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
|Condition or disease||Intervention/treatment||Phase|
|Other Cancer||Other: PediCARE Other: Usual Care||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
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.
- Feasibility of recruitment [ Time Frame: 6-months ]At least 75 percent consent to randomization (e.g. recruitment).
- Feasibility of retention [ Time Frame: 6-months ]At most 20 percent attrition per arm.
- 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.
- 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.
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
|Contact: Kira Bona, MD||617-632-4688||Kira_Bona@dfci.harvard.edu|
|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|
|Principal Investigator:||Kira Bona, MD||Dana-Farber Cancer Institute|