Let's Get REAL Tool for Pediatric Blood Cancers

N/A

Recruiting

Led By Ginny Schulz, Ph.D., RN, CPNP-PC

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks after sctct consultation (estimated to be week 8)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new tool called Let's Get REAL to see if it can help young patients and their families make better decisions about stem cell transplants and cellular therapy. They will test this

Who is the study for?

This trial is for young patients with conditions like metabolic disorders, diabetes, blood cancers, and immune deficiencies who are undergoing stem cell transplants or cellular therapy. It's open to kids aged 8-17 along with their parents. Specific eligibility details aren't provided.

What is being tested?

The 'Let's Get REAL' tool is being tested to see if it helps kids involved in the study make real-time decisions about their stem cell transplant and cellular therapy treatments. The study will involve two age groups: one for children aged 8-12 and another for teens aged 13-17.

What are the potential side effects?

Since this trial tests a communication tool rather than a medical treatment, there are no direct physical side effects associated with 'Let's Get REAL'. However, emotional or psychological impacts due to discussing health issues should be considered.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 weeks after sctct consultation (estimated to be week 8)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 weeks after sctct consultation (estimated to be week 8)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks after sctct consultation (estimated to be week 8) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of intervention as measured by the Acceptability of Intervention questionnaire

Acceptability of intervention as measured qualitatively

Appropriateness of intervention as measured by the Intervention of Appropriateness questionnaire

+3 more

Secondary study objectives

Change in the level of youth's general anxiety as measured by the Likert-type PROMIS Anxiety 8a Short Form or parent proxy

Change in youth-parent communication as measured by the Likert-type Parent-Adolescent Communication Scale

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

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Let's Get REAL family health communication tool: Patients (8-12 years of age)Experimental Treatment1 Intervention

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.

Group II: Let's Get REAL family health communication tool: Patients (13-17 years of age)Experimental Treatment1 Intervention

Group III: Let's Get REAL family health communication tool: ParentsExperimental Treatment1 Intervention

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