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

This study is testing a new family health communication tool called "Let's Get REAL." The goal is to see if this tool helps young people aged 8-17 become more involved in decisions about their stem cell transplant and cellular therapy (SCTCT) treatment. You might be able to join if you are 8-17 years old, have a malignant (cancerous) or nonmalignant (non-cancerous) disorder, and are planning to discuss SCTCT with a doctor. The study will look at how practical, acceptable, and appropriate the "Let's Get REAL" tool is. There are 60 planned participants, but the current status of recruitment is unclear.

Study design
This is an interventional pilot study involving 24 youth and their parents, divided into two age groups (8-12 years and 13-17 years).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main assessments for the study will be completed up to 4 weeks after your SCTCT consultation, which is estimated to be around week 8.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06689800

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

Recruiting
NAAges 8+InterventionalHealth services
Washington University School of Medicine
~60 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Let's Get REAL

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of intervention as measured by the Feasibility of Intervention questionnaire
Measured over Up to 4 weeks after SCTCT consultation (estimated to be week 8)
+5 more outcomes measured

Conditions

Hematologic Malignancy
Solid Tumor
Sickle Cell Disease
Aplastic Anemia
Immune Deficiency
Metabolic Disorder

Explore related trials

Aplastic AnemiaImmunodeficiencyMalignant neoplasm of lymphoid, hematopoietic and/or related tissueMetabolic DisorderSickle Cell DiseaseSolid Neoplasm

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Ginny Schulz, Ph.D., RN, CPNP-PC · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Ginny L Schulz, Ph.D., RN, CPNP-PC
[email protected]
314-454-6018
Email the study team

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Eligibility criteria

Inclusion

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.
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

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.
Their youth referred for SCTCT does not assent to participate.

What this trial measures

  • Feasibility of intervention as measured by the Feasibility of Intervention questionnaireUp to 4 weeks after SCTCT consultation (estimated to be week 8)

    This is a 4-item scale that youth and their parents report feasibility of the intervention on a 5-point Likert scale ranging from 'Completely disagree' to Completely agree'. A higher score indicates greater feasibility.

  • Acceptability of intervention as measured by the Acceptability of Intervention questionnaireUp to 4 weeks after SCTCT consultation (estimated to be week 8)

    This is a 4-item scale that youth and their parents report acceptability of the intervention on a 5-point Likert scale ranging from 'Completely disagree' to Completely agree'. A higher score indicates greater acceptability.

  • Appropriateness of intervention as measured by the Intervention of Appropriateness questionnaireUp to 4 weeks after SCTCT consultation (estimated to be week 8)

    This is a 4-item scale that youth and their parents report appropriateness of the intervention on a 5-point Likert scale ranging from 'Completely disagree' to Completely agree'. A higher score indicates greater appropriateness.

  • Feasibility of intervention as measured qualitativelyUp to 8 weeks after SCTCT consultation (estimated to be week 16)

    Content analysis of open-ended survey responses and quotations from individual interviews. Will be collecting number of feasibility content codes.

  • Acceptability of intervention as measured qualitativelyUp to 8 weeks after SCTCT consultation (estimated to be week 16)

    Content analysis of open-ended survey responses and quotations from individual interviews. Will be collecting number of acceptability content codes.

  • Appropriateness of intervention as measured qualitativelyUp to 8 weeks after SCTCT consultation (estimated to be week 16)

    Content analysis of open-ended survey responses and quotations from individual interviews. Will be collecting number of appropriateness content codes.