PediCARE Health Equity Intervention in High-Risk Neuroblastoma

NCT06335745 | Withdrawn

• 1 other identifier: 24-066
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Neuroblastoma; High-risk Neuroblastoma; Pediatric Cancer; Disparities; Financial Stress; Poverty

Keywords

Neuroblastoma; High-Risk Neuroblastoma; Disparities; Pediatric cancer; Financial stress; Poverty

Outcome Measures

Primary Outcomes (1)

• Change in Kessler-6 Psychological Distress Scale Score

  As measured by the Kessler-6 Psychological Distress Scale (K6), a 6-item measure for the level of psychological distress in the past month. Responses are scored on a 5-point Likert scare with answers ranging from 0 "None of the time" to 4 "All of the time," and with a total score range of 0 - 4. Scores \> or = 7 suggest "high" distressed and those \> or = 13 meet criteria for serious or debilitating psychological distress. A t-test of differences in mean change scores of parent/guardian psychological distress from T1 (baseline) to T2 (3 months) will be used to compare across PediCARE and usual supportive care arms. The distribution of parent psychological distress scores across PediCARE and usual supportive care arms will also be descriptively characterized. The descriptive analyses will be intention-to-treat, defined as all randomized participants with at least one post-baseline contact or follow-up measure.

  At baseline and 3 months

Secondary Outcomes (2)

• Proportion of Enrolled Participants (Feasibility)

  5 years

• Change in Mean Household Material Hardship (HMH) Score

  At baseline and 3-months

Study Arms (2)

Arm 1: PediCARE + Usual Supportive Care Experimental

EXPERIMENTAL

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.

Behavioral: PediCARE Intervention

Arm 2: Usual Supportive Care Arm

NO 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

Interventions

PediCARE Intervention BEHAVIORAL

A household material hardship intervention with monthly, direct provision of groceries and transportation. Resources will be centrally administered by the Dana-Farber Cancer Institute study team.

Also known as: PediCARE

Arm 1: PediCARE + Usual Supportive Care Experimental

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Patient has transferred to ANBL1531 Arm E.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

MeSH Terms

Conditions

Neuroblastoma; Neoplasms; Financial Stress

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Kira Bona, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 28, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu