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Tw HER2 Positive Breast Cancer Productivity & Utility Study

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ClinicalTrials.gov Identifier: NCT04011085
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Taiwan Epidemiology Association

Tracking Information
First Submitted Date April 10, 2019
First Posted Date July 8, 2019
Last Update Posted Date July 8, 2019
Actual Study Start Date December 24, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 5, 2019)
Work Productivity and Activity Impairment [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 5, 2019)
  • EQ-5D-5L [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]
    north, central and south
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tw HER2 Positive Breast Cancer Productivity & Utility Study
Official Title Tw HER2 Positive Breast Cancer Productivity & Utility Study
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population HER2 POSITIVE BREAST CANCER
Condition HER2-positive Breast Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 5, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Chao-Hsiun Tang, Ph.D +886-2-66382736 ext 1017 hsiun.tang@gmail.com
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04011085
Other Study ID Numbers ML40952
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Taiwan Epidemiology Association
Study Sponsor Taiwan Epidemiology Association
Collaborators Not Provided
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
PRS Account Taiwan Epidemiology Association
Verification Date July 2019