Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program
- Conditions
- Financial StressPediatric Cancer
- Interventions
- Other: FINassist PatientOther: FINassist Caregiver
- Registration Number
- NCT05876325
- Lead Sponsor
- Jean Edward
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- 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
- Unable to provide consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Financial Navigation and Insurance Assistance (FINassist) FINassist Patient FINassist is a comprehensive oncology financial and legal navigation program in oncology care Financial Navigation and Insurance Assistance (FINassist) FINassist Caregiver FINassist is a comprehensive oncology financial and legal navigation program in oncology care
- Primary Outcome Measures
Name Time Method Change in Total Financial Toxicity Baseline and post intervention, approximately 12 weeks 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.
Change in Participant Quality of Life (Depression) Baseline and post intervention, approximately 12 weeks 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.
Number of participants enrolled 12 months Feasibility was defined as 60% or higher enrolled participant retention and resolution of financial or legal issue (based on existing oncology financial navigation studies)
Change in PROMIS Parent Proxy Pain Interference Baseline and post intervention, approximately 12 weeks 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.
FINassist Adherence through issue resolution up to 12 months Adherence is defined by the percentage of participants that maintain communication with the team and provide documents necessary for issue resolution
Resolution of Socio-legal Issue 12 months Number of participants that resolved a legal or financial case as a result of FINassist
Change in PROMIS Parent Proxy Global Health Baseline and post intervention, approximately 12 weeks 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.
FINassist Acceptability assessed by 5-item survey Post intervention at 12 months 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
Change in Participant Quality of Life (physical and mental) Baseline and post intervention, approximately 12 weeks 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.
Change in Patient-Provider Trust Baseline and post intervention, approximately 12 weeks 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
FINassist Retention through study completion up to 12 months percentage of participants that complete both pre and post-intervention surveys
Change in Participant Quality of Life (Anxiety) Baseline and post intervention, approximately 12 weeks 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.
Change in PROMIS Parent Proxy Fatigue Baseline and post intervention, approximately 12 weeks 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Receiving Financial Benefit 12 months financial benefit defined as economic hardship avoided or decreased public/government income
Trial Locations
- Locations (1)
University of Kentucky DanceBlue Pediatric Hematology/oncology clinic
🇺🇸Lexington, Kentucky, United States