Resource Intervention to Support Equity (RISE) in High-Risk Neuroblastoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorDana-Farber Cancer Institute
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Foreign national family receiving care as an Embassy-pay patient.
Child or household member receiving SSI
Trial design
Design model
Parallel
Treatments tested in this trial
RISE Intervention
BehavioralIncome-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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Arm 1: RISE Intervention + Usual Supportive CareExperimental treatment 1 intervention
Group B: Arm 2: Usual Supportive CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (T1) and 6-months (end-intervention; T3)Secondary outcomes
1
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.
Time frame
3-months (end-of-induction; T2) and 6-months (end-intervention; T3)2
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.
Time frame
Baseline (T1) and 6-months (end-intervention; T3)3
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.
Time frame
Baseline (T1) and 6-months (end-intervention; T3)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov