Financial Distress During Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States
NCT ID: NCT04928599
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2022-03-14
2028-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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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
Electronic Health Record Review
Review of medical records
Interview
Complete interview
Survey Administration
Complete survey
Interventions
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Electronic Health Record Review
Review of medical records
Interview
Complete interview
Survey Administration
Complete survey
Eligibility Criteria
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Inclusion Criteria
* 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
* KMT2A-R (formerly MLL-R) not receiving ALL therapy
* Mixed-phenotype acute leukemia (MPAL) not receiving ALL therapy
* Burkitt's leukemia
18 Years
ALL
Yes
Sponsors
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Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Melissa P Beauchemin
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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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
Augusta University Medical Center
Augusta, Georgia, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Blank Children's Hospital
Des Moines, Iowa, United States
Children's Hospital New Orleans
New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 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
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
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
Renown Regional Medical Center
Reno, Nevada, United States
Morristown Medical Center
Morristown, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Prisma Health Richland Hospital
Columbia, South Carolina, 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
Dell Children's Medical Center of Central Texas
Austin, Texas, 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
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
University Pediatric Hospital
San Juan, , Puerto Rico
Countries
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References
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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.
Other Identifiers
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NCI-2021-03567
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACCL20N1CD
Identifier Type: OTHER
Identifier Source: secondary_id
COG-ACCL20N1CD
Identifier Type: OTHER
Identifier Source: secondary_id
ACCL20N1CD
Identifier Type: OTHER
Identifier Source: secondary_id
ACCL20N1CD
Identifier Type: -
Identifier Source: org_study_id
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