Pediatric CancerNCT06283251
PediRISE Feasibility
A study testing PediRISE Resource Program in people with Pediatric Cancer and Financial Stress, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
The goal of this research study is to learn whether investigators can successfully give the PediRISE program to families-in other words, whether most families are interested in participating in a study about the PediRISE program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pediatric Cancer, Financial Stress, Financial Hardship
- What is being tested?
- PediRISE Resource Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 May 2024to 30 Jun 2027
- Phase
- Interventional
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cohort 1: Poverty-exposed children with cancer receiving front-line cancer-directed therapy
- Child diagnosed with de novo cancer
- Child has established care at a study site and initiated cancer directed therapy in the prior 2-months
- Child planned to receive at least 4-months of cancer-directed therapy at study site from time of diagnosis per initial cancer treatment plan
- Child is <18 years at time of enrollment
- Parent/guardian screened positive for self-reported low-income (<200% FPL)
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- Family primary residence in CA, CT, MA, ME, NH, NJ, NY or RI
- Provider approval for permission to approach
- Cohort 2: Poverty-exposed children with cancer undergoing HSCT
- Child undergoing allogeneic HSCT for treatment of cancer
- Child has established care at a study site and is between 30 days prior to start of planned conditioning through day +7 of HSCT at time of enrollment
- Child planned to receive follow-up care after discharge for HSCT at study site
- Child is <18 years at the time of enrollment
- Parent/guardian screen positive for self-reported low-income (<200% FPL)
- Family primary residence in CA, CT, MA, ME, NH, NJ, NY or RI
- Provider approval for permission to approach
Who cannot join
- Cohort 1: Poverty-exposed children with cancer receiving front-line cancer-directed therapy
- Planned transfer of child to a non-DFCI or non-Columbia facility for cancer-directed therapy
- Foreign national family receiving care as an Embassy-pay patient
- Child is enrolled on embedded correlative health equity aims of open or upcoming clinical drug trials which are powered on descriptive parent-reported poverty data (e.g. AALL1731, DFCI 25-001). Co-enrollment on a poverty intervention study would confound the specified endpoints of these open trial correlative studies
- Child or household member receiving SSI
- Cohort 2: Poverty-exposed children with cancer undergoing HSCT
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- Planned transfer of child to a non-DFCI, non-Columbia, or non UCSF facility for cancer-directed therapy
- Foreign national family receiving care as an Embassy-pay patient
- Child is enrolled on embedded correlative health equity aims of open or upcoming clinical drug trials which are powered on descriptive parent-reported poverty data (e.g. AALL1731, DFCI 25-001). Co-enrollment on a poverty intervention study would confound the specified endpoints of these open trial correlative studies
- Child previously received RISE intervention
- Child or household member receiving SSI
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02215
Kira Bona, MD, MPH, 617-632-4688, Kira_Bona@dfci.harvard.edu
Kira Bona, MD, MPH
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Kira Bona, MD, MPH, 617-632-4688, Kira_Bona@dfci.harvard.edu
Kira Bona, MD, MPH
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Justine Kahn, MD, (212) 305-9770, jk2034@cumc.columbia.edu
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Lena Winestone, MD, MPH, (877) 822-4453, lena.winestone@ucsf.edu
About this study
Official title: Pilot Randomized Pediatric RISE (Resource Intervention to Support Equity) Feasibility Study
The goal of this research study is to learn whether investigators can successfully give the PediRISE program to families-in other words, whether most families are interested in participating in a study about the PediRISE program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of receiving the PediRISE support program.
The names of the study groups in this research study are:
- PediRISE Program Group
- Usual Care Group
Read the detailed description
This is a pilot, multi-center, randomized research study for the feasibility of the administration of the PediRISE program among 40 poverty exposed children with (1) a new diagnosis of childhood cancer at DFCI and Columbia University and among poverty-exposed families with a child with cancer and (2) receiving hematopoietic stem cell transplant (HSCT) at DFCI, Columbia University, or the University of California - San Francisco (UCSF). Randomization means there is an equal chance of being assigned to the PediRISE Program Group or the Usual Care Group.
Study procedures include screening for eligibility, study visits, and completion of surveys and questionnaires.
Participation in this study will last for about 6-months.
It is expected that about 40 pediatric participants with parents/guardians will take part in this research study.
This study is being supported by grants from the American Cancer Society and the Children's Cancer Research Fund.
- Conditions
- Pediatric Cancer, Financial Stress, Financial Hardship, Disparities
- Being tested
- PediRISE Resource Program
- Keywords
- Pediatric Cancer, Financial Stress, Financial Hardship, Disparities
- Medical subject headings
- Neoplasms, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PediRISE Resource ProgramBehavioural
Also called PediRISE
A centrally administered, income-poverty targeted intervention that includes twice-monthly direct provision of unrestricted cash transfers along with benefits counseling to mitigate the risk of loss of means-tested benefits. Funds will be dispersed to families via provided debit card or through personal banking, PayPal, or Venmo.
| Study group | Role | What they receive |
|---|---|---|
| PediRISE Program Group | Experimental | Participants will be randomized in a 1:1 fashion and will be stratified by site. Participant parents will complete:
* Baseline survey in-person, by telephone, or virtually.
* PediRISE program orientation with study team member, in-person or virtual.
* Optional meeting with certified benefits counselor.
* Receive fixed funds twice a month for 6 months.
* Standard supportive care from social worker and/or resource specialist to identify and discuss available resources.
* End of study survey. Receives: Behavioral: PediRISE Resource Program |
| Usual Care Group | No intervention | Participants will be randomized in a 1:1 fashion and will be stratified by site. Participant parents will complete: * Baseline survey in-person, by telephone, or virtually, and orientation with study team member. * Standard supportive care from social worker and/or resource specialist to identify and discuss available resources. * End of study survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Consent Rate
The proportion of eligible participants who provide informed consent to participate in the randomized guaranteed income intervention.
Measured: 1 Day
Participant Attrition Rate
The proportion of participants who withdraw from the study, are lost to follow-up, or otherwise do not complete the assigned study procedures.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 May 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Children's Cancer Research Fund
- Responsible party
- Principal investigator, Kira Bona, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Kira Bona, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283251
- Sponsor's protocol ID
- 23-590
- Status last verified
- Oct 2026
- First submitted
- 22 Feb 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Dr. Kira Bona. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.