Quality of Life in Chinese Postmenopausal HR(+) Early Breast Cancer (EBC) Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment

A Prospective, Multicenter, Non-interventional Study to Evaluate Quality of Life in Chinese Postmenopausal HR(+) EBC Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01144572

Acronym

BC Qol NIS

Enrollment

494

Registered

2010-06-15

Start date

2010-07-31

Completion date

2013-10-31

Last updated

2014-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Quality of Life, postmenopausal HR(+), Early Breast Cancer, adjuvant AI treatment, Quality of Life in Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Postmenopausal women ≤ 70 years old, with histologically proven HR (+) early breast cancer. * Undergoing upfront AIs adjuvant treatment within 7 days.

Exclusion criteria

* Patients who disagree to participate this study * Patients who, for whatever reason (eg, confusion, infirmity), are unlikely to comply with trial requirements. * The AIs have not been approved by SFDA for the indication of upfront adjuvant endocrine therapy in early breast cancer.

Design outcomes

Primary

Measure	Time frame
The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months.	24 months

Secondary

Measure	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	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

Countries

China

Outcome results