PediRISE Feasibility
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorDana-Farber Cancer Institute
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Child diagnosed with de novo cancer
Child has established care at a study site and initiated cancer directed therapy in the prior 2-months
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 is <18 years at time of enrollment
Disqualifiers
Planned transfer of child to a non-DFCI or non-Columbia facility for cancer-directed therapy
Foreign national family receiving care as an Embassy-pay patient
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
Child or household member receiving SSI
Trial design
Design model
Parallel
Treatments tested in this trial
PediRISE Resource Program
BehavioralA 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: PediRISE Program GroupExperimental treatment 1 intervention
Group B: Usual Care GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Participant Consent Rate
The proportion of eligible participants who provide informed consent to participate in the randomized guaranteed income intervention.
Time frame
1 Day2
Participant Attrition Rate
The proportion of participants who withdraw from the study, are lost to follow-up, or otherwise do not complete the assigned study procedures.
Time frame
At 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
American Cancer Society, Inc.
Collaborator
Children's Cancer Research Fund
Collaborator
Source ClinicalTrials.gov