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NCT Number: NCT06283251

PediRISE Feasibility

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

Recruiting

Interested in participating?

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco, San Francisco, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

PediRISE Resource Program

Behavioral

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.

Other names: PediRISE

Primary outcomes

  1. Participant Consent Rate

    Time frame: 1 Day

    The proportion of eligible participants who provide informed consent to participate in the randomized guaranteed income intervention.

  2. Participant Attrition Rate

    Time frame: At 6 months

    The proportion of participants who withdraw from the study, are lost to follow-up, or otherwise do not complete the assigned study procedures.

Study contacts

Contact information is provided by the study sponsor or research team.

Kira Bona, MD, MPH

CONTACT

[email protected]

617-632-4688

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • American Cancer Society, Inc.
  • Children's Cancer Research Fund

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2024
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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