HER2-positive Breast Cancer
Conditions
Brief summary
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
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). 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.
Interventions
None listed
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged ≥18 years; 2. Women; 3. Have signed the informed consent form as per local regulations; 4. Newly diagnosed with non-metastatic breast cancer (stage I-II-III, HER2+) at the time of starting anti-HER2 therapy; 5. Be able to comply with the follow-up visits, assessments, answering questionnaires.
Exclusion criteria
1. Metastatic breast cancer; 2. Prior systemic treatment for any malignancy; 3. Active secondary cancer requiring anti-HER2 therapy; 4. 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; 5. Men.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EORTC QLQ-C30 Summary Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EORTC QLQ-C30 | Through study completion, an average of 1 year. | Beyond the summary score, the 15 specific subscales of EORTC QLQ-C30 were analyzed to identify changes in quality of life. For functional subscales and global health status, higher scores reflect superior health status, whereas for symptom subscales, higher scores reflect greater symptom severity. |
| PDQ-5 score | Through study completion, an average of 1 year. | 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 always"for 4 score. A higher score indicated a more serious decline in cognitive function. |
| PHQ-9 score | Through study completion, an average of 1 year. | 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. |
| GAD-7 score | Through study completion, an average of 1 year. | 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 |
| ISI score | Through study completion, an average of 1 year. | 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. |
| TASQ-SC score | Through study completion, an average of 1 year. | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORKeda Yu, MD, PhD
Fudan University
Outcome results
None listed