Study of parents' and teens' views on genetic research in sickle cell disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for parents of children with sickle cell disease, and for teenagers with sickle cell disease. They take part in interviews, surveys, focus groups or tool testing.

Age

Teenagers aged 13 and up. In one group, patients aged 13-18. In another, patients aged 16-18, or adults. Parents of children aged 12 months to 18 years.

Sex

Everyone can join.

Disease stage

Sickle cell disease of type HbSS, HbS/β0 thalassemia, HbSC, or β+ thalassemia (the last one only in the focus group and testing groups). Any clinical severity.

Biomarker or test result

Sickle cell disease genotype HbSS, HbS/β0 thalassemia, HbSC, or β+ thalassemia (the last one only in the focus group and testing groups).

Main reasons for not taking part

• Cannot talk fluently in English
• A condition or chronic illness that the investigator thinks makes taking part unsafe or not workable, such as cognitive impairment or a current acute illness
• Cannot or will not give written informed consent (or a legal guardian will not)

The registry criteria, word for word

What the trial wants to find out

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.

The 3 groups in the trial

• 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.

• 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.

• 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.