Family-based health intervention for children with leukemia
A Healthy Weight Intervention for Family Stress During the Early Phases of ALL Treatment: NOURISH-ALL
This study is testing a family-based program to see if it helps children with leukemia and their families cope better during treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 46 (estimated) |
| Ages | 2 Years to 12 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 2 sites (Kansas City, Kansas and 1 other locations) |
| Trial ID | NCT06050850 on ClinicalTrials.gov |
What this trial studies
This study evaluates the NOURISH-ALL intervention, a family-based health promotion program designed for children aged 2-12 diagnosed with acute lymphoblastic leukemia (ALL). It involves a 6-session intervention aimed at improving family engagement and coping strategies during the early phases of treatment. The study will adapt an existing program, NOURISH-T, to better fit the needs of families dealing with the stress of a cancer diagnosis. Data will be collected at three time points to assess participant engagement and the feasibility of the intervention.
Who should consider this trial
Good fit: Ideal candidates include children aged 2-12 who have been diagnosed with ALL and their primary caregivers who are actively involved in their oncology care.
Not a fit: Patients who are not in the early phases of ALL treatment or those whose primary oncology provider has safety concerns may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help prevent excessive weight gain in children undergoing treatment for leukemia, improving their overall health and well-being.
How similar studies have performed: Previous studies have shown success with similar family-based interventions for childhood cancer survivors, suggesting potential for this adapted approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kansas City, Kansas and 1 other locations
- University of Kansas Medical Center — Kansas City, Kansas, United States (Active_not_recruiting)
- Children's Mercy Kansas City — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Carolyn Bates, PhD — University of Kansas Medical Center
- Study coordinator: Carolyn Bates, PhD
- Email: cbates4@kumc.edu
- Phone: 913-588-6323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.