Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program

NCT05876325 | Completed

• 1 other identifier: 57238
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Financial Stress; Pediatric Cancer

Keywords

Financial toxicity; Hardship; Cost conversations; FINassist

Outcome Measures

Primary Outcomes (13)

• 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 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 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 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

• 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 Outcomes (1)

• Number of Participants Receiving Financial Benefit

  12 months

Study Arms (1)

Financial Navigation and Insurance Assistance (FINassist)

EXPERIMENTAL

FINassist is a comprehensive oncology financial and legal navigation program in oncology care

Other: FINassist Patient; Other: FINassist Caregiver

Interventions

FINassist Patient OTHER

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

Financial Navigation and Insurance Assistance (FINassist)

FINassist Caregiver OTHER

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

Financial Navigation and Insurance Assistance (FINassist)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years and older

You may not qualify if:

• Unable to provide consent

Sponsors & Collaborators

• Jean Edward: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

University of Kentucky DanceBlue Pediatric Hematology/oncology clinic

Lexington, Kentucky, 40506, United States

Location

Related Publications (1)

• Edward J, Northrip KD, Rayens MK, Welker A, O'Farrell R, Knuf J, Fariduddin H, Costich J, D'Orazio J. Financial-legal navigation reduces financial toxicity of pediatric, adolescent, and young adult cancers. JNCI Cancer Spectr. 2024 Apr 30;8(3):pkae025. doi: 10.1093/jncics/pkae025.

  PMID: 38552323 DERIVED

MeSH Terms

Conditions

Financial Stress; Neoplasms

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Jean Edward, PhD, RN

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: April 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 31, 2022
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

US (1)