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

Let's Get REAL: A Pilot Trial of a Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy

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).

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor; Sickle Cell Disease; Hematologic Malignancy; Aplastic Anemia; Immune Deficiency; Metabolic Disorder
• Intervention / Treatment: Behavioral: Let's Get REAL

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ginny L Schulz, Ph.D., RN, CPNP-PC; Phone Number: 314-454-6018; Email: schulz_g@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Sub-Investigator: Shalini Shenoy, M.D.
      • Contact: Ginny L Schulz, Ph.D., RN, CPNP-PC; Phone Number: 314-454-6018; Email: schulz_g@wustl.edu
      • Principal Investigator: Ginny L Schulz, Ph.D., RN, CPNP-PC
      • Sub-Investigator: Amy McQueen, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Let's Get REAL; Family health communication tool
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.	Behavioral: Let's Get REAL; Family health communication tool
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.	Behavioral: Let's Get REAL; Family health communication tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)
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	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)
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	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)
Perceived levels of decision-making involvement in youth 8-17 years of age and their parents as measured by the Decision Making Involvement Scale	This is a 30-item scale that youth and their parents report youth involvement behaviors in a decision related to their illness on a 4-point Likert scale ranging from 'A Little Bit' to 'A Lot'. The higher the subscale score (child seek, child express, parent seek, parent express, and joint/options), the more that behavior or type of involvement occurred in the decision making process.	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	Number of utterance occurrences for the following: 1) who uttered (youth, parent), 2) was utterance prompted (yes/no), if so, by who, 3) type of utterance (questions, opinion, concern, other), and 4) content of utterance (prognosis, side effect, expectation).	Up to 4 weeks after SCTCT consultation (estimated to be week 8)
Change in youth-parent communication as measured by the Likert-type Parent-Adolescent Communication Scale	This is a 20-item scale that youth and parents report the degree of openness in family communication and the extent of problems with family communications on a 5-point Likert ranging from 'strongly disagree' to 'strongly agree'. A higher score on the degree of openness subscale indicates better communication between parent and adolescent. For extent of problems subscale, a higher score indicates more problems in the parent-child communication.	Up to 4 weeks prior to SCTCT consultation and up to 4 weeks after SCTCT consultation (estimated to be 8 weeks)
Change in the level of youth's general anxiety as measured by the Likert-type PROMIS Anxiety 8a Short Form or parent proxy	This is an 8-item scale that measures youth's general anxiety in those 8-17 years of age on a 5-point Likert scale ranging from 'never' to 'almost always'.	Up to 4 weeks prior to SCTCT consultation and up to 4 weeks after SCTCT consultation (estimated to be 8 weeks)
Level of decisional conflict as measured by the Likert-type Decisional Conflict Scale	This is a 10-item scale that youth and parents report their personal uncertainty and decisional conflict related to a specific decision. We are using the question format as it is recommended for those with limited reading or response skills. They respond 'Yes', 'No, or 'Unsure'. A total decision conflict score ranges from 0 (no decisional conflict) to 100 (extremely high decision conflict). Higher scores on subscales uncertainty, informed, values clarity, and support reflect feeling extremely uncertain about the best choice, feeling extremely uninformed, feeling extremely unclear about personal values, and feeling extremely unsupported in decision making respectively.	Up to 4 weeks after SCTCT consultation (estimated to be week 8)
Youth-parent congruence of youth decision making involvement as measured by two Likert type statements	Number of dyads that agree on these two statements measured on a 4-point Likert scale ranging from 'Not at all' to 'A lot': 1)"I/my child should be involved in future talks about transplant" and 2) "I/my child wants to be involved in future talks about transplant".	Up to 4 weeks after SCTCT consultation (estimated to be week 8)
Satisfaction with the decision making involvement as measured by one Likert type statement	This is a one item statement, "I am satisfied with my/my child's involvement in the transplant decision making process", measured on a 4-point Likert scale ranging from 'Not at all' to 'A lot'. A higher score indicates more satisfaction.	Up to 4 weeks after SCTCT consultation (estimated to be week 8)
Number of patients who chose SCTCT		Up to 4 weeks after SCTCT consultation (estimated to be week 8)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI); St. Louis Children's Hospital Foundation
• Investigators: Principal Investigator: Ginny Schulz, Ph.D., RN, CPNP-PC, Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Family; Pediatric; Intervention; Decision making; Health Communication
• Additional Relevant MeSH Terms: Bone Marrow Failure Disorders; Neoplasms by Site; Neoplasms; Genetic Diseases, Inborn; Immune System Diseases; Hematologic Diseases; Bone Marrow Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Anemia, Sickle Cell; Immunologic Deficiency Syndromes; Metabolic Diseases; Anemia, Aplastic
• Other Study ID Numbers: 202410119; K12CA167540 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No