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.
Brief Title
Financial Distress During Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Acute Lymphoblastic Leukemia
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04928599
Org Class
Network
Org Full Name
Children's Oncology Group
Org Study Id
ACCL20N1CD
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Financial Distress During Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States
Primary Outcomes
Outcome Description
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.
Outcome Measure
Change in financial distress
Outcome Time Frame
From start through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years
Secondary Ids
Secondary Id
NCI-2021-03567
Secondary Id
ACCL20N1CD
Secondary Id
COG-ACCL20N1CD
Secondary Id
ACCL20N1CD
Secondary Id
UG1CA189955
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
From start of through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years
Outcome Measure
Factors associated with financial distress
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Parents of children who are receiving induction chemotherapy for newly diagnosed ALL
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Lisa Gennarini
Investigator Email
lfigueir@montefiore.org
Investigator Phone