Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aplastic Anemia | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Immune Deficiency | — | UNRESOLVED | — |
| Metabolic Disorder | — | UNRESOLVED | — |
| Sickle Cell Disease | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Let's Get REAL | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Let's Get REAL family health communication tool: Patients (8-12 years of age)
- description
- Patients and parent(s) will be given the Let's Get REAL family health communication tool to use up to one month prior to their SCTCT consultation visit. It is a guide for pediatric patients and their families to learn about and discuss SCTCT. Participants will complete demographic and baseline surveys prior to using the tool, and then additional surveys up to one month after SCTCT consultation visit and up to one month post-discharge from SCTCT. SCTCT consultation visits will be audio-recorded. Participants may also participate in an optional semi-structured interview up to 8 weeks after SCTCT consultation.
- interventionNames
- Behavioral: Let's Get REAL
- type
- EXPERIMENTAL
- label
- Let's Get REAL family health communication tool: Patients (13-17 years of age)
- description
- Patients and parent(s) will be given the Let's Get REAL family health communication tool to use up to one month prior to their SCTCT consultation visit. It is a guide for pediatric patients and their families to learn about and discuss SCTCT. Participants will complete demographic and baseline surveys prior to using the tool, and then additional surveys up to one month after SCTCT consultation visit and up to one month post-discharge from SCTCT. SCTCT consultation visits will be audio-recorded. Participants may also participate in an optional semi-structured interview up to 8 weeks after SCTCT consultation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available