Other Cancer
Conditions
Keywords
Pedi Care
Brief summary
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.
Detailed description
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
Interventions
OTHERPediCARE
PediCARE provides support for groceries (using an online grocery delivery service called Instacart) and transportation to and from the hospital (using rides through RideHealth).
OTHERUsual Care
Standard care per hospital guidelines.
Sponsors
Charles H. Hood Foundation
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 17 Years
Healthy volunteers
No
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: * Food insecurity. * Housing Insecurity. * Energy Insecurity. * Transportation Insecurity. HMH screening is performed as standard of care by site-specific psychosocial providers.
Exclusion criteria
* Child with diagnosis of relapsed cancer; * Child planned to receive fewer than 4 cycles of chemotherapy * Child planned to receive observation, radiation or surgical resection only; * Planned transfer of child to a non-DFCI or UAB facility for chemotherapy treatment; * Foreign national family receiving cancer care as an Embassy-pay patient; * Child is enrolled on DFCI 16-001 (due to ongoing embedded descriptive HMH study)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Recruited | 6-months | At least 75 percent consent to randomization (e.g. recruitment). |
| Percentage of Attrition | 6-months | At most 20 percent attrition per arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Household Material Hardship (HMH) in PediCARE vs Usual Care | 6-months | 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. |
| Proportion of Patients With at Least One Emergency Department (ED) Visit or Intensive Care Unit (ICU) for Each Arm | 6 Months | The proportion of patients with at least one ED and/or ICU visit will be estimated for PediCARE and Usual Care groups. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PediCARE * PediCARE Administered x6 mos
* Resource Provision: Monthly Groceries (delivery via Instacart)
* Resource Provision: Transport to/from home/hospital 8x per month (via RideHealth)
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). | 20 |
| Usual Care The control group will receive usual supportive care
Usual Care: Standard care per hospital guidelines. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | PediCARE | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 8.9 years STANDARD_DEVIATION 6.3 | 8.3 years STANDARD_DEVIATION 5.8 | 8.6 years STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 5 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 15 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 8 Participants | 9 Participants | 17 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 10 Participants | 10 Participants | 20 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 11 Participants | 15 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Percentage of Attrition
At most 20 percent attrition per arm.
Time frame: 6-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PediCARE | Percentage of Attrition | 20 Participants |
| Usual Care | Percentage of Attrition | 20 Participants |
Primary
Percentage of Participants Recruited
At least 75 percent consent to randomization (e.g. recruitment).
Time frame: 6-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PediCARE | Percentage of Participants Recruited | 20 Participants |
| Usual Care | Percentage of Participants Recruited | 20 Participants |
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.
Time frame: 6-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PediCARE | Change in Household Material Hardship (HMH) in PediCARE vs Usual Care | 17 Participants |
| Usual Care | Change in Household Material Hardship (HMH) in PediCARE vs Usual Care | 14 Participants |
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.
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PediCARE | Proportion of Patients With at Least One Emergency Department (ED) Visit or Intensive Care Unit (ICU) for Each Arm | 13 Participants |
| Usual Care | Proportion of Patients With at Least One Emergency Department (ED) Visit or Intensive Care Unit (ICU) for Each Arm | 9 Participants |