PediCARE Health Equity Intervention in High-Risk Neuroblastoma

Neuroblastoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335745
• Other study ID #: 24-066
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: April 1, 2030

Study information

• Verified date: March 2024
• Source: Dana-Farber Cancer Institute
• Contact: Kira Bona, MD, MPH
• Phone: 617-632-4688
• Email: Kira_Bona[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: April 1, 2030
• Est. primary completion date: April 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• PediCARE Intervention
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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of Enrolled Participants (Feasibility)	Feasibility of conducting a centrally-administered companion health equity intervention study among COG trial-enrolled participants will be described using proportions and 95% confidence intervals. Successful feasibility is defined as >75% consent to participation and randomization and <20% attrition. Feasibility metrics will be collected and monitored in real time throughout the duration of the study (about 5 years). An interim analysis for early stopping will also be conducted halfway through accrual (n=40 participants) to assess futility of the feasibility endpoint.	5 years
Secondary	Change in Mean Household Material Hardship (HMH) Score	Household Material Hardship (HMH) information will via parent/guardian-completed survey instruments using standardized measures of housing, food, utility, and transportation insecurity. HMH scores will be calculated based on parent/guardian responses and will range from 0-4 based on the number of discrete areas of insecurity endorsed by participants. A t-test of differences in mean HMH change scores from T1 (baseline) to T2 (month 3) will be used to compare across PediCARE and usual supportive care arms. Investigators will also characterize the distribution between T1 and T2 HMH scores across PediCARE and usual supportive care arms on the ordinal scale from 0 to 4 using a chi-square test.	At baseline and 3-months