HER2-positive Breast Cancer
Conditions
Keywords
HER2-positive Breast Cancer, work productivity, health-related quality of life
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Taiwan Epidemiology Association
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Work Productivity and Activity Impairment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-5L | 1 year | 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. |
| EQ Visual Analogue scale (EQ VAS) | 1 year | The EQ VAS records the respondent's self-rated health on a visual analogue scale. |
| Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) | 1 year | 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). |
| Demographics | 1 year | age, gender, height, weight, marital status, education level, employment status, monthly household income, and family history of breast cancer |
| Site of survey administration | 1 year | north, central and south |
Countries
Taiwan
Contacts
Primary ContactChao-Hsiun Tang, Ph.D
Outcome results
None listed