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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RISE Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (T1) and 6-months (end-intervention; T3) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kira Bona, MD, MPH | Contact | 617-632-4688 | Kira_Bona@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kira Bona, MD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Recruiting | Hartford | Connecticut | 06106 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
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| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| 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. | 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. | Baseline (T1) and 6-months (end-intervention; T3) |
| Children's Healthcare of Atlanta | Recruiting | Atlanta | Georgia | 30329 | United States |
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| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 03079 | United States |
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| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
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| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |