Financial Distress During Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States
4 other identifiers
observational
100
2 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2022
Longer than P75 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
June 16, 2021
CompletedStudy Start
First participant enrolled
March 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
January 8, 2026
January 1, 2026
5 years
May 4, 2021
January 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in financial distress
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.
From start through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years
Secondary Outcomes (1)
Factors associated with financial distress
From start of through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years
Other Outcomes (2)
Domains of financial toxicity
From start through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years
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
Study Arms (1)
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
Interventions
Review of medical records
Eligibility Criteria
Parents of children who are receiving induction chemotherapy for newly diagnosed ALL
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207, United States
Nemours Children's Hospital
Orlando, Florida, 32827, United States
Sacred Heart Hospital
Pensacola, Florida, 32504, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Blank Children's Hospital
Des Moines, Iowa, 50309, United States
Children's Hospital New Orleans
New Orleans, Louisiana, 70118, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Maine Children's Cancer Program
Scarborough, Maine, 04074, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203, United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
El Paso Children's Hospital
El Paso, Texas, 79905, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
University Pediatric Hospital
San Juan, 00926, Puerto Rico
Related Publications (1)
Beauchemin M, Santacroce SJ, Bona K, Dang H, Alexander S, Allen K, De Los Santos C, Fisher B, Muneton-Castano Y, Ponce O, Vargas S, Sugalski A, Sung L, Parsons S. Rationale and design of Children's Oncology Group (COG) study ACCL20N1CD: financial distress during treatment of acute lymphoblastic leukemia in the United States. BMC Health Serv Res. 2022 Jun 28;22(1):832. doi: 10.1186/s12913-022-08201-0.
PMID: 35764995DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa P Beauchemin
Children's Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2021
First Posted
June 16, 2021
Study Start
March 14, 2022
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
January 8, 2026
Record last verified: 2026-01