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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Patients currently undergoing treatment for early breast cancer (either targeted HER2 therapy and chemotherapy OR targeted HER therapy alone) | ||
| 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) | ||
| Group3 | Patients receiving treatment for metastatic breast cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Work Productivity and Activity Impairment | • 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 |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D-5L | 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. | 1 year |
| EQ Visual Analogue scale (EQ VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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HER2 POSITIVE BREAST CANCER
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao-Hsiun Tang, Ph.D | Contact | +886-2-66382736 | 1017 | hsiun.tang@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ching-Hung Lin, Ph.D | National Taiwan University Hospital | Study Chair |
| Liang-Chih Liu, Ph.D | China Medical University Hospital | Study Chair |
| Ming-Feng Hou, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University hospital | Recruiting | Taipei | 100 | Taiwan |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 19, 2021 | |
| Reset | Jun 14, 2021 | |
| Release | Oct 23, 2021 | |
| Reset | Nov 29, 2021 | |
| Release | Dec 26, 2021 | |
| Reset | Mar 11, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 19, 2021 | Jun 14, 2021 | |||
| Oct 23, 2021 |
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The EQ VAS records the respondent's self-rated health on a visual analogue scale. |
| 1 year |
| Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) | 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). | 1 year |
| Demographics | age, gender, height, weight, marital status, education level, employment status, monthly household income, and family history of breast cancer | 1 year |
| Site of survey administration | north, central and south | 1 year |
| Kaohsiung Medical University |
| Study Chair |
| Nov 29, 2021 |
| Dec 26, 2021 | Mar 11, 2022 |