Understanding of Genetics by Men at Risk for Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Focus group analyses.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 40 years — 95 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Focus group analyses
Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14 for analysis.
Primary outcome measures
- Estimate Genetic Literacy [Time frame: Baseline]
- Estimate Genetic Literacy [Time frame: Pre-intervention]
- Estimate Genetic Literacy [Time frame: Immediately after the intervention]
- Prostate Cancer Genetic Understanding [Time frame: Baseline]
- Focus Group Discussion [Time frame: Baseline]
- Focus Group Discussion [Time frame: Immediately after the intervention]
Secondary outcome measures (4)
- Prostate Cancer Knowledge Scale [Time frame: Baseline]
- Prostate Cancer Knowledge Scale [Time frame: Pre-intervention]
- Prostate Cancer Knowledge Scale [Time frame: Immediately after the intervention]
- Demographic Characteristics [Time frame: Baseline]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
United States · 3 centers
- Mayo Clinic — Phoenix
- Mayo Clinic in Florida — Jacksonville
- Mayo Clinic — Rochester
Identifiers
NCT: NCT04550845 · 22-011303 · K01CA230193 · NCI-2023-05978