Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
Let's Get REAL: A Pilot Trial of a Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 8 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a family health communication tool called Let's Get REAL. It aims to help young people take part in decisions about stem cell transplants and cell therapies. The study is for 24 young people ages 8–17 and their parents or guardians.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Youth must be ages 8–17 and referred for a stem cell transplant or cell therapy.
- Youth may have cancer or a condition that is not cancer.
- Any type of stem cell transplant or cell therapy is allowed, using their own cells or a donor's cells.
- Youth must plan to meet with a health care provider to discuss this treatment.
- Youth must understand the study information and agree to take part.
- Parents or guardians must usually care for the youth and have the right to make medical decisions for them.
- Parents or guardians must understand the study information and agree to take part.
- Youth and parents or guardians must speak English and be able to understand and complete study activities.
Who can't join
- Youth have current medical problems serious enough to keep them from taking part.
- The youth's main transplant doctor does not want them to take part.
- The staff member seeking agreement to join decides the youth cannot understand and complete study activities.
- Parents or guardians cannot join if their child does not agree to take part.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
MO
- Washington University School of Medicine · St Louis, MO 63110Ginny L Schulz, Ph.D., RN, CPNP-PC · Study contact · 314-454-6018 · schulz_g@wustl.eduGinny L Schulz, Ph.D., RN, CPNP-PC · Principal investigatorShalini Shenoy, M.D. · Sub-investigatorAmy McQueen, Ph.D. · Sub-investigatorMore trials in St Louis