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

NCT ID: NCT03638453

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-28
• Study Completion Date: 2022-05-06

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

Conditions

Other Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PediCARE

• PediCARE Administered x6 mos
• Resource Provision: Monthly Groceries (delivery via Instacart)
• Resource Provision: Transport to/from home/hospital 8x per month (via RideHealth)

Group Type: EXPERIMENTAL

PediCARE

Intervention Type: OTHER

PediCARE provides support for groceries (using an online grocery delivery service called Instacart) and transportation to and from the hospital (using rides through RideHealth).

Usual Care

The control group will receive usual supportive care

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Standard care per hospital guidelines.

Interventions

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).

Intervention Type: OTHER

Usual Care

Standard care per hospital guidelines.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles H. Hood Foundation

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Kira Bona, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kira Bona, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

Newman H, Jones E, Li Y, Umaretiya PJ, Wolfson JA, Wolfe J, Bona K. Providing Groceries and Transportation to Poverty-Exposed Pediatric Oncology Families: The PediCARE Pilot Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2412890. doi: 10.1001/jamanetworkopen.2024.12890.

Reference Type: DERIVED

PMID: 38819828 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K07CA211847-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-294

Identifier Type: -

Identifier Source: org_study_id