Genetic Education for Prostate Cancer

Recruiting at 4 trial locations

Overseen By Ewan K Cobran, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Women

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help men with localized prostate cancer understand genetic information that can guide their treatment choices. It will explore how African American and rural White men comprehend genetic technology through video education and nurse-navigated coaching. Participants will join focus group discussions to assess their understanding. This trial suits African American or White men living in rural or urban areas who are willing to learn about prostate cancer genetic testing. As an unphased trial, this study offers a unique opportunity to contribute to understanding the impact of genetic education on treatment decisions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational method is safe?

Research shows that educational videos, such as the Prostate Cancer Genetic Literacy Application (PCGLA), enhance understanding of prostate cancer genetics. This method boosts knowledge about genetic testing without safety concerns. Adding communication coaching has also reduced disparities in genetic testing and screening, particularly for African American men, with no reported negative effects.

These educational tools aim to improve understanding and communication about prostate cancer genetics. They are non-invasive, meaning they don't involve medication or medical procedures, so there's no risk of physical harm. Participants have generally responded well to these methods, with no safety issues reported in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they aim to boost understanding and communication about prostate cancer genetics. Unlike typical treatments that focus on drugs or surgery, these approaches use educational videos and nurse-guided coaching. The Prostate Cancer Genetic Literacy Application (PCGLA) video alone helps clarify complex genetic information, while the combination of the video with personalized coaching enhances patient communication skills. This innovative approach could empower patients to make more informed decisions about their health.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Studies have shown that educational videos like the Prostate Cancer Genetic Literacy Application (PCGLA) effectively teach people about genetic testing for prostate cancer. Research indicates that these tools enhance understanding of genetic terms and testing, which is crucial for informed decision-making in prostate cancer care. In this trial, one group will receive only the PCGLA educational video, while another group will receive the video along with communication coaching. Adding communication coaching may further improve understanding of genetic risks and treatment planning. This combination could help patients, especially in underserved communities, better understand their condition and engage in more informed conversations with healthcare providers. ^{1 3 4 6 7}

Who Is on the Research Team?

Ewan K Cobran, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This study is for English-speaking African American and rural White men aged 40 or older who have early-stage (stage 1 or 2) prostate cancer. Participants must be willing to provide informed consent and participate in the study. Men with advanced prostate cancer, plans to move soon, or severe mental illness like dementia cannot join.

Inclusion Criteria

English-speaking

My prostate cancer is in the early stages (1 or 2).

I am willing to participate in the study.

Exclusion Criteria

You have a serious and ongoing mental illness like dementia.

I am a man with prostate cancer that has spread.

Plan to move out of the area within the next 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments including demographic characteristics and prostate cancer genetic understanding

1 week

1 visit (in-person)

Intervention

Participants view the PCGLA educational video and engage in focus group discussions

1 week

1 visit (in-person)

Follow-up

Participants are monitored for genetic literacy and understanding immediately after the intervention

Immediately after intervention

What Are the Treatments Tested in This Trial?

Interventions

• Nurse-navigated coaching

Trial Overview The trial is focused on understanding how these men perceive genetic technology that helps predict the outcome of localized prostate cancer. It involves participating in focus group discussions to gather insights into their decision-making processes regarding treatment planning.

How Is the Trial Designed?

Group I: Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video. Experimental Treatment 1 Intervention

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.

Group II: Prostate Cancer Genetic Literacy Application (PCGLA) Educational Video plus Communication Coaching. Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

University of Georgia

Lead Sponsor

Trials

109

Recruited

43,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study of 573 oncology nurses revealed that those with higher education and specialized training in cancer genetics had significantly better knowledge about the subject, highlighting the importance of ongoing education in this field.

Despite nearly half of the nurses receiving patient inquiries about cancer genetics, only 35% knew about referral resources, indicating a critical need for targeted educational programs to enhance their ability to address genetic concerns in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology nurses' knowledge, practice, and educational needs regarding cancer genetics. Peterson, SK., Rieger, PT., Marani, SK., et al.[2019]

A study involving 299 women who received uninformative BRCA test results showed that 93.6% had a positive experience with nurse-driven genetic counseling, indicating high satisfaction with this model of care.

While most women accurately reported their test results, only 22.4% understood that a normal result does not eliminate the possibility of hereditary cancer risk, highlighting a need for improved education on cancer risk perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with a nurse-driven genetic counseling pathway of Italian women with uninformative BRCA test result. Blondeaux, E., Lambertini, M., Buzzatti, G., et al.[2023]

An interactive continuing education module significantly improved the knowledge of pharmacogenomics among 434 oncology nurses, with pre-test scores averaging 72.7 and post-test scores averaging 85.9, indicating effective learning.

