Clinical Trials Outreach & Education

Sponsor

H. Lee Moffitt Cancer Center and Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05064423

Collaborator

National Cancer Institute (NCI) (NIH)

100

Enrollment

Location

Arm

26.5

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Knowledge, Attitudes, Practice	Behavioral: Clinical Trials Education Program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Clinical Trials Outreach & Education

Actual Study Start Date :

Jun 15, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Participants Clinical Trials Knowledge [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center	Tampa	Florida	United States	33612

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

H. Lee Moffitt Cancer Center and Research Institute

ClinicalTrials.gov Identifier:

NCT05064423

Other Study ID Numbers:

MCC-21235
3P30CA076292-21S3

First Posted:

Oct 1, 2021

Last Update Posted:

Jul 28, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 28, 2022