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

NCT06689800 | Recruiting

• 2 other identifiers: 202410119K12CA167540
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Pediatric; Family; Decision making; Health Communication; Intervention

Outcome Measures

Primary Outcomes (6)

• Feasibility of intervention as measured by the Feasibility of Intervention questionnaire

  This is a 4-item scale that youth and their parents report feasibility of the intervention on a 5-point Likert scale ranging from 'Completely disagree' to Completely agree'. A higher score indicates greater feasibility.

  Up to 4 weeks after SCTCT consultation (estimated to be week 8)

• Acceptability of intervention as measured by the Acceptability of Intervention questionnaire

  This is a 4-item scale that youth and their parents report acceptability of the intervention on a 5-point Likert scale ranging from 'Completely disagree' to Completely agree'. A higher score indicates greater acceptability.

  Up to 4 weeks after SCTCT consultation (estimated to be week 8)

• Appropriateness of intervention as measured by the Intervention of Appropriateness questionnaire

  This is a 4-item scale that youth and their parents report appropriateness of the intervention on a 5-point Likert scale ranging from 'Completely disagree' to Completely agree'. A higher score indicates greater appropriateness.

  Up to 4 weeks after SCTCT consultation (estimated to be week 8)

• Feasibility of intervention as measured qualitatively

  Content analysis of open-ended survey responses and quotations from individual interviews. Will be collecting number of feasibility content codes.

  Up to 8 weeks after SCTCT consultation (estimated to be week 16)

• Acceptability of intervention as measured qualitatively

  Content analysis of open-ended survey responses and quotations from individual interviews. Will be collecting number of acceptability content codes.

  Up to 8 weeks after SCTCT consultation (estimated to be week 16)

• Appropriateness of intervention as measured qualitatively

  Content analysis of open-ended survey responses and quotations from individual interviews. Will be collecting number of appropriateness content codes.

  Up to 8 weeks after SCTCT consultation (estimated to be week 16)

Secondary Outcomes (11)

• Difference in feasibility scores in those 8-12 years of age and those 13-17 years of age as measured by the Feasibility of Intervention questionnaire

  Up to 4 weeks after SCTCT consultation (estimated to be week 8)

• Difference in acceptability scores in those 8-12 years of age and those 13-17 years of age as measured by the Acceptability of Intervention questionnaire

  Up to 4 weeks after SCTCT consultation (estimated to be week 8)

• Difference in appropriateness scores in those 8-12 years of age and those 13-17 years of age as measured by the Intervention of Appropriateness questionnaire

  Up to 4 weeks after SCTCT consultation (estimated to be week 8)

• Perceived levels of decision-making involvement in youth 8-17 years of age and their parents as measured by the Decision Making Involvement Scale

  Up to 4 weeks after SCTCT consultation (estimated to be week 8)

• Observed levels of decision-making involvement in youth 8-17 years of age and their parents

  Up to 4 weeks after SCTCT consultation (estimated to be week 8)

Study Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Let's Get REAL family health communication tool: Parents

EXPERIMENTAL

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

Interventions

Let's Get REAL BEHAVIORAL

Family health communication tool

Let's Get REAL family health communication tool: Parents; Let's Get REAL family health communication tool: Patients (13-17 years of age); Let's Get REAL family health communication tool: Patients (8-12 years of age)

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Hematologic Neoplasms; Anemia, Sickle Cell; Anemia, Aplastic; Immunologic Deficiency Syndromes; Metabolic Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Marrow Failure Disorders; Bone Marrow Diseases; Immune System Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ginny Schulz, Ph.D., RN, CPNP-PC

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

314-454-6018; schulz_g@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)