Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy

NCT ID: NCT06689800

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-26
• Study Completion Date: 2026-05-31

Brief 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).

Conditions

Hematologic Malignancy; Solid Tumor; Sickle Cell Disease; Aplastic Anemia; Immune Deficiency; Metabolic Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Let's Get REAL

Intervention Type: BEHAVIORAL

Family health communication tool

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.

Group Type: EXPERIMENTAL

Let's Get REAL

Intervention Type: BEHAVIORAL

Family health communication tool

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.

Group Type: EXPERIMENTAL

Let's Get REAL

Intervention Type: BEHAVIORAL

Family health communication tool

Interventions

Let's Get REAL

Family health communication tool

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Their youth referred for SCTCT does not assent to participate.

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ginny Schulz, Ph.D., RN, CPNP-PC

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ginny L Schulz, Ph.D., RN, CPNP-PC

Role: CONTACT

schulz_g@wustl.edu

314-454-6018

Facility Contacts

Ginny L Schulz, Ph.D., RN, CPNP-PC

Role: primary

schulz_g@wustl.edu

314-454-6018

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

K12CA167540

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202410119

Identifier Type: -

Identifier Source: org_study_id