RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2023-10-17
Study Completion:2029-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06050850

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Children ages 2-12 years old and their primary caregiver ages 18-90
  2. * Child diagnosed with acute lymphoblastic leukemia (ALL)
  3. * Child completed induction phase of therapy and not yet in maintenance phase of therapy
  4. * Primary caregiver and child English language proficient
  5. * Primary caregiver able to provide permission for child to participate in research
  6. * Primary caregiver identifies as being involved with child's oncology care
  7. * Primary caregiver lives with child at least 50% of the time
  8. * Primary oncology provider confirms child is eligible to participate
  1. * Primary oncology provider identifies safety concerns regarding the child's participation in the study.

Contacts and Locations

Study Contact

Carolyn Bates, PhD
CONTACT
913-588-6323
cbates4@kumc.edu
Kelsey M Dean
CONTACT
(816) 652-0065
kdean@kumc.edu

Principal Investigator

Carolyn Bates, PhD
PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Keith August, MD
PRINCIPAL_INVESTIGATOR
Children's Mercy Kansas City

Study Locations (Sites)

University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Children's Mercy Kansas City
Kansas City, Missouri, 64118
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

  • Carolyn Bates, PhD, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center
  • Keith August, MD, PRINCIPAL_INVESTIGATOR, Children's Mercy Kansas City

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-17
Study Completion Date2029-10-01

Study Record Updates

Study Start Date2023-10-17
Study Completion Date2029-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • ALL, Childhood
  • Behavior, Health