Feasibility of the PediRISE program for families of children with cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to assess the feasibility of implementing the PediRISE program among families of children newly diagnosed with cancer who are experiencing financial hardship. It involves a randomized approach where participants have an equal chance of receiving either the PediRISE support program or standard usual care. The study will include screening for eligibility, study visits, and the completion of surveys and questionnaires over a period of approximately six months. The target population consists of 40 pediatric participants and their parents or guardians, focusing on those from low-income backgrounds.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California San Francisco
  San Francisco, California, United States Recruiting
• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Columbia University Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Kira Bona, MD, MPH — Dana-Farber Cancer Institute
• Study coordinator: Kira Bona, MD, MPH
• Email: Kira_Bona@dfci.harvard.edu
• Phone: 617-632-4688

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.