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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
United States
Kansas
University of Kansas Medical Center
ACTIVE_NOT_RECRUITING
Kansas City
Missouri
Children's Mercy Kansas City
RECRUITING
Kansas City
Contact Information
Primary
Carolyn Bates, PhD
cbates4@kumc.edu
913-588-6323
Backup
Kelsey M Dean
kdean@kumc.edu
(816) 652-0065
Time Frame
Start Date: 2023-10-17
Estimated Completion Date: 2029-10-01
Participants
Target number of participants: 46
Treatments
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.
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
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).
Sponsors
Collaborators: Children's Mercy Hospital Kansas City, National Cancer Institute (NCI)
Leads: University of Kansas Medical Center

This content was sourced from clinicaltrials.gov

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