Financial Distress During Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States
- Conditions
- Acute Lymphoblastic Leukemia
- Interventions
- Other: Electronic Health Record ReviewOther: InterviewOther: 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
-
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
-
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 (41)
Sunrise Hospital and Medical Center
🇺🇸Las Vegas, Nevada, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
🇺🇸Las Vegas, Nevada, United States
Summerlin Hospital Medical Center
🇺🇸Las Vegas, Nevada, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Tampa General Hospital
🇺🇸Tampa, Florida, 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
Nemours Children's Clinic-Jacksonville
🇺🇸Jacksonville, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
🇺🇸Tampa, Florida, United States
Augusta University Medical Center
🇺🇸Augusta, Georgia, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Mercy Hospital Saint Louis
🇺🇸Saint Louis, Missouri, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Sanford Broadway Medical Center
🇺🇸Fargo, North Dakota, United States
Prisma Health Richland Hospital
🇺🇸Columbia, South Carolina, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
BI-LO Charities Children's Cancer Center
🇺🇸Greenville, South Carolina, United States
Sanford USD Medical Center - Sioux Falls
🇺🇸Sioux Falls, South Dakota, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
El Paso Children's Hospital
🇺🇸El Paso, Texas, United States
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
Saint Vincent Hospital Cancer Center Green Bay
🇺🇸Green Bay, Wisconsin, United States
University Pediatric Hospital
🇵🇷San Juan, Puerto Rico
Kaiser Permanente-Oakland
🇺🇸Oakland, California, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Nemours Children's Hospital
🇺🇸Orlando, Florida, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
Children's Hospital New Orleans
🇺🇸New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson
🇺🇸New Orleans, Louisiana, United States
Dell Children's Medical Center of Central Texas
🇺🇸Austin, Texas, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Blank Children's Hospital
🇺🇸Des Moines, Iowa, United States
Montefiore Medical Center - Moses Campus
🇺🇸Bronx, New York, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States