Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-05-15
2025-12-31
Brief Summary
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The names of the study groups in this research study are:
* PediRISE Program Group
* Usual Care Group
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
17 Years
ALL
No
Sponsors
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American Cancer Society, Inc.
OTHER
Children's Cancer Research Fund
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Kira Bona, MD, MPH
Principal Investigator
Principal Investigators
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Kira Bona, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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University of California San Francisco
San Francisco, California, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Columbia University Medical Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Lena Winestone, MD, MPH
Role: primary
Kira Bona, MD, MPH
Role: primary
Kira Bona, MD, MPH
Role: primary
Justine Kahn, MD
Role: primary
Other Identifiers
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23-590
Identifier Type: -
Identifier Source: org_study_id