Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
Recruiting · NCT06689800 · Interventional (participants receive a specific treatment) · Lead sponsor: Washington University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Let's Get REAL
What this trial is about
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).
Who can take part
Age range
8 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Washington University School of Medicine - St Louis, Missouri, United States