CClinicalTrials.gg
Sign In
CompletedNCT00558233InfoPCUpdated Aug 9, 2018

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

An interventional study of CHOICE decision aid and YourMeds patient education program in Colorectal Cancer and Health Literacy, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-09.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
264
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Colorectal Cancer
  • Health Literacy

Keywords

  • Colorectal cancer
  • Screening
  • Health literacy
  • Patient education
  • Computer assisted instruction
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 264 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
264 participants (actual)

Study arms

  • Experimental
    Intervention group

    Behavioral: CHOICE decision aid

  • Placebo comparator
    Placebo group

    Behavioral: YourMeds patient education program

Interventions

  • BehavioralCHOICE decision aid

    computer-based patient decision aid about colorectal cancer screening delivered immediately before a healthcare provider visit

    Also known as: CHOICE

  • BehavioralYourMeds patient education program

    computer-based patient education program about prescription drug safety seen immediately before a healthcare provider visit

    Also known as: YourMeds

06

What researchers measure

Primary outcomes

  1. Receipt of colorectal cancer screening

    Time frame: 24 weeks

Secondary outcomes

  1. Change in participants' readiness to be screened (Stage of Change)

    Time frame: Day 1

  2. Self-reported intent to discuss colorectal cancer screening with healthcare provider

    Time frame: Day 1

  3. Provider ordering a colorectal cancer screening test

    Time frame: Day 1

  4. Participant completion of computer program without assistance

    Time frame: Day 1

  5. Participant acceptance of computer program

    Time frame: Day 1

  6. Number of polyps and cancers found by screening tests performed

    Time frame: 24 weeks

07

Study locations

1 site
  • Wake Forest University Baptist Medical Center; Downtown Health Plaza
    Winston-Salem, North Carolina 27101, United States
08

References and documents

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. PubMed 21565651 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00558233
Lead sponsor
Wake Forest University Health Sciences
Collaborators
American Cancer Society, Inc., University of North Carolina, Chapel Hill
Responsible party
Sponsor
First posted
Nov 14, 2007
Start date
Nov 2007
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Aug 9, 2018

Study contacts

David P Miller, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Colorectal Neoplasms→

Other studies from this sponsor

Wake Forest University Health Sciences

Start the discussion