Online Communication Modalities for Genetic Results Communication

(BWHS RoR Trial)

Overseen By Catharine Wang, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: Cognitive impairments, VUS results

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

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods of delivering genetic results to participants: a traditional phone call with a genetic counselor and an online program where participants can view their results and choose to speak with a counselor later. The researchers aim to determine if the online method effectively shares genetic information, particularly for African American women. This approach could simplify and enhance access to personal health information. Women who participated in a breast cancer sequencing project and do not have cognitive impairments are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to research that may improve access to genetic information for diverse populations.

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 these online communication modalities are safe for genetic results disclosure?

Research has shown that online tools for sharing genetic test results, like My46, are generally well-received and safe. These tools allow individuals to view their genetic information independently and often provide the option to consult a genetic counselor if needed. This flexibility can make the process more comfortable and less stressful for many users.

Studies have found that these online methods do not cause significant problems or side effects. Designed for ease of use, they provide a secure way to access personal health data. This allows individuals to learn about their genetic results in a way that suits them best, with minimal risk involved.

Overall, using online platforms to share genetic results is considered safe and effective. They offer a modern way to access important health information, making it easier and more convenient for everyone involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the online modality for communicating genetic results because it offers a new, more direct approach. Unlike the conventional method, which involves discussing genetic results over the phone with a counselor, the online modality allows participants to access their results directly online. This self-guided method not only empowers individuals with immediate access to their genetic information but also provides the flexibility of optional counselor follow-up if needed. This approach is expected to streamline the process, making it more efficient and potentially more accessible for participants.

What evidence suggests that this trial's modalities could be effective for genetic results communication?

Research has shown that using online tools to share genetic results can be effective. In this trial, participants in the online modality arm will receive their genetic results directly through an online self-guided platform, with optional follow-up from a genetic counselor via telephone. For example, a platform like GUÍA is designed to simplify access to and understanding of genetic information. Studies on tools like My46 have demonstrated that they help people manage their genetic results independently, leading to a better understanding of their genetic data. Evaluations of digital genetic assistants have also shown positive results in real-life situations, especially for genetic screening. These tools aim to empower individuals by providing easy access to their genetic data, helping them make more informed health decisions. ^{2 6 7 8 9}

Who Is on the Research Team?

Catharine Wang, PhD

Principal Investigator

BU School of Public Health

Are You a Good Fit for This Trial?

This trial is for African American women who were part of the BWHS breast cancer sequencing project. It's not open to those with uncertain genetic test results or known cognitive impairments.

Inclusion Criteria

I was part of the breast cancer sequencing project in the BWHS.

Exclusion Criteria

I am a woman with unclear genetic test results.

I have a known cognitive impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive genetic results through either a conventional telephone disclosure or an online self-guided program

6 weeks

1 visit (virtual or telephone)

Follow-up

Participants are monitored for psychological impact and uptake of genetic information

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Genetic counselor follow-up
• Online modality

Trial Overview The study tests an online self-guided program for returning genetic results related to certain cancers, comparing it with follow-up by a genetic counselor. The goal is to find scalable ways to share health information effectively.

How Is the Trial Designed?

Group I: Online modality Experimental Treatment 2 Interventions

Online self-guided modality entails return of genetic results directly to participants, with optional genetic counselor follow-up via telephone.

Group II: Conventional modality Active Control 1 Intervention

Control arm. Conventional modality entails telephone disclosure of genetic results by a licensed genetic counselor.

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

MGH Institute of Health Professions

Collaborator

Trials

19

Recruited

2,200+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

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]

The GUÍA web-based platform significantly improved parents' perceived understanding of genetic test results, with participants in the GUÍA arm reporting a 2.8 times higher understanding compared to standard care, based on a study involving 551 participants.

Hispanic/Latino(a) participants using GUÍA showed even greater benefits, with a 3.9 times higher perceived understanding and improved confidence in explaining results, highlighting the platform's effectiveness in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The NYCKidSeq randomized controlled trial: Impact of GUÍA digitally enhanced genetic counseling in racially and ethnically diverse families. Suckiel, SA., Kelly, NR., Odgis, JA., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11029319/

Linking genetic counseling communication skills to patient ... This study will link genetic counseling (GC) communication skills with patient outcomes and experiences, filling a significant gap in the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8105171/

GUÍA: a digital platform to facilitate result disclosure in ... GUÍA is a web-based platform designed to enhance the delivery of genomic results and related clinical information to patients and families.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1098360021024370

My46: a Web-based tool for self-guided management of ... My46 is a Web-based tool for managing the return of genetic results that was designed and developed to support a wide range of approaches to disclosing results.

4. nature.com nature.com/articles/s41746-025-01573-7

Evaluation of the digital genetic assistant in technology ... We evaluated the digital genetic assistant (DGA) for reproductive genetic carrier screening (RGCS) in a real-life clinical setting using a “couple-based” ...

5. cancer.gov cancer.gov/news-events/cancer-currents-blog/2016/comet-study

Educating Patients about Genetic Test Results - NCI The COMET study will examine the impact of counseling patients about the results of their tumor profiling results.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5352554/

My46: a web-based tool for self-guided management ... My46 is a web-based tool for managing the return of genetic results that was designed and developed to support a wide range of approaches to results disclosure ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8143032/

Usefulness of mobile apps for communication of genetic ... ShareDNA is a mobile app designed to help patients communicate genetic test results to their at-risk relatives. Development of the mobile app was funded by a ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0738399125001132

DNA-poli: Design and development of a digital platform for ... DNA-poli is a digital platform for family communication support and cascade testing. The digital genetic journey provides both pre- and post-test genetic ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jgc4.1967

An analysis of direct‐to‐consumer genetic testing portals ... Through a qualitative content analysis of three different DTC genetic testing online portals, we examine how companies communicate relative and absolute health ...