Colorectal CancerInfoPCNCT00558233
Effectiveness Study of a Computer-Based Colorectal Cancer Screening Decision Aid
A study testing CHOICE decision aid and YourMeds patient education program in people with Colorectal Cancer and Health Literacy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colorectal Cancer, Health Literacy
- What is being tested?
- CHOICE decision aid and YourMeds patient education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Scheduled to see an internal medicine provider
- No recent colorectal cancer screening
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Baptist Medical Center; Downtown Health Plaza
Winston-Salem, North Carolina, 27101
About this study
Official title: 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.
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.
- Conditions
- Colorectal Cancer, Health Literacy
- Being tested
- CHOICE decision aid, YourMeds patient education program
- Keywords
- Colorectal cancer, Screening, Health literacy, Patient education, Computer assisted instruction
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOICE decision aidBehavioural
Also called CHOICE
computer-based patient decision aid about colorectal cancer screening delivered immediately before a healthcare provider visit
YourMeds patient education programBehavioural
Also called YourMeds
computer-based patient education program about prescription drug safety seen immediately before a healthcare provider visit
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: CHOICE decision aid |
| Placebo group | Placebo comparator | Not described Receives: Behavioral: YourMeds patient education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of colorectal cancer screening
Measured: 24 weeks
Secondary outcomes (6)
Change in participants' readiness to be screened (Stage of Change)
Measured: Day 1
Self-reported intent to discuss colorectal cancer screening with healthcare provider
Measured: Day 1
Provider ordering a colorectal cancer screening test
Measured: Day 1
Participant completion of computer program without assistance
Measured: Day 1
Participant acceptance of computer program
Measured: Day 1
Number of polyps and cancers found by screening tests performed
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- David P Miller, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558233
- Sponsor's protocol ID
- CCCDA-05-162-01
- Acronym
- InfoPC
- Status last verified
- Aug 2018
- First submitted
- 13 Nov 2007
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Literacy Barriers in Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT00558233
- Acronym / sponsor ID
- InfoPC / CCCDA-05-162-01
- Conditions
- Colorectal Cancer, Health Literacy
- Keywords
- Colorectal cancer, Screening, Health literacy, Patient education, Computer assisted instruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., University of North Carolina, Chapel Hill
- Study start
- Nov 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: CHOICE decision aid |
| Placebo group | Placebo comparator | Behavioral: YourMeds patient education program |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- Scheduled to see an internal medicine provider
- No recent colorectal cancer screening
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHOICE decision aidAlso: CHOICEcomputer-based patient decision aid about colorectal cancer screening delivered immediately before a healthcare provider visit | Behavioural | Intervention group |
| YourMeds patient education programAlso: YourMedscomputer-based patient education program about prescription drug safety seen immediately before a healthcare provider visit | Behavioural | Placebo group |
Primary outcome
Receipt of colorectal cancer screening
Time frame: 24 weeks
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Derived from this study: PubMed 21565651Miller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David P Miller, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHOICE decision aid and YourMeds patient education program in people with Colorectal Cancer and Health Literacy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of colorectal cancer screening (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00558233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.