Knowledge, Attitudes, PracticeNCT05064423
Clinical Trials Outreach & Education
A study testing Clinical Trials Education Program in people with Knowledge, Attitudes, Practice, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to provide education and information about clinical trials and clinical trials participation. Investigators also aim to see if education makes a difference in increasing knowledge of clinical trials and clinical trials participation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Attitudes, Practice
- What is being tested?
- Clinical Trials Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2021to 23 Mar 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English or Spanish speaking
- Able to provide informed consent
- Reside in the Tampa Bay Area (Hillsborough, Pinellas, Polk or Pasco county)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to provide education and information about clinical trials and clinical trials participation. Investigators also aim to see if education makes a difference in increasing knowledge of clinical trials and clinical trials participation.
- Conditions
- Knowledge, Attitudes, Practice
- Being tested
- Clinical Trials Education Program
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Trials Education ProgramBehavioural
The Community Health Educator (CHE) will provide CT education and outreach to increase clinical trial knowledge and the importance of clinical trials research and participation. The clinical trials educational activities will include the use of NCI Colorectal Cancer resources and materials, including a PowerPoint presentation, clinical trials information, and online resources. The CHE will tailor the PowerPoint slides to ensure that they are culturally tailored, visually appealing, low-literacy, language appropriate and include appropriate visuals. The CTs educational sessions will be delivered in Spanish and English and will take approximately 45 minutes to 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Trials Education | Experimental | Community Health Educators (CHE) will provide Clinical Trial Education to increase knowledge of Clinical Trials and the importance of Clinical Trial participation. Receives: Behavioral: Clinical Trials Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Participants Clinical Trials Knowledge
To assess the impact of the educational intervention on participants knowledge and beliefs about clinical trials, participants will be asked to complete a survey prior to and after the educational intervention. The pre-assessment and post assessment survey includes 11 items assessing knowledge of clinical trials, risks and benefits to clinical trials participation, and the consent process. Additionally, the assessment includes 6 items to determine intentions to seek out information related to clinical trials, speak with one's healthcare provider about appropriate clinical trials, clinical trials participation, and talking with family/friends about participating in clinical trials.
Measured: Change from baseline to immediately after receiving intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start15 Jun 2021
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Clement K Gwede, PhD, MPH, RN, FAAN, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064423
- Sponsor's protocol ID
- MCC-21235
- Other IDs
- 3P30CA076292-21S3
- Status last verified
- Feb 2026
- First submitted
- 22 Sep 2021
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trials Outreach & Education
- ClinicalTrials.gov ID
- NCT05064423
- Acronym / sponsor ID
- MCC-21235
- Conditions
- Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 1 Oct 2021 (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.
The purpose of this study is to provide education and information about clinical trials and clinical trials participation. Investigators also aim to see if education makes a difference in increasing knowledge of clinical trials and clinical trials participation.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Trials Education | Experimental | Behavioral: Clinical Trials Education ProgramCommunity Health Educators (CHE) will provide Clinical Trial Education to increase knowledge of Clinical Trials and the importance of Clinical Trial participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English or Spanish speaking
- Able to provide informed consent
- Reside in the Tampa Bay Area (Hillsborough, Pinellas, Polk or Pasco county)
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 |
|---|---|---|
| Clinical Trials Education ProgramThe Community Health Educator (CHE) will provide CT education and outreach to increase clinical trial knowledge and the importance of clinical trials research and participation. The clinical trials educational activities will include the use of NCI Colorectal Cancer resources and materials, including a PowerPoint presentation, clinical trials information, and online resources. The CHE will tailor the PowerPoint slides to ensure that they are culturally tailored, visually appealing, low-literacy, language appropriate and include appropriate visuals. The CTs educational sessions will be delivered in Spanish and English and will take approximately 45 minutes to 1 hour. | Behavioural | Clinical Trials Education |
Primary outcome
Change in Participants Clinical Trials Knowledge
Time frame: Change from baseline to immediately after receiving intervention
To assess the impact of the educational intervention on participants knowledge and beliefs about clinical trials, participants will be asked to complete a survey prior to and after the educational intervention. The pre-assessment and post assessment survey includes 11 items assessing knowledge of clinical trials, risks and benefits to clinical trials participation, and the consent process. Additionally, the assessment includes 6 items to determine intentions to seek out information related to clinical trials, speak with one's healthcare provider about appropriate clinical trials, clinical trials participation, and talking with family/friends about participating in clinical trials.
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 Feb 2026.
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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.
Clement K Gwede, PhD, MPH, RN, FAAN principal investigator
Moffitt 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 Clinical Trials Education Program in people with Knowledge, Attitudes, Practice, run by H. Lee Moffitt Cancer Center and Research Institute 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 3 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 Feb 2026. 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 Participants Clinical Trials Knowledge (time frame: Change from baseline to immediately after receiving intervention). 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 Feb 2026.