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Genetic Testing

Reporting of Adult-Onset Genomic Results in Pediatric Patients

Q: What is the desired outcome of this research endeavor?

This research focuses on the uptake of cascade testing, and secondary outcomes include Decision Regret scale, Self-Esteem Scale, and Children's Revised Impact of Events (CRIES) measure. Baseline assessments are conducted at commencement with follow-up surveys being administered after 1 month, 6 months, and 12 months post-disclosure. The Decision Regret Scale consists of 5 items scored out of 4 points each; while the Self-Esteem Score is made up 10 items that must be combined to determine a score; CRIES features 13 measurements which when totalled can indicate <a href="https://www.withpower.com/clinical-trials/ptsd">PTSD</a> levels above 30.

Q: What is the capacity of participants for this medical experiment?

Indeed, the information displayed on clinicaltrials.gov reveals that this research study is currently enrolling participants. The trial was first advertised on November 25th 2020 and has been recently updated as of February 15th 2022. It seeks to recruit 705 individuals located at a single site.

Q: Is enlistment in the research still available?

That is correct. According to information hosted on clinicaltrials.gov, this research trial was first posted in November 2020 and has been actively recruiting participants since then. The study requires 705 patients from 1 medical centre.

Phase < 1

Waitlist Available

Led By Adam H Buchanan, MS, MPH, CGC

Research Sponsored by Geisinger Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any pediatric MyCode participant (ages 0-17)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 6, &12 months post-disclosure

Awards & highlights

Study Summary

This trial will assess the psychological effects on children and their parents who receive genomic results, as well as health behaviors of parents whose children receive an adult- or pediatric-onset genomic result.

Who is the study for?

This trial is for children (ages 0-17) enrolled in the MyCode study and their parents. It's not open to those who've already had genetic counseling for conditions like colorectal cancer, high cholesterol, or breast and ovarian cancer syndrome through other studies or routine care.Check my eligibility

What is being tested?

The study looks at how getting genomic results about diseases that could affect them as adults impacts kids and their families. Some will get info on adult-onset conditions, others on pediatric-onset ones, while a control group won't receive any results.See study design

What are the potential side effects?

There are no direct medical side effects since this isn't a drug trial. However, receiving genetic information may cause psychological distress or impact family dynamics and health behaviors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am under 18 and part of the MyCode study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 6, &12 months post-disclosure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 6, &12 months post-disclosure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 6, &12 months post-disclosure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Health-Related Quality of Life (HRQOL)

Initiation of risk reduction behavior

The General Functioning 12-item subscale (GF12) of The McMaster Family Assessment Device (FAD)

+2 more

Secondary outcome measures

Body Image instrument

Children's Revised Impact of Events scale

Decision Regret scale

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Receive an adult-onset resultExperimental Treatment1 Intervention

Compare change in psychosocial outcomes and health behaviors of those with a pathogenic variant in a gene associated with adult onset of disease.

Group II: Receive a pediatric-onset resultExperimental Treatment1 Intervention

Compare change in psychosocial outcomes and health behaviors of those with a pathogenic variant in a gene associated with pediatric onset of disease or with risk reduction interventions that begin in childhood.

Group III: Control - No resultActive Control1 Intervention

Compare change in psychosocial outcomes and health behaviors of those without a genomic result.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Human Genome Research Institute (NHGRI)NIH

263 Previous Clinical Trials

283,705 Total Patients Enrolled

Geisinger ClinicLead Sponsor

148 Previous Clinical Trials

1,885,666 Total Patients Enrolled

Adam H Buchanan, MS, MPH, CGCPrincipal InvestigatorGeisinger - Genomic Medicine Institute

Media Library

Control - No Result (Genetic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT03832985 — Phase < 1

High Cholesterol Research Study Groups: Receive an adult-onset result, Receive a pediatric-onset result, Control - No result

High Cholesterol Clinical Trial 2023: Control - No Result Highlights & Side Effects. Trial Name: NCT03832985 — Phase < 1

Control - No Result (Genetic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03832985 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the desired outcome of this research endeavor?

"This research focuses on the uptake of cascade testing, and secondary outcomes include Decision Regret scale, Self-Esteem Scale, and Children's Revised Impact of Events (CRIES) measure. Baseline assessments are conducted at commencement with follow-up surveys being administered after 1 month, 6 months, and 12 months post-disclosure. The Decision Regret Scale consists of 5 items scored out of 4 points each; while the Self-Esteem Score is made up 10 items that must be combined to determine a score; CRIES features 13 measurements which when totalled can indicate PTSD levels above 30."

Answered by AI

What is the capacity of participants for this medical experiment?

"Indeed, the information displayed on clinicaltrials.gov reveals that this research study is currently enrolling participants. The trial was first advertised on November 25th 2020 and has been recently updated as of February 15th 2022. It seeks to recruit 705 individuals located at a single site."

Answered by AI

Is enlistment in the research still available?

"That is correct. According to information hosted on clinicaltrials.gov, this research trial was first posted in November 2020 and has been actively recruiting participants since then. The study requires 705 patients from 1 medical centre."

Answered by AI

Recent research and studies

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The Validity of the Hospital Anxiety and Depression Scale

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Validation of a Decision Regret Scale

Brehaut, Jamie C., Annette M. O'Connor, Timothy J. Wood, Thomas F. Hack, Laura Siminoff, Elisa Gordon, and Deb Feldman-Stewart. 2003. “Validation of a Decision Regret Scale”. Medical Decision Making. SAGE Publications. doi:10.1177/0272989x03256005.

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