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Behavioral Intervention

Arm 1: PediCARE + Usual Supportive Care Experimental for Neuroblastoma

N/A
Waitlist Available
Led By Kira Bona, MD, MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a new program called PediCARE for children with high-risk neuroblastoma. The children will either receive the standard care or the standard care plus PediCARE.

Who is the study for?
This trial is for children with a serious type of cancer called high-risk neuroblastoma, who are also dealing with poverty. The study aims to see if adding a special support program, PediCARE, can help these families alongside the regular care they receive.Check my eligibility
What is being tested?
The trial is testing whether the Pediatric Cancer Resource Equity (PediCARE) intervention improves outcomes when added to usual supportive care in kids with high-risk neuroblastoma. Participants will be randomly placed into two groups: one receiving standard care and the other getting PediCARE plus standard care.See study design
What are the potential side effects?
Since this trial focuses on a supportive intervention rather than medication, traditional side effects like those seen with drugs may not apply. However, there could be unintended consequences related to resource allocation or emotional impacts from participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Kessler-6 Psychological Distress Scale Score
Secondary outcome measures
Change in Mean Household Material Hardship (HMH) Score
Proportion of Enrolled Participants (Feasibility)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: PediCARE + Usual Supportive Care ExperimentalExperimental Treatment1 Intervention
Participants will be randomized in a 1:1 ratio and stratified according to treatment group and household material hardship (HMH) severity group and participant parents/guardians will complete: Remote baseline visit with introduction to PediCARE intervention by central study team Parent completion of baseline survey. Receipt of monthly PediCARE resource provisions x 6-months. Parent completion of 3-month follow-up survey. Parent completion of 6-month follow up survey and end of intervention period.
Group II: Arm 2: Usual Supportive Care ArmActive Control1 Intervention
Participants will be randomized in a 1:1 ratio and stratified according to treatment group and HMH severity group and participant parent/guardians will complete: Remote baseline visit Parent completion of baseline survey. Receipt of site-specific routine supportive care x6-month study period Parent completion of 3-month follow-up survey Parent completion of 6-month follow-up survey

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,847 Total Patients Enrolled
10 Trials studying Neuroblastoma
3,850 Patients Enrolled for Neuroblastoma
Kira Bona, MD, MPHPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are considered the most suitable candidates for participation in this research endeavor?

"Patients with neuroblastoma aged between 0 and 17 are eligible to participate in this medical study. Approximately 130 individuals will be recruited for the trial."

Answered by AI

Is the clinical trial limited to participants under the age of 75?

"Participants aged between 1 and 16 years are eligible for enrollment in this trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PediCARE Health Equity Intervention in High-Risk Neuroblastoma
Kira Bona, MD, MPH 2024. "PediCARE Health Equity Intervention in High-Risk Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06335745.
All > Neuroblastoma > Pediatric Cancer
~87 spots leftby Apr 2028
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