Understanding of Genetics by Men at Risk for Prostate Cancer
NCT ID: NCT04550845
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2023-05-01
2027-09-27
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video.
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.
Focus group analyses
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.
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.
Focus group analyses
Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14 for analysis.
Interventions
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Focus group analyses
Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14 for analysis.
Eligibility Criteria
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Inclusion Criteria
* 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
40 Years
95 Years
MALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Ewan Cobran, Ph.D.
Senior Associate Consultant, Principal Investigator
Principal Investigators
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Ewan K Cobran, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2023-05978
Identifier Type: REGISTRY
Identifier Source: secondary_id
22-011303
Identifier Type: -
Identifier Source: org_study_id