Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT06689800

Conditions

Hematologic Malignancy

Solid Tumor

Sickle Cell Disease

Aplastic Anemia

Immune Deficiency

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Interventions

Let's Get REAL

Study Details

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

Study ID

NCT06689800

Start date

Nov 26, 2024

Status verified date

Jun, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

Let's Get REAL

Family health communication tool

Primary outcome measure

  • Feasibility of intervention as measured by the Feasibility of Intervention questionnaire [ Time Frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8) ]
  • Acceptability of intervention as measured by the Acceptability of Intervention questionnaire [ Time Frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8) ]
  • Appropriateness of intervention as measured by the Intervention of Appropriateness questionnaire [ Time Frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8) ]
  • Feasibility of intervention as measured qualitatively [ Time Frame: Up to 8 weeks after SCTCT consultation (estimated to be week 16) ]
  • Acceptability of intervention as measured qualitatively [ Time Frame: Up to 8 weeks after SCTCT consultation (estimated to be week 16) ]
  • Appropriateness of intervention as measured qualitatively [ Time Frame: Up to 8 weeks after SCTCT consultation (estimated to be week 16) ]

Central Contacts and Locations

Central contacts

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

314-454-6018schulz_g@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

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

314-454-6018schulz_g@wustl.edu

Principal Investigator:

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

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Pediatric
  • Family
  • Decision making
  • Health Communication
  • Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-06-04.