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Aim 1a: Adapting the NOURISH-ALL Intervention for Families of Youth with ALL (Year 1) for Health Behaviors (NOURISH-ALL Trial)

N/A
Recruiting
Led By Carolyn Bates, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-intervention (week 6), follow-up (month 6)
Awards & highlights

Summary

The purpose of this study is to conduct a single arm pilot of the NOURISH-ALL (Nourishing Our Understanding of Role modeling to Improve Support and Health in Acute Lymphoblastic Leukemia) intervention focused on three components of participant engagement. This is a single arm intervention study that involves participation in a 6-session family intervention and three time points of multimethod data collection. The primary outcome is participant engagement, measured as recruitment, retention, and intended dose received. This study will be conducted over 5 years in three phases: * Aim 1a: Adapting the NOURISH-ALL Intervention for Families of Youth with ALL (Year 1) * Aim 1b: Iteratively Refining the NOURISH-ALL Intervention (Year 2) * Aim 2: Pilot Single-Arm Trial of NOURISH-ALL Focused on Participant Engagement (Years 3-5)

Eligible Conditions
  • Health Behaviors
  • Acute Lymphoblastic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-intervention (week 6), follow-up (month 6)
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention (week 6), follow-up (month 6) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intended dose received
Recruitment Rate
Retention Rate
Secondary study objectives
Body Composition
Child Body Mass Index (BMI)
Child Dietary Intake
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Aim 2: Pilot Single-Arm Trial of NOURISH-ALL Focused on Participant Engagement (Years 3-5)Experimental Treatment1 Intervention
Pilot testing key components of engagement is critical to optimizing design and methodology of fully powered efficacy trials. The purpose of Aim 2 is to pilot a single-arm trial of the finalized NOURISH-ALL intervention in a sample of families of youth in the early phases of ALL treatment to assess recruitment, retention, and dose received. Results will directly inform the design of the fully powered randomized control trial to test intervention efficacy (R01 application to be submitted in Year 4).
Group II: Aim 1b: Iteratively Refining the NOURISH-ALL Intervention (Year 2)Experimental Treatment1 Intervention
The purpose of Aim 1b is to adaptively refine NOURISH-ALL through sequential testing with individual families during the early phases of ALL treatment, with the goal of optimizing feasibility and acceptability from the family perspective. In line with the ORBIT model, the study will utilize an adaptive approach, similar to the commonly known "PDSA cycle," to maximize responsivity to individual patient/family feedback. Participants will receive NOURISH-ALL and provide feedback throughout the intervention (i.e., after each session and upon intervention completion), which will be iteratively analyzed and incorporated to improve intervention delivery for the next family
Group III: Aim 1a: Adapting the NOURISH-ALL Intervention for Families of Youth with ALL (Year 1)Experimental Treatment0 Interventions
The purpose of Aim 1a is to adapt the NOURISH-T intervention to meet the specific needs of families during the early phases of ALL treatment. To achieve this goal, the study will initiate a three-step intervention adaptation process that includes (1) initial integration of cognitive behavioral therapy (CBT) and family systems frameworks, (2) formative assessment with families of youth with ALL, and (3) formative assessment with multidisciplinary experts.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,465 Total Patients Enrolled
13 Trials studying Health Behaviors
8,101 Patients Enrolled for Health Behaviors
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,954 Total Patients Enrolled
8 Trials studying Health Behaviors
7,239 Patients Enrolled for Health Behaviors
University of Kansas Medical CenterLead Sponsor
488 Previous Clinical Trials
172,409 Total Patients Enrolled
4 Trials studying Health Behaviors
429 Patients Enrolled for Health Behaviors
~31 spots leftby Oct 2028
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