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| ID | Type | Description | Link |
|---|---|---|---|
| 1K07CA211847-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Charles H. Hood Foundation | OTHER |
| National Cancer Institute (NCI) | NIH |
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The goal of this new intervention is to make it easier for families to meet their basic household needs during childhood cancer treatment. The investigators want to learn how to best use PediCARE to help care for families.
The investigators know from previous studies that in addition to the basic worries about a child's cancer therapy, many families experience financial stress during their child's treatment. Financial stress may include difficulty paying the rent or mortgage, keeping the electricity or heat on, or putting food on the table. One of the investigators' research goals is to find ways to decrease the financial impact of treatment on each family, and make sure that financial stress does not impact a child's experience during treatment.
The investigators have developed a new supportive care intervention called PediCARE (which stands for Pediatric Cancer Resource Equity) which provides support for groceries (using an online grocery delivery service called Instacart) and transportation to and from the hospital (using rides through services such as Uber and Lyft). The investigators have evaluated the PediCARE support program in a small group of parents and used feedback from these parents to improve PediCARE. The investigators are now ready to do a feasibility study to find out whether the investigators can reliably deliver the PediCARE intervention to families.
This type of study is called a feasibility study. The goal of this research study is to learn whether the investigators can successfully give the PediCARE support program to families-in other words, whether most families are interested in participating in a randomized study about the PediCARE support program and whether they use the PediCARE support program during the study. The investigators will also begin to understand whether the PediCARE support program reduces financial stress for families during therapy. Long-term, the investigators plan to test the PediCARE support program in a larger group of randomized families to answer the question of whether PediCARE reduces financial stress for families and improves outcomes during cancer treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PediCARE | Experimental |
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| Usual Care | Active Comparator | The control group will receive usual supportive care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PediCARE | Other | PediCARE provides support for groceries (using an online grocery delivery service called Instacart) and transportation to and from the hospital (using rides through RideHealth). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Recruited | At least 75 percent consent to randomization (e.g. recruitment). | 6-months |
| Percentage of Attrition | At most 20 percent attrition per arm. | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Household Material Hardship (HMH) in PediCARE vs Usual Care | Change in HMH score (0-4) at intervention completion (6-months) compared to baseline. For each family, the difference between 6-month and baseline HMH scores will be categorized as 1) stabilized or decreased or 2) increased HMH exposure. For each arm, the proportion of families with stabilized or decreased HMH at the completion of the intervention (6-months) will be estimated. |
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Inclusion Criteria:
Child newly diagnosed with cancer within 2 months;
Planned receipt of at least 4 cycles of chemotherapy at DFCI or UAB;
Parent/guardian screened positive for HMH*;
Child is <18 years at time of enrollment
In accordance with previous research1 families will be operationalized as having HMH for eligibility purposes if they report at least one of the below four concrete needs assessed during routine clinical care as follows:
HMH screening is performed as standard of care by site-specific psychosocial providers.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kira Bona, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38819828 | Derived | Newman H, Jones E, Li Y, Umaretiya PJ, Wolfson JA, Wolfe J, Bona K. Providing Groceries and Transportation to Poverty-Exposed Pediatric Oncology Families: The PediCARE Pilot Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2412890. doi: 10.1001/jamanetworkopen.2024.12890. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PediCARE |
PediCARE: PediCARE provides support for groceries (using an online grocery delivery service called Instacart) and transportation to and from the hospital (using rides through RideHealth). |
| FG001 | Usual Care | The control group will receive usual supportive care Usual Care: Standard care per hospital guidelines. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PediCARE |
PediCARE: PediCARE provides support for groceries (using an online grocery delivery service called Instacart) and transportation to and from the hospital (using rides through RideHealth). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Recruited | At least 75 percent consent to randomization (e.g. recruitment). | Posted | Count of Participants | Participants | 6-months |
|
Adverse event data was collected over the study period of 6 months.
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from the clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PediCARE |
PediCARE: PediCARE provides support for groceries (using an online grocery delivery service called Instacart) and transportation to and from the hospital (using rides through RideHealth). |
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At study conclusion, investigators identified concerns regarding the validity of ED visits given reported frequency of participants potentially being seen at ED's outside of the enrolling site that could not be quantified via chart abstraction. As a result, it was determined that data analysis for effect size estimation using this endpoint would not be informative from this pilot study, and these data were not reported in the primary manuscript.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kira Bona, MD, MPH | Dana Farber Cancer Institute/Boston Children's Hospital | 617-632-4688 | kira.bona@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2021 | Jun 18, 2024 | Prot_SAP_000.pdf |
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| Usual Care | Other | Standard care per hospital guidelines. |
|
| 6-months |
| Proportion of Patients With at Least One Emergency Department (ED) Visit or Intensive Care Unit (ICU) for Each Arm | The proportion of patients with at least one ED and/or ICU visit will be estimated for PediCARE and Usual Care groups. | 6 Months |
| BG001 | Usual Care | The control group will receive usual supportive care Usual Care: Standard care per hospital guidelines. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Percentage of Attrition | At most 20 percent attrition per arm. | Posted | Count of Participants | Participants | 6-months |
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| Secondary | Change in Household Material Hardship (HMH) in PediCARE vs Usual Care | Change in HMH score (0-4) at intervention completion (6-months) compared to baseline. For each family, the difference between 6-month and baseline HMH scores will be categorized as 1) stabilized or decreased or 2) increased HMH exposure. For each arm, the proportion of families with stabilized or decreased HMH at the completion of the intervention (6-months) will be estimated. | Posted | Count of Participants | Participants | 6-months |
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|
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| Secondary | Proportion of Patients With at Least One Emergency Department (ED) Visit or Intensive Care Unit (ICU) for Each Arm | The proportion of patients with at least one ED and/or ICU visit will be estimated for PediCARE and Usual Care groups. | Posted | Count of Participants | Participants | 6 Months |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Usual Care | The control group will receive usual supportive care Usual Care: Standard care per hospital guidelines. | 0 | 20 | 0 | 20 | 0 | 20 |
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