Tw HER2 Positive Breast Cancer Productivity & Utility Study
Breast cancer ranks top 4 Taiwan mortality cause in 2016 and the incidence rate has been increasing. Since advances in screening and treatment over last decades, disease-free survival in HER2 positive breast cancer improved and relapse rates decrease as well. While health-related quality of life (HRQoL) and productivity benefit is not currently formally assessed by Taiwan Health Technology Agency (HTA) in Taiwan, the value of therapy in terms of a wider societal benefit is a critical factor which is increasingly being considered as part of the overall assessment of the value of a new medicine.
Sort of productivity study in cancer is lack of in Taiwan. Referenced Roche UK team published comprehensive productivity studies1 Taiwan Epidemiology Association wants to initiate study to understand holistic value in each stage of breast cancer and quantify the value of new drug to support HTA assessment.
The data will be collected through study, and adapt to cost-effectiveness model for future reimbursement submission.
研究概览
地位
条件
详细说明
Breast cancer ranks top 4 Taiwan mortality cause in 2016 and the incidence rate has been increasing. Since advances in screening and treatment over last decades, disease-free survival in HER2 positive breast cancer improved and relapse rates decrease as well. While health-related quality of life (HRQoL) and productivity benefit is not currently formally assessed by Taiwan Health Technology Agency (HTA) in Taiwan, the value of therapy in terms of a wider societal benefit is a critical factor which is increasingly being considered as part of the overall assessment of the value of a new medicine.
Sort of productivity study in cancer is lack of in Taiwan. Referenced Roche UK team published comprehensive productivity studies1 Taiwan Epidemiology Association wants to initiate study to understand holistic value in each stage of breast cancer and quantify the value of new drug to support HTA assessment.
The data will be collected through study, and adapt to cost-effectiveness model for future reimbursement submission.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Taipei、台湾、100
- 招聘中
- National Taiwan University Hospital
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接触：
- Ching-Hung Lin, Ph.D
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Aged 18 years or over;
- Diagnosed with early stage or metastatic (Stage IV) HER2-positive breast cancer (confirmed by the study site physician). [HER2-positive is defined as IHC3+ and/or ISH≥2.0]
- eBC patients should have received at least 2 cycles of adjuvant anti-cancer therapy following surgery at time of interview; metastasis breast cancer (mBC) patients should have received at least 1 cycle of treatment for their metastatic disease at time of interview.
- Able to provide written, informed consent.
Exclusion Criteria:
- Patients with ECOG performance status (PS) ≥3
- Unwilling or unable to provide written, informed consent
- Unable to complete written quality of life questionnaires
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Group1
Patients currently undergoing treatment for early breast cancer (either targeted HER2 therapy and chemotherapy OR targeted HER therapy alone)
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Group2
Patients with early breast cancer who have completed treatment and are in disease-free survival (i.e.
no longer receiving locoregional treatment, chemotherapy or targeted HER2 therapy; patients may still be receiving hormone therapy)
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Group3
Patients receiving treatment for metastatic breast cancer
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Work Productivity and Activity Impairment
大体时间：1 year
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• Percent work time missed due to health: Hours missed due to health problems/(Hours missed due to health problems+ Hours actually worked) • Percent impairment while working due to health: Degree health affected productivity while working/10 • Percent overall work impairment due to health: Hours missed due to health problems/(Hours missed due to health problems+ Hours actually worked)+[(1-( hours missed due to health problems/( hours missed due to health problems+ hours actually worked)))x(degree health affected productivity while working/10)] • Percent activity impairment due to health: Degree health affected regular activities/10 |
1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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EQ-5D-5L
大体时间：1 year
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The descriptive system of EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
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1 year
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EQ Visual Analogue scale (EQ VAS)
大体时间：1 year
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The EQ VAS records the respondent's self-rated health on a visual analogue scale.
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1 year
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Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)
大体时间：1 year
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the FACT-B consists of the following subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB), social/family well-being (SWB), and breast cancer-specific concerns (BCS).
A total FACT-B score is calculated by summing the subscales.
The instrument has a total of 41 items asking respondents to rate how true each statement is for the last 7 days.
Response scales range from 0 (not at all) to 4 (very much).
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1 year
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Demographics
大体时间：1 year
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age, gender, height, weight, marital status, education level, employment status, monthly household income, and family history of breast cancer
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1 year
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Site of survey administration
大体时间：1 year
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north, central and south
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1 year
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合作者和调查者
调查人员
- 学习椅：Ching-Hung Lin, Ph.D、National Taiwan University Hospital
- 学习椅：Liang-Chih Liu, Ph.D、China Medical University Hospital
- 学习椅：Ming-Feng Hou, M.D.、Kaohsiung Medical University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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