PediRISE Program for Families Facing Pediatric Cancer

Recruiting at 1 trial location

Overseen By Kira Bona, MD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Non-DFCI transfer, Embassy-pay, SSI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the PediRISE program serves as a helpful support option for families dealing with pediatric cancer. Participants will join one of two groups: one receiving the PediRISE program, which provides financial support and resources over six months, and the other receiving standard care. Families with a child diagnosed with a new case of cancer, who have started treatment in the past two months and live in Massachusetts, New York, or New Jersey, may qualify. The trial examines whether families are interested in trying this new support program compared to usual care. As an unphased trial, it offers families the opportunity to explore innovative support options tailored to their needs.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PediRISE program is safe for families facing pediatric cancer?

Research shows that programs like the PediRISE Resource Program, which provide cash support, are generally safe and well-received. Studies have found that direct cash support can benefit children. Although specific safety data for PediRISE is unavailable, no reports have indicated problems caused by the program itself. Designed to help families through financial support, this program is not expected to cause harm. Participants might experience improvements in their situation, and current research has not identified any health risks associated with this type of program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PediRISE Program because it offers a comprehensive support system for families dealing with pediatric cancer, which is a distinct approach compared to traditional medical treatments. Unlike standard care that primarily focuses on medical and emotional support, PediRISE provides financial assistance through fixed funds and access to certified benefits counselors, which can ease the financial burden on families. By integrating these financial and resource-oriented components with standard supportive care, this program aims to improve the overall well-being and quality of life for families during a challenging time.

What evidence suggests that the PediRISE program could be effective for families facing pediatric cancer?

Research shows that programs like the PediRISE Resource Program, which participants in this trial may receive, have successfully helped families manage the financial stress of childhood cancer. Similar studies have demonstrated that direct cash support to families improved their stability and benefited children. For instance, the PediCARE trial found that providing resources such as groceries and transport reduced financial strain compared to standard care. These results suggest that the PediRISE program could significantly support families, potentially easing financial stress during tough times. Although no direct data yet exists on the PediRISE program's effectiveness, the positive outcomes from similar programs are encouraging. ^{3 4 5 6 7}

Who Is on the Research Team?

Kira Bona, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for families dealing with financial stress due to pediatric cancer. Participants must be interested in a study where they have an equal chance of receiving either standard care or the PediRISE support program, which aims to alleviate financial hardship.

Inclusion Criteria

Provider approval for permission to approach

My child is set to undergo cancer treatment for at least 4 months from diagnosis.

My child was diagnosed with cancer for the first time.

Exclusion Criteria

Child or household member receiving SSI

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)

Foreign national family receiving care as an Embassy-pay patient

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person or virtual)

Treatment

Participants are randomized to either the PediRISE Program Group or Usual Care Group, with activities including surveys, program orientation, and supportive care

6 months

Multiple visits (in-person, telephone, or virtual)

Follow-up

Participants are monitored for completion of the 6-month survey and overall feasibility of the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PediRISE Resource Program

Trial Overview The PediRISE Feasibility study is testing the effectiveness of the PediRISE Resource Program compared to usual care in managing financial difficulties associated with pediatric cancer. Families will be randomly assigned to one of two groups: those who receive standard care and those who get additional support from PediRISE.

How Is the Trial Designed?

Group I: PediRISE Program Group Experimental Treatment 1 Intervention

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.

Group II: Usual Care Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Children's Cancer Research Fund

Collaborator

Trials

3

Recruited

150+

Children's Cancer Research Fund

Collaborator

Citations

1. withpower.com withpower.com/trial/phase-financial-stress-5-2024-2b35d

PediRISE Program for Families Facing Pediatric Cancer Trial Overview The PediRISE Feasibility study is testing the effectiveness of the PediRISE Resource Program compared to usual care in managing financial ...

2. childrenshospital.org childrenshospital.org/clinical-trials/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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11143457/

The PediCARE Pilot Randomized Clinical Trial - PMC This randomized clinical trial evaluates the Pediatric Cancer Resource Equity (PediCARE) intervention, which provided groceries and transportation, vs usual ...

4. acf.gov acf.gov/sites/default/files/documents/ofa/pediatric-rise-casestudy-508.pdf

Pediatric Cancer Trial Illuminates Pain Points in Public ... To ensure that the Pediatric RISE study is able to determine the effect of additional income supports on low-income families with a child in cancer treatment, ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pbc.32103

Pediatric RISE: Development of a Poverty‐Targeted Cash ... Prior data show that direct cash support interventions are feasible and improve child outcomes; however, no such interventions exist within ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06283251

Study Details | NCT06283251 | PediRISE Feasibility This is a pilot, multi-center, randomized research study for the feasibility of the administration of the PediRISE program among 40 poverty exposed children ...

7. dana-farber.org dana-farber.org/newsroom/news-releases/2024/program-targets-poverty-to-improve-childhood-cancer-treatment

Program targets poverty to improve childhood cancer ... Pediatric RISE aims to address these disparities with twice-monthly direct transfers of cash to eligible families for three months.