Web-Based Genetic Education for Prostate Cancer

Recruiting at 4 trial locations

Overseen By Veda Giri

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Age < 18, Cognitive impairment, Non-English, Prior genetic testing

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

Compensation: Varies

Number of Visits: 1

346 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial performs user testing of a mobile-friendly patient history collection and genetic education tool to improve healthcare providers' understanding of prostate cancer genetic testing. This trial also compares traditional genetic counseling versus a web-based genetic education (WBGE) tool to provide information about genetic testing to men with prostate cancer. The WBGE tool has educational modules on genetic counseling and testing, as well as a patient history collection tool to help providers learn which patients may carry genetic mutations and may be considered for genetic counseling and genetic testing. The purpose of this research is to use technology to deliver information on genetic testing for prostate cancer to patients to help them decide whether or not to receive genetic testing.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on genetic education and testing, so it's unlikely that your medications will be affected, but you should confirm with the trial organizers.

What data supports the effectiveness of the treatment Web-Based Genetic Education for Prostate Cancer?

Research shows that digital tools, like interactive computer programs, can effectively educate patients about genetic testing, improving their knowledge and decision-making. These tools have been well-accepted and can enhance the efficiency of genetic counseling, making them a promising option for delivering genetic education. ^{1 2 3 4 5}

Is web-based genetic education for prostate cancer safe for humans?

Research on web-based genetic education tools, like interactive e-learning and telephone counseling, suggests they are generally well-accepted and safe for users. These tools have been used in genetic counseling for conditions like breast and ovarian cancer, with studies indicating they do not increase distress and are effective in delivering genetic knowledge. ^{1 2 5 6 7}

How does the Web-Based Genetic Education for Prostate Cancer treatment differ from other treatments for this condition?

This treatment is unique because it uses the internet to provide genetic education and counseling, making it more accessible and convenient for patients compared to traditional in-person sessions. It leverages interactive tools to help patients understand their genetic testing options, which can be particularly beneficial when access to genetic counselors is limited. ^{1 2 5 8 9}

Research Team

Veda Giri, MD

Principal Investigator

Clinical Cancer Genetics Yale School of Medicine

Stacy Loeb, MD, MSc

Principal Investigator

NYU- Langone Health, Manhattan VA Hospital

Eligibility Criteria

This trial is for English-speaking men aged 18 or older with prostate cancer who have access to a computer and the web. They must meet certain clinical criteria like advanced disease stage, high PSA levels, or specific family history of cancer. It's not for those with mental impairments affecting consent, non-English speakers, minors, or those who've had prior genetic testing.

Inclusion Criteria

I am a man over 18 with prostate cancer, have computer and web access.

My cancer has spread to other parts of my body.

My cancer has returned, indicated by blood tests.

Exclusion Criteria

I have undergone genetic testing for inherited cancer risk.

I am able to understand and make decisions about my health care.

I do not speak English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Provider Tool Testing

Providers attend an interview to discuss the tool, test it in their clinic for 2 weeks, and provide feedback.

2 weeks

1 interview, 1 feedback session

Genetic Counseling and Education

Patients are randomized to receive either traditional genetic counseling or web-based genetic education, followed by potential genetic testing.

6 months

Follow-up

Participants are monitored for outcomes such as cancer genetics knowledge, satisfaction, and genetic testing uptake.

Up to 5 years

Treatment Details

Interventions

• Genetic Counseling
• Genetic Testing
• Internet Based Intervention
• Internet-Based Intervention

Trial Overview The TARGET Study tests a mobile tool that collects patient history and educates about genetic testing versus traditional counseling. It aims to help healthcare providers identify patients for potential genetic mutations related to prostate cancer and decide on testing.

Participant Groups

Group I: Aim II: Arm II (WBGE, Genetic Couseling, Genetic Testing) Experimental Treatment 4 Interventions

Patients receive a link to the web-based genetic education tool online including all elements of genetic counseling in written modules and in a series of professional videos. Patient may then undergo genetic testing. Patient may cross-over to Arm I to see a genetic counselor.

Group II: Aim I (Interview) Experimental Treatment 3 Interventions

Providers attend an interview over 1 hour to discuss how they would use the tool, then receive the tool to test in their clinic for 2 weeks. After 2 weeks, providers discuss their experience using the tool over 10-15 minutes. Providers have the option to use the tool for up to 6 months and complete a brief survey about the benefits and limitations of the tool for patient identification in Arm II.

