- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03287453
Educational Intervention - Improving Knowledge and Screening Rates for Colorectal Cancer
Screen to Save Initiative
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To increase colorectal cancer (CRC) knowledge, attitudes, positive behavior change, intent for screening, and screening among at-risk groups.
OUTLINE:
Participants attend educational sessions comprising of an inflatable colon interactive exhibit that allows visitors to walk through a colon while seeing images, or a PowerPoint presentation that contains messages that are tailored to meet the cultural and linguistic needs of Black/African Americans, Appalachians, and Hispanics/Latinos, and flip books/flip charts. Participants also receive a copy of the study information sheet which contains the basic elements of informed consent and a pre-education session knowledge survey.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants from Franklin County or from Appalachia Ohio (depending on program location)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Screening (educational intervention)
Participants attend educational sessions comprising of an inflatable colon interactive exhibit that allows visitors to walk through a colon while seeing images, a PowerPoint presentation that contains messages that are tailored to meet the cultural and linguistic needs of Black/African Americans, Appalachians, and Hispanics/Latinos, and or flip books/flip charts.
Participants also receive a copy of the study information sheet which contains the basic elements of informed consent and a pre-education session knowledge survey.
|
Ancillary studies
View an inflatable colon interactive exhibit, PowerPoint presentation, flip books, and flipcharts
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in knowledge and degree to which reported intentions regarding colorectal cancer screening are related to the educational session
Time Frame: Up to two years
|
Change in knowledge will be examined as a function of the important covariates: race/ethnicity, sex, age, education and primary language.
A paired t-test or Wilcoxon signed-rank test will be used to determine whether there is a statistically significant difference in pre and post session scores.
The paired t-test provides a hypothesis test to determine whether pre and post session assessment mean scores differ from each other in a significant way under the assumptions that the paired differences are independent and identically normally distributed.
The test statistic is t with n-1 degrees of f
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Up to two years
|
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Change in knowledge and strength of intention to be screened
Time Frame: Up to two years
|
Will be correlated with key outcomes, specifically actual screening and actions promoting colorectal cancer screening (e.g., encouraging colorectal screening with family/friends).
Multivariable logistic regression analyses will be conducted to examine the impact of knowledge change and strength of intentions on these binary outcomes (screened/not screened and encouraged/did not encourage colorectal screening) controlling for important covariates such as sex, race/ethnicity, age, education and primary language.
A paired t-test or Wilcoxon signed-rank test will be used to determine whether there
|
Up to two years
|
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Frequency of reported family history of colorectal cancer
Time Frame: Up to two years
|
Will be described in total and as a function of specific racial/ethnic groups.
|
Up to two years
|
|
Participants' plans for future screening
Time Frame: Up to two years
|
Will examine relationships between stated plans and key covariates.
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Up to two years
|
|
Reasons reported for not obtaining colorectal screening
Time Frame: Up to two years
|
Response categories will be examined by key covariates.
|
Up to two years
|
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Self-reported intentions to engage in behavior change to reduce risk of colorectal cancer
Time Frame: Up to two years
|
Will be examined by race/ethnicity, sex, education, and health insurance/healthcare coverage.
|
Up to two years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Electra Paskett, PhD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-17069 (Ohio State University Comprehensive Cancer Center)
- NCI-2017-01357 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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