Financial StressNCT07443839
Oncology Legal Navigation Study
A study testing oncology legal navigation services in people with Financial Stress and Oncology Patients, run by Jean Edward at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Financial Stress, Oncology Patients
- What is being tested?
- oncology legal navigation services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oncology Legal Navigation- Medical Legal Partnership
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.
- Conditions
- Financial Stress, Oncology Patients
- Being tested
- oncology legal navigation services
- Keywords
- Financial toxicity, Hardship, Cost conversations
- Medical subject headings
- Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Adult patient or caregiver of patient with cancer diagnosis | Experimental | legal navigation program in oncology care Receives: Other: oncology legal navigation services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
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.
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
Measured: 12 months
Secondary outcomes (3)
Number of Participants Receiving Financial Benefit
financial benefit defined as economic hardship avoided or decreased public/government income
Measured: 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.
Measured: 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.
Measured: Baseline and post-intervention at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start24 Mar 2025
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Financial StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean Edward
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor-investigator, Jean Edward, University of Kentucky
- Investigators
- Jean Edward, PhD, RN, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443839
- Sponsor's protocol ID
- 99798
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncology Legal Navigation- Medical Legal Partnership
- ClinicalTrials.gov ID
- NCT07443839
- Acronym / sponsor ID
- 99798
- Conditions
- Financial Stress, Oncology Patients
- Keywords
- Financial toxicity, Hardship, Cost conversations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Jean EdwardUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patient or caregiver of patient with cancer diagnosis | Experimental | Other: oncology legal navigation serviceslegal navigation program in oncology care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oncology legal navigation servicesParticipants 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 | Other | Adult patient or caregiver of patient with cancer diagnosis |
Primary outcome
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)
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
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.
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.
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.
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.
Resolution of legal Issue
Time frame: 12 months
Number of participants that resolved a legal or financial case as a result of the intervention
3 secondary outcomes
Number of Participants Receiving Financial Benefit
Time frame: 12 months
Single Item Literacy Screener (SILS)
Time frame: Baseline and post-intervention at 12 months
Health Insurance Literacy (HIL)
Time frame: Baseline and post-intervention at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Edward, PhD, RN principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oncology legal navigation services in people with Financial Stress and Oncology Patients, run by Jean Edward at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants enrolled (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.