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

Not Applicable
Completed
Conditions
Malignant Solid Neoplasm
Hematopoietic and Lymphoid System Neoplasm
Interventions
Other: Educational Intervention
Behavioral: Health Education
Other: Survey Administration
Registration Number
NCT06112002
Lead Sponsor
Ohio State University Comprehensive Cancer Center
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.

Detailed Description

PRIMARY OBJECTIVE:

I. 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
78
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
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Health Services Research (educational session and materials)Health EducationParticipants attend an educational session with CHEs and receive educational materials on study.
Health Services Research (educational session and materials)Educational InterventionParticipants attend an educational session with CHEs and receive educational materials on study.
Health Services Research (educational session and materials)Survey AdministrationParticipants attend an educational session with CHEs and receive educational materials on study.
Primary Outcome Measures
NameTimeMethod
Prior clinical trial participation statusUp 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.

Change in knowledgeUp 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center

🇺🇸

Columbus, Ohio, United States

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