Tw HER2 Positive Breast Cancer Productivity & Utility Study

HER2-positive Breast Cancer Clinical Trial

Official title:

Tw HER2 Positive Breast Cancer Productivity & Utility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04011085
• Other study ID #: ML40952
• Status: Recruiting
• Start date: December 24, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2019
• Source: Taiwan Epidemiology Association
• Contact: Chao-Hsiun Tang, Ph.D
• Phone: +886-2-66382736
• Email: hsiun.tang[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Locations

Country	Name	City	State
Taiwan	National Taiwan University hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taiwan Epidemiology Association

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	EQ Visual Analogue scale (EQ VAS)	The EQ VAS records the respondent's self-rated health on a visual analogue scale.	1 year
Secondary	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
Secondary	Demographics	age, gender, height, weight, marital status, education level, employment status, monthly household income, and family history of breast cancer	1 year
Secondary	Site of survey administration	north, central and south	1 year