Clinical trial NCT04550845: Understanding of Genetics by Men At Risk for Prostate Cancer
Official title: Understanding of Genetics by Men At Risk for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Genetic Literacy
Heath Communication
Focus Group Discussions
Prognostic Genomics Technology
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-09-16
Enrollment: 90
Sex: MALE
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Estimate Genetic Literacy
timeFrame: Baseline
measure: Estimate Genetic Literacy
timeFrame: Pre-intervention
measure: Estimate Genetic Literacy
timeFrame: Immediately after the intervention
measure: Prostate Cancer Genetic Understanding
timeFrame: Baseline
measure: Focus Group Discussion
timeFrame: Baseline
measure: Focus Group Discussion
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Prostate Cancer Knowledge Scale
timeFrame: Baseline
measure: Prostate Cancer Knowledge Scale
timeFrame: Pre-intervention
measure: Prostate Cancer Knowledge Scale
timeFrame: Immediately after the intervention
measure: Demographic Characteristics
timeFrame: Baseline
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ewan K Cobran, PhD
role: PRINCIPAL_INVESTIGATOR
References: