跳至主要内容
临床试验/NCT04550845
NCT04550845招募中不适用

Understanding of Genetics by Men at Risk for Prostate Cancer

Mayo Clinic5 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Mayo Clinic
入组人数
90
试验地点
5
主要终点
Focus Group Discussion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 95 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video.

Experimental

Focus group discussions about the PCGLA educational video post-study. Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus.

干预措施: Focus group analyses (Behavioral)

Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video plus Communication Coaching.

Experimental

Focus group discussions about the PCGLA educational plus nurse-navigated, tailored, prostate cancer education and communication coaching post-study.

Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus. post-study. Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14. A data dictionary will be created for each technical term to establish acceptable and unacceptable responses. Trained coders will evaluate comprehension of the technical terms independently and then resolve disagreement by consensus.

干预措施: Focus group analyses (Behavioral)

结局指标

主要结局

Focus Group Discussion

时间窗: Immediately after the intervention

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

Estimate Genetic Literacy

时间窗: 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

时间窗: 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.

Estimate Genetic Literacy

时间窗: Baseline

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

Estimate Genetic Literacy

时间窗: Pre-intervention

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

Focus Group Discussion

时间窗: Baseline

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

次要结局

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

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ewan Cobran, Ph.D.

Senior Associate Consultant, Principal Investigator

Mayo Clinic

研究点 (5)

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