A tool to improve family communication in pediatric stem cell transplant decisions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial evaluates the feasibility and efficacy of a family health communication tool called 'Let's Get REAL' aimed at enhancing youth involvement in decision-making during stem cell transplant and cellular therapy discussions. The study will involve 24 youth aged 8-17 and their parents, who will be stratified by age groups. Participants will be referred for various types of stem cell and cellular therapies, and the intervention will be assessed for its impact on communication and decision-making processes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Ginny Schulz, Ph.D., RN, CPNP-PC — Washington University School of Medicine
• Study coordinator: Ginny L Schulz, Ph.D., RN, CPNP-PC
• Email: schulz_g@wustl.edu
• Phone: 314-454-6018

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.