Status:

RECRUITING

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

Lead Sponsor:

Washington University School of Medicine

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Hematologic Malignancy

Solid Tumor

Eligibility:

All Genders

8+ years

Phase:

NA

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 ce...

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.

Key Trial Info

Start Date :

November 26 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 31 2026

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06689800

Start Date

November 26 2024

End Date

May 31 2026

Last Update

December 2 2025

Active Locations (1)

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1

Washington University School of Medicine

St Louis, Missouri, United States, 63110