Gene Therapy Communication: Use of a Needs Assessment to Drive Decision-AIDS for Gene Therapy for Rare Diseases (GENETX)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 8 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This interview study asks about views and questions about gene therapy, a treatment that uses genes. It is for patients age 8 and older with certain rare diseases, parents or caregivers, and healthcare workers. The team will use what they learn to build online learning tools and guides to help families make treatment choices.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Patients age 8 or older, or parents/caregivers of children, may join a group for people who received gene therapy for a rare genetic disease.
- Parents/caregivers whose child died after gene therapy may qualify. Gene therapy must have been given 6–24 months before joining; contact must be 3 months to 2 years after the death.
- Patients age 8 or older, or parents/caregivers, may join if gene therapy was offered but they could not join a trial or chose not to receive it.
- Separate groups include people with bone marrow failure, when the body cannot make enough blood cells. These groups include those who received, declined, could not get, or were never offered gene therapy.
- Healthcare workers may join if they have cared for at least 2 patients receiving gene therapy.
- Be willing to do a one-on-one video interview using your own computer or mobile device with internet. Healthcare workers may interview in person instead.
- Agree to take part after learning about the study. Patients and caregivers must give this agreement out loud.
- Patients and caregivers must sign a form allowing the team to contact their healthcare provider. The provider must confirm the rare genetic disease and, if gene therapy was received, confirm the treatment and type.
Who can't join
- Cannot speak English fluently.
- Cannot or will not give spoken agreement to take part.
- Do not have access to a computer or mobile device that supports video calls.
- Have a health condition that study doctors believe makes taking part unsafe or not possible, such as trouble thinking clearly or another current illness.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. For Group 1 participants only (Undergone Gene Therapy): * Parent/caregiver whose child has undergone gene therapy. OR Parent/caregiver of a child who died after receiving gene therapy at least 6 months prior to enrollment, but no more than 24 months prior to enrollment, to be contacted no sooner than 3 months after the death has occurred and no longer than 2 years. OR Patients age 8 and above who have undergone gene therapy. * Willingness to participate in one-on-one video interview with a study team member using a personal mobile device or computer with working internet connection. * Must be willing to provide verbal informed consent. * Release of information form signed by participant providing our study team with permission to contact healthcare provider to verify their diagnosis and receipt of gene therapy (if received). * Successful verification of diagnosis of rare genetic disease targeted for treatment using gene therapy. * A positive confirmation on receipt of gene therapy and type received from their healthcare provider (only for those received gene therapy). 2. For Group 2 participants only (Offered, but did not Undergo Gene Therapy): * Parent/caregiver of children (or patients 8 and above ) with a rare genetic disease who had been offered but were not eligible for a trial or decided against receiving gene therapy. * Willingness to participate in one-on-one video interview with a study team member using a personal mobile device or computer with working internet connection. * Must be willing to provide verbal informed consent. * Signed release of information form providing GeneTx study team with permission to contact participant's healthcare provider to verify the diagnosis. * Successful verification of diagnosis of rare genetic disease targeted for treatment using gene therapy. 3. For Group 3 participants only (Provider Interviews): * Healthcare worker who has provided care to ≥ 2 patients receiving gene therapy. * Willingness to participate in one-on-one video (or in-person) interview with a study team member using a personal mobile device or computer with working internet connection. * Informed consent from a study participant. 4. For Group 4 participants only (Undergone Gene Therapy for Bone Marrow Failure Condition): * Parent/caregiver whose child has undergone gene therapy. OR Parent/caregiver of a child who died after receiving gene therapy at least 6 months prior to enrollment, but no more than 24 months prior to enrollment, to be contacted no sooner than 3 months after the death has occurred and no longer than 2 years. OR Patients age 8 and above who have undergone gene therapy. * Willingness to participate in one-on-one video interview with a study team member using a personal mobile device or computer with working internet connection. * Must be willing to provide verbal informed consent. * Release of information form signed by participant providing our study team with permission to contact healthcare provider to verify their diagnosis and receipt of gene therapy (if received). * Successful verification of diagnosis of rare genetic disease targeted for treatment using gene therapy. * A positive confirmation on receipt of gene therapy and type received from their healthcare provider (only for those received gene therapy). 5. For Group 5 participants only (Offered, but did not Undergo Gene Therapy for Bone Marrow Failure Condition ): * Parent/caregiver of children (or patients 8 and above ) with a bone marrow failure disease who had been offered but were not eligible for a trial or decided against receiving gene therapy. * Willingness to participate in one-on-one video interview with a study team member using a personal mobile device or computer with working internet connection. * Must be willing to provide verbal informed consent. * Signed release of information form providing GeneTx study team with permission to contact participant's healthcare provider to verify the diagnosis. * Successful verification of diagnosis of rare genetic disease targeted for treatment using gene therapy. 6. For Group 6 participants only (Never offered gene therapy for Bone Marrow Failure Condition): * Parent/caregiver of children (or patients 8 and above ) with a bone marrow failure disease who had not been offered gene therapy. * Willingness to participate in one-on-one video interview with a study team member using a personal mobile device or computer with working internet connection. * Must be willing to provide verbal informed consent. * Signed release of information form providing GeneTx study team with permission to contact participant's healthcare provider to verify the diagnosis. * Successful verification of diagnosis of rare genetic disease targeted for treatment using gene therapy. 7. For Group 7 participants only (Provider Interviews for Bone Marrow Failure Condition): * Healthcare worker who has provided care to ≥ 2 patients receiving gene therapy. * Willingness to participate in one-on-one video (or in-person) interview with a study team member using a personal mobile device or computer with working internet connection. * Informed consent from a study participant. Exclusion Criteria (for all 7 groups): * Participants who are unable to converse fluently in English will be excluded. * Inability or unwillingness of research participant to give verbal informed consent. * Participants who lack access to a computer or mobile device that supports video communications will be excluded. * Condition or chronic illness, which in the opinion of the PI/Co-I, makes participation unsafe or untenable (i.e., cognitive impairment, concurrent acute morbidity).
Study sites (1)
TN
- St. Jude Children's Research Hospital · Memphis, TN 38105 · Study contact · 888-226-4343 · referralinfo@stjude.orgMore trials in Memphis