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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Nurse-navigated coaching for prostate cancer?

Research shows that nurse-led decision coaching can help patients make informed decisions about their health, as seen in studies with women at risk for breast and ovarian cancer. This suggests that similar nurse-navigated coaching could be beneficial for prostate cancer patients in understanding genetic risks and making treatment decisions. ^{1 2 3 4 5}

How does the treatment in the Genetic Education for Prostate Cancer trial differ from other treatments for prostate cancer?

The treatment in this trial focuses on genetic education, which is unique because it aims to increase understanding of hereditary prostate cancer, particularly among high-risk groups, rather than directly treating the cancer itself. This approach is different from standard treatments that typically involve medication or surgery. ^{2 6 7 8 9}

Research Team

Ewan K Cobran, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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 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 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 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]

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]

References

1. England 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. [2022]

2. Netherlands 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A genetics perspective on prostate cancer. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Oncology nurses' knowledge, practice, and educational needs regarding cancer genetics. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Knowledge of hereditary prostate cancer among high-risk African American men. [2022]

7. Netherlands 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Experience with a nurse-driven genetic counseling pathway of Italian women with uninformative BRCA test result. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Patient and Health Care Provider Needs and Preferences in Understanding Pharmacogenomic and Genomic Testing: A Meta-Data Analysis. [2020]