PediRISE Feasibility
Purpose
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
Eligibility
- Eligible Ages
- Under 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
San Francisco 5391959, California 5332921 94143
Boston 4930956, Massachusetts 6254926 02215
Boston 4930956, Massachusetts 6254926 02215
New York 5128581, New York 5128638 10032
More Details
- Status
- Recruiting
- Sponsor
- Dana-Farber Cancer Institute
Detailed Description
This is a pilot, multi-center, randomized research study for the feasibility of the administration of the PediRISE program among 40 poverty exposed children with (1) a new diagnosis of childhood cancer at DFCI and Columbia University and among poverty-exposed families with a child with cancer and (2) receiving hematopoietic stem cell transplant (HSCT) at DFCI, Columbia University, or the University of California - San Francisco (UCSF). Randomization means there is an equal chance of being assigned to the PediRISE Program Group or the Usual Care Group. 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.