Colorectal NeoplasmsNCT00965965
Comprehensibility of Colorectal Cancer Screening Educational Materials: Effects on Patient Knowledge and Motivation
A study testing New colorectal cancer screening patient education document and Traditional colorectal cancer screening education document in people with Colorectal Neoplasms, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a newly developed patient education document concerning colorectal cancer screening will be better understood and have greater effects on patient knowledge of and motivation for screening than a standard educational document. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- New colorectal cancer screening patient education document and Traditional colorectal cancer screening education document
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Apr 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Receive primary care at one of the participating outpatient offices
- Age 50-75
- Able to read and speak English
- Adequate vision, hearing, and hand function to read printed documents, communicate with research staff, answer questionnaires, and otherwise participate
- Not up to date for colorectal cancer screening (defined as fecal occult blood test within 1 year, flexible sigmoidoscopy within 5 years, or colonoscopy within 10 years)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Effects of Comprehensibility of Colorectal Cancer Screening Educational Materials on Patient Knowledge and Motivation: A Randomized Controlled Trial
The purpose of this study is to determine whether a newly developed patient education document concerning colorectal cancer screening will be better understood and have greater effects on patient knowledge of and motivation for screening than a standard educational document.
- Conditions
- Colorectal Neoplasms
- Being tested
- New colorectal cancer screening patient education document, Traditional colorectal cancer screening education document
- Keywords
- health behavior, randomized controlled trials, self-efficacy, patient education, comprehension, mass screening, prevention and control
- Medical subject headings
- Colorectal Neoplasms, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New colorectal cancer screening patient education documentBehavioural
The newly developed educational document was created accounting for health behavioral models (such as the Expanded Health Behavior Model, Social Cognitive Theory, and the Transtheoretical Model) and related research studies indicating the factors that most strongly and positively influence patients' cognitions regarding colorectal cancer screening and are, in turn, predictive of actual colorectal cancer screening behavior.
Traditional colorectal cancer screening education documentBehavioural
The traditional educational document is a slightly edited version of materials freely available on the National Cancer Institute (NCI) web site, used in this study with the permission of the NCI.
| Study group | Role | What they receive |
|---|---|---|
| Experimental patient education document | Experimental | Not described Receives: Behavioral: New colorectal cancer screening patient education document |
| Traditional patient education document | Active comparator | Not described Receives: Behavioral: Traditional colorectal cancer screening education document |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehension of randomly assigned educational document
Measured: Immediately after receiving randomly assigned study intervention (that same day)
Secondary outcomes (4)
Colorectal cancer screening knowledge
Measured: Immediately after receiving randomly assigned study intervention (that same day)
Self-efficacy for undergoing colorectal cancer screening
Measured: Immediately after receiving randomly assigned study intervention (that same day)
Perceived barriers to undergoing colorectal cancer screening
Measured: Immediately after receiving randomly assigned study intervention (that same day)
Readiness to undergo colorectal cancer screening
Measured: Immediately after receiving randomly assigned study intervention (that same day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- California Academy of Family Physicians
- Responsible party
- Sponsor
- Investigators
- Tonantzin Rodriguez, MPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965965
- Sponsor's protocol ID
- 200917361-1
- Status last verified
- Apr 2012
- First submitted
- 20 Aug 2009
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Comprehensibility of Colorectal Cancer Screening Educational Materials on Patient Knowledge and Motivation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00965965
- Acronym / sponsor ID
- 200917361-1
- Conditions
- Colorectal Neoplasms
- Keywords
- health behavior, randomized controlled trials, self-efficacy, patient education, comprehension, mass screening, prevention and control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- California Academy of Family Physicians
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 Aug 2009 (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 newly developed patient education document concerning colorectal cancer screening will be better understood and have greater effects on patient knowledge of and motivation for screening than a standard educational document.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental patient education document | Experimental | Behavioral: New colorectal cancer screening patient education document |
| Traditional patient education document | Active comparator | Behavioral: Traditional colorectal cancer screening education document |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Receive primary care at one of the participating outpatient offices
- Age 50-75
- Able to read and speak English
- Adequate vision, hearing, and hand function to read printed documents, communicate with research staff, answer questionnaires, and otherwise participate
- Not up to date for colorectal cancer screening (defined as fecal occult blood test within 1 year, flexible sigmoidoscopy within 5 years, or colonoscopy within 10 years)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| New colorectal cancer screening patient education documentThe newly developed educational document was created accounting for health behavioral models (such as the Expanded Health Behavior Model, Social Cognitive Theory, and the Transtheoretical Model) and related research studies indicating the factors that most strongly and positively influence patients' cognitions regarding colorectal cancer screening and are, in turn, predictive of actual colorectal cancer screening behavior. | Behavioural | Experimental patient education document |
| Traditional colorectal cancer screening education documentThe traditional educational document is a slightly edited version of materials freely available on the National Cancer Institute (NCI) web site, used in this study with the permission of the NCI. | Behavioural | Traditional patient education document |
Primary outcome
Comprehension of randomly assigned educational document
Time frame: Immediately after receiving randomly assigned study intervention (that same day)
4 secondary outcomes
Colorectal cancer screening knowledge
Time frame: Immediately after receiving randomly assigned study intervention (that same day)
Self-efficacy for undergoing colorectal cancer screening
Time frame: Immediately after receiving randomly assigned study intervention (that same day)
Perceived barriers to undergoing colorectal cancer screening
Time frame: Immediately after receiving randomly assigned study intervention (that same day)
Readiness to undergo colorectal cancer screening
Time frame: Immediately after receiving randomly assigned study intervention (that same day)
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 27 Apr 2012.
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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.
Tonantzin Rodriguez, MPH principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New colorectal cancer screening patient education document and Traditional colorectal cancer screening education document in people with Colorectal Neoplasms, run by University of California, Davis 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 5 inclusion and 0 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 27 Apr 2012. 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. 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?
Comprehension of randomly assigned educational document (time frame: Immediately after receiving randomly assigned study intervention (that same day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2012.