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PediRISE Program for Families Facing Pediatric Cancer

N/A

Recruiting

Led By Kira Bona, MD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 diagnosed with de novo cancer

Must not have

Planned transfer of child to a non-DFCI or non-Columbia facility for cancer-directed therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if families are willing to participate in a study about the PediRISE program, where they have an equal chance of receiving either standard care or the PediRISE support

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on a resource program rather than a medical intervention, there are no direct physical side effects expected. However, participants may experience emotional or psychological impacts related to discussions about finances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My child was diagnosed with cancer for the first time.

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My child is younger than 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child will be transferred to a non-DFCI/Columbia facility for cancer treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

6-Month Follow Up Rate for PediRISE Program Group

6-Month Follow Up Rate for Usual Care Group

Rate of Participant Consent

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PediRISE Program GroupExperimental Treatment1 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 GroupActive Control1 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.

0 / 4Eligibility criteria met