Financial Distress During Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVE:
- 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:
- 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:
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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.
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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:
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Health Services Research (survey, interview, chart 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 |
Other: Electronic Health Record Review
Review of medical records
Other: Interview
Complete interview
Other: Survey Administration
Complete survey
|
Outcome Measures
Primary Outcome Measures
- 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 cores can range from 1 to 10, with 1 indicating overwhelming financial distress and 10 indicating no financial distress.
Secondary Outcome Measures
- 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.
Other Outcome Measures
- Domains of financial toxicity [From start through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years]
Descriptive statistics will be used to report domains of financial distress, informed by the conceptual framework guiding this study.
- Parental experiences of financial distress and material hardship, and perceptions about financial screening/assessments during their child's/adolescent's treatment [From start through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years]
Each audio-recorded interview, and the associated field notes and summary, will be transcribed verbatim. These data will be coded using a directed content analysis approach.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Parents age 18 years and above are eligible for this study. Index child must be between the ages of 1 and 14.9 years at the time of the parent's enrollment
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Parents of an index child with newly diagnosed with de novo ALL are eligible for this study
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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
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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
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REGULARTORY REQUIREMENTS: All parents must sign a written informed consent for their participation in the study
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REGULARTORY REQUIREMENTS: All institutional and NCI requirements for human studies must be met
Exclusion Criteria:
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Parents of index children with any of the following clinical characteristics will be excluded from the study:
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KMT2A-R (formerly MLL-R) not receiving ALL therapy
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Mixed-phenotype acute leukemia (MPAL) not receiving ALL therapy
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Burkitt's leukemia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente-Oakland | Oakland | California | United States | 94611 |
| 2 | Alfred I duPont Hospital for Children | Wilmington | Delaware | United States | 19803 |
| 3 | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | United States | 32207 |
| 4 | Nemours Children's Hospital | Orlando | Florida | United States | 32827 |
| 5 | Sacred Heart Hospital | Pensacola | Florida | United States | 32504 |
| 6 | Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | United States | 33607 |
| 7 | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | United States | 96826 |
| 8 | Maine Children's Cancer Program | Scarborough | Maine | United States | 04074 |
| 9 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
| 10 | Morristown Medical Center | Morristown | New Jersey | United States | 07960 |
| 11 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
| 12 | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
| 13 | Prisma Health Richland Hospital | Columbia | South Carolina | United States | 29203 |
| 14 | BI-LO Charities Children's Cancer Center | Greenville | South Carolina | United States | 29605 |
| 15 | Driscoll Children's Hospital | Corpus Christi | Texas | United States | 78411 |
| 16 | Methodist Children's Hospital of South Texas | San Antonio | Texas | United States | 78229 |
| 17 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229 |
| 18 | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | United States | 54301 |
Sponsors and Collaborators
- Children's Oncology Group
Investigators
- Principal Investigator: Melissa P Beauchemin, Children's Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACCL20N1CD
- NCI-2021-03567
- ACCL20N1CD
- COG-ACCL20N1CD
- ACCL20N1CD
- UG1CA189955