NCT04416178Recruiting
Sickle Cell Disease and the Genomic and Gene Therapy Needs of Stakeholders
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 352 (estimated)
- First submitted
- 27 May 2020
- Start date
- 17 Dec 2020
- Primary completion date
- 26 Mar 2024
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Sickle cell disease, Thalassaemia
- NCT number
- NCT04416178
What you commit to
- Study type: Observational
- Planned participants: 352
- From 17 Dec 2020 to the primary completion date, 26 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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). Participant may be re-evaluated.
Other
- Participants who are unable to converse fluently in English will be excluded. (Permanent)
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Who the study is looking for
- Group 1 (Survey and Interview) Participants only:
- Parent of child with HbSS, HbS/ β0thalassemia, or HbSC aged 12 months to 18 years at study initiation, irrespective of clinical severity or patient aged 13-18 with aforementioned SCD genotype.
- Informed consent from parent or legal guardian and assent of adolescent participant.
- Has been previously approached for SCRIPP.
- Group 2 (Focus Group) Participants only:
- 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.
- Informed consent from parent or legal guardian and assent of adolescent participant.
- Group 3 (Usability and Pilot Testing) Participants only:
- 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.
- Informed consent from parent or legal guardian and assent of adolescent participant.
Age in the registry: 13 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.