Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, Davis | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patient or caregiver of patient with cancer diagnosis | Experimental | legal navigation program in oncology care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oncology legal navigation services | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Receiving Financial Benefit | financial benefit defined as economic hardship avoided or decreased public/government income | 12 months |
| Single Item Literacy Screener (SILS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean Edward, PhD, RN | Contact | 8593235815 | jean.edward@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jean Edward, PhD, RN | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40506 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086522 | Financial Stress |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
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.
| 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. | Baseline and post-intervention at 12 months |