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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

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.


Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Tw HER2 Positive Breast Cancer Productivity & Utility Study
Actual Study Start Date : December 24, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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



Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. Demographics [ Time Frame: 1 year ]
    age, gender, height, weight, marital status, education level, employment status, monthly household income, and family history of breast cancer

  5. Site of survey administration [ Time Frame: 1 year ]
    north, central and south



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HER2 POSITIVE BREAST CANCER
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011085


Contacts
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Contact: Chao-Hsiun Tang, Ph.D +886-2-66382736 ext 1017 hsiun.tang@gmail.com

Locations
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Taiwan
National Taiwan University hospital Recruiting
Taipei, Taiwan, 100
Contact: Ching-Hung Lin, Ph.D         
Sponsors and Collaborators
Taiwan Epidemiology Association
Investigators
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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
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Responsible Party: Taiwan Epidemiology Association
ClinicalTrials.gov Identifier: NCT04011085    
Other Study ID Numbers: ML40952
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taiwan Epidemiology Association:
HER2-positive Breast Cancer
work productivity
health-related quality of life
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases