Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
Purpose
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
- Hematologic Malignancy
- Solid Tumor
- Sickle Cell Disease
- Aplastic Anemia
- Immune Deficiency
- Metabolic Disorder
Eligibility
- Eligible Ages
- Over 8 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Let's Get REAL family health communication tool: Patients (8-12 years of age) |
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. |
|
|
Experimental Let's Get REAL family health communication tool: Patients (13-17 years of age) |
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. |
|
|
Experimental Let's Get REAL family health communication tool: Parents |
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. |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT06689800
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine