Healthy Weight Intervention Families During ALL Treatment: NOURISH-ALL

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-12
SponsorUniversity of Kansas Medical Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • NOURISH-ALL

Treatment groups

46 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Kansas Medical Center

Lead sponsor

Children's Mercy Hospital Kansas City

Collaborator

National Cancer Institute (NCI)

Collaborator