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Oncology Legal Navigation Study

Oncology Legal Navigation- Medical Legal Partnership

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07443839
Enrollment
70
Registered
2026-03-02
Start date
2025-03-24
Completion date
2026-06-15
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Financial Stress, Oncology Patients

Keywords

Financial toxicity, Hardship, Cost conversations

Brief summary

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.

Interventions

OTHERoncology 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

Sponsors

Jean Edward
Lead SponsorOTHER
University of California, Davis
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants enrolled12 monthsFeasibility was defined as 60% or higher enrolled participant retention and resolution of financial or legal issue (based on existing oncology financial navigation studies)
Acceptability assessed by 5-item surveyPost intervention at 12 monthsAcceptability 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 Total Financial ToxicityBaseline and post intervention,up to 12 monthsMeasured 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)Baseline and post intervention, up to 12 monthsMeasured 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.
Change in Participant Quality of Life (Depression)Baseline and post intervention, up to 12 monthsMeasured 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)Baseline and post intervention, up to 12 monthsMeasured 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.
Resolution of legal Issue12 monthsNumber of participants that resolved a legal or financial case as a result of the intervention

Secondary

MeasureTime frameDescription
Number of Participants Receiving Financial Benefit12 monthsfinancial benefit defined as economic hardship avoided or decreased public/government income
Single Item Literacy Screener (SILS)Baseline and post-intervention at 12 monthsSingle 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.
Health Insurance Literacy (HIL)Baseline and post-intervention at 12 monthsSingle 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJean Edward, PhD, RN

University of Kentucky

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026