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

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ClinicalTrials.gov Identifier: NCT03638453
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : May 14, 2020
Sponsor:
Collaborators:
Charles H. Hood Foundation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kira Bona, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Other Cancer Other: PediCARE Other: Usual Care Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Feasibility of the Pediatric Cancer Resource Equity (PediCARE) Intervention
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

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.




Primary Outcome Measures :
  1. Feasibility of recruitment [ Time Frame: 6-months ]
    At least 75 percent consent to randomization (e.g. recruitment).

  2. Feasibility of retention [ Time Frame: 6-months ]
    At most 20 percent attrition per arm.


Secondary Outcome Measures :
  1. Change in Household Material Hardship (HMH) in PediCARE vs Usual Care [ Time Frame: 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 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.

  2. Proportion of patients with at least one Emergency Department (ED) visit or Intensive Care Unit (ICU) in PediCARE vs Usual Care [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638453


Contacts
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Contact: Kira Bona, MD 617-632-4688 Kira_Bona@dfci.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Kira Bona, MD    617-632-4688    Kira_Bona@dfci.harvard.edu   
Principal Investigator: Kira Bona, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Charles H. Hood Foundation
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kira Bona, MD Dana-Farber Cancer Institute
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Responsible Party: Kira Bona, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03638453    
Other Study ID Numbers: 18-294
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kira Bona, Dana-Farber Cancer Institute:
Pedi Care