Clinical trial NCT04928599: Financial Distress During Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States
Official title: Financial Distress During Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
First posted: 2021-06-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of children who are receiving induction chemotherapy for newly diagnosed ALL

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.

Eligibility criteria: 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
* 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

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

Primary outcomes:
measure: Change in financial distress
timeFrame: From start through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years
Secondary outcomes:
measure: Factors associated with financial distress
timeFrame: From start of through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years
Other outcomes:
measure: Domains of financial toxicity
timeFrame: From start through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years
measure: Parental experiences of financial distress and material hardship, and perceptions about financial screening/assessments during their child's/adolescent's treatment
timeFrame: From start through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente-Oakland
state: California
city: Wilmington
country: United States
facility: Alfred I duPont Hospital for Children
state: Delaware
city: Fort Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Fort Myers
country: United States
facility: Golisano Children's Hospital of Southwest Florida
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital/Joe DiMaggio Children's Hospital
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic-Jacksonville
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: Saint Joseph's Hospital/Children's Hospital-Tampa
state: Florida
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Des Moines
country: United States
facility: Blank Children's Hospital
state: Iowa
city: New Orleans
country: United States
facility: Children's Hospital New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center Jefferson
state: Louisiana
city: Scarborough
country: United States
facility: Maine Children's Cancer Program
state: Maine
city: Grand Rapids
country: United States
facility: Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Hospital Saint Louis
state: Missouri
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Sunrise Hospital and Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: Alliance for Childhood Diseases/Cure 4 the Kids Foundation
state: Nevada
city: Las Vegas
country: United States
facility: Summerlin Hospital Medical Center
state: Nevada
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus
state: New York
city: New York
country: United States
facility: NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
state: New York
city: Fargo
country: United States
facility: Sanford Broadway Medical Center
state: North Dakota
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: Prisma Health Richland Hospital
state: South Carolina
city: Greenville
country: United States
facility: BI-LO Charities Children's Cancer Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center - Sioux Falls
state: South Dakota
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: El Paso
country: United States
facility: El Paso Children's Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Children's Hospital of South Texas
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center Green Bay
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: University Pediatric Hospital
Study officials:
affiliation: Children's Oncology Group
name: Melissa P Beauchemin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.