Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Eligibility rate
研究概览
简要总结
The goal of this pilot study is to access the feasibility and 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:
- Is the intervention feasible and acceptable among participants?
- Does the intervention enhance participants' cost-related health literacy?
- Does the intervention reduce participants' financial toxicity?
Researchers will compare the financial navigation program with usual oncology care to preliminarily evaluate its effectiveness.
Participants will receive comprehensive information support, including:
- Strategies on patient-physician costs discussion
- Skills for inquiring and tracking treatment-related costs
- Basic knowledge about health insurance
- Guidance on accessing and applying for financial assistance
- Suggestions for returning to normal life and work
- Strategies for holding a financial-related family meeting
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
- •(1) Newly diagnosed with breast cancer and undergoing surgery during this admission;
- •(2) Female, age 18 years or older;
- •(3) Receiving or expected to receive one or more of the following therapies: chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy;
- •(4) Eastern Cooperative Oncology Group Performance Status 0-2;
- •(5) Provided informed consent to participate in this study.
排除标准
- •(1) Diagnosed with ductal carcinoma in situ (DCIS)
- •(2) Presence of any serious psychiatric disorders;
- •(3) Cognitive impairments;
- •(4) Difficulty in reading, writing, or communicating in Chinese.
结局指标
主要结局
Eligibility rate
时间窗: Approximately 1 month
The eligibility rate will be calculated as the proportion of participants who meet the eligibility criteria among the total number of participants who will be assessed for eligibility. Reasons for participants' ineligibility will be recorded.
Consent rate
时间窗: Approximately 1 month
The consent rate will be calculated as the proportion of eligible participants who consent to participate among those who will be approached and eligible for participation. Reasons for participants' refusal to participate will be recorded.
Attrition rate
时间窗: Through study completion, an average of 3 month
The attrition rate will be calculated as the percentage of participants who withdraw from or drop out of the study after enrolment. Reasons for participants' withdrawal or dropout will be recorded.
Patient-reported satisfaction
时间窗: 1 month after discharge in Financial Navigation Arm
Participants' satisfaction will be measured with homemade 5 item questionnaire, with higher scores indicating higher satisfaction.
Adherence rate
时间窗: Through study completion, an average of 3 month
The adherence rate will be calculated as the proportion of participants completing the entire program. Reasons for participants' nonadherence to the intervention will be recorded.
Qualitative assessment of the intervention
时间窗: 1 month after discharge in Financial Navigation Arm
Participants' experiences will be captured through one-on-one, semi-structured qualitative interviews.
次要结局
- Material domain of financial toxicity(1st month since baseline)
- Behavioral domain of financial toxicity(1st month since baseline)
- Cost-related health literacy(Baseline, 1st month since baseline)
- Financial toxicity(Baseline, 1st month since baseline)
研究者
Xiaoyi Yuan
Principal Investigator
Fudan University