A tool to improve family communication in pediatric stem cell transplant decisions
Let's Get REAL: A Pilot Trial of a Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
This study is testing a new tool to help families talk better and make decisions together about stem cell transplants for kids aged 8 to 17.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 8 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06689800 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include children and adolescents aged 8-17 who are referred for stem cell transplant or cellular therapy.
Not a fit: Patients who do not speak English or are unable to understand the consent process may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could empower pediatric patients and their families to make more informed decisions regarding stem cell transplant and cellular therapy.
How similar studies have performed: While this approach is innovative, similar studies focusing on family communication in pediatric healthcare have shown promise in enhancing decision-making.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
St Louis, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.