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Completed

NCT Number: NCT05876325

Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program

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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Key information

Conditions

Financial Stress Behavior Behavioral Symptoms Neoplasms Pediatric Cancer Stress, Psychological

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky DanceBlue Pediatric Hematology/oncology clinic

Lexington, Kentucky, 40506, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Number of participants enrolled

    Time frame: 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)

  2. FINassist Adherence

    Time frame: 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

    Time frame: through study completion up to 12 months

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

  4. FINassist Acceptability assessed by 5-item survey

    Time frame: 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 Total Financial Toxicity

    Time frame: 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)

    Time frame: 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.

  7. Change in Participant Quality of Life (Depression)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 12 months

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

  11. Change in PROMIS Parent Proxy Global Health

    Time frame: 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.

  12. Change in PROMIS Parent Proxy Pain Interference

    Time frame: 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.

  13. Change in PROMIS Parent Proxy Fatigue

    Time frame: 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 outcomes

  1. Number of Participants Receiving Financial Benefit

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Jean Edward

Other

Collaborators

  • Robert Wood Johnson Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 25, 2023
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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