Understanding of Genetics by Men at Risk for Prostate Cancer

October 27, 2023 updated by: Ewan Cobran, Ph.D., Mayo Clinic
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
    • Florida
      • Jacksonville, Florida, United States, 32224
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Ewan K Cobran, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Focus group analyses
Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14 for analysis.
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.
Behavioral: Focus group analyses
Focus group audiotapes will be transcribed verbatim, and then entered into the qualitative data software package, NVivo 14 for analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate Genetic Literacy
Time Frame: Baseline
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
Time Frame: 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.
Pre-intervention
Estimate Genetic Literacy
Time Frame: 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.
Immediately after the intervention
Focus Group Discussion
Time Frame: Baseline
A semi-structured focus group discussion about the Prostate Cancer Genetic Literacy Application (PCGLA) educational video.
Baseline
Focus Group Discussion
Time Frame: Immediately after the intervention
A semi-structured focus group discussion about the Prostate Cancer Genetic Literacy Application (PCGLA) educational video.
Immediately after the intervention
Prostate Cancer Genetic Understanding
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate Cancer Knowledge Scale
Time Frame: Baseline
The Prostate Cancer Knowledge Scales a 12-item self-report measure developed to assess men's knowledge of prostate cancer risk factors, symptoms, prevention, screening, and treatment. Response options were multiple choice or true/false with each question also including an I don't know response option. Scoring was based on the percentage of questions answered correctly and ranged from 0 to 100.
Baseline
Prostate Cancer Knowledge Scale
Time Frame: Pre-intervention
The Prostate Cancer Knowledge Scales a 12-item self-report measure developed to assess men's knowledge of prostate cancer risk factors, symptoms, prevention, screening, and treatment. Response options were multiple choice or true/false with each question also including an I don't know response option. Scoring was based on the percentage of questions answered correctly and ranged from 0 to 100.
Pre-intervention
Prostate Cancer Knowledge Scale
Time Frame: Immediately after the intervention
The Prostate Cancer Knowledge Scales a 12-item self-report measure developed to assess men's knowledge of prostate cancer risk factors, symptoms, prevention, screening, and treatment. Response options were multiple choice or true/false with each question also including an I don't know response option. Scoring was based on the percentage of questions answered correctly and ranged from 0 to 100.
Immediately after the intervention
Demographic Characteristics
Time Frame: Baseline
Patients will be asked ended-questions to assess (1) race, (2) age, (3) marital status, (4) employment status, (5) current and/or past prostate cancer diagnoses, (6) occupation, (7) level of education, and 8) income.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ewan K Cobran, PhD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

September 27, 2027

Study Completion (Estimated)

September 27, 2027

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 10, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-011303
  • K01CA230193 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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