Clinical trial NCT06161922: Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
Official title: Real World Patient-Reported Outcomes in Chinese Her2+ Early Breast Cancer Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HER2-positive Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: EORTC QLQ-C30 score
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: PDQ-5 score
timeFrame: Through study completion, an average of 1 year.
measure: PHQ-9 score
timeFrame: Through study completion, an average of 1 year.
measure: GAD-7 score
timeFrame: Through study completion, an average of 1 year.
measure: ISI score
timeFrame: Through study completion, an average of 1 year.
measure: TASQ-SC score
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
measure: Demographics characteristics
timeFrame: Through study completion, an average of 1 year.
measure: Socio-economic status
timeFrame: Through study completion, an average of 1 year.
measure: Clinical characteristics
timeFrame: Through study completion, an average of 1 year.
measure: Treatment sequence (neoadjuvant vs adjuvant) checklist
timeFrame: Through study completion, an average of 1 year.
measure: Clinical treatment checklist
timeFrame: Through study completion, an average of 1 year.
Locations:
city: Shanghai
country: China
facility: Keda Yu
Study officials:
affiliation: Fudan University
name: Keda Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: