Sickle Cell Disease and the Genomic and Gene Therapy Needs of Stakeholders

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT04416178
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Accepted

Study Details

The primary objectives of this prospective mixed-method interview study are to use semi-structured interviews in parents of sickle cell disease (SCD) patients to describe parental attitudes of research involving genomic sequencing, including concerns about participation and expectations from researchers and second, to use surveys to quantitatively measure genetic/genomic knowledge, trust in health care provider, and literacy/numeracy ability in parents of children with SCD and adolescents with SCD. Secondary objectives are development of a web-based tool about treatment options for SCD that fosters patient-clinician communication and promotes shared decision-making. The web-based tool will undergo usability and pilot testing to ensure it is accessible to families and provide data about strategies for integrating into clinical conversations about treatment options. Investigators will use the data generated to reduce the risk of misunderstanding about DNA and genetic research and build strong relationships between SCD families and researchers in the future. The project will design educational information and study materials to help parents of children with SCD understand important details about genomic medicine in SCD care.

Key Dates

Start date
Dec 17, 2020
Status verified
Apr 2026
Primary completion
Mar 26, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
352 participants (estimated)

Arms

  • Arm: Survey and Interview Group (Group1)
    Parent of child with HbSS, HbS/ β0thalassemia, β+ thalassemia or HbSC aged 12 months to 18 years at study initiation, irrespective of clinical severity or patient aged 13-18 with aforementioned SCD genotype.
  • Arm: Focus Group (Group 2)
    Adult Patient with or Parent of child with HbSS, HbS/ β0thalassemia, β+ thalassemia or HbSC aged 12 months to 18 years at study initiation, irrespective of clinical severity or patient aged 16-18 with aforementioned SCD genotype whose parent provides verbal informed consent for focus group participation.
  • Arm: Usability and Pilot Testing (Group 3)
    Parent of child with HbSS, HbS/ β0thalassemia, β+ thalassemia or HbSC aged 12 months to 18 years at study initiation, irrespective of clinical severity or patient aged 13 and up with aforementioned SCD genotype.

Primary Outcome Measure

Use of semi-structured interviews in parents of SCD patients to qualitatively describe parental attitudes of research involving genomic sequencing, including concerns about participation and expectations from researchers [ Time Frame: Day 1, or at a future visit (up to approximately 1 year) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Liza M. Johnson, MD, MPH, MSB
[email protected]
888-226-4343
Liza M. Johnson, MD, MPH, MSB (PRINCIPAL_INVESTIGATOR)

Find similar trials in Memphis, TN

By condition
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By research site
St. Jude Children's Research Hospital· Memphis, TN

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