The study highlights the importance of integrating pharmacogenomics education into nursing competencies, as the module successfully addressed knowledge gaps identified by nurses themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology Nurses' Knowledge of Pharmacogenomics Before and After Implementation of an Education Module. Dodson, C.[2019]

A study involving 79 high-risk African American men revealed that their knowledge about hereditary prostate cancer was significantly low, indicating a gap in understanding important health information.

The high rate of incorrect answers regarding genetic testing, prevention, and family history risk emphasizes the urgent need for targeted educational efforts by healthcare professionals, particularly nurses, to improve awareness and knowledge in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge of hereditary prostate cancer among high-risk African American men. Weinrich, S., Vijayakumar, S., Powell, IJ., et al.[2022]

A pilot study involving six nurses showed that a structured training program for nurse-led decision coaching is feasible and can effectively prepare nurses to support BRCA1/2 mutation carriers in making informed preventive health decisions.

The training program was adapted to a virtual format due to the COVID-19 pandemic, indicating flexibility in delivery methods, and highlights the need for further research to assess the effectiveness and acceptability of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-led decision coaching by specialized nurses for healthy BRCA1/2 gene mutation carriers - adaptation and pilot testing of a curriculum for nurses: a qualitative study. Berger-Höger, B., Vitinius, F., Fischer, H., et al.[2022]

A pilot study involving 32 oncology healthcare professionals showed that an online training program significantly improved their genetic literacy and communication skills regarding BRCA1/2 testing for breast and ovarian cancer, with 91% reporting new skills and 94% feeling more confident.

The training program was highly accepted, with over 93% of participants finding it clear, informative, and relevant, indicating its potential as a valuable resource for enhancing genetic discussions in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of an online training program to increase genetic literacy and communication skills in oncology healthcare professionals discussing BRCA1/2 genetic testing with breast and ovarian cancer patients. Meiser, B., Woodward, P., Gleeson, M., et al.[2022]

A review of 36 studies highlights that both patients and healthcare providers need better knowledge and understanding of genetics and pharmacogenomics to effectively utilize pharmacogenomic tests in treatment decisions.

The analysis identified key areas for improvement, including the experiences surrounding genetic testing and the need for better educational resources to help patients and providers understand test results and their implications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Health Care Provider Needs and Preferences in Understanding Pharmacogenomic and Genomic Testing: A Meta-Data Analysis. Veilleux, S., Bouffard, M., Bourque Bouliane, M.[2020]

Prostate cancer is the most common cancer in American men and can be linked to inherited genetic mutations, highlighting the importance of genetic testing for assessing risk.

Advancements in understanding the genetic basis of prostate cancer are crucial for improving prevention, diagnosis, and treatment strategies, which directly impacts nursing practices in urology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A genetics perspective on prostate cancer. Lessick, M., Katz, A.[2010]

A health literacy training program for surgical oncologists and specialized nurses did not significantly reduce disparities in referrals for genetic testing among breast cancer patients, despite training efforts.

The study involved 3179 patient referrals, and while the mean age of patients referred decreased after the intervention, there were no notable changes in educational level, health literacy, or migrant background among those referred for testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a health literacy training program for surgical oncologists and specialized nurses on disparities in referral to breast cancer genetic testing. van der Giessen, JAM., van Dulmen, S., Velthuizen, ME., et al.[2021]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-05978

Education-Based Video (The Prostate Cancer Genetic ... Education-based videos, such as PCGLA, may be an effective method to help people learn about prostate cancer genetic (genomic) terminology and testing.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12085863/

Pilot Trial of Streamlined Genetic Education and ... The primary goal of this study was to determine whether a proactive and streamlined 'Traceback' approach could yield increased genetic testing ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12148599/

Germline testing for prostate cancer - PubMed Central - NIH Germline testing (GT) for prostate cancer (PCA) is now central to PCA care and hereditary cancer assessment, with a rising role in PCA screening approaches.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.6_suppl.059

Impact of provider education on prostate cancer genetic ... Prostate cancer genetics referrals increased 118% following educational presentations to urologists, medical oncologists, and nurse navigators.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0027968425000409

Utilizing peer educators to increase genetic testing for ... We aimed to evaluate the impact of a peer-based educational intervention about PCa genetic testing for Black males in a community setting.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10939575/

TARGET: A Randomized, Noninferiority Trial of a Pretest ... These results support the use of a patient-driven digital webtool for expanding access to pretest education for germline GT among patients with PCA.

7. youtube.com youtube.com/watch?v=IouE0s-HI24

Prostate Cancer and Genetics (Special Episode) In this informative episode of PROSTATE CANCER: REAL TALK, hosts El and Shay are joined by Dr. Catherine Handy-Marshall, an Assistant ...