Other CancerNCT03638453
Pilot Feasibility of the Pediatric Cancer Resource Equity (PediCARE) Intervention
A study testing PediCARE in people with Other Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Other Cancer
- What is being tested?
- PediCARE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2019to 6 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 10Show fewer
- Housing Insecurity.
- Energy Insecurity.
- Transportation Insecurity.
- HMH screening is performed as standard of care by site-specific psychosocial providers.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
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.
Read the 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
- Being tested
- PediCARE, Usual Care
- Keywords
- Pedi Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Usual CareOther
Standard care per hospital guidelines.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: PediCARE |
| Usual Care | Active comparator | The control group will receive usual supportive care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Recruited
At least 75 percent consent to randomization (e.g. recruitment).
Measured: 6-months
Percentage of Attrition
At most 20 percent attrition per arm.
Measured: 6-months
Secondary outcomes (2)
Change in Household Material Hardship (HMH) in PediCARE vs Usual Care
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 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.
Measured: 6-months
Proportion of Patients With at Least One Emergency Department (ED) Visit or Intensive Care Unit (ICU) for Each Arm
The proportion of patients with at least one ED and/or ICU visit will be estimated for PediCARE and Usual Care groups.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start28 May 2019
- Primary completion10 Feb 2022
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Charles H. Hood Foundation, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kira Bona, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Kira Bona, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638453
- Sponsor's protocol ID
- 18-294
- Other IDs
- 1K07CA211847-01
- Status last verified
- Sep 2024
- First submitted
- 14 Aug 2018
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38819828
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility of the Pediatric Cancer Resource Equity (PediCARE) Intervention
- ClinicalTrials.gov ID
- NCT03638453
- Acronym / sponsor ID
- 18-294
- Conditions
- Other Cancer
- Keywords
- Pedi Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Charles H. Hood Foundation, National Cancer Institute (NCI)
- Study start
- 28 May 2019 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PediCARE | Experimental | Other: PediCARE* PediCARE Administered x6 mos * Resource Provision: Monthly Groceries (delivery via Instacart) * Resource Provision: Transport to/from home/hospital 8x per month (via RideHealth) |
| Usual Care | Active comparator | Other: Usual CareThe control group will receive usual supportive care |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PediCAREPediCARE provides support for groceries (using an online grocery delivery service called Instacart) and transportation to and from the hospital (using rides through RideHealth). | Other | PediCARE |
| Usual CareStandard care per hospital guidelines. | Other | Usual Care |
Primary outcome
Percentage of Participants Recruited
Time frame: 6-months
At least 75 percent consent to randomization (e.g. recruitment).
Percentage of Attrition
Time frame: 6-months
At most 20 percent attrition per arm.
2 secondary outcomes
Change in Household Material Hardship (HMH) in PediCARE vs Usual Care
Time frame: 6-months
Proportion of Patients With at Least One Emergency Department (ED) Visit or Intensive Care Unit (ICU) for Each Arm
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38819828Newman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kira Bona, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PediCARE in people with Other Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Recruited (time frame: 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03638453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.