Colorectal CarcinomaNCT03287453
Educational Intervention - Improving Knowledge and Screening Rates for Colorectal Cancer
A study testing Educational Intervention and Survey Administration in people with Colorectal Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Educational Intervention and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2017to 30 Sep 2017
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants from Franklin County or from Appalachia Ohio (depending on program location)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Screen to Save Initiative
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Colorectal Carcinoma
- Being tested
- Educational Intervention, Survey Administration
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
View an inflatable colon interactive exhibit, PowerPoint presentation, flip books, and flipcharts
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: Up to two years
Participants' plans for future screening
Will examine relationships between stated plans and key covariates.
Measured: Up to two years
Reasons reported for not obtaining colorectal screening
Response categories will be examined by key covariates.
Measured: 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.
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start8 Apr 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Electra Paskett, Ohio State University Comprehensive Cancer Center
- Investigators
- Electra Paskett, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287453
- Sponsor's protocol ID
- OSU-17069
- Other IDs
- NCI-2017-01357
- Status last verified
- Oct 2023
- First submitted
- 13 Sep 2017
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screen to Save Initiative
- ClinicalTrials.gov ID
- NCT03287453
- Acronym / sponsor ID
- OSU-17069
- Conditions
- Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 8 Apr 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 19 Sep 2017 (actual)
- 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.
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:
- 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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (educational intervention) | Experimental | Other: Educational Intervention, Other: Survey AdministrationParticipants 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. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants from Franklin County or from Appalachia Ohio (depending on program location)
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalView an inflatable colon interactive exhibit, PowerPoint presentation, flip books, and flipcharts | Other | Screening (educational intervention) |
| Survey AdministrationAncillary studies | Other | Screening (educational intervention) |
Primary outcome
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
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
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.
Participants' plans for future screening
Time frame: Up to two years
Will examine relationships between stated plans and key covariates.
Reasons reported for not obtaining colorectal screening
Time frame: Up to two years
Response categories will be examined by key covariates.
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.
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 Jan 2025.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Electra Paskett, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention and Survey Administration in people with Colorectal Carcinoma, run by Ohio State University Comprehensive Cancer Center 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 1 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 9 Jan 2025. 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?
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). The study lists 6 primary outcomes in all. 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 9 Jan 2025.