Electronic Decision Tool for Genetic Testing Decisions in Adolescents

Not currently recruiting at 1 trial location

Overseen By Melanie F Myers, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Non-English speakers, Developmental disabilities, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how adolescents prefer to receive genetic test results, particularly for conditions that might affect them as adults. An electronic decision tool (a digital resource) assists adolescents and their parents in deciding whether to learn about these results. Adolescents aged 13-21 who are interested in genetic testing and can participate in remote study visits will find this trial suitable. The study explores the ethical and practical aspects of involving young people in decisions about their genetic information. As an unphased trial, it provides a unique opportunity for adolescents to influence future approaches to genetic testing communication.

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 electronic decision tool is safe for adolescents?

Research has shown that electronic tools used in genetic counseling are generally safe. These tools assist individuals in making informed decisions about genetic testing. Studies have found that digital tools in genetic counseling enhance efficiency and accessibility. However, ethical considerations are crucial to protect users' privacy and ensure informed consent.

No evidence suggests that these tools cause harm. They empower users by providing clear information and support during decision-making, helping individuals better understand their genetic health risks.

Overall, users have well-received electronic decision tools. They guide people safely, focusing on providing helpful and easy-to-understand information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Electronic Decision Tool for Genetic Testing Decisions in Adolescents because it empowers young people and their families to make informed decisions about genetic testing. Unlike traditional methods, which may rely heavily on in-person counseling or less interactive resources, this tool uses technology to provide personalized information and guidance. This approach is unique as it allows adolescents to actively participate in their healthcare decisions, potentially leading to more satisfying and informed choices about their genetic information.

What evidence suggests that this electronic decision tool is effective for decision making about genetic results?

Research has shown that electronic decision tools can help teenagers make informed choices about genetic testing results. In past studies, these tools increased patient involvement, allowing young people to feel more engaged in decision-making. One study found that teens using an electronic decision tool understood their choices better and felt more satisfied with them. Additionally, digital tools improved communication between teens and their parents during these discussions. In this trial, participants will use an electronic decision tool to make decisions about learning genetic results. These findings suggest that electronic decision tools play a crucial role in helping teenagers make confident and informed decisions about their genetic information. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for parents or guardians of teens (13-17) who can assent, and young adults (18-21) who can consent to participate. They must be able to take part in remote study visits if needed. It's not open to non-English speakers or individuals with developmental disabilities affecting decision-making.

Inclusion Criteria

Ability to participate in remote study visits, if applicable

Parent / legal guardian of assenting or consenting adolescent

I am between 18 and 21 years old and agree to participate.

Exclusion Criteria

I have a developmental disability that affects my decision-making.

Those who do not meet inclusion criteria

I cannot communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Decision-Making Intervention

Adolescents and parents (if applicable) use an electronic decision tool to make choices about learning genomic research results

1 hour

1 visit (in-person or virtual)

Follow-up

Participants are monitored for decisional stability, conflict, and regret after the intervention

4 weeks

Multiple assessments (virtual)

Post Return of Results Follow-up

Participants' decision regret and understanding are assessed after receiving genomic results

1 year

1 assessment (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Electronic Decision Tool

Trial Overview The trial is testing an electronic tool designed to help adolescents make informed decisions about receiving their genomic research results. The focus is on understanding their preferences and creating ethical processes for decision-making.

How Is the Trial Designed?

Group I: Decision Making About Genetic Results Experimental Treatment 1 Intervention

Adolescents between 13-21 and parent (if applicable) will make decisions about learning results using an electronic decision tool. Results that match their choices will be returned.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Published Research Related to This Trial

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]

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]

A study involving 26 young women with breast cancer revealed that most preferred to receive information about treatment-focused genetic testing (TFGT) at the time of their diagnosis through face-to-face consultations.

The pilot-tested educational pamphlet on TFGT was well-received, indicating its potential effectiveness in helping women make informed decisions about genetic testing during a challenging time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting to the point: what women newly diagnosed with breast cancer want to know about treatment-focused genetic testing. Meiser, B., Gleeson, M., Watts, K., et al.[2019]

A new educational decision aid was developed for women who are carriers of pathogenic BRCA mutations to help them make informed choices about cancer risk management, ensuring it aligns with clinical guidelines and addresses psychosocial issues.

The decision aid was positively received in a pilot test with 23 participants, scoring above 3 on a scale of 1-4 for clarity and usefulness, indicating it effectively supports shared decision-making in cancer risk management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Testing of a Decision Aid for Unaffected Women with a BRCA1 or BRCA2 Mutation. Jabaley, T., Underhill-Blazey, ML., Berry, DL.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12043041/

Adolescents' and young adults' reactions to and perceived ... AYA participants then used an electronic decision tool to help them make decisions about categories of results to learn. A demo of the tool ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772628223000092

Results of a randomized controlled trial of a decision ... Results of a randomized controlled trial of a decision support intervention for disclosing maternal BRCA genetic test results to children and adolescents.

3. bcchr.ca bcchr.ca/GenCOUNSEL/decide

DECIDE DECIDE is an online integrated e-learning and decision support tool designed to help people who are making choices about whether to have genome-wide sequencing.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9306004/

The role of digital tools in the delivery of genomic medicine For patients undergoing genomic counseling, digital tools have been shown to result in greater patient participation and from our previous trial ...

5. bmcmedinformdecismak.biomedcentral.com bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-024-02784-w

Engaging adolescents and young adults in decisions about ... This study explores decision making and decision stability between adolescents and parents (where applicable), as well as the ethical implications and impact ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12104490/

The future of electronic health record‐based research By leveraging EHR data, genetic counselors can identify eligible patients, assess access and uptake patterns, evaluate the outcomes of germline ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05470920

Study Details | NCT05470920 | Genetic Testing Decision Aid The scale assesses how well the decision aid/oncology provider, or the genetic counselor engaged in shared decision-making as perceived by the subject. Higher ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1098360025000176

Digital technologies in genetic counseling Digital technologies in genetic counseling aim to increase efficiency, patient autonomy, and accessibility, but require careful ethical consideration and are ...

9. globalgenes.org globalgenes.org/blog/making-informed-and-shared-decisions-about-genetic-testing-and-clinical-trial-participation/

Making Informed and Shared Decisions About Genetic ... “If there is safety data, have your clinicians evaluate the relative risk you are taking. ... Empowered Patient Coalition Decision Support Tool.

10. informeddna.com informeddna.com/

Applied Genomics Solutions | Expertise Powering Precision ... An innovative, scalable precision health platform designed to guide members or employees through understanding their genetic health risks.