Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05122377
Status:
UNKNOWN
Last Update Posted:
2021-11-16
First Post:
2021-10-29
Brief Title:
RWE About QOL and Compliance of Patients With OFS in China
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
QoL and Treatment Compliance for Pre-menopausal Patients With HR Breast Cancer Using GnRHa as Ovarian Function SuppressionOFS Treatment in the Chinese Population a Real-world Observational Investigation
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
NOT_YET_RECRUITING
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:
The purpose of this study is to assess the patients feedback from using GnRHa depot formulation in postoperative premenopausal patients with hormone receptor-positive breast cancer
Detailed Description:
This was a real world observational study of adjuvant therapy with GnRHa for OFS in postoperative premenopausal women with endocrine responsive breast cancer This trial is designed to compare patients QOL and treatment compliance measured by FACT-B and self-administered questionnaires during OFS treatment period Total score of FACT-B and self-administered questionaries and change from baseline will be calculated and summarized descriptively Change from baseline will be compared between GnRHa 3-month and GnRHa 1-month using ANCOVA model with baseline value as a covariateThe number depends on the patients who received questionnaire during 18 months recruitment in planned 10 sites This analytical plan assumes homogeneity across 10 sites so that strata is not considered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None