Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161922
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-14
Brief Title:
Real World Patient-Reported Outcomes in Chinese Her2 EBC Patients Receiving Neo Adjuvant Anti-Her2 Based Therapy
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Real World Patient-Reported Outcomes in Chinese Her2 Early Breast Cancer Patients Receiving Neo Adjuvant Anti-Her2 Based Therapy
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None