Recruiting

Gene Therapy

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT05810181

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Accepted

Interventions

Interview

Interview

Interview

Interview

Interview

Study Details

Brief summary:

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

Sickle Cell Disease

Study ID

NCT05810181

Start date

Jun 1, 2023

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Accepted

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 Design

Enrollment

145 participants

Anticipated

Interventions and Outcome Measures

Arms

Young Adult

15-25 parents/families of children (patients aged 8 and above) with rare genetic diseases, who have recently received gene therapy

Parent/caregiver

10-20 patients/families of children with rare genetic diseases who were offered but have decided against receiving gene therapy or who were ultimately not eligible for a clinical trial.

Healthcare Worker

10-20 health care workers' who provide care to patients receiving gene therapy.

Bone marrow failure condition (received gene therapy)

5-10 parents/families of children with a bone marrow failure condition, who 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 OR patients age 8 and above who have undergone gene therapy

Bone marrow failure condition (did not receive gene therapy)

5-10 parent/caregiver of children (or patients 8 and above) with bone marrow failure conditions who were offered but have decided against receiving gene therapy or who were ultimately not eligible for a clinical trial

Bone marrow failure condition (never offered gene therapy)

30-40 parent/caregiver of children (or patients 8 and above) with a bone marrow failure condition who were never offered gene therapy

Healthcare Workers (for bone marrow failure condition)

10-20 health care workers who provide care to patients receiving gene therapy for bone marrow failure conditions.

Interventions

Interview

The following groups of stakeholders will be interviewed to assess the beliefs, attitudes, and informational needs around gene therapy for rare pediatric diseases:

(1) patients and families of children with rare genetic diseases who have received gene therapy (to assess their perspectives and understand their informational needs around participating in a clinical trial using gene therapy).

Interview

The following groups of stakeholders will be interviewed to assess the beliefs, attitudes, and informational needs around gene therapy for rare pediatric diseases: (2) patients and families of children with rare genetic diseases who were offered but have decided against receiving gene therapy or who were never offered gene therapy or ultimately did not qualify for a trial (to elicit feedback and to evaluate whether their informational needs and communication expectations about participating in a clinical trial using gene therapy were met).

Interview

The following groups of stakeholders will be interviewed to assess the beliefs, attitudes, and informational needs around gene therapy for rare pediatric diseases: (3) healthcare workers who provide care to patients receiving gene therapy (to assess their perspective regarding patient/family needs for gene therapy education and communication).

Interview

The following group of stakeholders will be interviewed to assess the beliefs, attitudes, and informational needs around gene therapy for rare pediatric diseases: (4) parents/caregivers of children with a bone marrow failure condition, who 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 OR patients age 8 and above who have undergone gene therapy (to assess their perspectives and understand their informational needs around participating in a clinical trial using gene therapy).

Interview

The following groups of stakeholders will be interviewed to assess the beliefs, attitudes, and informational needs around gene therapy for rare pediatric diseases: (5) parent/caregiver of children (or patients 8 and above) with bone marrow failure conditions who were offered but have decided against receiving gene therapy or who were ultimately not eligible for a clinical trial (to elicit feedback and to evaluate whether their informational needs and communication expectations about participating in a clinical trial using gene therapy were met).

Interview

The following groups of stakeholders will be interviewed to assess the beliefs, attitudes, and informational needs around gene therapy for rare pediatric diseases: (6) parent/caregiver of children (or patients 8 and above) with a bone marrow failure condition who were never offered gene therapy (to elicit feedback and to evaluate whether their informational needs and communication expectations about participating in a clinical trial using gene therapy)

Interview

The following groups of stakeholders will be interviewed to assess the beliefs, attitudes, and informational needs around gene therapy for rare pediatric diseases: (7) health care workers who provide care to patients receiving gene therapy for bone marrow failure conditions (to assess their perspective regarding patient/family needs for gene therapy education and communication).

Primary outcome measure

  • Use of semi-structured interviews to assess the beliefs, attitudes, and informational needs around gene therapy among patients and families with rare genetic diseases. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Liza-Marie Johnson, MD, MPH, MSB

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-08-10.