Clinical trial NCT04011085: Tw HER2 Positive Breast Cancer Productivity & Utility Study
Official title: Tw HER2 Positive Breast Cancer Productivity & Utility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HER2-positive Breast Cancer
Keywords: HER2-positive Breast Cancer
work productivity
health-related quality of life
Lead sponsor: Taiwan Epidemiology Association
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HER2 POSITIVE BREAST CANCER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Work Productivity and Activity Impairment
timeFrame: 1 year
Secondary outcomes:
measure: EQ-5D-5L
timeFrame: 1 year
measure: EQ Visual Analogue scale (EQ VAS)
timeFrame: 1 year
measure: Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)
timeFrame: 1 year
measure: Demographics
timeFrame: 1 year
measure: Site of survey administration
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ching-Hung Lin, Ph.D
role: STUDY_CHAIR
affiliation: China Medical University Hospital
name: Liang-Chih Liu, Ph.D
role: STUDY_CHAIR
affiliation: Kaohsiung Medical University
name: Ming-Feng Hou, M.D.
role: STUDY_CHAIR
References: