Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program

Study Overview
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Brief Summary
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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.

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

Conditions
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Financial Stress, Pediatric Cancer

Intervention / Treatment
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* Other: FINassist
* Other: FINassist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Financial Navigation and Insurance Assistance (FINassist) Patient Only<br>Patients only participated in FINassist program | Other: FINassist<br>* The FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved<br>|
| Experimental: Financial Navigation and Insurance Assistance (FINassist) Patient Caregiver<br>Caregivers of minor patients only participated in FINassist program | Other: FINassist<br>* The FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FINassist Feasibility | Feasibility is defined by number of participants enrolled | 12 months | 
| 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 | 
| FINassist Acceptability | 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 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. | Baseline and post intervention, approximately 12 weeks | 
| 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 | 

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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Financial toxicity, Hardship, Cost conversations, FINassist