Tw HER2 Positive Breast Cancer Productivity & Utility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Work Productivity and Activity Impairment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •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.
排除标准
- •Patients with ECOG performance status (PS) ≥3
- •Unwilling or unable to provide written, informed consent
- •Unable to complete written quality of life questionnaires
结局指标
主要结局
Work Productivity and Activity Impairment
时间窗: 1 year
• 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
次要结局
- EQ-5D-5L(1 year)
- EQ Visual Analogue scale (EQ VAS)(1 year)
- Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)(1 year)
- Demographics(1 year)
- Site of survey administration(1 year)