NCT03638453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

May 28, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2022

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.7 years

First QC Date

August 14, 2018

Results QC Date

June 28, 2024

Last Update Submit

September 13, 2024

Conditions

Other Cancer

Keywords

Pedi Care

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Recruited

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

    6-months

  • Percentage of Attrition

    At most 20 percent attrition per arm.

    6-months

Secondary Outcomes (2)

  • Change in Household Material Hardship (HMH) in PediCARE vs Usual Care

    6-months

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

    6 Months

Study Arms (2)

PediCARE

EXPERIMENTAL

* 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

Usual Care

ACTIVE COMPARATOR

The control group will receive usual supportive care

Other: Usual Care

Interventions

PediCAREOTHER

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

PediCARE
Usual CareOTHER

Standard care per hospital guidelines.

Usual Care

Eligibility Criteria

Age1 Day - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 38819828DERIVED

Limitations and Caveats

At study conclusion, investigators identified concerns regarding the validity of ED visits given reported frequency of participants potentially being seen at ED's outside of the enrolling site that could not be quantified via chart abstraction. As a result, it was determined that data analysis for effect size estimation using this endpoint would not be informative from this pilot study, and these data were not reported in the primary manuscript.

Results Point of Contact

Title
Dr. Kira Bona, MD, MPH
Organization
Dana Farber Cancer Institute/Boston Children's Hospital
kira.bona@childrens.harvard.edu
617-632-4688

Study Officials

  • Kira Bona, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 20, 2018

Study Start

May 28, 2019

Primary Completion

February 10, 2022

Study Completion

May 6, 2022

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)