Actively Recruiting
Let's Get REAL: A Pilot Trial of a Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
Led by Washington University School of Medicine · Updated on 2026-06-04
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new family health communication tool called Let's Get REAL designed to increase youth involvement in real-time decisions about stem cell transplant and cellular therapy (SCTCT). This pilot trial focuses on pediatric patients aged 8 to 17 years who are referred for SCTCT due to malignant or nonmalignant disorders. The study aims to assess the feasibility, acceptability, and appropriateness of this communication tool in helping families discuss treatment decisions. Participants, including youth in two age groups (8-12 and 13-17 years) and their parents, will receive the Let's Get REAL tool to use up to one month before their SCTCT consultation visit. They will complete surveys before using the tool, up to one month after the consultation, and up to one month post-discharge from SCTCT. The consultation visits will be audio-recorded, and participants may opt to take part in a semi-structured interview within eight weeks after the consultation. During the study, participants will provide demographic and baseline information and complete several questionnaires measuring decision-making involvement, anxiety, communication, and satisfaction. Researchers will analyze both quantitative survey data and qualitative feedback to evaluate the tool's impact. The total study participation spans from before the consultation through up to eight weeks after, with ongoing monitoring of youth-parent communication and decision-making processes.
CONDITIONS
Brief Title
Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children or adolescents 8-17 years of age referred for stem cell transplant and cellular therapy (SCTCT).
- Diagnosed with malignant or nonmalignant disorder.
- Referred for any type of SCTCT including autologous and allogeneic stem cell and cellular therapies.
- Planning to meet with a provider to discuss SCTCT.
- Ability to understand and willingness to consent or assent after reviewing approved documents.
- Must speak English and be cognitively able to participate.
- Parent or guardian of eligible child with authority to make medical decisions and able to consent.
You will not qualify if you...
- Active medical problems severe enough to prevent study participation at recruitment.
- Primary transplant physician does not approve participation.
- Lacks cognitive capacity to complete study activities.
- Parent or guardian's child does not assent to participate.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants must meet age, diagnosis, language, and cognitive criteria, and provide consent or assent.
Duration - Up to 1 month prior to SCTCT consultation
Participants and their families use the Let's Get REAL family health communication tool up to one month prior to their stem cell transplant and cellular therapy (SCTCT) consultation visit. They complete demographic and baseline surveys before using the tool.
1 baseline visit and SCTCT consultation visit (in-person)
Duration - Up to 2 months after SCTCT consultation
Participants complete additional surveys up to one month after the SCTCT consultation visit and up to one month post-discharge from SCTCT. SCTCT consultation visits are audio-recorded. Participants may choose to join an optional semi-structured interview up to 8 weeks after SCTCT consultation.
Surveys and an optional interview visit up to 8 weeks post-consultation
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
G
Ginny L Schulz, Ph.D., RN, CPNP-PC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
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