Tw HER2 Positive Breast Cancer Productivity & Utility Study

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.

Study Overview

• Status: Unknown
• Conditions: HER2-positive Breast Cancer

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Ching-Hung Lin, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

HER2 POSITIVE BREAST CANCER

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Taiwan Epidemiology Association
• Investigators: Study Chair: 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., Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 5, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: health-related quality of life; HER2-positive Breast Cancer; work productivity
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ML40952

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No