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Completed

NCT Number: NCT07443839

Oncology Legal Navigation Study

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.

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Key information

Conditions

Financial Stress Behavior Behavioral Symptoms Oncology Patients Stress, Psychological

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

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

  • 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

Treatment and study plan

oncology legal navigation services

Other

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

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. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Resolution of legal Issue

    Time frame: 12 months

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

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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Jean Edward

Other

Collaborators

  • University of California, Davis

Registry information

Official study title

Oncology Legal Navigation- Medical Legal Partnership

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Jul 16, 2026

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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