Let's Get REAL: A Pilot Trial of a Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Ginny L Schulz, Ph.D., RN, CPNP-PC
schulz_g@wustl.edu
314-454-6018
Time Frame
Start Date: 2024-11-26
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 60
Treatments
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.
Sponsors
Leads: Washington University School of Medicine
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov