Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program

Leveraging Medical Legal Partnerships to Enhance Patient-Centered, Team-Based Cost Conversations With Pediatric Oncology Patients and Families

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Cancer; Financial Stress
• Intervention / Treatment: Other: FINassist Patient; Other: FINassist Caregiver

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky DanceBlue Pediatric Hematology/oncology clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Financial Navigation and Insurance Assistance (FINassist); FINassist is a comprehensive oncology financial and legal navigation program in oncology care	Other: FINassist Patient; The FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved; Other: FINassist Caregiver; The FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FINassist Adherence	Adherence is defined by the percentage of participants that maintain communication with the team and provide documents necessary for issue resolution	through issue resolution up to 12 months
FINassist Retention	percentage of participants that complete both pre and post-intervention surveys	through study completion up to 12 months
Change in Participant Quality of Life (Depression)	Measured using the 6-item Patient-Reported Outcomes Measurement Information System PROMIS® Depression Short Form. Scores range from 6 to 30. Higher scores indicate more of the construct being measured.	Baseline and post intervention, approximately 12 weeks
Change in Participant Quality of Life (Anxiety)	Measured using the 4-item Patient-Reported Outcomes Measurement Information System PROMIS® Anxiety short form. Scores range from 4 to 20. Higher scores indicate more of the construct being measured.	Baseline and post intervention, approximately 12 weeks
Change in Patient-Provider Trust	Measured using the the Health Care Relationship (HCR) Trust Scale. The HCR-Trust scale is scored from 0 to 4 with a maximum score of 52. Higher scores represent more trust in healthcare providers	Baseline and post intervention, approximately 12 weeks
Resolution of Socio-legal Issue	Number of participants that resolved a legal or financial case as a result of FINassist	12 months
Number of participants enrolled	Feasibility was defined as 60% or higher enrolled participant retention and resolution of financial or legal issue (based on existing oncology financial navigation studies)	12 months
FINassist Acceptability assessed by 5-item survey	Acceptability is measured using a 5 item post-intervention survey of relevance, helpfulness, convenience, recommendation to others, and value. Ratings on a scale from 0 to 10 where a higher score means greater acceptability	Post intervention at 12 months
Change in Total Financial Toxicity	Measured using the COmprehensive Score for financial Toxicity (COST) tool, a measure that describes the financial distress experienced by cancer patients. Scores range from 0-44 with a higher score representing better financial well-being.	Baseline and post intervention, approximately 12 weeks
Change in Participant Quality of Life (physical and mental)	Measured using the 10-item PROMIS® (Patient-Reported Outcomes Measurement Information System) Parent Proxy Global Health scale. A 7-item summary assessment of a child's self-reported health with higher scores representing better quality of life. Values range from 7-35, with higher scores representing better health.	Baseline and post intervention, approximately 12 weeks
Change in PROMIS Parent Proxy Global Health	used to measure child QOL (when applicable), with summary scores for proxy measures of global health, pain interference, and fatigue Overall evaluation of physical, mental health, and social health.	Baseline and post intervention, approximately 12 weeks
Change in PROMIS Parent Proxy Pain Interference	used to measure child QOL (when applicable), with summary scores for proxy measures of global health, pain interference, and fatigue Consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.	Baseline and post intervention, approximately 12 weeks
Change in PROMIS Parent Proxy Fatigue	used to measure child QOL (when applicable), with summary scores for proxy measures of global health, pain interference, and fatigue Range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion.	Baseline and post intervention, approximately 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Receiving Financial Benefit	financial benefit defined as economic hardship avoided or decreased public/government income	12 months

Collaborators and Investigators

• Sponsor: Jean Edward
• Collaborators: Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Jean Edward, PhD, RN, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Financial toxicity; Hardship; Cost conversations; FINassist
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Financial Stress
• Other Study ID Numbers: 57238

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No