Real World Patient-Reported Outcomes in Chinese Her2+ Early Breast Cancer Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- EORTC QLQ-C30 score
研究概览
简要总结
This is a non-interventional observational, multi-center cohort study to evaluate patient-reported outcomes in Chinese HER2+ early breast cancer patients undergoing (neo) adjuvant anti-HER2 based therapy and describe changes over time, from baseline to 12 months.
详细描述
This is a non-interventional observational, multi-center cohort study with primary prospective data collection. This study will be conducted at approximately 9 sites in China.
The study population is Chinese HER2+ early breast cancer patients receiving (neo) adjuvant anti-HER2 based therapy.
Patients who are eligible for (neo) adjuvant anti-HER2 based therapy will enroll in this study.
Treatment choice in this non-interventional study will be at the discretion of the treating physician as per CACA-CBCS guidelines.
Participants are longitudinally assessed at baseline (T0, prior to treatment), mid-chemotherapy (T1, after 2 cycles), 1-month post-chemotherapy (T2) and at 12-month follow-up (T3).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years;
- •Have signed the informed consent form as per local regulations;
- •Newly diagnosed with non-metastatic breast cancer (stage I-II-III, HER2+) at the time of starting anti-HER2 therapy;
- •Be able to comply with the follow-up visits, assessments, answering questionnaires.
排除标准
- •Metastatic breast cancer;
- •Prior systemic treatment for any malignancy;
- •Active secondary cancer requiring anti-HER2 therapy;
- •Vulnerable populations [e.g., decisional impaired (cognitive, psychiatric), terminally ill, prisoners], or patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent;
结局指标
主要结局
EORTC QLQ-C30 score
时间窗: Through study completion, an average of 1 year.
EORTC QLQ C30 /+ BR23(EORTC breast cancer-specific quality of life) questionnaire to evaluate quality of life. Participants report the extent to which they have experienced those symptoms or problems during the past week. Each of the symptoms or problems is indicated with four extents, including "not at all" for 1 score, "a little" for 2 score, "quit a bit" for 3 score and "very much" for 4 score. A higher score indicated a worse quality of life.
EORTC QLQ-C30 Summary Score
时间窗: Through study completion, an average of 1 year.
EORTC QLQ C30 questionnaire to evaluate quality of life. The EORTC QLQ-C30 is a 30-item questionnaire consisting of five multi-item functional subscales (physical, role, cognitive, emotional, and social), three multi-item symptom subscales (fatigue, pain, nausea and vomiting), and six single-item symptom subscales (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), in addition to a two-item subscale for global health status. After linear transformation, all subscales range in score from 0-100. The EORTC QLQ-C30 summary score was calculated from the mean of 13 component subscales, excluding global health status and financial difficulties, if all 13 included subscales are non-missing. Prior to calculating the mean, symptom subscales were reversed to obtain a consistent direction for all subscales. Therefore, a higher summary score indicates higher HRQoL.
次要结局
- PDQ-5 score(Through study completion, an average of 1 year.)
- PHQ-9 score(Through study completion, an average of 1 year.)
- GAD-7 score(Through study completion, an average of 1 year.)
- ISI score(Through study completion, an average of 1 year.)
- TASQ-SC score(Through study completion, an average of 1 year.)
- EORTC QLQ-C30(Through study completion, an average of 1 year.)