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The purpose of the study is to evaluate quality of life (Qol) in postmenopausal HR (+) EBC patients during adjuvant AIs treatment in terms of: the change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months. This study will recruit approximately 500 patients from 21 sites in China. The patients should be postmenopausal HR (+) EBC patients who have already start adjuvant AIs treatment but within 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 6 months, 12 months and 18 months | 6-18 months | |
| The change of the emotional well-being (EWB) subscales score of the FACT-B questionnaire from baseline to 6 months, 12 months, 18 months and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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The eligible patients will be recruited when they start their upfront AIs adjuvant treatment within 7 days.
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Shao Zhimin | Fudan University | Principal Investigator |
| Karen Atkin | AstraZeneca | Study Director |
| Xu Johnson | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | Beijing Municipality | China | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27009092 | Derived | Cao A, Zhang J, Liu X, Wu W, Liu Y, Fan Z, Zhang A, Zhou T, Fu P, Wang S, Ouyang Q, Tang J, Jiang H, Zhang X, Pang D, He J, Shi L, Wang X, Sheng Y, Mao D, Shao Z. Health-related quality of life of postmenopausal Chinese women with hormone receptor-positive early breast cancer during treatment with adjuvant aromatase inhibitors: a prospective, multicenter, non-interventional study. Health Qual Life Outcomes. 2016 Mar 24;14:51. doi: 10.1186/s12955-016-0446-2. |
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| 6-18 months |
| The change of the social well-being (SWB) subscales score of the FACT-B questionnaire from baseline to 6 months, 12 months, 18 months and 24 months. | 6-18 months |
| Guangzhou |
| Guangdong |
| China |
| Research Site | Shenzhen | Guangdong | China |
| Research Site | Guiyang | Guizhou | China |
| Research Site | Harbin | Heilongjiang | China |
| Research Site | Changsha | Hunan | China |
| Research Site | Nanjing | Jiangsu | China |
| Research Site | Changchun | Jilin | China |
| Research Site | Shanghai | Shanghai Municipality | China |
| Research Site | Xi’an | Shanxi | China |
| Research Site | Tianjin | Tianjin Municipality | China |
| Research Site | Kunming | Yunnan | China |
| Research Site | Hangzhou | Zhejiang | China |
| Research Site | Ningbo | Zhejiang | China |
| Research Site | Wenzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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