NCT04550845

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
17mo left

Started May 2023

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
May 2023Sep 2027

First Submitted

Initial submission to the registry

September 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
2.6 years until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2027

Last Updated

November 6, 2025

Status Verified

October 1, 2025

Enrollment Period

4.4 years

First QC Date

September 9, 2020

Last Update Submit

November 4, 2025

Conditions

Prostate Cancer

Keywords

Prostate CancerGenetic LiteracyHeath CommunicationFocus Group DiscussionsPrognostic Genomics Technology

Outcome Measures

Primary Outcomes (6)

  • Estimate Genetic Literacy

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

    Baseline

  • Estimate Genetic Literacy

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

    Pre-intervention

  • Estimate Genetic Literacy

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

    Immediately after the intervention

  • Prostate Cancer Genetic Understanding

    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.

    Baseline

  • Focus Group Discussion

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

    Baseline

  • Focus Group Discussion

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

    Immediately after the intervention

Secondary Outcomes (4)

  • Prostate Cancer Knowledge Scale

    Baseline

  • Prostate Cancer Knowledge Scale

    Pre-intervention

  • Prostate Cancer Knowledge Scale

    Immediately after the intervention

  • Demographic Characteristics

    Baseline

Study Arms (2)

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

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.

Behavioral: Focus group analyses

Interventions

Focus group analysesBEHAVIORAL

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.Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video.

Eligibility Criteria

Age40 Years - 95 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic

Phoenix, Arizona, 85054, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Ewan K Cobran, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ewan K Cobran, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate Consultant, Principal Investigator

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 16, 2020

Study Start

May 1, 2023

Primary Completion (Estimated)

September 27, 2027

Study Completion (Estimated)

September 27, 2027

Last Updated

November 6, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)