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| Name | Class |
|---|---|
| Robert Wood Johnson Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Financial Navigation and Insurance Assistance (FINassist) | Experimental | FINassist is a comprehensive oncology financial and legal navigation program in oncology care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Receiving Financial Benefit | financial benefit defined as economic hardship avoided or decreased public/government income | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Edward, PhD, RN | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky DanceBlue Pediatric Hematology/oncology clinic | Lexington | Kentucky | 40506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38552323 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086522 | Financial Stress |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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 |
|
| 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 |