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

Full Information

First Posted
November 13, 2007
Last Updated
August 7, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
American Cancer Society, Inc., University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT00558233
Brief Title
Effectiveness Study of a Computer-Based Colorectal Cancer Screening Decision Aid
Acronym
InfoPC
Official Title
Overcoming Literacy Barriers in Colorectal Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
American Cancer Society, Inc., University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Health Literacy
Keywords
Colorectal cancer, Screening, Health literacy, Patient education, Computer assisted instruction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
CHOICE decision aid
Other Intervention Name(s)
CHOICE
Intervention Description
computer-based patient decision aid about colorectal cancer screening delivered immediately before a healthcare provider visit
Intervention Type
Behavioral
Intervention Name(s)
YourMeds patient education program
Other Intervention Name(s)
YourMeds
Intervention Description
computer-based patient education program about prescription drug safety seen immediately before a healthcare provider visit
Primary Outcome Measure Information:
Title
Receipt of colorectal cancer screening
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in participants' readiness to be screened (Stage of Change)
Time Frame
Day 1
Title
Self-reported intent to discuss colorectal cancer screening with healthcare provider
Time Frame
Day 1
Title
Provider ordering a colorectal cancer screening test
Time Frame
Day 1
Title
Participant completion of computer program without assistance
Time Frame
Day 1
Title
Participant acceptance of computer program
Time Frame
Day 1
Title
Number of polyps and cancers found by screening tests performed
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P Miller, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Baptist Medical Center; Downtown Health Plaza
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21565651
Citation
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.
Results Reference
derived

Learn more about this trial

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

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