NCT06689800 Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
| NCT ID | NCT06689800 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Hematologic Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-11-26 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-11-26 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Ginny Schulz, Ph.D., RN, CPNP-PC
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT06689800 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06689800 currently recruiting?
Yes, NCT06689800 is actively recruiting participants. Contact the research team at schulz_g@wustl.edu for enrollment information.
Where is the NCT06689800 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT06689800 clinical trial?
NCT06689800 is sponsored by Washington University School of Medicine. The principal investigator is Ginny Schulz, Ph.D., RN, CPNP-PC at Washington University School of Medicine. The trial plans to enroll 60 participants.