Clinical trial NCT06689800: Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
Official title: Let's Get REAL: A Pilot Trial of a Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Malignancy
Solid Tumor
Sickle Cell Disease
Aplastic Anemia
Immune Deficiency
Metabolic Disorder
Keywords: Pediatric
Family
Decision making
Health Communication
Intervention
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility 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.

Primary outcomes:
measure: Feasibility of intervention as measured by the Feasibility of Intervention questionnaire
timeFrame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
measure: Acceptability of intervention as measured by the Acceptability of Intervention questionnaire
timeFrame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
measure: Appropriateness of intervention as measured by the Intervention of Appropriateness questionnaire
timeFrame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
measure: Feasibility of intervention as measured qualitatively
timeFrame: Up to 8 weeks after SCTCT consultation (estimated to be week 16)
measure: Acceptability of intervention as measured qualitatively
timeFrame: Up to 8 weeks after SCTCT consultation (estimated to be week 16)
measure: Appropriateness of intervention as measured qualitatively
timeFrame: Up to 8 weeks after SCTCT consultation (estimated to be week 16)
Secondary outcomes:
measure: 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
timeFrame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
measure: 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
timeFrame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
measure: 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
timeFrame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
measure: Perceived levels of decision-making involvement in youth 8-17 years of age and their parents as measured by the Decision Making Involvement Scale
timeFrame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
measure: Observed levels of decision-making involvement in youth 8-17 years of age and their parents
timeFrame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
measure: Change in youth-parent communication as measured by the Likert-type Parent-Adolescent Communication Scale
timeFrame: Up to 4 weeks prior to SCTCT consultation and up to 4 weeks after SCTCT consultation (estimated to be 8 weeks)
measure: Change in the level of youth's general anxiety as measured by the Likert-type PROMIS Anxiety 8a Short Form or parent proxy
timeFrame: Up to 4 weeks prior to SCTCT consultation and up to 4 weeks after SCTCT consultation (estimated to be 8 weeks)
measure: Level of decisional conflict as measured by the Likert-type Decisional Conflict Scale
timeFrame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
measure: Youth-parent congruence of youth decision making involvement as measured by two Likert type statements
timeFrame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
measure: Satisfaction with the decision making involvement as measured by one Likert type statement
timeFrame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
measure: Number of patients who chose SCTCT
timeFrame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ginny Schulz, Ph.D., RN, CPNP-PC
role: PRINCIPAL_INVESTIGATOR
References: