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

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

ArmDescriptionAssigned 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.
  • Behavioral: Let's Get REAL
    Family health communication tool
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.
  • Behavioral: Let's Get REAL
    Family health communication tool
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.
  • Behavioral: Let's Get REAL
    Family health communication tool

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Ginny L Schulz, Ph.D., RN, CPNP-PC
314-454-6018
schulz_g@wustl.edu

More Details

NCT ID
NCT06689800
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Ginny L Schulz, Ph.D., RN, CPNP-PC
314-454-6018
schulz_g@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.