Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a non-interventional observational, multi-center cohort study with primary prospective data collection. This study will be conducted at approximately 10 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, before treatment), during chemotherapy (T1, after 2 cycles), 1-month after completion of chemotherapy (T2) and at 12-month follow-up (T3). The PRO instruments will be captured by electronic devices through WeChat mini-program which are input by patients, before or after their clinic visit but before administration of anti-HER2 therapy. Paper questionnaires will be available only as a last option if the electronic devices cannot be used for any reason (such as issues with internet access or if the device is not working). Oncology staff provided no assistance with filling in the questionnaires, but a prerecorded video will provide a detailed explanation of the questionnaires before the ePRO questionnaires. The PROs data will be restored centrally at the server of the leading site. The usage of PROs is considered non-interventional according to local regulation. PRO measures include EORTC QLQ-C30, PDQ-5 (cognitive), PHQ-9 (depression), GAD-7 (anxiety) and Insomnia Severity Index (ISI). Patient satisfaction for subcutaneous injection will be assessed using TASQ-SC at T3.

Official Title
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Real World Patient-Reported Outcomes in Chinese Her2+ Early Breast Cancer Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy

Conditions
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HER2-positive Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥18 years; Women; 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. Exclusion Criteria: 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; Men.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC QLQ-C30 score | 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. | Through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDQ-5 score | Perceived Deficits Questionnaire to capture decline in cognitive function. 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  never for 0 score, rarely for 1 score,  sometimes for 2 score and  often for 3 score, almost alwaysfor 4 score. A higher score indicated a more serious decline in cognitive function. | Through study completion, an average of 1 year. | 
| PHQ-9 score | Patient Health Questionnaire to measure the severity of depression. 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 0 score, several days  for 1 score,  more than half the days  for 2 score and  nearly every day  for 3 score. A higher score indicated a worse state. | Through study completion, an average of 1 year. | 
| GAD-7 score | GAD-7 (Generalized Anxiety Disorder-7) questionnaire to evaluate anxiety: includes scores for all 7 items and date of self-assessment at T0 to T3. 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 0 score, several days  for 1 score,  more than h | Through study completion, an average of 1 year. | 
| ISI score | ISI (Insomnia Severity Index) questionnaire to evaluate Insomnia Severity: includes scores for all 7 items and date of self-assessment . Participants report the extent to which they have experienced those symptoms or problems during the past two weeks. Each of the symptoms or problems is indicated with four extents, the total value range from 0 to 21, and higher scores mean a more severe insomnia. | Through study completion, an average of 1 year. | 
| TASQ-SC score | Therapy Administration Satisfaction Questionnaire is a 12-item questionnaire measuring the impact of each mode of treatment administration on five domains: physical impact, psychological impact, impact on activities of daily living, convenience, and satisfaction. Each of the domain/scale scores is scored on a 1-100 scale, where 0 is worst and 100 is best. | Through study completion, an average of 1 year. |