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临床试验/NCT07443839
NCT07443839已完成不适用

Oncology Legal Navigation- Medical Legal Partnership

Jean Edward1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年3月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Number of participants enrolled

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Unable to provide consent

研究组 & 干预措施

Adult patient or caregiver of patient with cancer diagnosis

Experimental

legal navigation program in oncology care

干预措施: oncology legal navigation services (Other)

结局指标

主要结局

Number of participants enrolled

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: 12 months

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

次要结局

  • 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)

研究者

发起方
Jean Edward
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jean Edward

Associate Professor

University of Kentucky

研究点 (1)

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