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

932 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Efforts to examine the utility of alternate modalities for genetic results disclosure has widespread implications for how precision medicine research might yield direct health benefits for study participants. This study will examine the efficacy of an online self-guided program to return genetic results to a racial minority cohort population. Study results will provide empirical evidence on the effectiveness of alternate modalities for genetic results return, inform ongoing efforts to establish scalable approaches for effective return of genetic research results, and increase access to personal health information among African American women.

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 it safe to receive genetic test results online?

There is no specific safety data on receiving genetic test results online, but studies show that people generally trust results more when they receive them in-person from a genetic counselor compared to online. This suggests that while online communication is not unsafe, it may not be as effective in ensuring trust and understanding. ^{1 2 3 4 5}

How does the online modality treatment for genetic results communication differ from other treatments?

The online modality treatment for genetic results communication is unique because it uses digital platforms like social media and YouTube to share genetic information, making it more accessible and overcoming traditional communication barriers. This approach is novel compared to standard in-person or paper-based methods, as it allows for easy, widespread dissemination of information and can be tailored to individual preferences for receiving updates. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment Genetic counselor follow-up, Online modality?

Research shows that digital tools for delivering genetic services can improve patient knowledge, well-being, and engagement, while also making the process more efficient for healthcare providers. This suggests that online communication methods for genetic results can be effective in enhancing patient understanding and care. ^{1 5 10 11 12}

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. England pubmed.ncbi.nlm.nih.gov

Recommendations for designing genetic test reports to be understood by patients and non-specialists. [2021]

2. England pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

The Impact of an Educational Video in Arabic Language on Patients' Knowledge and Attitudes Towards Genetic Testing for Cancer Therapy. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Understanding the Return of Genomic Sequencing Results Process: Content Review of Participant Summary Letters in the eMERGE Research Network. [2021]

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

The NYCKidSeq randomized controlled trial: Impact of GUÍA digitally enhanced genetic counseling in racially and ethnically diverse families. [2023]

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

Public trust in genomic risk assessment for type 2 diabetes mellitus. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Impact of direct-to-consumer predictive genomic testing on risk perception and worry among patients receiving routine care in a preventive health clinic. [2021]

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

Patient Preferences for Receiving Reports of Test Results. [2022]

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

Social media usage in family communication about genetic information: 'I no longer speak with my sister but she needed to know'. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Developing and assessing the utility of a You-Tube based clinical genetics video channel for families affected by inherited tumours. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Preferences for Updates on General Research Results: A Survey of Participants in Genomic Research from Two Institutions. [2023]

12. Canada pubmed.ncbi.nlm.nih.gov

Discussion groups on the Internet: journaling. [2006]