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Recruiting NCT06689800

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

No phase Interventional Hematologic Malignancy Solid Tumor Sickle Cell Disease Aplastic Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Let's Get REAL.
Who it may be relevant to
Registry conditions: Hematologic Malignancy, Solid Tumor, Sickle Cell Disease, Aplastic Anemia. Basic parameters: from 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Let's Get REAL: A Pilot Trial of a Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy

Overview

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).

Interventions

  • Behavioral Let's Get REAL
    Family health communication tool

Primary outcome measures

  • Feasibility of intervention as measured by the Feasibility of Intervention questionnaire [Time frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)]
  • Acceptability of intervention as measured by the Acceptability of Intervention questionnaire [Time frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)]
  • Appropriateness of intervention as measured by the Intervention of Appropriateness questionnaire [Time frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)]
  • Feasibility of intervention as measured qualitatively [Time frame: Up to 8 weeks after SCTCT consultation (estimated to be week 16)]
  • Acceptability of intervention as measured qualitatively [Time frame: Up to 8 weeks after SCTCT consultation (estimated to be week 16)]
  • Appropriateness of intervention as measured qualitatively [Time frame: Up to 8 weeks after SCTCT consultation (estimated to be week 16)]
Secondary outcome measures (11)
  • Difference in feasibility scores in those 8-12 years of age and those 13-17 years of age as measured by the Feasibility of Intervention questionnaire [Time frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)]
  • Difference in acceptability scores in those 8-12 years of age and those 13-17 years of age as measured by the Acceptability of Intervention questionnaire [Time frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)]
  • Difference in appropriateness scores in those 8-12 years of age and those 13-17 years of age as measured by the Intervention of Appropriateness questionnaire [Time frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)]
  • Perceived levels of decision-making involvement in youth 8-17 years of age and their parents as measured by the Decision Making Involvement Scale [Time frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)]
  • Observed levels of decision-making involvement in youth 8-17 years of age and their parents [Time frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)]
  • Change in youth-parent communication as measured by the Likert-type Parent-Adolescent Communication Scale [Time frame: Up to 4 weeks prior to SCTCT consultation and up to 4 weeks after SCTCT consultation (estimated to be 8 weeks)]
  • Change in the level of youth's general anxiety as measured by the Likert-type PROMIS Anxiety 8a Short Form or parent proxy [Time frame: Up to 4 weeks prior to SCTCT consultation and up to 4 weeks after SCTCT consultation (estimated to be 8 weeks)]
  • Level of decisional conflict as measured by the Likert-type Decisional Conflict Scale [Time frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)]
  • Youth-parent congruence of youth decision making involvement as measured by two Likert type statements [Time frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)]
  • Satisfaction with the decision making involvement as measured by one Likert type statement [Time frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)]
  • Number of patients who chose SCTCT [Time frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT06689800 · 202410119 · K12CA167540

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