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Educational Intervention - Improving Knowledge and Screening Rates for Colorectal Cancer

Primary Purpose

Colorectal Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Survey Administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Carcinoma

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants from Franklin County or from Appalachia Ohio (depending on program location)

Sites / Locations

  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening (educational intervention)

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in knowledge and degree to which reported intentions regarding colorectal cancer screening are related to the educational session
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
Change in knowledge and strength of intention to be screened
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
Frequency of reported family history of colorectal cancer
Will be described in total and as a function of specific racial/ethnic groups.
Participants' plans for future screening
Will examine relationships between stated plans and key covariates.
Reasons reported for not obtaining colorectal screening
Response categories will be examined by key covariates.
Self-reported intentions to engage in behavior change to reduce risk of colorectal cancer
Will be examined by race/ethnicity, sex, education, and health insurance/healthcare coverage.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2017
Last Updated
May 9, 2022
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03287453
Brief Title
Educational Intervention - Improving Knowledge and Screening Rates for Colorectal Cancer
Official Title
Screen to Save Initiative
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 8, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

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

5. Study Description

Brief Summary
This clinical trial studies how well educational intervention works in improving knowledge and screening rates of colorectal cancer. An educational intervention, such as viewing an inflatable colon, PowerPoint presentation, or flip books/flipcharts, may help improve knowledge about colorectal cancer and how often people get checked for colorectal cancers.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening (educational intervention)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
View an inflatable colon interactive exhibit, PowerPoint presentation, flip books, and flipcharts
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in knowledge and degree to which reported intentions regarding colorectal cancer screening are related to the educational session
Description
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
Time Frame
Up to two years
Title
Change in knowledge and strength of intention to be screened
Description
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
Time Frame
Up to two years
Title
Frequency of reported family history of colorectal cancer
Description
Will be described in total and as a function of specific racial/ethnic groups.
Time Frame
Up to two years
Title
Participants' plans for future screening
Description
Will examine relationships between stated plans and key covariates.
Time Frame
Up to two years
Title
Reasons reported for not obtaining colorectal screening
Description
Response categories will be examined by key covariates.
Time Frame
Up to two years
Title
Self-reported intentions to engage in behavior change to reduce risk of colorectal cancer
Description
Will be examined by race/ethnicity, sex, education, and health insurance/healthcare coverage.
Time Frame
Up to two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants from Franklin County or from Appalachia Ohio (depending on program location)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Electra Paskett, PhD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

Educational Intervention - Improving Knowledge and Screening Rates for Colorectal Cancer

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