NCT03638453

Pilot Feasibility of the Pediatric Cancer Resource Equity (PediCARE) Intervention

Completed NA Results posted Last updated 19 September 2024

What this trial tests

NA trial testing PediCARE in Other Cancer in 40 participants. Completed in 6 May 2022.

Timeline

28 May 2019

Primary endpoint
10 February 2022

6 May 2022

Quick facts

Lead sponsor	Dana-Farber Cancer Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	40
Start date	28 May 2019
Primary completion	10 February 2022
Estimated completion	6 May 2022
Sites	1 location across United States

Drugs / interventions tested

• PediCARE
• Usual Care

Conditions studied

• Other Cancer — all drugs for Other Cancer →

Sponsor

Dana-Farber Cancer Institute

Who can join

Adults 1 Day to 17, any sex, with Other Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Recruited Primary · 6-months

At least 75 percent consent to randomization (e.g. recruitment).

Group	Value	95% CI
PediCARE	20
Usual Care	20

Percentage of Attrition Primary · 6-months

At most 20 percent attrition per arm.

Group	Value	95% CI
PediCARE	20
Usual Care	20

Change in Household Material Hardship (HMH) in PediCARE vs Usual Care Secondary · 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.

Group	Value	95% CI
PediCARE	17
Usual Care	14

Proportion of Patients With at Least One Emergency Department (ED) Visit or Intensive Care Unit (ICU) for Each Arm Secondary · 6 Months

The proportion of patients with at least one ED and/or ICU visit will be estimated for PediCARE and Usual Care groups.

Group	Value	95% CI
PediCARE	13
Usual Care	9

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Providing Groceries and Transportation to Poverty-Exposed Pediatric Oncology Families: The PediCARE Pilot Randomized Clinical Trial.
   Newman H, Jones E, Li Y, Umaretiya PJ, et al · · 2024 · cited 10× · PMID 38819828 · DOI 10.1001/jamanetworkopen.2024.12890
2. Inequitable Poverty Exposures: A Subspecialty Opportunity to Address Disparities.
   Karvonen KA, Umaretiya PJ, Koch VB, Flamand Y, et al · · 2024 · cited 4× · PMID 38239110 · DOI 10.1542/hpeds.2023-007482
3. Pediatric Transplant and Cellular Therapy Consortium RESILIENT Conference on Pediatric Chronic Graft-Versus-Host Disease Survivorship After Hematopoietic Cell Transplantation: Part IV. Patient Important Outcomes.
   Rotz SJ, Wiener L, Baker KS, Baker KS, et al · · 2025 · cited 2× · PMID 39733839 · DOI 10.1016/j.jtct.2024.12.019