Financial Distress During Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Financial Distress During Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04928599
• Other study ID #: ACCL20N1CD
• Secondary ID: NCI-2021-03567AC
• Status: Suspended
• Start date: March 14, 2022
• Est. completion date: March 31, 2028

Study information

• Verified date: April 2024
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: March 31, 2028
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• Electronic Health Record Review
Review of medical records
• Interview
Complete interview
• Survey Administration
Complete survey

Locations

Country	Name	City	State
Puerto Rico	University Pediatric Hospital	San Juan
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Augusta University Medical Center	Augusta	Georgia
United States	Dell Children's Medical Center of Central Texas	Austin	Texas
United States	Montefiore Medical Center - Moses Campus	Bronx	New York
United States	Prisma Health Richland Hospital	Columbia	South Carolina
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Blank Children's Hospital	Des Moines	Iowa
United States	El Paso Children's Hospital	El Paso	Texas
United States	Sanford Broadway Medical Center	Fargo	North Dakota
United States	Broward Health Medical Center	Fort Lauderdale	Florida
United States	Golisano Children's Hospital of Southwest Florida	Fort Myers	Florida
United States	Helen DeVos Children's Hospital at Spectrum Health	Grand Rapids	Michigan
United States	Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Wisconsin
United States	BI-LO Charities Children's Cancer Center	Greenville	South Carolina
United States	Memorial Regional Hospital/Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Nemours Children's Clinic-Jacksonville	Jacksonville	Florida
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
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	Sunrise Hospital and Medical Center	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Morristown Medical Center	Morristown	New Jersey
United States	Children's Hospital New Orleans	New Orleans	Louisiana
United States	Ochsner Medical Center Jefferson	New Orleans	Louisiana
United States	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Nemours Children's Hospital	Orlando	Florida
United States	Sacred Heart Hospital	Pensacola	Florida
United States	Renown Regional Medical Center	Reno	Nevada
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	Mercy Hospital Saint Louis	Saint Louis	Missouri
United States	Methodist Children's Hospital of South Texas	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Maine Children's Cancer Program	Scarborough	Maine
United States	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota
United States	Saint Joseph's Hospital/Children's Hospital-Tampa	Tampa	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	Alfred I duPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Children's Oncology Group

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Domains of financial toxicity	Descriptive statistics will be used to report domains of financial distress, informed by the conceptual framework guiding this study.	From start through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years
Other	Parental experiences of financial distress and material hardship, and perceptions about financial screening/assessments during their child's/adolescent's treatment	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.	From start through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years
Primary	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	Factors associated with financial distress	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.	From start of through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years