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Evaluation of an Education Program to Increase Knowledge and Participation in Clinical Trials Among Racial/Ethnic and Rural Populations

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT06112002
Collaborator
(none)
175
Enrollment
1
Location
1
Arm
28.6
Anticipated Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial evaluates a culturally tailored educational outreach intervention for increasing clinical trial knowledge, referral, and participation among racial/ethnic minority and rural populations. Clinical trials are research studies that involve people. Through clinical trials, researchers are able to determine whether new treatments are safe and effective and work better than current treatments. Clinical trials can also help find new ways to prevent and detect cancer and improve the quality of life for people during and after treatment. Recruitment and retention of underrepresented groups in clinical trials remains a challenge. Racial and ethnic minority groups bear a disproportionate burden of cancer compared with other groups yet these populations continue to be underrepresented in clinical trials. This clinical trial uses community health educators (CHEs) to facilitate individual and group education sessions to improve knowledge of what constitutes a clinical trial, the value of participating in clinical trials, and why it is important for racial/ethnic minorities to participate in clinical trials.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Intervention
  • Behavioral: Health Education
  • Other: Survey Administration
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. To implement culturally tailored educational outreach activities with the goal of increasing clinical trial (CT) knowledge, referral and participation among racial/ethnic and rural populations.
OUTLINE:

Participants attend an educational session with CHEs and receive educational materials on study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
175 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Clinical Trial (CT) &Amp; Biospecimen Studies Participation Education Program
Actual Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Health Services Research (educational session and materials)

Participants attend an educational session with CHEs and receive educational materials on study.

Other: Educational Intervention
Attend an educational session
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

    • Behavioral: Health Education
    Receive educational materials

    Other: Survey Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Change in knowledge [Up to 1 year]

      Change in knowledge will be correlated with key outcomes, specifically likely hood of joining a clinical trial and actions promoting clinical trial participation (e.g., seeking out information regarding clinical trials, seeking out trials he/she might be eligible for, talking to their doctor/provider about the clinical trials). Multivariable logistic regression analyses will be conducted to examine the impact of knowledge change and strength of intentions on binary outcomes controlling for important covariates such as age, sex, race/ethnicity, education, primary language, and health insurance/health care coverage. 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.

    2. Prior clinical trial participation status [Up to 2 years]

      Prior clinical trial participation status will be examined by age, sex, race/ethnicity, education, primary language, and health insurance/health care coverage.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Adult males and females 18 years of age and older from Ohio

    • Will not let anyone who is not cognitively able to give voluntary informed consent take part in the education sessions

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Electra D Paskett, PhD, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Electra Paskett, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT06112002
    Other Study ID Numbers:
    • OSU-21293
    • NCI-2022-04986
    First Posted:
    Nov 1, 2023
    Last Update Posted:
    Nov 1, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Nov 1, 2023