PediRISE Feasibility

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Disparities; Financial Stress; Financial Hardship; Pediatric Cancer

Treatments: Behavioral: PediRISE Resource Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06283251

23-590

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

PediRISE Program Group

Experimental group

Description:

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.

Treatment:

Behavioral: PediRISE Resource Program

Usual Care Group

No Intervention group

Description:

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.