Healthy Weight Intervention Families During ALL Treatment: NOURISH-ALL

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06050850
Status
Recruiting
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Conditions

  • ALL, Childhood
  • Behavior, Health

Eligibility Criteria

Sex
ALL
Age
2 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • NOURISH-ALL — BEHAVIORAL
    Our NOURISH-ALL intervention will build on this existing NOURISH-T family based behavioral intervention with families of cancer survivors. The intervention, NOURISH-ALL, will adapt these family-based health promotion strategies to the early ALL treatment context.

Study Details

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)

Key Dates

Start date
Oct 17, 2023
Status verified
Oct 2025
Primary completion
Oct 1, 2028
Completion
Oct 1, 2029

Study Design

Enrollment
46 participants (estimated)

Arms

  • Arm: Aim 1a: Adapting the NOURISH-ALL Intervention for Families of Youth with ALL (Year 1)
    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.
  • Arm: Aim 1b: Iteratively Refining the NOURISH-ALL Intervention (Year 2)
    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
  • Arm: Aim 2: Pilot Single-Arm Trial of NOURISH-ALL Focused on Participant Engagement (Years 3-5)
    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).

Primary Outcome Measure

Recruitment Rate [ Time Frame: Baseline (Week 0) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160-
Children's Mercy Kansas CityKansas CityMissouri64118
Keith August, MD
[email protected]
(816) 302-6801
Keith August, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Kansas Medical Center· Kansas City, KSChildren's Mercy Kansas City· Kansas City, MO

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