NCT07443839

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Mar 2025Dec 2026

Study Start

First participant enrolled

March 24, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

February 24, 2026

Last Update Submit

March 3, 2026

Conditions

Financial StressOncology Patients

Keywords

Financial toxicityHardshipCost conversations

Outcome Measures

Primary Outcomes (7)

  • Number of participants enrolled

    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

    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

    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)

    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)

    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)

    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

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

    12 months

Secondary Outcomes (3)

  • Number of Participants Receiving Financial Benefit

    12 months

  • Single Item Literacy Screener (SILS)

    Baseline and post-intervention at 12 months

  • Health Insurance Literacy (HIL)

    Baseline and post-intervention at 12 months

Study Arms (1)

Adult patient or caregiver of patient with cancer diagnosis

EXPERIMENTAL

legal navigation program in oncology care

Other: oncology legal navigation services

Interventions

oncology legal navigation servicesOTHER

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

Adult patient or caregiver of patient with cancer diagnosis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

MeSH Terms

Conditions

Financial Stress

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Jean Edward, PhD, RN

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Edward, PhD, RN

CONTACT

8593235815jean.edward@uky.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 2, 2026

Study Start

March 24, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)