N/A
N=40
Pilot Feasibility of the Pediatric Cancer Resource Equity (PediCARE) Intervention
Other Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03638453 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Percentage of Participants Recruited — 20; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PediCARE (Other); Usual Care (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Recruited |
20; 20 | — |
| PRIMARY Percentage of Attrition |
20; 20 | — |
| SECONDARY Change in Household Material Hardship (HMH) in PediCARE vs Usual Care |
17; 14 | — |
| SECONDARY Proportion of Patients With at Least One Emergency Department (ED) Visit or Intensive Care Unit (ICU) for Each Arm |
13; 9 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03638453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.