Other Cancer Clinical Trial
Official title:
Pilot Feasibility of the Pediatric Cancer Resource Equity (PediCARE) Intervention
Verified date | May 2023 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 6, 2022 |
Est. primary completion date | February 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 17 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Charles H. Hood Foundation, National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of recruitment | At least 75 percent consent to randomization (e.g. recruitment). | 6-months | |
Primary | Feasibility of retention | At most 20 percent attrition per arm. | 6-months | |
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 improved (change score <0) or not improved (change score =0). For each arm, the proportion of families with improved HMH at the completion of the intervention (6-months) will be estimated along with a 90 percent exact CI. Based on prior data, the study team assumes a 30 percent resolution in HMH in UC, thus the 90 percent CI will be within ±24.9 percent. | 6-months | |
Secondary | Proportion of patients with at least one Emergency Department (ED) visit or Intensive Care Unit (ICU) in PediCARE vs Usual Care | The proportion of patients with at least one ED and/or ICU visit will be estimated for each arm, as well as the difference between arms, along with a 90 percent confidence interval. | 6 months |
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