Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program

Sponsor
Jean Edward (Other)
Overall Status
Completed
CT.gov ID
NCT05876325
Collaborator
Robert Wood Johnson Foundation (Other)
61
1
2
21
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: FINassist
  • Other: FINassist
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Leveraging Medical Legal Partnerships to Enhance Patient-Centered, Team-Based Cost Conversations With Pediatric Oncology Patients and Families
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Sep 1, 2022
Actual Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Financial Navigation and Insurance Assistance (FINassist) Patient Only

Patients only participated in FINassist program

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

Experimental: Financial Navigation and Insurance Assistance (FINassist) Patient Caregiver

Caregivers of minor patients only participated in FINassist program

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

Outcome Measures

Primary Outcome Measures

  1. FINassist Feasibility [12 months]

    Feasibility is defined by number of participants enrolled

  2. 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

  3. FINassist Retention [through study completion up to 12 months]

    percentage of participants that complete both pre and post-intervention surveys

  4. FINassist Acceptability [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

  5. Change in 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. Resolution of Socio-legal Issue [12 months]

    Number of participants that resolved a legal or financial case as a result of FINassist

Secondary Outcome Measures

  1. Number of Participants Receiving Financial Benefit [12 months]

    financial benefit defined as economic hardship avoided or decreased public/government income

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kentucky DanceBlue Pediatric Hematology/oncology clinic Lexington Kentucky United States 40506

Sponsors and Collaborators

  • Jean Edward
  • Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Jean Edward, PhD, RN, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jean Edward, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier:
NCT05876325
Other Study ID Numbers:
  • 57238
First Posted:
May 25, 2023
Last Update Posted:
May 25, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jean Edward, Associate Professor, University of Kentucky
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2023