Clinical trial NCT06504407: BINGO: Bridging Knowledge, Increasing Awareness
Official title: BINGO: Bridging Knowledge, Increasing Awareness - Empowering the Black Community Through Educational Gamification on Cancer Screenings and Clinical Trial Diversity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Education
Health Equity
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm interventional study
Primary purpose: SCREENING

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age: Adults aged 18 years and above.
2. Gender Identity: Individuals identifying as cisgender, transgender, or females.
3. Language Proficiency: Proficiency in English equivalent to middle school/high school level.
4. Registration: Completion of registration via the provided RedCap link prior to the Bingo session.
5. Consent: Willingness to provide written consent at the beginning of the Bingo session to participate in the research study.

Exclusion Criteria:

1. Age: Individuals under the age of 18 years.
2. Gender Identity: Participants who do not identify as cisgender, transgender, or females.
3. Language Proficiency: Inability to understand English at a middle school/high school level.
4. Previous Participation: Individuals who have already participated in a previous Bingo game session for this study.
5. Medical or Cognitive Impairment: Participants unable to provide informed consent or actively participate due to medical or cognitive reasons.

Primary outcomes:
measure: Feasibility Measure
timeFrame: one year
measure: Utility Measure
timeFrame: one year
measure: Engagement Measure
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Penn State Cancer Institute
name: Monali Vasekar, MD
role: PRINCIPAL_INVESTIGATOR
References: