NeuroblastomaRISE in HR NBLNCT06831552
Resource Intervention to Support Equity (RISE) in High-Risk Neuroblastoma
A study testing RISE Intervention in people with Neuroblastoma and High-risk Neuroblastoma, run by Dana-Farber Cancer Institute at 6 sites in United States.
Trial summary
The goal of this study is to test if the addition of a novel income-poverty targeted supportive care intervention (Pediatric Resource Intervention to Support Equity [Pediatric RISE]) to usual supportive care for low-income children with high-risk neuroblastoma can improve parent- and child-centered outcomes. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Neuroblastoma, High-risk Neuroblastoma
- What is being tested?
- RISE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Apr 2025to 1 Jun 2029
- 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
- Patient cohort: The randomized Phase II multi-center RISE intervention will be conducted among a population of poverty-exposed children with high-risk neuroblastoma. Poverty will be a priori defined as parent-reported low-income (<200% Federal Poverty Level). Children receiving treatment for cancer at study sites will serve as the study cohort, with parents/guardians as survey informants and intervention recipients on behalf of their minor children given that parents (not children) typically manage household finances.
- Patient newly diagnosed with high-risk neuroblastoma
- Patient has established care at study site and initiated cancer-directed therapy
- Patient has not yet initiated Induction Cycle 3
- Patient aged 0-17 years at the time of consent
- Parent/guardian screened positive for self-reported low-income (<200% Federal Poverty) *
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- Family primary residence in MA, PA, IL, CA, WA, CT, GA, WI and OH
- Both patients co-enrolled on ANBL2131 or those receiving standard of care therapy at their center are eligible to participate
- Patients of all languages are eligible to participate
Who cannot join
- Foreign national family receiving care as an Embassy-pay patient.
- Child or household member receiving SSI
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Thomas Cash, MD, 404-785-1200, william.cash@choa.org
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 03079
Kira Bona, MD, MPH, 203-464-9417, kira.bona@childrens.harvard.edu
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Puja Umaretiya, MD, (214) 456-2382, puja.umaretiya@utsouthwestern.edu
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Andrea Orsey, MD, MSCE, 860-545-9630, aorsey@connecticutchildrens.org
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Rochelle Bagatell, MD, 267-426-9737, bagatellr@chop.edu
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Anurekha Hall, MD, 206-987-2106, anurekha.hall@seattlechildrens.org
Kristine Karvonen, MD, Kristine.Karvonen@seattlechildrens.org
About this study
Official title: A Randomized Phase II Trial Evaluation of the Addition of the Resource Intervention to Support Equity (RISE) to Usual Supportive Care for Children With Newly Diagnosed High-Risk Neuroblastoma
The goal of this study is to test if the addition of a novel income-poverty targeted supportive care intervention (Pediatric Resource Intervention to Support Equity [Pediatric RISE]) to usual supportive care for low-income children with high-risk neuroblastoma can improve parent- and child-centered outcomes.
Participants will be randomized to receive one of the following for 6-months:
- Usual supportive care alone or
- Usual supportive care plus Pediatric RISE
Read the detailed description
This is a randomized Phase II trial evaluating the addition of the RISE supportive care equity intervention to usual supportive care for poverty-exposed children participants with newly diagnosed high-risk neuroblastoma. Participants will be randomized into one of two groups: Usual supportive care or Pediatric RISE plus usual supportive care. Randomization means a participant is placed into a study group by chance.
The research study procedures include screening for eligibility, in-person or virtual appointments, and surveys.
Participation in this research study is expected to last for about 6-months.
It is expected that about 84 participants will take part in this research study.
