Understanding of Genetics by Men at Risk for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Understanding of Genetics by Men at Risk for Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04550845
• Other study ID #: 22-011303
• Secondary ID: K01CA230193
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: September 27, 2027

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: Ewan K Cobran, PhD
• Phone: 480-301-6392
• Email: cobran.ewan[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 27, 2027
• Est. primary completion date: September 27, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Focus Group Discussion	A semi-structured focus group discussion about the Prostate Cancer Genetic Literacy Application (PCGLA) educational video.	Baseline
Primary	Focus Group Discussion	A semi-structured focus group discussion about the Prostate Cancer Genetic Literacy Application (PCGLA) educational video.	Immediately after the intervention
Secondary	Prostate Cancer Knowledge Scale	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
Secondary	Prostate Cancer Knowledge Scale	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
Secondary	Prostate Cancer Knowledge Scale	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
Secondary	Demographic Characteristics	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