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Clinical Trials/NCT04550845
NCT04550845
Recruiting
N/A

Understanding of Genetics by Men at Risk for Prostate Cancer

Mayo Clinic2 sites in 1 country90 target enrollmentMay 1, 2023
ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Mayo Clinic
Enrollment
90
Locations
2
Primary Endpoint
Focus Group Discussion
Status
Recruiting
Last Updated
5 months ago

Overview

Brief Summary

With this greater certainty regarding prognosis, men with localized prostate cancer are now equipped with make better treatment planning decisions. This study is designed to investigate the understanding of prognostic genetic technology in African American and rural White men at risk for localized prostate cancer.

Detailed Description

Novel genomic technology, such as microarray analyses and next-generation sequencing, have improved the understanding of prostate cancer biology and prognosis. The National Comprehensive Cancer Network (NCCN), in 2016, recommended that patients and clinicians consider tissue-based genetic tests for localized prostate cancer. However, while much enthusiasm currently exits for the rapidly increasing field of genomic medicine, the use of multi-gene mRNA expression panels raises the potential for further divergence in prostate cancer treatment outcomes by race and low socioeconomic status. We know that health disparities persist in low income groups despite the existence of evidence-based guidelines and that adoption of state-of-the-art methods often lag behind in these groups. The goals of this study are to explore how men at risk for localized prostate cancer comprehend prognostic genetic technology, and examine how an educational video about genetics impacts patient-caregiver communication of prognostic genetic technology. The study rationale is that without direct attention to genomic comprehension, the enthusiasm that exists in the rapidly increasing field of prostate cancer genomic medicine may not translate into health benefits for men with localized prostate cancer. The central hypotheses are men with lower levels of education will demonstrate a severe lack of genomic comprehension of tissue-based genetic tests for localized prostate cancer; and tailored prostate cancer education will significantly improve communication in a low literacy population. The study approach is innovative because it applies a mixed-methods community-engagement research framework to explore how African American and rural White men at risk for localized prostate cancer, comprehend and interpret data generated from genetic technology. The proposed research is significant because of its potential to improve public health by improving the understanding of prognostic genetics in minority, low income, and rural populations, and engage and educate these diverse communities about genomics.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
September 27, 2027
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ewan Cobran, Ph.D.

Senior Associate Consultant, Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • African-American or White men
  • Living in a rural or urban areas
  • Age 40 to 95 years old
  • Able and willing to provide informed consent
  • English-speaking
  • Willing to participate in the study.
  • This study will use the United States Department of Agriculture Office of Rural Development's definition of rural, which is as a city or town that has a population less than 50,000 inhabitants to define rural.
  • This study will use the United States Census Bureau's definition of urban, which is a city or town that has a population greater than 50,000 inhabitants to define urban.

Exclusion Criteria

  • Women will be excluded from participating in this study. However, women will be recruited to serve on an advisory panel to review the video-based educational tool for the comprehension of genomic terminology for prognostic genetic testing in patients with localized prostate cancer.

Outcomes

Primary Outcomes

Focus Group Discussion

Time Frame: Immediately after the intervention

A semi-structured focus group discussion about the Prostate Cancer Genetic Literacy Application (PCGLA) educational video.

Estimate Genetic Literacy

Time Frame: Immediately after the intervention

The Rapid Estimate of Adult Literacy in Genetic - Short Form: An 8-item measure to asses adult literacy in genetics will be used.

Prostate Cancer Genetic Understanding

Time Frame: Baseline

The Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video, which was developed for this research, will be used as the study educational intervention. Prostate Cancer Genetic understanding will be assess with an 18-item knowledge prostate cancer genetic survey. The items are True or False.

Secondary Outcomes

  • Prostate Cancer Knowledge Scale(Immediately after the intervention)
  • Demographic Characteristics(Baseline)

Study Sites (2)

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