Clinical trial · Observational
Financial Distress During Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States
NCT04928599CI-TRIAL-00100421active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Interview | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Health Services Research (survey, interview, chart review)
- description
- 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
- interventionNames
- Other: Electronic Health Record Review
- Other: Interview
- Other: Survey Administration
Primary outcomes (1)
- measure
- Change in financial distress
- timeFrame
- From start through completion of acute lymphoblastic leukemia therapy, an average of 2.5 years
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * 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: * 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
References
Publications (1)
- DERIVEDBeauchemin 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 35764995