NCT04928599

Financial Distress During Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The overall goals of this study are to measure parents' financial distress (worry or anxiety about money) during their child's/adolescent's treatment for acute lymphoblastic leukemia and whether it changes over time, and to learn what factors are associated with changes in financial distress. Information gathered from this study will inform future intervention studies that may mitigate financial distress for parents of children/adolescents being treated for acute lymphoblastic leukemia.

Detailed description

PRIMARY OBJECTIVE: I. Determine the trajectory of financial distress over time, as reported by parents of children and adolescents ages 1 to 14.9 years with acute lymphoblastic leukemia (ALL), from start to completion of ALL therapy. SECONDARY OBJECTIVE: I. Identify factors associated with financial distress over time for families of children and adolescents ages 1 to 14.9 years with newly diagnosed ALL. EXPLORATORY OBJECTIVES: I. Describe domains of financial toxicity, informed by the conceptual framework guiding this study, specifically treatment-related material hardship during treatment for pediatric ALL, potential financial coping behaviors during treatment for pediatric ALL, and institutional factors. II. In a sub-cohort of participants, qualitatively explore parental experiences of financial distress and material hardship, and perceptions about financial screening/assessments during their child's/adolescent's treatment for ALL. OUTLINE: This is an observational study. Parents complete surveys over 15-30 minutes at the beginning of their child's induction chemotherapy, at the beginning of maintenance chemotherapy, and at the end of last chemotherapy. Parents may also participate in one-time individual interview over 30-45 minutes. Additionally, children's medical records are reviewed during the study.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
OTHER	Electronic Health Record Review	Review of medical records
OTHER	Interview	Complete interview
OTHER	Survey Administration	Complete survey

Timeline

• Start date: 2022-03-14
• Primary completion: 2027-03-31
• Completion: 2028-03-31
• First posted: 2021-06-16
• Last updated: 2026-01-08

Locations

40 sites across 2 countries: United States, Puerto Rico