Understanding of Genetics by Men at Risk for Prostate Cancer

Clinicaltrials.gov ID: NCT04550845
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age 40 - 95 Years
b-bullseye-arrow Enrollments 90

Conditions

Prostate Cancer

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.

Locations

3 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Ewan K Cobran, PhD

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Ewan K Cobran, PhD

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Ewan K Cobran, PhD

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.

Study Plan

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.

  • BEHAVIORAL:

    Focus group analyses

    Description:

    Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14 for analysis.

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.nnFocus 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.

  • BEHAVIORAL:

    Focus group analyses

    Description:

    Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14 for analysis.

Outcome Measures

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

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

Timeline

  • Last Updated
    October 31, 2023
  • Start Date
    September 16, 2020
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    September 27, 2027

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