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NCT06689800NARecruiting

Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy

Washington University School of Medicine

Start Date

11/26/2024

Completion Date

11/30/2026

Summary

The investigators will conduct a pilot feasibility and efficacy trial of a newly developed family health communication tool (called Let's Get REAL) in increasing youth involvement in real-time stem cell transplant and cellular therapy decisions (SCTCT). The investigators will pilot the intervention among 24 youth and their parents, stratified by youth age (stratum 1, 8-12 years of age and stratum 2, 13-17 years of age).

Eligibility Criteria

Age Range: 8 years to No maximum

Inclusion Criteria Youth: * Children or adolescents 8-17 years of age referred for SCTCT. * Diagnosis of malignant or nonmalignant disorder. * Referred for any type of SCTCT. Autologous and allogeneic stem cell and cellular therapies are eligible. * Planning to meet with a provider to discuss SCTCT. * Must have the ability to understand and willingness to consent to participate after reviewing an IRB approved informed assent document. * Must speak English and be cognitively able to participate. Inclusion Criteria Parents: * Parent or guardian of a child 8-17 years of age with any diagnosis referred for any type of SCTCT. Diagnoses may include malignant and nonmalignant disorders. Autologous and allogeneic stem cell and cellular therapies are eligible. Parent or guardian is defined as an adult who usually cares for the youth and has authority to make medical decisions for them. * Must have the ability to understand and willingness to consent to participate after reviewing an IRB approved informed consent document. * Must speak English and be cognitively able to participate. Exclusion Criteria Youth: * Active medical problems severe enough to preclude study participation at the time of recruitment. * Patients who are otherwise eligible, but whose primary transplant physician does not want them to participate in the study. * Lacks cognitive capacity to complete study activities, as determined by consenting professional. Exclusion Criteria Parents: * Their youth referred for SCTCT does not assent to participate.

Interventions

BEHAVIORAL

Let's Get REAL

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Conditions

Hematologic MalignancySolid TumorSickle Cell DiseaseAplastic AnemiaImmune DeficiencyMetabolic Disorder

Locations

Washington University School of Medicine

St Louis, Missouri 63110

United States