Group III: Aim II: Arm I (Genetic Counseling, Genetic Testing) Active Control 3 Interventions

Patients receive genetic counseling with a certified genetic counselor in-person, by telehealth, or over the phone (according to patient preference). Patients may then undergo genetic testing.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Prostate Cancer Foundation

Collaborator

Trials

52

Recruited

3,000+

Findings from Research

In-person genetic counseling (GC) may not always be the most effective or accessible option for patients, especially given the increasing demand for genetic testing and limited availability of genetic counselors.

A review of 21 studies on interactive e-learning and decision support tools found that these e-tools can enhance knowledge and comfort in decision-making for patients, suggesting they could effectively supplement traditional GC methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive e-counselling for genetics pre-test decisions: where are we now? Birch, PH.[2022]

A study involving 72 women with a family history of breast cancer found that both face-to-face counseling by a genetic counselor and education through an interactive computer program significantly improved knowledge about breast cancer genetics, with the computer program yielding slightly higher scores.

Despite the increase in knowledge, both educational methods, when combined with counseling, led to a decrease in the intent to undergo genetic testing, suggesting that increased awareness may lead to more cautious decision-making regarding testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An interactive computer program can effectively educate patients about genetic testing for breast cancer susceptibility. Green, MJ., Biesecker, BB., McInerney, AM., et al.[2022]

Genetic counseling and testing are crucial for cancer patients, as they can influence treatment decisions and help identify individuals at risk before a cancer diagnosis, allowing for better surveillance and prevention.

With up to 10% of cancers being hereditary, there is a pressing need to enhance access to genetic services, especially in underserved communities, through innovative models like telehealth and collaboration with non-genetics healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic Counseling and Testing in a Community Setting: Quality, Access, and Efficiency. Cohen, SA., Bradbury, A., Henderson, V., et al.[2019]

A systematic review of 87 studies found that 84% reported positive outcomes for patients using digital genetics tools, enhancing knowledge, psychosocial well-being, and engagement in genetic service delivery.

Digital tools not only improved patient outcomes but also increased workflow efficiency for healthcare providers, suggesting they can effectively support patient-centered care in the growing demand for genetic services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-facing digital tools for delivering genetic services: a systematic review. Whiwon, L., Salma, S., Daniel, A., et al.[2023]

Telephone genetic counseling for BRCA1 and BRCA2 testing is as effective as in-person counseling in terms of reducing cancer-specific distress and improving genetic knowledge, based on a systematic review of four studies.

This approach may provide a viable alternative for delivering genetic services, especially during situations like the COVID-19 pandemic, although more research is needed to confirm these findings across broader populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of telephone vs in-person genetic counseling in BRCA1/BRCA2 genetic testing. Bracke, X., Roberts, J., McVeigh, TP.[2021]

The Family Gene Toolkit, a customized web application for families with BRCA1/BRCA2 pathogenic variants, was developed based on feedback from 68 women and is designed to improve family communication about genetic testing results.

In a usability test with 18 women, participants reported high satisfaction with the toolkit, finding it useful for coping strategies and family communication, indicating its potential to promote cascade genetic testing among at-risk relatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Usability of the Family Gene Toolkit for Swiss and Korean Families Harboring BRCA1/BRAC2 Pathogenic Variants: A Web-Based Platform for Cascade Genetic Testing. Baroutsou, V., Duong, V., Signorini, A., et al.[2023]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Interactive e-counselling for genetics pre-test decisions: where are we now? [2022]

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

An interactive computer program can effectively educate patients about genetic testing for breast cancer susceptibility. [2022]

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

Genetic Counseling and Testing in a Community Setting: Quality, Access, and Efficiency. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Patient-facing digital tools for delivering genetic services: a systematic review. [2023]

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

Who should provide genetic education prior to gene testing? Computers and other methods for improving patient understanding. [2009]

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

A systematic review and meta-analysis of telephone vs in-person genetic counseling in BRCA1/BRCA2 genetic testing. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Acceptability and Usability of the Family Gene Toolkit for Swiss and Korean Families Harboring BRCA1/BRAC2 Pathogenic Variants: A Web-Based Platform for Cascade Genetic Testing. [2023]

8. England pubmed.ncbi.nlm.nih.gov

An interactive computer program for educating and counseling patients about genetic susceptibility to breast cancer. [2009]

9. England pubmed.ncbi.nlm.nih.gov

Delivery of Internet-based cancer genetic counselling services to patients' homes: a feasibility study. [2021]