An interventional study of oncology legal navigation services in Financial Stress and Oncology Patients, sponsored by Jean Edward. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Jean Edward · Not applicable, Interventional, and Health services research
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.
93 studies on the registry are indexed under Financial Stress; 32 are open to participants now.
This study's enrollment of 70 is below the median of 124 across 55 interventional studies indexed under Financial Stress.
Browse Financial Stress studies →Jean Edward is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 12 months
Number of Participants Receiving Financial Benefit
financial benefit defined as economic hardship avoided or decreased public/government income
Time frame: 12 months
Single Item Literacy Screener (SILS)
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.
Time frame: Baseline and post-intervention at 12 months
Health Insurance Literacy (HIL)
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.
Time frame: Baseline and post-intervention at 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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