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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06112002
Other study ID # OSU-21293
Secondary ID NCI-2022-04986
Status Recruiting
Phase N/A
First received
Last updated
Start date August 15, 2022
Est. completion date December 31, 2024

Study information

Verified date October 2023
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State University Comprehensive Cancer Center
Phone 800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 175
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Educational Intervention
Attend an educational session
Behavioral:
Health Education
Receive educational materials
Other:
Survey Administration
Ancillary studies

Locations

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in knowledge 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. Up to 1 year
Primary Prior clinical trial participation status Prior clinical trial participation status will be examined by age, sex, race/ethnicity, education, primary language, and health insurance/health care coverage. Up to 2 years
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