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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Pediatric RISE (Resource Intervention to Support Equity) Feasibility Study
- ClinicalTrials.gov ID
- NCT06283251
- Acronym / sponsor ID
- 23-590
- Conditions
- Pediatric Cancer, Financial Stress, Financial Hardship, Disparities
- Keywords
- Pediatric Cancer, Financial Stress, Financial Hardship, Disparities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Children's Cancer Research Fund
- Study start
- 15 May 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
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 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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PediRISE Program Group | Experimental | Behavioral: PediRISE Resource ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| PediRISE Resource ProgramAlso: PediRISEA 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. | Behavioural | PediRISE Program Group |
Primary outcome
Participant Consent Rate
Time frame: 1 Day
The proportion of eligible participants who provide informed consent to participate in the randomized guaranteed income intervention.
Participant Attrition Rate
Time frame: At 6 months
The proportion of participants who withdraw from the study, are lost to follow-up, or otherwise do not complete the assigned study procedures.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: 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.
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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.
Kira Bona, MD, MPH principal investigator
Dana-Farber Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 16 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kira Bona, MD, MPH (617-632-4688, Kira_Bona@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Consent Rate (time frame: 1 Day). 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?
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 5 Oct 2026.