Oncology Legal Navigation Study

March 3, 2026 updated by: Jean Edward

Oncology Legal Navigation- Medical Legal Partnership

The overall objective of this study is to implement a sustainable oncology legal navigation program that will provide direct legal navigation services to help patients and caregivers overcome legal barriers to care in order to reduce cancer-related financial toxicity (FT) and improve health-related quality of life (QOL) among patients/caregivers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Recruiting
        • University Of Kentucky
        • Contact:
          • Jean Edward, PhD, RN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • receiving or have received services at the Markey Cancer Center, University of Kentucky
  • patient with cancer diagnosis
  • caregiver of patient with cancer diagnosis
  • 18 years or older
  • facing legal barriers to care

Exclusion Criteria:

  • Unable to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adult patient or caregiver of patient with cancer diagnosis
legal navigation program in oncology care
Other: oncology legal navigation services
Participants receive direct legal assistance/navigation followed by consultation, and assistance with legal issues related to health/social benefits, housing, employment/education, planning ahead, and family law

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months
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
Post intervention at 12 months
Change in Total Financial Toxicity
Time Frame: Baseline and post intervention,up to 12 months
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,up to 12 months
Change in Participant Quality of Life (physical and mental)
Time Frame: Baseline and post intervention, up to 12 months
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.
Baseline and post intervention, up to 12 months
Change in Participant Quality of Life (Depression)
Time Frame: Baseline and post intervention, up to 12 months
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, up to 12 months
Change in Participant Quality of Life (Anxiety)
Time Frame: Baseline and post intervention, up to 12 months
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, up to 12 months
Resolution of legal Issue
Time Frame: 12 months
Number of participants that resolved a legal or financial case as a result of the intervention
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Receiving Financial Benefit
Time Frame: 12 months
financial benefit defined as economic hardship avoided or decreased public/government income
12 months
Single Item Literacy Screener (SILS)
Time Frame: Baseline and post-intervention at 12 months
Single Item Literacy Screener (SILS); SILS asks "How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?" with answer options: "Never, Rarely, Sometimes, Often Always". Higher scores indicate lower health literacy.
Baseline and post-intervention at 12 months
Health Insurance Literacy (HIL)
Time Frame: Baseline and post-intervention at 12 months
Single Item Health Insurance Literacy Scale; "Did you ever have a problem understanding health insurance or medical bills related to your cancer, its treatment, or the lasting effects of that treatment?" Those who answered "Yes" were coded as having inadequate health insurance literacy and those who responded "No" were coded as having adequate HIL.
Baseline and post-intervention at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jean Edward

Collaborators

University of California, Davis

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99798

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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