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

Children's Oncology Group

Status: Active, not recruiting

Conditions: Acute Lymphoblastic Leukemia

Treatments: Other: Electronic Health Record Review; Other: Survey Administration; Other: Interview

Study type: Observational

Funder types: NETWORK

Identifiers

NCT04928599

COG-ACCL20N1CD (Other Identifier)

ACCL20N1CD (Other Identifier)

UG1CA189955 (U.S. NIH Grant/Contract)

NCI-2021-03567 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

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

• REGULATORY 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

Trial design

100 participants in 1 patient group

Health Services Research (survey, interview, chart review)

Description:

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

Treatment:

Other: Interview

Other: Survey Administration

Other: Electronic Health Record Review