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临床试验/NCT04931251
NCT04931251已完成不适用

Addressing Cancer-Related Financial Toxicity in Rural North Carolina Oncology Care Settings

UNC Lineberger Comprehensive Cancer Center16 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2021年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
258
试验地点
16
主要终点
COST (Comprehensive Score for Financial Toxicity) measure

研究概览

简要总结

The financial burden, or financial toxicity (FT), of cancer is a consequential and growing problem, particularly for rural patients. It is important to improve our understanding of how financial navigation (FN) can reduce the material, psychological, and behavioral burden of costs associated with cancer care in both rural and non-rural community settings. The purpose of this study is to conduct a financial navigation program in 5 rural and 4 non-rural oncology practices in North Carolina and evaluate the effects of financial navigation on patient outcomes, including financial toxicity and health-related quality of life.

详细描述

This study is designed to evaluate the implementation and effectiveness of a financial navigation intervention within 5 rural and 4 non-rural oncology settings in North Carolina. Financial navigators from each of the 9 sites will recruit and enroll 255 patients total across all sites into a financial navigation program. The financial navigation intervention consists of screening patients using the COST measure for financial toxicity. If the patient scores 23 or lower, they are considered to have moderate to severe financial toxicity and will be enrolled in the study. Patients will then complete a series of baseline questionnaires to measure their health related quality of life and then they will meet with a financial navigator for a comprehensive intake process to determine potential financial assistance resources the patient may be eligible for and continued visits with the financial navigator until all financial assistance resources have been explored and patients have received benefits or referrals to financial assistance programs. At the end of the intervention, the patients will complete the COST measure again, and repeat baseline surveys to measure health-related quality of life and the patient's acceptability and responsiveness of the financial navigation intervention. Patient participation depends on the depth of patient need but ranges from 2 visits to 6 visits with the financial navigator over approximately 4 months but possibly longer depending on the complexity of the patient's financial need.

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

盲法说明

no masking

入排标准

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

入选标准

  • Patients 18 years of age and older
  • Patients with any type of cancer diagnosed within 5 years and/or living with advanced disease
  • Patients who score 22 or lower on the COST measure indicating high FT
  • Patients must be able to read and speak English

排除标准

  • Participants without a cancer diagnosis
  • Patients diagnosed more than 5 years ago without advanced disease
  • Patients or caregivers under the age of 18
  • Patients who do not sign the consent form
  • Patients who do not complete the baseline COST survey
  • Patients who cannot read and speak English

结局指标

主要结局

COST (Comprehensive Score for Financial Toxicity) measure

时间窗: 4-6 months

To evaluate the change from baseline to follow-up in scores from the Comprehensive Score for Financial Toxicity (COST) measure after participation in the financial navigation program among 780 rural and non-rural NC cancer patients with high baseline financial distress.

次要结局

  • Health-Related Quality of Life (HrQoL) Measures(4-6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (16)

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