Understanding of Genetics by Men at Risk for Prostate Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Focus group analyses.
- Кому может быть актуально
- Состояния в реестре: Prostate Cancer. Базовые параметры: 40 лет — 95 лет · Мужчины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Focus group analyses
Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14 for analysis.
Первичные конечные точки
- Estimate Genetic Literacy [Срок оценки: Baseline]
- Estimate Genetic Literacy [Срок оценки: Pre-intervention]
- Estimate Genetic Literacy [Срок оценки: Immediately after the intervention]
- Prostate Cancer Genetic Understanding [Срок оценки: Baseline]
- Focus Group Discussion [Срок оценки: Baseline]
- Focus Group Discussion [Срок оценки: Immediately after the intervention]
Вторичные конечные точки (4)
- Prostate Cancer Knowledge Scale [Срок оценки: Baseline]
- Prostate Cancer Knowledge Scale [Срок оценки: Pre-intervention]
- Prostate Cancer Knowledge Scale [Срок оценки: Immediately after the intervention]
- Demographic Characteristics [Срок оценки: Baseline]
Критерии участия
Критерии включения
- 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.
Критерии исключения
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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 3 центра
- Mayo Clinic — Phoenix
- Mayo Clinic in Florida — Jacksonville
- Mayo Clinic — Rochester
Идентификаторы
NCT: NCT04550845 · 22-011303 · K01CA230193 · NCI-2023-05978