Clinical Trials Outreach & Education

March 18, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Principal Investigator:
          • Clement K Gwede, PhD, MPH, RN, FAAN
        • Principal Investigator:
          • Cathy D Meade, PhD, RN, FAAN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • English or Spanish speaking
  • Able to provide informed consent
  • Reside in the Tampa Bay Area (Hillsborough, Pinellas, Polk or Pasco county)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinical Trials Education
Community Health Educators (CHE) will provide Clinical Trial Education to increase knowledge of Clinical Trials and the importance of Clinical Trial participation.
Behavioral: Clinical Trials Education Program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to immediately after receiving intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Clement K Gwede, PhD, MPH, RN, FAAN, Moffitt Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MCC-21235
  • 3P30CA076292-21S3 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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