Идёт набор NCT06831552

Resource Intervention to Support Equity (RISE) in High-Risk Neuroblastoma

Без фазы С лечением Neuroblastoma High-risk Neuroblastoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: RISE Intervention.
Кому может быть актуально: Состояния в реестре: Neuroblastoma, High-risk Neuroblastoma. Базовые параметры: до 17 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Randomized Phase II Trial Evaluation of the Addition of the Resource Intervention to Support Equity (RISE) to Usual Supportive Care for Children With Newly Diagnosed High-Risk Neuroblastoma

Обзор

The goal of this study is to test if the addition of a novel income-poverty targeted supportive care intervention (Pediatric Resource Intervention to Support Equity \[Pediatric RISE\]) to usual supportive care for low-income children with high-risk neuroblastoma can improve parent- and child-centered outcomes. Participants will be randomized to receive one of the following for 6-months: * Usual supportive care alone or * Usual supportive care plus Pediatric RISE

Подробное описание

This is a randomized Phase II trial evaluating the addition of the RISE supportive care equity intervention to usual supportive care for poverty-exposed children participants with newly diagnosed high-risk neuroblastoma. Participants will be randomized into one of two groups: Usual supportive care or Pediatric RISE plus usual supportive care. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, in-person or virtual appointments, and surveys.

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

It is expected that about 84 participants will take part in this research study.

Вмешательства

Поведенческое RISE Intervention
Income-poverty targeted, supportive care intervention that includes direct cash transfers delivered by the Fund for Guaranteed Income, a non-profit organization, along with benefits counseling to discuss the risk of means-tested benefits loss or reduction. Funds will be dispersed to families via debit card or through personal banking, PayPal, or Venmo on a twice monthly basis for a total of twelve disbursements (6-months). Meetings with a benefits counselor will be conducted by the HIPAA-complia

Первичные конечные точки

Household Material Hardship (HMH) Score Reduction Rate [Срок оценки: Baseline (T1) and 6-months (end-intervention; T3)]

Вторичные конечные точки (3)

Pediatric-Modified Comprehensive Score for Financial Toxicity (COST) [Срок оценки: 3-months (end-of-induction; T2) and 6-months (end-intervention; T3)]
Parent Psychological Distress (Kessler-6) Score Change from Baseline to 6 Months [Срок оценки: Baseline (T1) and 6-months (end-intervention; T3)]
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Abilities Score Change from Baseline to 6 Months [Срок оценки: Baseline (T1) and 6-months (end-intervention; T3)]

Критерии участия

Критерии включения

Patient cohort: The randomized Phase II multi-center RISE intervention will be conducted among a population of poverty-exposed children with high-risk neuroblastoma. Poverty will be a priori defined as parent-reported low-income (<200% Federal Poverty Level). Children receiving treatment for cancer at study sites will serve as the study cohort, with parents/guardians as survey informants and intervention recipients on behalf of their minor children given that parents (not children) typically manage household finances.

Patient newly diagnosed with high-risk neuroblastoma
Patient has established care at study site and initiated cancer-directed therapy
Patient has not yet initiated Induction Cycle 3
Patient aged 0-17 years at the time of consent
Parent/guardian screened positive for self-reported low-income (<200% Federal Poverty) \*
Family primary residence in MA, PA, IL, CA, WA, CT, GA, WI and OH
Both patients co-enrolled on ANBL2131 or those receiving standard of care therapy at their center are eligible to participate
Patients of all languages are eligible to participate