Web-Based Genetic Education for BRCA Mutation Carriers

Enrolling by invitation at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgetown University

Disqualifiers: Metastatic cancer, Prior genetic testing, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based program that educates people about genetic testing for cancer risk. The goal is to help individuals from families with hereditary cancer determine if they should get tested for BRCA mutations, which can increase the risk of certain cancers. The trial compares this online education with traditional care to see if more people choose genetic counseling and testing after using the web program. Ideal candidates for the trial have close family members who recently discovered a BRCA mutation but have not undergone genetic testing themselves. As an unphased trial, this study offers participants the opportunity to contribute to innovative educational approaches that could improve genetic testing decisions for at-risk families.

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 web-based genetic education intervention is safe?

Research has shown that online genetic education programs are generally well-received by participants. In one study involving men from families with hereditary cancer, participants were randomly assigned to receive online genetic education. The results showed that this method was safe and did not cause any significant negative effects. Thus, using an online platform for genetic education is considered safe for participants.

As this trial is not linked to a specific phase, it focuses more on education than traditional treatment. The goal is to provide information safely and effectively, rather than administering a new drug or therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Web-based Genetic Education for BRCA Mutation Carriers program because it offers a more accessible approach to genetic counseling. Unlike traditional face-to-face sessions, this method combines web-based education with streamlined telephone counseling, making it more convenient for participants. This approach could potentially reach more people, providing crucial genetic information to those who might otherwise skip in-person appointments due to time, cost, or location constraints. This innovative delivery method could lead to more informed decisions about health management for BRCA mutation carriers.

What evidence suggests that this web-based genetic education intervention is effective for BRCA mutation carriers?

This trial will compare two approaches: proactive outreach with web-based counseling and streamlined telephone genetic counseling, versus usual care. Studies have shown that online genetic education helps people make informed choices about genetic testing. Research also suggests that phone counseling for hereditary cancer risks, such as BRCA mutations, often leads to good results. Many genetic counselors have successfully used phone calls to share test results. These methods improve access to genetic counseling and can encourage more people to undergo genetic testing. Combining online education with simple phone counseling aims to provide comprehensive support while simplifying the process. ^{2 4 6 7}

Who Is on the Research Team?

Marc D Schwartz, PhD

Principal Investigator

Georgetown University

Are You a Good Fit for This Trial?

This trial is for men and women who have a close relative with a BRCA1 or BRCA2 mutation, indicating they might be at risk for hereditary cancer. They should not have metastatic cancer themselves, no prior genetic testing for these mutations, and must understand English to give informed consent.

Inclusion Criteria

A close family member of mine has a BRCA1 or BRCA2 mutation.

Exclusion Criteria

I have undergone genetic testing for breast/ovarian cancer.

I cannot participate in or understand English.

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Eligible participants complete a baseline survey via telephone or electronically

1 week

1 visit (virtual or telephone)

Randomization

Participants are randomized to either the W+T intervention or usual care

1 month post-baseline

Intervention

W+T participants receive web-based education and a streamlined telephone genetic information session

1 month

1 visit (virtual)

Follow-up

Participants are monitored for uptake of genetic counseling and testing, and psychosocial outcomes

6 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Web + Streamlined Telephone Genetic Counseling

Trial Overview The study compares standard care with a web-based educational tool followed by streamlined telephone counseling about genetic testing. Participants will complete surveys before the study starts and again at 1-month and 6-month intervals to measure outcomes like test uptake and quality of life.

How Is the Trial Designed?

Group I: Proactive Outreach + Web Counseling Experimental Treatment 1 Intervention

Web + Streamlined Telephone Genetic Information

Group II: Usual Care Active Control 1 Intervention

Participants in the usual care arm will not be provided with access to the web-based intervention nor will they have access to streamlined genetic counseling. They can pursue clinical genetic counseling on their own.

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

George Washington University

Collaborator

Trials

263

Recruited

476,000+

Published Research Related to This Trial

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]

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]

In a study involving 29 women at moderate risk for breast cancer, participants preferred genetic counselors for personal interactions, emotional support, and individualized decision-making during genetic education and counseling.

However, many participants appreciated the interactive computer program for its self-paced learning, privacy, and efficiency, suggesting that combining both methods could enhance the overall genetic counseling experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education about genetic testing for breast cancer susceptibility: patient preferences for a computer program or genetic counselor. Green, MJ., McInerney, AM., Biesecker, BB., et al.[2019]

A web-based educational tool significantly increased knowledge and feelings of empowerment regarding genetic testing among 305 patients, regardless of their health literacy levels, indicating its effectiveness in educating patients before genetic counseling.

The tool may help address the shortage of trained genetic providers by streamlining the delivery of genetic services, as it was shown to enhance patient understanding without altering attitudes towards testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Tool to Automate Portions of Pretest Genetic Counseling for Inherited Cancer. Cragun, D., Weidner, A., Tezak, A., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-4-2020-5fef2

Web-Based Genetic Education for BRCA Mutation Carriers The primary goal of this research is to test a web-based genetic education intervention that is designed to educate men and women from hereditary cancer ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/keydates/NCT02957981

Study Details | The Genetic Education for Men Trial: Web- ... Aim 1: Develop a web-based intervention to increase genetic counseling/testing uptake in men at high risk for carrying a BRCA mutation. Aim 2: Evaluate the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4829475/

Patient Perceptions of Telephone vs. In-Person BRCA1/ ... Telephone genetic counseling (TC) for hereditary breast/ovarian cancer risk has been associated with positive outcomes in high risk women.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3059740/

Genetic counselor opinions of, and experiences with ... The results of our study suggest that the majority of genetic counselors have used telephone to communicate BRCA1/2 test results to patients, although only 30% ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03544983?term=AREA%5BConditionSearch%5D(BRCA1%20Mutation)&rank=7

NCT03544983 | Genetic Education in BRCA Families Women who carry a pathogenic BRCA variant (PV) have a lifetime breast cancer risk of 55-70% and a lifetime ovarian cancer risk of 16-45%. Men with a PV are at ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11407795/

Streamlined Genetic Education and Cascade Testing in ... Methods: We randomized 63 untested men from hereditary cancer families to Web-based genetic education (WGE) versus enhanced usual care (EUC).

7. nature.com nature.com/articles/s41523-024-00686-8

BRCA genetic testing and counseling in breast cancer In a large, US population-based study, only 62% of high-risk patients with newly diagnosed breast cancer who were tested had a genetic counselor ...