Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-03567 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| ACCL20N1CD | Other Identifier | Children's Oncology Group | |
| COG-ACCL20N1CD | Other Identifier | DCP | |
| ACCL20N1CD | Other Identifier | CTEP | |
| UG1CA189955 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Health Record Review | Other | Review of medical records |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Parental experiences of financial distress and material hardship, and perceptions about financial screening/assessments during their child's/adolescent's treatment |
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:
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:
Not provided
Not provided
Not provided
Parents of children who are receiving induction chemotherapy for newly diagnosed ALL
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Melissa P Beauchemin | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente-Oakland | Oakland | California | 94611 | United States | ||
| Alfred I duPont Hospital for Children |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35764995 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Interview | Other | Complete interview |
|
| Survey Administration | Other | Complete survey |
|
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 |
| Wilmington |
| Delaware |
| 19803 |
| United States |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | United States |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | United States |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | United States |
| Nemours Children's Hospital | Orlando | Florida | 32827 | United States |
| Sacred Heart Hospital | Pensacola | Florida | 32504 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | United States |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | United States |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | United States |
| Maine Children's Cancer Program | Scarborough | Maine | 04074 | United States |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| Sunrise Hospital and Medical Center | Las Vegas | Nevada | 89109 | United States |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | 89135 | United States |
| Summerlin Hospital Medical Center | Las Vegas | Nevada | 89144 | United States |
| Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | United States |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Prisma Health Richland Hospital | Columbia | South Carolina | 29203 | United States |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | United States |
| El Paso Children's Hospital | El Paso | Texas | 79905 | United States |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | United States |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | United States |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | United States |
| University Pediatric Hospital | San Juan | 00926 | Puerto Rico |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided