NCT03287453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

January 9, 2025

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

September 13, 2017

Last Update Submit

January 7, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

    Up to two years

  • 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

    Up to two years

  • Frequency of reported family history of colorectal cancer

    Will be described in total and as a function of specific racial/ethnic groups.

    Up to two years

  • Participants' plans for future screening

    Will examine relationships between stated plans and key covariates.

    Up to two years

  • Reasons reported for not obtaining colorectal screening

    Response categories will be examined by key covariates.

    Up to two years

  • 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.

    Up to two years

Study Arms (1)

Screening (educational intervention)

EXPERIMENTAL

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.

Other: Educational InterventionOther: Survey Administration

Interventions

View an inflatable colon interactive exhibit, PowerPoint presentation, flip books, and flipcharts

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Screening (educational intervention)

Ancillary studies

Screening (educational intervention)

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Early Intervention, EducationalEducational StatusMethods

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesSocioeconomic FactorsPopulation CharacteristicsInvestigative Techniques

Study Officials

  • Electra Paskett, PhD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 19, 2017

Study Start

April 8, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

January 9, 2025

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations