Actively Recruiting

Age: 8Years +
All Genders
Healthy Volunteers
NCT05810181

Gene Therapy Communication: Use of a Needs Assessment to Drive Decision-AIDS for Gene Therapy for Rare Diseases (GENETX)

Led by St. Jude Children's Research Hospital · Updated on 2026-05-07

145

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This prospective mixed-method interview study aims to qualitatively describe the beliefs, attitudes, and informational needs around gene therapy for rare pediatric diseases among patients and parents of children with a rare disease targeted for treatment using gene therapy techniques. Using learned insights, the team will develop an online platform providing educational content and patient decision aids for patients and their families.

CONDITIONS

Official Title

Gene Therapy Communication: Use of a Needs Assessment to Drive Decision-AIDS for Gene Therapy for Rare Diseases (GENETX)

Who Can Participate

Age: 8Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants age 8 and above who have undergone gene therapy for a rare genetic disease.
  • Parent or caregiver of a child who has undergone gene therapy or died 6 to 24 months after receiving gene therapy.
  • Parent or caregiver of children (or patients age 8 and above) with a rare genetic disease who were offered but did not receive gene therapy.
  • Healthcare workers who have cared for 2 or more patients receiving gene therapy.
  • Parent or caregiver of children (or patients age 8 and above) with a bone marrow failure condition who have undergone gene therapy.
  • Parent or caregiver of children (or patients age 8 and above) with a bone marrow failure condition who were offered but did not receive gene therapy.
  • Parent or caregiver of children (or patients age 8 and above) with a bone marrow failure condition who were never offered gene therapy.
  • Willingness to participate in a one-on-one video or in-person interview.
  • Must provide verbal informed consent.
  • Signed release of information form allowing contact with healthcare provider to verify diagnosis and gene therapy receipt.
Not Eligible

You will not qualify if you...

  • Inability to converse fluently in English.
  • Inability or unwillingness to provide verbal informed consent.
  • Lack of access to a computer or mobile device supporting video communication.
  • Condition or illness making participation unsafe or impossible as determined by the study investigators.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

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Research Team

L

Liza-Marie Johnson, MD, MPH, MSB

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

7

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