PediCARE Health Equity Intervention in High-Risk Neuroblastoma

Study Purpose

- Usual supportive care.

- PediCARE + usual supportive care

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	0 Years - 17 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06335745
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Dana-Farber Cancer Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kira Bona, MD, MPH
Principal Investigator Affiliation	Dana-Farber Cancer Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroblastoma, High-risk Neuroblastoma, Pediatric Cancer, Disparities, Financial Stress, Poverty

Additional Details

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.#46; 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.

Arms & Interventions

Arms

Experimental: Arm 1: PediCARE + Usual Supportive Care 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.

No Intervention: Arm 2: Usual Supportive Care Arm

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston Children's Hospital, Boston, Massachusetts

Status

Address

Boston Children's Hospital

Boston, Massachusetts, 02215

Site Contact

[email protected]

617-632-4688

Dana Farber Cancer Institute, Boston, Massachusetts