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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06283251
Other study ID # 23-590
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date December 31, 2024

Study information

Verified date February 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
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute American Cancer Society, Inc., Children's Cancer Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Participant Consent Feasibility of intervention is defined as >75% of screened participants consent to randomization. 1 Day
Primary 6-Month Follow Up Rate for PediRISE Program Group Feasibility of the intervention is defined as <20% of randomized participants who do not complete 6-month survey in PediRiSE Program group. At 6 months
Primary 6-Month Follow Up Rate for Usual Care Group Feasibility of the intervention is defined as <20% of randomized participants who do not complete 6-month survey in Usual Care Group. At 6 months
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