Behavior, Health Clinical Trial
— NOURISH-ALLOfficial title:
A Healthy Weight Intervention for Family Stress During the Early Phases of ALL Treatment: NOURISH-ALL
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)
Status | Recruiting |
Enrollment | 46 |
Est. completion date | October 1, 2029 |
Est. primary completion date | October 1, 2028 |
Accepts healthy volunteers | |
Gender | All |
Age group | 2 Years to 12 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Mercy Kansas City | Kansas City | Missouri |
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center | Children's Mercy Hospital Kansas City, National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment Rate | Measured by # enrolled / # eligible | Baseline (Week 0) | |
Primary | Retention Rate | Measured by # completed intervention / # enrolled | Post-Intervention (Week 6), Follow-Up (Month 6) | |
Primary | Intended dose received | Measured by # sessions attended / # sessions offered | Post-Intervention (Week 6), Follow-Up (Month 6) | |
Secondary | Child Body Mass Index (BMI) | Measured by child height and weight | Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6) | |
Secondary | Child Physical Activity | Measured by Actigraph wGT3x+ activity monitor | Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6) | |
Secondary | Child Sleep | Measured by Actigraph wGT3x+ activity monitor | Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6) | |
Secondary | Child Dietary Intake | Total calories, % calories from fat, and other nutrition variables will be measured by Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) | Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6) | |
Secondary | Family Stress Measures | Measured by Psychosocial Assessment Tool v3.0 (PAT 3.0) | Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6) | |
Secondary | Family Distress | Measured by Distress Thermometer (DT) | Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6) |
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