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

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.

Study Overview

• Status: Completed
• Conditions: Other Cancer
• Intervention / Treatment: Other: PediCARE; Other: Usual Care

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PediCARE; PediCARE Administered x6 mos; Resource Provision: Monthly Groceries (delivery via Instacart); Resource Provision: Transport to/from home/hospital 8x per month (via RideHealth)	Other: 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).
Active Comparator: Usual Care; The control group will receive usual supportive care	Other: Usual Care; Standard care per hospital guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	At least 75 percent consent to randomization (e.g. recruitment).	6-months
Feasibility of retention	At most 20 percent attrition per arm.	6-months

Secondary Outcome Measures

Outcome Measure	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 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
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI); Charles H. Hood Foundation
• Investigators: Principal Investigator: Kira Bona, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Actual): February 10, 2022
• Study Completion (Actual): May 6, 2022

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pedi Care
• Other Study ID Numbers: 18-294; 1K07CA211847-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No