Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05876325
• Other study ID #: 57238
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 31, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Financial Stress
• Pediatric Cancer

Intervention

Other:
• FINassist
The FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved
• FINassist
The FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved

Locations

Country	Name	City	State
United States	University of Kentucky DanceBlue Pediatric Hematology/oncology clinic	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Jean Edward	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FINassist Feasibility	Feasibility is defined by number of participants enrolled	12 months
Primary	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
Primary	FINassist Retention	percentage of participants that complete both pre and post-intervention surveys	through study completion up to 12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Resolution of Socio-legal Issue	Number of participants that resolved a legal or financial case as a result of FINassist	12 months
Secondary	Number of Participants Receiving Financial Benefit	financial benefit defined as economic hardship avoided or decreased public/government income	12 months