Web-Based Genetic Education for Prostate Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new web-based tool designed to educate men with prostate cancer about genetic testing. The study compares traditional genetic counseling, which provides information and support about genetic conditions, with this online tool. The tool offers educational modules and videos to help patients and healthcare providers better understand genetic testing. Men with prostate cancer who meet certain criteria, such as a high PSA level or a family history of related cancers, may be eligible. The goal is to simplify the decision-making process for patients considering genetic testing. As an unphased trial, this study allows participants to contribute to innovative educational approaches in 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 prior data suggests that this web-based genetic education tool is safe for patients with prostate cancer?

Research has shown that online tools for learning about genetics are generally safe and easy to use. One study created an online program for men and tested it in a small trial, demonstrating that these tools can be designed for safe and simple use.

Studies on genetic counseling have found that patients have positive experiences. Most people express satisfaction with how genetic counseling helps them understand their genetic risks, indicating its safety and effectiveness for informed decision-making.

Regarding genetic testing, patients report positive experiences. Many feel good about the process, suggesting that genetic testing is generally safe and comfortable.

Overall, evidence supports the safety and positive patient experiences of the treatments in this trial—online education, genetic counseling, and genetic testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Web-Based Genetic Education for Prostate Cancer trial because it explores innovative ways to enhance genetic counseling and testing. Unlike traditional in-person genetic counseling, this method offers a web-based tool that provides written modules and professional videos, making it more accessible and convenient for patients. This approach could significantly increase patient engagement and understanding by allowing individuals to learn at their own pace and revisit the materials anytime. Additionally, the option to combine this online education with traditional counseling creates a flexible, hybrid model, potentially streamlining the process and improving patient outcomes.

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

Research has shown that online tools for learning about genetic testing can simplify access to information about prostate cancer. In this trial, some participants will use web-based genetic education (WBGE) tools, which have proven as effective as in-person meetings with a genetic counselor for understanding genetic testing. Users of these web-based platforms comprehend the information and feel satisfied with the process, similar to those who receive face-to-face counseling.

Participants in this trial may also receive genetic counseling, which encourages more individuals to opt for genetic testing. This is crucial for identifying a higher familial cancer risk. Genetic testing can detect gene changes that may increase prostate cancer risk, aiding doctors in developing better treatment plans. Overall, both online education and traditional counseling effectively support patients through the genetic testing process for prostate cancer. ^{1 2 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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

My cancer has spread to other parts of my body.

My cancer has returned, indicated by blood tests.

I have at least 2 close relatives with breast or prostate cancer.

Exclusion Criteria

I have undergone genetic testing for inherited cancer risk.

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

I am under 18 years old.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/OP-24-00809

Results From a Randomized Study | JCO Oncology Practice We compare the uptake of GT among 250 patients with breast, ovarian, pancreatic, or metastatic prostate cancer randomly assigned to receive ...

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

TARGET: A Randomized, Noninferiority Trial of a Pretest ... To compare pretest genetic education via a webtool for noninferiority to traditional genetic counseling (GC) in patients with prostate cancer ( ...

3. ascopubs.org ascopubs.org/doi/10.1200/OP.23.00007

Pretest Video Education Versus Genetic Counseling for ... Rates of cancer genetic counseling (GC) are unacceptably low (approximately 20%) among individuals with standard or guideline-based indications ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37733980/

Pretest Video Education Versus Genetic Counseling for ... Participants had 67 genes analyzed (Ambry), with results disclosed via telephone by a genetic counselor. Outcomes included GT consent, GT completion, PV ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT358362

Impact of pretest video genetic education in prostate ... Studies have shown no difference in genetic testing uptake, satisfaction, or knowledge when patients undergo face-to-face genetic counseling compared to pre- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03328091

Study Details | NCT03328091 | Genetic Counseling ... Study Plan ; Prevalence of germline mutations in males with prostate cancer, The proportion of participants who test positive for pathogenic or likely pathogenic ...

7. asco.org asco.org/abstracts-presentations/ABSTRACT243795

Genetic counseling processes and outcomes among ... Background: Prostate cancer (PC) is among the leading causes of cancer mortality in males. Recent studies found 8-12% of advanced PC cases may be hereditary ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12462908/

Patient-Reported Outcomes from Males Regarding ... Relevance: Our results show generally positive patient experiences with GT for prostate cancer through various genetics care delivery models.