Recruiting

Prognostic Genetic Technology

Sponsor:

Mayo Clinic

Code:

NCT04550845

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Focus group analyses

Study Details

Brief 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.

Conditions

Prostate Cancer

Study ID

NCT04550845

Start date

May 1, 2023

Status verified date

Oct, 2025

Completion date

Sep 27, 2027

Anticipated

Primary completion date

Sep 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Ewan K Cobran, PhD

480-301-6392cobran.ewan@mayo.edu

Locations

Mayo Clinic

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Ewan K. Cobran, PhD

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Folakemi Odedina, PhD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Christi A. Patten, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Nov 6, 2025

Last verified

Oct, 2025

Keywords

  • Prostate Cancer
  • Genetic Literacy
  • Heath Communication
  • Focus Group Discussions
  • Prognostic Genomics Technology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-11-06.