Clinical trial NCT05876325: Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program
Official title: Leveraging Medical Legal Partnerships to Enhance Patient-Centered, Team-Based Cost Conversations With Pediatric Oncology Patients and Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Financial Stress
Pediatric Cancer
Keywords: Financial toxicity
Hardship
Cost conversations
FINassist
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2023-05-25
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall objective of this study was to develop and evaluate FINassist (Financial and Insurance Navigation Assistance), a patient-centered, interdisciplinary team-based oncology financial and legal navigation program. The program leverages Medical Legal Partnerships to enhance cost of care conversations with pediatric oncology patients and caregivers. FINassist optimizes the team-based care model by integrating clinicians, social workers, financial navigators, and legal advocates who work in tandem to enhance cost of care conversations with patients and caregivers, identify and intervene on patient socio-legal needs, and advocate for system-level changes.


Eligibility criteria: Inclusion Criteria:

* Caregivers of patients who have any cancer or hematologic disorder diagnosis at the DanceBlue Pediatric Hematology/oncology clinic at Kentucky Children's hospital
* Patients with childhood cancers and/or hematologic disorders at the DanceBlue Pediatric Hematology/oncology clinic at Kentucky Children's hospital
* 18 years and older

Exclusion Criteria:

* Unable to provide consent

Primary outcomes:
measure: Number of participants enrolled
timeFrame: 12 months
measure: FINassist Adherence
timeFrame: through issue resolution up to 12 months
measure: FINassist Retention
timeFrame: through study completion up to 12 months
measure: FINassist Acceptability assessed by 5-item survey
timeFrame: Post intervention at 12 months
measure: Change in Total Financial Toxicity
timeFrame: Baseline and post intervention, approximately 12 weeks
measure: Change in Participant Quality of Life (physical and mental)
timeFrame: Baseline and post intervention, approximately 12 weeks
measure: Change in Participant Quality of Life (Depression)
timeFrame: Baseline and post intervention, approximately 12 weeks
measure: Change in Participant Quality of Life (Anxiety)
timeFrame: Baseline and post intervention, approximately 12 weeks
measure: Change in Patient-Provider Trust
timeFrame: Baseline and post intervention, approximately 12 weeks
measure: Resolution of Socio-legal Issue
timeFrame: 12 months
measure: Change in PROMIS Parent Proxy Global Health
timeFrame: Baseline and post intervention, approximately 12 weeks
measure: Change in PROMIS Parent Proxy Pain Interference
timeFrame: Baseline and post intervention, approximately 12 weeks
measure: Change in PROMIS Parent Proxy Fatigue
timeFrame: Baseline and post intervention, approximately 12 weeks
Secondary outcomes:
measure: Number of Participants Receiving Financial Benefit
timeFrame: 12 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky DanceBlue Pediatric Hematology/oncology clinic
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jean Edward, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: