Clinical trial NCT06283251: PediRISE Feasibility
Official title: Pilot Randomized Pediatric RISE (Resource Intervention to Support Equity) Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Financial Stress
Financial Hardship
Disparities
Keywords: Pediatric Cancer
Financial Stress
Financial Hardship
Disparities
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Children's Cancer Research Fund
First posted: 2024-02-28
Enrollment: 40
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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 newly diagnosed cancer. 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.

Eligibility criteria: Inclusion Criteria:

* 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 MA, NY or NJ
* Provider approval for permission to approach

Exclusion Criteria:

* 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, AHOD2131, ANBL2131, DFCI 23-001).
* Child or household member receiving SSI.

Primary outcomes:
measure: Rate of Participant Consent
timeFrame: 1 Day
measure: 6-Month Follow Up Rate for PediRISE Program Group
timeFrame: At 6 months
measure: 6-Month Follow Up Rate for Usual Care Group
timeFrame: At 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Kira Bona, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: