Clinical trial NCT06050850: Healthy Weight Intervention Families During ALL Treatment: NOURISH-ALL
Official title: A Healthy Weight Intervention for Family Stress During the Early Phases of ALL Treatment: NOURISH-ALL
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ALL, Childhood
Behavior, Health
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Children's Mercy Hospital Kansas City
name: National Cancer Institute (NCI)
First posted: 2023-09-22
Enrollment: 46
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Families of youth aged 2-12 years who are newly diagnosed with acute lymphoblastic leukemia.

Brief 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)

Detailed description: The long-term goal of this work is to establish an efficacious family-based health promotion intervention that curbs excessive weight gain among youth with newly diagnosed acute lymphoblastic leukemia (ALL) by integrating support for family coping with stress during the early phases of treatment.

The objectives of the current study are to adapt an existing family-based health promotion intervention, NOURISH-T, to meet the needs of families of youth in the early phases of ALL treatment (NOURISH-ALL) and (2) assess three key components of engagement in preparation for a fully powered efficacy trial.

NOURISH-T is a 6-session family-based health promotion intervention that has demonstrated improved physical activity (PA), dietary intake, and weight among youth who are cancer survivors. Guided by the ORBIT Model of Behavioral Intervention Development, this study will modify NOURISH-T to fit the early ALL treatment context through a multi-stage adaptation and refinement process. Adaptations will incorporate family systems and cognitive behavioral intervention components to support healthy family coping with diagnosis and treatment stress. Additional, patient-centered adaptations will be informed by semi-structured family input around intervention content and delivery.

The central hypothesis is that this rigorous approach to adaptation will yield an intervention that is feasible, acceptable, and engaging for families of youth with ALL. By incorporating tailored strategies for health promotion during the early phases of ALL treatment, the proposed study seeks to shift clinical practice paradigms to prevent weight-related disparities in treatment outcomes.

Hypothesis:

The central hypothesis is that this rigorous approach to adaptation will yield an intervention that is feasible, acceptable, and engaging for families of youth with ALL.

Aims:

AIM 1: To (a) adapt the NOURISH-T intervention to target the early phases of ALL treatment (NOURISH-ALL) and (b) refine this ALL-tailored intervention for optimal feasibility and acceptability from the patient and family perspective. (Years 1-2) Defining the specific needs of families of youth with newly diagnosed ALL is essential to effectively adapting behavior change interventions to the early phases of ALL treatment. Refining interventions for optimal feasibility and acceptability from the family perspective is critical to successful intervention development.

Aim 1a: Intervention Adaptation. 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. Refinement to Optimize Feasibility and Acceptability. 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: To conduct an external pilot single-arm trial of NOURISH-ALL focused on three components of 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).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

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

Primary outcomes:
measure: Recruitment Rate
timeFrame: Baseline (Week 0)
measure: Retention Rate
timeFrame: Post-Intervention (Week 6), Follow-Up (Month 6)
measure: Intended dose received
timeFrame: Post-Intervention (Week 6), Follow-Up (Month 6)
Secondary outcomes:
measure: Child Body Mass Index (BMI)
timeFrame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
measure: Child Physical Activity
timeFrame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
measure: Child Sleep
timeFrame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
measure: Child Dietary Intake
timeFrame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
measure: Family Stress Measures
timeFrame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
measure: Family Distress
timeFrame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
measure: Body Composition - Bioelectrical Impedance Analysis
timeFrame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
measure: Body Composition
timeFrame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
measure: Subcutaneous fat
timeFrame: Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Carolyn Bates, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Mercy Kansas City
name: Keith August, MD
role: PRINCIPAL_INVESTIGATOR
References: