240 Participants Needed

Web-Based Genetic Education for BRCA Mutation Carriers

Recruiting at 3 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Georgetown University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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 families about the personal relevance of genetic testing in order to help them male decisions about whether to pursue genetic testing. We will test this intervention against standard care for men and women from hereditary cancer families. The web-based educational intervention includes all of the information typically covered during genetic counseling. As a result, after completing the education intervention, participants can proceed directly to a brief telephone call with a genetic counselor followed by testing if they choose. A baseline survey will be administered prior to randomization and then follow-up surveys will be administered at 1-month and 6-months post-randomization. Primary outcomes will be completion of genetic counseling, uptake of genetic testing, genetic test results and quality of life.

Will I have to stop taking my current medications?

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

Is web-based genetic education for BRCA mutation carriers safe?

The research indicates that web-based and telephone genetic counseling methods, like DNA-direct, are generally safe and do not increase distress among participants. Participants reported satisfaction and lower distress levels compared to traditional face-to-face counseling, suggesting these methods are safe for use in humans.12345

How does the Web + Streamlined Telephone Genetic Counseling treatment differ from other treatments for BRCA mutation carriers?

This treatment is unique because it combines web-based education with streamlined telephone counseling, making genetic counseling more accessible and convenient for BRCA mutation carriers. It allows patients to learn at their own pace online while still providing the opportunity for personalized support through phone counseling, which can help address individual concerns and enhance understanding.678910

What data supports the effectiveness of the treatment Web + Streamlined Telephone Genetic Counseling for BRCA Mutation Carriers?

Research shows that many breast cancer patients prefer receiving genetic counseling through digital and telephone methods rather than face-to-face meetings, with high satisfaction and reduced distress. Additionally, tailored web-based information can improve patients' knowledge and expectations, suggesting that web-based education combined with telephone counseling could be effective for BRCA mutation carriers.1231112

Who Is on the Research Team?

MD

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 child has tested positive for a BRCA1 or BRCA2 mutation.
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Proactive Outreach + Web CounselingExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

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.
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.
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 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.
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]

Citations

Experience with a nurse-driven genetic counseling pathway of Italian women with uninformative BRCA test result. [2023]
Adherence to Recommended Risk Management among Unaffected Women with a BRCA Mutation. [2018]
Modes of delivery of genetic testing services and the uptake of cancer risk management strategies in BRCA1 and BRCA2 carriers. [2021]
A pre-visit tailored website enhances counselees' realistic expectations and knowledge and fulfils information needs for breast cancer genetic counselling. [2021]
More breast cancer patients prefer BRCA-mutation testing without prior face-to-face genetic counseling. [2021]
Genetic counseling for BRCA1/2: a randomized controlled trial of two strategies to facilitate the education and counseling process. [2020]
Factors determining dissemination of results and uptake of genetic testing in families with known BRCA1/2 mutations. [2021]
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]
Education about genetic testing for breast cancer susceptibility: patient preferences for a computer program or genetic counselor. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
A Web-Based Tool to Automate Portions of Pretest Genetic Counseling for Inherited Cancer. [2021]
Interactive e-counselling for genetics pre-test decisions: where are we now? [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Online Module for Carrier Screening in Ashkenazi Jewish Individuals Compared with In-Person Genetics Education: A Randomized Controlled Trial. [2019]
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