Trial Outcomes & Findings for Pilot Feasibility of the Pediatric Cancer Resource Equity (PediCARE) Intervention (NCT NCT03638453)
NCT ID: NCT03638453
Last Updated: 2024-09-19
Results Overview
At least 75 percent consent to randomization (e.g. recruitment).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
6-months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
PediCARE
* PediCARE Administered x6 mos
* Resource Provision: Monthly Groceries (delivery via Instacart)
* Resource Provision: Transport to/from home/hospital 8x per month (via RideHealth)
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).
|
Usual Care
The control group will receive usual supportive care
Usual Care: Standard care per hospital guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Feasibility of the Pediatric Cancer Resource Equity (PediCARE) Intervention
Baseline characteristics by cohort
| Measure |
PediCARE
n=20 Participants
* PediCARE Administered x6 mos
* Resource Provision: Monthly Groceries (delivery via Instacart)
* Resource Provision: Transport to/from home/hospital 8x per month (via RideHealth)
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).
|
Usual Care
n=20 Participants
The control group will receive usual supportive care
Usual Care: Standard care per hospital guidelines.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.9 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
8.3 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
8.6 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-monthsAt least 75 percent consent to randomization (e.g. recruitment).
Outcome measures
| Measure |
PediCARE
n=20 Participants
* PediCARE Administered x6 mos
* Resource Provision: Monthly Groceries (delivery via Instacart)
* Resource Provision: Transport to/from home/hospital 8x per month (via RideHealth)
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).
|
Usual Care
n=20 Participants
The control group will receive usual supportive care
Usual Care: Standard care per hospital guidelines.
|
|---|---|---|
|
Percentage of Participants Recruited
|
20 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 6-monthsAt most 20 percent attrition per arm.
Outcome measures
| Measure |
PediCARE
n=20 Participants
* PediCARE Administered x6 mos
* Resource Provision: Monthly Groceries (delivery via Instacart)
* Resource Provision: Transport to/from home/hospital 8x per month (via RideHealth)
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).
|
Usual Care
n=20 Participants
The control group will receive usual supportive care
Usual Care: Standard care per hospital guidelines.
|
|---|---|---|
|
Percentage of Attrition
|
20 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 6-monthsChange 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 1) stabilized or decreased or 2) increased HMH exposure. For each arm, the proportion of families with stabilized or decreased HMH at the completion of the intervention (6-months) will be estimated.
Outcome measures
| Measure |
PediCARE
n=20 Participants
* PediCARE Administered x6 mos
* Resource Provision: Monthly Groceries (delivery via Instacart)
* Resource Provision: Transport to/from home/hospital 8x per month (via RideHealth)
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).
|
Usual Care
n=20 Participants
The control group will receive usual supportive care
Usual Care: Standard care per hospital guidelines.
|
|---|---|---|
|
Change in Household Material Hardship (HMH) in PediCARE vs Usual Care
|
17 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsThe proportion of patients with at least one ED and/or ICU visit will be estimated for PediCARE and Usual Care groups.
Outcome measures
| Measure |
PediCARE
n=20 Participants
* PediCARE Administered x6 mos
* Resource Provision: Monthly Groceries (delivery via Instacart)
* Resource Provision: Transport to/from home/hospital 8x per month (via RideHealth)
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).
|
Usual Care
n=20 Participants
The control group will receive usual supportive care
Usual Care: Standard care per hospital guidelines.
|
|---|---|---|
|
Proportion of Patients With at Least One Emergency Department (ED) Visit or Intensive Care Unit (ICU) for Each Arm
|
13 Participants
|
9 Participants
|
Adverse Events
PediCARE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kira Bona, MD, MPH
Dana Farber Cancer Institute/Boston Children's Hospital
Phone: 617-632-4688
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place