Evaluation of the Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Material domain of financial toxicity
研究概览
简要总结
The goal of this study is to access the impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China.
The main questions it aims to answer are:
- Does the intervention alleviate participants' financial toxicity?
- Does the intervention enhance participants' cost-related health literacy?
- Does the intervention improve participants' shared decision-making?
- Does the intervention reduce participants' perceived stress?
Researchers will compare the financial navigation program with usual oncology care to evaluate its effectiveness.
Participants will receive the comprehensive financial navigation, including:
- Needs assessment;
- Cost-related health education, mainly including topics regarding communication of cost, treatment-related cost, health insurance policies, and family support;
- Resource and service referral;
- Personalized counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with breast cancer and undergoing surgery during this admission;
- •Female, age 18 years or older;
- •Receiving or expected to receive one or more of the following therapies: chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy;
- •Eastern Cooperative Oncology Group Performance Status 0-2;
- •Provided informed consent to participate in this study.
排除标准
- •Diagnosed with ductal carcinoma in situ (DCIS)
- •Presence of any serious psychiatric disorders;
- •Cognitive impairments;
- •Difficulty in reading, writing, or communicating in Chinese.
研究组 & 干预措施
Financial Navigation
Participants will receive financial navigation service, including
- Needs Assessment: provide a brief introduction of cancer-related FT and assess patients' information needs using a self-made cost-related health literacy questionnaire;
- Cost-Related Health Education: mainly include topics regarding communication of cost, treatment-related cost, health insurance policies, and family support;
- Resource and Service Referral: promote timely referral to financial assistance programs and clinical professionals when identify unaddressed problems;
- Personalized Counseling Module: provide one-on-one counseling for symptom management, cost-related issues, and coping strategies.
干预措施: Financial Navigation (Behavioral)
Usual Care
Participants will receive usual care during hospitalization and regular follow-up after discharge. Participants have the freedom to utilize any financial resources, but financial navigators do not offer comprehensive information support. When participants actively inquire about cancer treatment-related costs or financial planning strategies, financial navigators will answer their questions.
干预措施: Usual Care (Other)
结局指标
主要结局
Material domain of financial toxicity
时间窗: 1st month and 3rd month since baseline
Material domain of financial toxicity will be measured with 2 items adapted from the Medical Expenditure Panel Survey (MEPS).
Financial toxicity
时间窗: Baseline, 1st month and 3rd month since baseline
Financial toxicity will be measured with the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy Version 2 (COST-FACIT-V2); lower scores (range, 0-44) indicating greater financial toxicity.
Behavioral domain of financial toxicity
时间窗: 1st month and 3rd month since baseline
Behavioral domain of financial toxicity will be measured by employment changes and cost-related nonadherence with 6 items adapted from MEPS and previous literature.
次要结局
- Perceived stress(Baseline, 1st month and 3rd month since baseline)
- Shared decision-making(Baseline, 1st month and 3rd month since baseline)
- Cost-related health literacy(Baseline, 1st month and 3rd month since baseline)
研究者
Xiaoyi Yuan
Principal Investigator
Fudan University