Oncology Legal Navigation Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorJean Edward
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Unable to provide consent
Trial design
Design model
Single group
Treatments tested in this trial
oncology legal navigation services
Other interventionParticipants 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
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Adult patient or caregiver of patient with cancer diagnosisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 months4
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 monthsSecondary outcomes
1
Number of Participants Receiving Financial Benefit
financial benefit defined as economic hardship avoided or decreased public/government income
Time frame
12 months2
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 months3
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jean Edward
Lead sponsor
University of Kentucky
Sponsor institution
University of California, Davis
Collaborator
Source ClinicalTrials.gov