- Conditions
- Neuroblastoma, High-risk Neuroblastoma
- Being tested
- RISE Intervention
- Keywords
- Neuroblastoma, High-risk Neuroblastoma
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISE InterventionBehavioural
Also called Pediatric Resource Intervention to Support Equity
Income-poverty targeted, supportive care intervention that includes direct cash transfers delivered by the Fund for Guaranteed Income, a non-profit organization, along with benefits counseling to discuss the risk of means-tested benefits loss or reduction. Funds will be dispersed to families via debit card or through personal banking, PayPal, or Venmo on a twice monthly basis for a total of twelve disbursements (6-months). Meetings with a benefits counselor will be conducted by the HIPAA-compliant video conference platform, Zoom.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: RISE Intervention + Usual Supportive Care | Experimental | Participants will be randomized in a 1:1 ratio and stratified according to treatment group and Household Material Hardship (HMH) severity score. Participant parents/guardians will complete:
* Orientation visit in-person, by phone, or virtually with survey
* Access to usual supportive oncology care comprised of social workers, resource specialists and/or psychosocial oncology teams
* Meeting with a benefits counselor by phone or virtually and follow up meetings if needed
* Fixed amount of cash assistance 2x monthly
* 3 months survey
* 6 month survey Receives: Behavioral: RISE Intervention |
| Arm 2: Usual Supportive Care | No intervention | Participants will be randomized in a 1:1 ratio and stratified according to treatment group and HMH severity score. Participant parents/guardians will complete: * Orientation visit in-person, by phone, or virtually with survey * Access to usual supportive oncology care comprised of social workers, resource specialists and/or psychosocial oncology teams * 3 month survey * 6 month survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Household Material Hardship (HMH) Score Reduction Rate
HMH score reduction rate is defined as the proportion of patients achieving at least 1 domain reduction in (food, housing, utility or transportation insecurity). HMH scores range from 0 to 4, with scores of 0 indicating no hardship (unexposed) and scores of 1-4 indicating the presence of hardship (exposed). Patients who are unexposed to HMH at baseline (HMH score of 0) are excluded from the analysis.
Measured: Baseline (T1) and 6-months (end-intervention; T3)
Secondary outcomes (3)
Pediatric-Modified Comprehensive Score for Financial Toxicity (COST)
Financial toxicity will be assessed with the 12-item modified COST measure. Each item is rated on a 0-4 scale, yielding a total score range of 0-48, with higher scores indicating better financial well-being. The final COST score will be calculated per established methods. A change of approximately 5 points is considered a minimally important difference (MID), representing a clinically meaningful change in financial toxicity.
Measured: 3-months (end-of-induction; T2) and 6-months (end-intervention; T3)
Parent Psychological Distress (Kessler-6) Score Change from Baseline to 6 Months
Psychological distress will be assessed using the 6-item Kessler-6 scale. The scale includes 6 items scored from 0 ('none of the time') to 4 ('all of the time'), yielding a total score ranging from 0 to 24, with higher scores indicating greater psychological distress. A reduction in scores of approximately 2.8 points is considered a minimally important difference (MID), representing a clinically meaningful improvement in psychological distress.
Measured: Baseline (T1) and 6-months (end-intervention; T3)
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Abilities Score Change from Baseline to 6 Months
The PROMIS Applied Cognition-Abilities short form is an 8-item measure assessing subjective learning and memory, attention and concentration, executive function, and processing speed. Responses are scored on a scale of 1-5, and the total score is converted to a T-score with a mean of 50 and a standard deviation (SD) fixed at 10. Higher scores suggest better perceived cognitive function.
Measured: Baseline (T1) and 6-months (end-intervention; T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start30 Apr 2025
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- 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
- NCT06831552
- Sponsor's protocol ID
- 24-600
- Acronym
- RISE in HR NBL
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial Evaluation of the Addition of the Resource Intervention to Support Equity (RISE) to Usual Supportive Care for Children With Newly Diagnosed High-Risk Neuroblastoma
- ClinicalTrials.gov ID
- NCT06831552
- Acronym / sponsor ID
- RISE in HR NBL / 24-600
- Conditions
- Neuroblastoma, High-risk Neuroblastoma
- Keywords
- Neuroblastoma, High-risk Neuroblastoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 18 Feb 2025 (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 study is to test if the addition of a novel income-poverty targeted supportive care intervention (Pediatric Resource Intervention to Support Equity [Pediatric RISE]) to usual supportive care for low-income children with high-risk neuroblastoma can improve parent- and child-centered outcomes.
