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Search / Trial NCT06689800

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

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Nov 12, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Pediatric Family Decision Making Health Communication Intervention

ClinConnect Summary

The clinical trial titled "Let's Get REAL" is exploring a new tool designed to help families communicate better about decisions related to stem cell transplants and cellular therapies for children and teens with serious health conditions, such as blood cancers, solid tumors, and certain genetic disorders. The goal is to involve young patients more actively in discussions about their treatment options. This trial will include 24 participants, divided into two age groups: 8-12 years and 13-17 years.

To be eligible for the study, youth should be between 8 and 17 years old and have been referred for a stem cell transplant or cellular therapy. Their parent or guardian must also be involved and able to understand the study. Participants will meet with healthcare providers to discuss the treatment, and they will use the new communication tool to help guide these conversations. This trial is currently recruiting participants, and it aims to see how well this tool works in helping families navigate important health decisions together.

Gender

ALL

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.

About Washington University School Of Medicine

Washington University School of Medicine is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research, education, and patient care. With a strong emphasis on translating scientific discoveries into practical applications, the institution conducts a diverse array of clinical trials aimed at improving treatment outcomes and enhancing the understanding of various medical conditions. Its collaborative environment fosters partnerships between researchers, clinicians, and community stakeholders, ensuring that the trials not only contribute to scientific knowledge but also address the pressing health needs of diverse populations.

Locations

Saint Louis, Missouri, United States

Patients applied

0 patients applied

Trial Officials

Ginny Schulz, Ph.D., RN, CPNP-PC

Principal Investigator

Washington University School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported