- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06504407
BINGO: Bridging Knowledge, Increasing Awareness
BINGO: Bridging Knowledge, Increasing Awareness - Empowering the Black Community Through Educational Gamification on Cancer Screenings and Clinical Trial Diversity
The U.S. population is becoming more diverse, but minority groups are still significantly underrepresented in cancer clinical trials. This disparity limits our understanding of how treatments work across different populations. Efforts like the 21st Century Cures Act aim to improve inclusion, but challenges persist due to historical mistrust and complex barriers in healthcare.
To address these issues, Penn State Health is using a fun and educational approach called "BINGO" to engage the African American/Black community in Dauphin and surrounding counties. Led by the PSCI Diversity Navigator, these BINGO games will provide information about cancer and clinical trials in a relaxed setting. The goal is to build trust, increase awareness, and ultimately improve participation of underrepresented groups in clinical trials.
Through this initiative, they hope to connect participants with needed healthcare services and gather feedback to tailor future trials to community needs. This approach aims to foster collaboration between minority communities and the healthcare system, ensuring that clinical trials reflect the diversity of the population they aim to serve.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Penn State Health is addressing the underrepresentation of minority groups in cancer clinical trials through a community-engagement initiative using a BINGO educational game. Despite efforts like the 21st Century Cures Act, minority participation remains low, impacting the generalizability of trial results and access to novel treatments for diverse populations.
Led by the PSCI Diversity Navigator, this initiative focuses on the African American/Black community in Dauphin and surrounding counties. The BINGO games serve as a platform to educate participants about cancer, clinical trials, and the importance of diversity in research. By creating a relaxed and enjoyable atmosphere, the initiative aims to build trust and increase awareness among community members.
The project's long-term goals include fostering collaboration between minority communities and Penn State Health, improving clinical trial participation rates among underrepresented populations, and addressing healthcare disparities. Immediate objectives involve assessing the feasibility, educational utility, and engagement of the BINGO game through pre- and post-game surveys and knowledge tests.
Recruitment efforts target community centers and organizations like historically Black sororities and churches, leveraging their influence and trust within the community. The initiative strategically focuses on areas with high African American populations, such as Harrisburg, to maximize impact and engagement.
Feedback gathered from participants will guide future trial designs tailored to community needs, enhancing the inclusivity and relevance of research efforts. By promoting understanding and trust, Penn State Health aims to create a model that can be replicated to improve minority participation in clinical trials nationwide.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age: Adults aged 18 years and above.
- Gender Identity: Individuals identifying as cisgender, transgender, or females.
- Language Proficiency: Proficiency in English equivalent to middle school/high school level.
- Registration: Completion of registration via the provided RedCap link prior to the Bingo session.
- Consent: Willingness to provide written consent at the beginning of the Bingo session to participate in the research study.
Exclusion Criteria:
- Age: Individuals under the age of 18 years.
- Gender Identity: Participants who do not identify as cisgender, transgender, or females.
- Language Proficiency: Inability to understand English at a middle school/high school level.
- Previous Participation: Individuals who have already participated in a previous Bingo game session for this study.
- Medical or Cognitive Impairment: Participants unable to provide informed consent or actively participate due to medical or cognitive reasons.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bingo Educational Intervention
Single-arm, interventional study where all participants will engage in the Bingo game as an educational intervention.
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The intervention involves Bingo games designed to educate African American/Black community members about cancer and clinical trials.
During each game, educational facts are shared, and prizes promoting healthy lifestyles are awarded.
Led by a Diversity Navigator, the sessions include pre- and post-test surveys to assess knowledge gain and engagement.
The intervention also connects participants with needed medical services.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility Measure
Time Frame: one year
|
Percentage of Participants Attending a Complete Bingo Game Session and Completing Pre- and Post-Test Surveys.
|
one year
|
|
Utility Measure
Time Frame: one year
|
Pre- and post-test scores on knowledge-based questions will be compared to measure the effectiveness of the educational content.
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one year
|
|
Engagement Measure
Time Frame: one year
|
Participant engagement will be evaluated using a 5-point Likert scale, with the percentage of participants who "strongly agree or agree" that Bingo game was engaging being the primary measure.
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Monali Vasekar, MD, Penn State Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PSCI-24-021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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