Participants will be randomized to receive one of the following for 6-months:
- Usual supportive care alone or
- Usual supportive care plus Pediatric RISE
Detailed description
This is a randomized Phase II trial evaluating the addition of the RISE supportive care equity intervention to usual supportive care for poverty-exposed children participants with newly diagnosed high-risk neuroblastoma. Participants will be randomized into one of two groups: Usual supportive care or Pediatric RISE plus usual supportive care. Randomization means a participant is placed into a study group by chance.
The research study procedures include screening for eligibility, in-person or virtual appointments, and surveys.
Participation in this research study is expected to last for about 6-months.
It is expected that about 84 participants will take part in this research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: RISE Intervention + Usual Supportive Care | Experimental | Behavioral: RISE InterventionParticipants will be randomized in a 1:1 ratio and stratified according to treatment group and Household Material Hardship (HMH) severity score. Participant parents/guardians will complete: * Orientation visit in-person, by phone, or virtually with survey * Access to usual supportive oncology care comprised of social workers, resource specialists and/or psychosocial oncology teams * Meeting with a benefits counselor by phone or virtually and follow up meetings if needed * Fixed amount of cash assistance 2x monthly * 3 months survey * 6 month survey |
| Arm 2: Usual Supportive Care | No intervention | –Participants will be randomized in a 1:1 ratio and stratified according to treatment group and HMH severity score. Participant parents/guardians will complete: * Orientation visit in-person, by phone, or virtually with survey * Access to usual supportive oncology care comprised of social workers, resource specialists and/or psychosocial oncology teams * 3 month survey * 6 month survey |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Patient cohort: The randomized Phase II multi-center RISE intervention will be conducted among a population of poverty-exposed children with high-risk neuroblastoma. Poverty will be a priori defined as parent-reported low-income (<200% Federal Poverty Level). Children receiving treatment for cancer at study sites will serve as the study cohort, with parents/guardians as survey informants and intervention recipients on behalf of their minor children given that parents (not children) typically manage household finances.
- Patient newly diagnosed with high-risk neuroblastoma
- Patient has established care at study site and initiated cancer-directed therapy
- Patient has not yet initiated Induction Cycle 3
- Patient aged 0-17 years at the time of consent
Key exclusion criteria (2 listed)
- Foreign national family receiving care as an Embassy-pay patient.
- 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 |
|---|---|---|
| RISE InterventionAlso: Pediatric Resource Intervention to Support EquityIncome-poverty targeted, supportive care intervention that includes direct cash transfers delivered by the Fund for Guaranteed Income, a non-profit organization, along with benefits counseling to discuss the risk of means-tested benefits loss or reduction. Funds will be dispersed to families via debit card or through personal banking, PayPal, or Venmo on a twice monthly basis for a total of twelve disbursements (6-months). Meetings with a benefits counselor will be conducted by the HIPAA-compliant video conference platform, Zoom. | Behavioural | Arm 1: RISE Intervention + Usual Supportive Care |
Primary outcome
Household Material Hardship (HMH) Score Reduction Rate
Time frame: Baseline (T1) and 6-months (end-intervention; T3)
HMH score reduction rate is defined as the proportion of patients achieving at least 1 domain reduction in (food, housing, utility or transportation insecurity). HMH scores range from 0 to 4, with scores of 0 indicating no hardship (unexposed) and scores of 1-4 indicating the presence of hardship (exposed). Patients who are unexposed to HMH at baseline (HMH score of 0) are excluded from the analysis.
3 secondary outcomes
Pediatric-Modified Comprehensive Score for Financial Toxicity (COST)
Time frame: 3-months (end-of-induction; T2) and 6-months (end-intervention; T3)
Parent Psychological Distress (Kessler-6) Score Change from Baseline to 6 Months
Time frame: Baseline (T1) and 6-months (end-intervention; T3)
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Abilities Score Change from Baseline to 6 Months
Time frame: Baseline (T1) and 6-months (end-intervention; T3)
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 10 Feb 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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RISE Intervention in people with Neuroblastoma and High-risk Neuroblastoma, run by Dana-Farber Cancer Institute at 6 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 9 inclusion and 2 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 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Household Material Hardship (HMH) Score Reduction Rate (time frame: Baseline (T1) and 6-months (end-intervention; T3)). 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 10 Feb 2026.