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

Clinical Trial (CT) &Amp; Biospecimen Studies Participation Education Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06112002
Enrollment
78
Registered
2023-11-01
Start date
2022-08-15
Completion date
2024-12-31
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm

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.

Interventions

OTHEREducational Intervention

Attend an educational session

BEHAVIORALHealth Education

Receive educational materials

OTHERSurvey Administration

Ancillary studies

Sponsors

Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in knowledgeUp to 1 yearChange 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.
Prior clinical trial participation statusUp to 2 yearsPrior clinical trial participation status will be examined by age, sex, race/ethnicity, education, primary language, and health insurance/health care coverage.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026