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

The Washington University

Status: Enrolling

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

Treatments: Behavioral: Let's Get REAL

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06689800

K12CA167540 (U.S. NIH Grant/Contract)

202410119

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Let's Get REAL family health communication tool: Patients (8-12 years of age)

Experimental group

Description:

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.

Treatment:

Behavioral: Let's Get REAL

Let's Get REAL family health communication tool: Patients (13-17 years of age)

Experimental group

Description:

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.

Treatment:

Behavioral: Let's Get REAL

Let's Get REAL family health communication tool: Parents

Experimental group

Description:

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.

Treatment:

Behavioral: Let's Get REAL