Clinical trial NCT06335745: PediCARE Health Equity Intervention in High-Risk Neuroblastoma
Official title: A Randomized Phase II Trial Evaluation of the Addition of the Pediatric Cancer Resource Equity (PediCARE) Health Equity Intervention to Usual Supportive Care for Children With Newly Diagnosed High-Risk Neuroblastoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neuroblastoma
High-risk Neuroblastoma
Pediatric Cancer
Disparities
Financial Stress
Poverty
Keywords: Neuroblastoma
High-Risk Neuroblastoma
Disparities
Pediatric cancer
Financial stress
Poverty
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma.

The names of the intervention groups in this research study are:

* Usual supportive care
* PediCARE + usual supportive care

Detailed description: This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma.

Participants will be randomized into one of two groups: Usual Supportive Care vs. PediCARE + Usual Supportive Care. Randomization means a participant is placed into a group by chance.

Participation in this research study is expected to last 6-months.

It is expected about 130 people will participate in this research study.

Eligibility criteria: Inclusion Criteria:

* Patient must have a new diagnosis of high-risk neuroblastoma.
* Patient must be enrolled on APEC14B1 and must have consented to future contact on APEC14B1.
* Patient must be enrolled on ANBL2131.
* Patient aged 0-17 years at the time of consent to ANBL2131.
* Patient must have opted-in to embedded optional ANBL2131 Household Survey.
* Family screened positive for HMH or low-income on ANBL2131 Household Survey. \*
* Patient has not yet initiated Induction Cycle 3 on ANBL2131.
* Patient being treated at a U.S. site.
* Patients of all languages are eligible to participate.

  * Eligibility based on Household Survey will be determined by central study team review. HMH exposure will be operationalized as the report of at least one of the following four concrete resource insecurities: (1) Food insecurity, (2) Housing Insecurity, (3) Utility Insecurity, (4) Transportation Insecurity. Low-income will be defined as reported annual household income of less than 200% federal poverty level (FPL).

Exclusion Criteria:

-Patient has transferred to ANBL1531 Arm E.

Primary outcomes:
measure: Change in Kessler-6 Psychological Distress Scale Score
timeFrame: At baseline and 3 months
Secondary outcomes:
measure: Proportion of Enrolled Participants (Feasibility)
timeFrame: 5 years
measure: Change in Mean Household Material Hardship (HMH) Score
timeFrame: At baseline and 3-months
Other outcomes:
Locations:
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Kira Bona, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: