Electronic Decision Tool for Genetic Testing Decisions in Adolescents

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

787 Participants Needed

Trial Summary

What is the purpose of this trial?

Recent recommendations to return children's results for adult-onset conditions to parents anytime whole exome or genome sequencing is performed, as well as growing expectations to return research results to participants on a large-scale basis, mean adolescents will increasingly be engaged in assenting (\<age 18) and consenting (\>age 18) to return of genomic research results. There is an urgent need to understand adolescents' informational preferences and to create ethically informed, scalable processes that empower adolescents from diverse backgrounds to participate in the decision-making process about learning genomic results. This research will provide important insights into adolescents' choices, as well as the ethical, legal and societal implications of engaging adolescents in making choices about learning genomic results in genomic research and community-based research settings.

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 data supports the effectiveness of the treatment Electronic Decision Tool for Genetic Testing Decisions in Adolescents?

Research on similar digital decision tools shows they can help people make informed choices by increasing their knowledge and comfort with decisions. These tools are generally well-accepted and can improve decision-making and engagement, suggesting potential benefits for adolescents considering genetic testing. ^{1 2 3 4 5}

Is the Electronic Decision Tool safe for use in humans?

The Electronic Decision Tool, known as DECIDE, has been tested with parents making genetic testing decisions for their children. It was found to be as effective as traditional genetic counseling in increasing knowledge and was well-received by users, indicating it is safe for use in humans. ^{1 6 7 8 9}

How does the electronic decision tool for genetic testing decisions in adolescents differ from other treatments?

This electronic decision tool is unique because it provides an interactive, online platform that combines educational material with decision aids, allowing adolescents and their parents to make informed choices about genetic testing. Unlike traditional genetic counseling, this tool can be used independently or alongside a healthcare professional, making genetic counseling more accessible and personalized. ^{1 8 10 11 12}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

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

DECIDE: a Decision Support Tool to Facilitate Parents' Choices Regarding Genome-Wide Sequencing. [2018]

2. Denmark pubmed.ncbi.nlm.nih.gov

Interactive e-counselling for genetics pre-test decisions: where are we now? [2022]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Development and Testing of a Decision Aid for Unaffected Women with a BRCA1 or BRCA2 Mutation. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The development of an online decision aid to support persons having a genetic predisposition to cancer and their partners during reproductive decision-making: a usability and pilot study. [2020]

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

The NYCKidSeq randomized controlled trial: Impact of GUÍA digitally enhanced genetic results disclosure in diverse families. [2023]

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

Evaluation of current genetic testing reports in German-speaking countries with regard to secondary use and future electronic implementation. [2021]

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

Assessing an Interactive Online Tool to Support Parents' Genomic Testing Decisions. [2019]

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

Getting to the point: what women newly diagnosed with breast cancer want to know about treatment-focused genetic testing. [2019]

10. England pubmed.ncbi.nlm.nih.gov

The effects of decision aids for genetic counselling among people considering genetic testing: A systematic review. [2023]

11. Denmark pubmed.ncbi.nlm.nih.gov

Decisional conflict among adolescents and parents making decisions about genomic sequencing results. [2021]

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

Engaging Adolescents and Young Adults in Decisions About Return of Genomic Research Results: a mixed-methods longitudinal clinical trial protocol. [2023]