Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FINassist

About this trial

This is an interventional health services research trial for Financial Stress focused on measuring Financial toxicity, Hardship, Cost conversations, FINassist

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Kentucky DanceBlue Pediatric Hematology/oncology clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Financial Navigation and Insurance Assistance (FINassist) Patient Only

Financial Navigation and Insurance Assistance (FINassist) Patient Caregiver

Arm Description

Patients only participated in FINassist program

Caregivers of minor patients only participated in FINassist program

Outcomes

Primary Outcome Measures

FINassist Feasibility

Feasibility is defined by number of participants enrolled

FINassist Adherence

Adherence is defined by the percentage of participants that maintain communication with the team and provide documents necessary for issue resolution

FINassist Retention

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

FINassist Acceptability

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 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.

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.

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.

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.

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

Resolution of Socio-legal Issue

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

Secondary Outcome Measures

Number of Participants Receiving Financial Benefit

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

Full Information

NCT ID

NCT05876325

First Posted

May 16, 2023

Last Updated

May 16, 2023

Sponsor

Jean Edward

Collaborators

Robert Wood Johnson Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05876325

Brief Title

Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

September 1, 2022 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jean Edward

Collaborators

Robert Wood Johnson Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Financial Stress, Pediatric Cancer

Keywords

Financial toxicity, Hardship, Cost conversations, FINassist

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Financial Navigation and Insurance Assistance (FINassist) Patient Only

Arm Type

Experimental

Arm Description

Patients only participated in FINassist program

Arm Title

Financial Navigation and Insurance Assistance (FINassist) Patient Caregiver

Arm Type

Experimental

Arm Description

Caregivers of minor patients only participated in FINassist program

Intervention Type

Other

Intervention Name(s)

FINassist

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

FINassist

Intervention Description

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

Primary Outcome Measure Information:

Title

FINassist Feasibility

Description

Feasibility is defined by number of participants enrolled

Time Frame

12 months

Title

FINassist Adherence

Description

Adherence is defined by the percentage of participants that maintain communication with the team and provide documents necessary for issue resolution

Time Frame

through issue resolution up to 12 months

Title

FINassist Retention

Description

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

Time Frame

through study completion up to 12 months

Title

FINassist Acceptability

Description

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

Time Frame

Post intervention at 12 months

Title

Change in Financial Toxicity

Description

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.

Time Frame