Recruiting

Observational Study

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06283251

Conditions

Pediatric Cancer

Financial Stress

Financial Hardship

Disparities

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

PediRISE Resource Program

Study Details

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

Conditions

Pediatric Cancer

Financial Stress

Financial Hardship

Disparities

Study ID

NCT06283251

Start date

May 15, 2024

Status verified date

Feb, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria

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

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

Cohort 2: Poverty-exposed children with cancer undergoing HSCT

1. Child undergoing allogeneic HSCT for treatment of cancer
2. 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
3. Child planned to receive follow-up care after discharge for HSCT at study site
4. Child is <18 years at the time of enrollment
5. Parent/guardian screen positive for self-reported low-income (<200% FPL)
6. Family primary residence in CA, CT, MA, ME, NH, NJ, NY or RI
7. Provider approval for permission to approach

Exclusion Criteria

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

1. Planned transfer of child to a non-DFCI or non-Columbia facility for cancer-directed therapy
2. Foreign national family receiving care as an Embassy-pay patient
3. 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
4. Child or household member receiving SSI

Cohort 2: Poverty-exposed children with cancer undergoing HSCT

1. Planned transfer of child to a non-DFCI, non-Columbia, or non UCSF facility for cancer-directed therapy
2. Foreign national family receiving care as an Embassy-pay patient
3. 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
4. Child previously received RISE intervention
5. Child or household member receiving SSI

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: PediRISE Program Group

Participants will be randomized in a 1:1 fashion and will be stratified by site. Participant parents will complete:

  • Baseline survey in-person, by telephone, or virtually.
  • PediRISE program orientation with study team member, in-person or virtual.
  • Optional meeting with certified benefits counselor.
  • Receive fixed funds twice a month for 6 months.
  • Standard supportive care from social worker and/or resource specialist to identify and discuss available resources.
  • End of study survey.

no intervention: Usual Care Group

Participants will be randomized in a 1:1 fashion and will be stratified by site. Participant parents will complete:

  • Baseline survey in-person, by telephone, or virtually, and orientation with study team member.
  • Standard supportive care from social worker and/or resource specialist to identify and discuss available resources.
  • End of study survey.

Interventions

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.

Primary outcome measure

  • Participant Consent Rate [ Time Frame: 1 Day ]
  • Participant Attrition Rate [ Time Frame: At 6 months ]

Central Contacts and Locations

Central contacts

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Kira Bona, MD, MPH

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Kira Bona, MD, MPH

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • Pediatric Cancer
  • Financial Stress
  • Financial Hardship
  • Disparities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-02-10.