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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.
| Condition or disease |
|---|
| HER2-positive Breast Cancer |
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 |
| 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 |
| Group/Cohort |
|---|
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Group1
Patients currently undergoing treatment for early breast cancer (either targeted HER2 therapy and chemotherapy OR targeted HER therapy alone)
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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)
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Group3
Patients receiving treatment for metastatic breast cancer
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- 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
- 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
| 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 |
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
| Contact: Chao-Hsiun Tang, Ph.D | +886-2-66382736 ext 1017 | hsiun.tang@gmail.com |
| Taiwan | |
| National Taiwan University hospital | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Ching-Hung Lin, Ph.D | |
| 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 |
| 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 |
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
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures |
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| 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. |
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| 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 | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| 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 |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Taiwan Epidemiology Association | |||||||||
| Study Sponsor | Taiwan Epidemiology Association | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | Taiwan Epidemiology Association | |||||||||
| Verification Date | July 2019 | |||||||||
