PediRISE Feasibility

Официальное название

Pilot Randomized Pediatric RISE (Resource Intervention to Support Equity) Feasibility Study

Обзор

The goal of this research study is to learn whether investigators can successfully give the PediRISE program to families-in other words, whether most families are interested in participating in a study about the PediRISE program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of receiving the PediRISE support program. The names of the study groups in this research study are: * PediRISE Program Group * Usual Care Group

Подробное описание

This is a pilot, multi-center, randomized research study for the feasibility of the administration of the PediRISE program among 40 poverty exposed children with (1) a new diagnosis of childhood cancer at DFCI and Columbia University and among poverty-exposed families with a child with cancer and (2) receiving hematopoietic stem cell transplant (HSCT) at DFCI, Columbia University, or the University of California - San Francisco (UCSF). Randomization means there is an equal chance of being assigned to the PediRISE Program Group or the Usual Care Group.

Study procedures include screening for eligibility, study visits, and completion of surveys and questionnaires.

Participation in this study will last for about 6-months.

It is expected that about 40 pediatric participants with parents/guardians will take part in this research study.

This study is being supported by grants from the American Cancer Society and the Children's Cancer Research Fund.

Вмешательства

• Поведенческое PediRISE Resource Program
  A centrally administered, income-poverty targeted intervention that includes twice-monthly direct provision of unrestricted cash transfers along with benefits counseling to mitigate the risk of loss of means-tested benefits. Funds will be dispersed to families via provided debit card or through personal banking, PayPal, or Venmo.

Первичные конечные точки

• Participant Consent Rate [Срок оценки: 1 Day]
• Participant Attrition Rate [Срок оценки: At 6 months]

Критерии участия

Критерии включения

Cohort 1: Poverty-exposed children with cancer receiving front-line cancer-directed therapy

• Child diagnosed with de novo cancer
• Child has established care at a study site and initiated cancer directed therapy in the prior 2-months
• Child planned to receive at least 4-months of cancer-directed therapy at study site from time of diagnosis per initial cancer treatment plan
• Child is <18 years at time of enrollment
• Parent/guardian screened positive for self-reported low-income (<200% FPL)
• Family primary residence in CA, CT, MA, ME, NH, NJ, NY or RI
• Provider approval for permission to approach

Cohort 2: Poverty-exposed children with cancer undergoing HSCT

• Child undergoing allogeneic HSCT for treatment of cancer
• Child has established care at a study site and is between 30 days prior to start of planned conditioning through day +7 of HSCT at time of enrollment
• Child planned to receive follow-up care after discharge for HSCT at study site
• Child is <18 years at the time of enrollment
• Parent/guardian screen positive for self-reported low-income (<200% FPL)
• Family primary residence in CA, CT, MA, ME, NH, NJ, NY or RI
• Provider approval for permission to approach

Критерии исключения

Cohort 1: Poverty-exposed children with cancer receiving front-line cancer-directed therapy

• Planned transfer of child to a non-DFCI or non-Columbia facility for cancer-directed therapy
• Foreign national family receiving care as an Embassy-pay patient
• Child is enrolled on embedded correlative health equity aims of open or upcoming clinical drug trials which are powered on descriptive parent-reported poverty data (e.g. AALL1731, DFCI 25-001). Co-enrollment on a poverty intervention study would confound the specified endpoints of these open trial correlative studies
• Child or household member receiving SSI

Cohort 2: Poverty-exposed children with cancer undergoing HSCT

• Planned transfer of child to a non-DFCI, non-Columbia, or non UCSF facility for cancer-directed therapy
• Foreign national family receiving care as an Embassy-pay patient
• Child is enrolled on embedded correlative health equity aims of open or upcoming clinical drug trials which are powered on descriptive parent-reported poverty data (e.g. AALL1731, DFCI 25-001). Co-enrollment on a poverty intervention study would confound the specified endpoints of these open trial correlative studies
• Child previously received RISE intervention
• Child or household member receiving SSI

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 4 центра

• University of California San Francisco — San Francisco
• Boston Children's Hospital — Boston
• Dana Farber Cancer Institute — Boston
• Columbia University Medical Center — New York

Идентификаторы

NCT: NCT06283251 · 23-590

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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