RecruitingNCT06050850

Healthy Weight Intervention Families During ALL Treatment: NOURISH-ALL

A Healthy Weight Intervention for Family Stress During the Early Phases of ALL Treatment: NOURISH-ALL

Sponsor

University of Kansas Medical Center

Enrollment

46 participants

Start Date

Oct 17, 2023

Study Type

OBSERVATIONAL

Conditions

ALL, Childhood Behavior, Health

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)

Eligibility

Min Age: 2 YearsMax Age: 12 Years

Inclusion Criteria8

Children ages 2-12 years old and their primary caregiver ages 18-90
Child diagnosed with acute lymphoblastic leukemia (ALL)
Child completed induction phase of therapy and not yet in maintenance phase of therapy
Primary caregiver and child English language proficient
Primary caregiver able to provide permission for child to participate in research
Primary caregiver identifies as being involved with child's oncology care
Primary caregiver lives with child at least 50% of the time
Primary oncology provider confirms child is eligible to participate

Exclusion Criteria1

Primary oncology provider identifies safety concerns regarding the child's participation in the study.

Interventions

BEHAVIORALNOURISH-ALL

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.