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

Active, not recruiting

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Other: Electronic Health Record Review; Other: Interview; Other: Survey Administration

• Registration Number: NCT04928599
• Lead Sponsor: Children's Oncology Group

Brief 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.

Study Timeline

• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-16
• Study Start: 2022-03-14
• Status Verified: 2024-10
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-11
• Primary Completion: 2027-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All Children's Oncology Group (COG) NCI Community Oncology Research Program (National Cancer Institute [N]CORP) institutions are eligible for participation in this study upon first parent enrollment

• Parents of an index child who meets the following characteristics are eligible for this study:

  • Index child must be newly diagnosed with de novo ALL
  • Index child must be between the ages of 1 and 14.9 years at the time of the parent's enrollment
  • At the parent's entry to the study, the index child must be receiving induction chemotherapy for newly diagnosed ALL at the enrolling institution. The index child may be enrolled in therapeutic clinical ALL trials or receiving ALL therapy per standard of care

• Parents age 18 years and above are eligible for this study

• Parent must speak English or Spanish in order to participate in the consent process and provide consent. The parent's language skills must be sufficient to understand the study requirements and complete the survey and interview questions

• At the parent's entry to the study, the index child must be receiving induction chemotherapy for newly diagnosed ALL at the enrolling institution. The index child may be enrolled in therapeutic clinical ALL trials or receiving ALL therapy per standard of care

• REGULARTORY REQUIREMENTS: All parents must sign a written informed consent for their participation in the study

• REGULARTORY REQUIREMENTS: All institutional and NCI requirements for human studies must be met

Exclusion Criteria

• Parents of index children with any of the following clinical characteristics will be excluded from the study:

  • KMT2A-R (formerly MLL-R) not receiving ALL therapy
  • Mixed-phenotype acute leukemia (MPAL) not receiving ALL therapy
  • Burkitt's leukemia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Health Services Research (survey, interview, chart review)	Interview	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
Health Services Research (survey, interview, chart review)	Survey Administration	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
Health Services Research (survey, interview, chart review)	Electronic Health Record Review	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

Primary Outcome Measures

Name	Time	Method
Change in financial distress	From start through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years	Financial distress will be measured serially using the Personal Finance Wellbeing (PFW) scale (previously InCharge Financial Distress/Financial Well-Being scale). Scores on the PFW scale will be computed by adding numerical responses for each of the 8 questions, then dividing the total by 8. These scores can range from 1 to 10, with 1 indicating overwhelming financial distress and 10 indicating no financial distress.

Secondary Outcome Measures

Name	Time	Method
Factors associated with financial distress	From start of through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years	Candidate factors include socio-demographic variables, clinical variables, institutional variables, financial variables (e.g., Household Material Hardship \[HMH\] scores, change in household income), and financial coping behaviors.

Trial Locations

Locations (40)

Kaiser Permanente-Oakland; 🇺🇸 Oakland, California, United States

Alfred I duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States

Broward Health Medical Center; 🇺🇸 Fort Lauderdale, Florida, United States

Golisano Children's Hospital of Southwest Florida; 🇺🇸 Fort Myers, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital; 🇺🇸 Hollywood, Florida, United States

Nemours Children's Clinic-Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Nemours Children's Hospital; 🇺🇸 Orlando, Florida, United States

Sacred Heart Hospital; 🇺🇸 Pensacola, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Saint Joseph's Hospital/Children's Hospital-Tampa; 🇺🇸 Tampa, Florida, United States

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