Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089083
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-12
Brief Title:
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2023-10
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:
PROOF
Brief Summary:
This study seeks to understand how frailty a term that describes people who are more vulnerable stressors such as a new medical problem affects the outcomes and quality of life in adult patients with gynecologic cancer
Detailed Description:
PRIMARY OBJECTIVE
I Assess the risk factors associated with frailty in newly diagnosed gynecologic cancer participants
SECONDARY OBJECTIVES
I Compare primary quality of life endpoint of healthy days at home between non-frail and frail participants primary quality of life endpoint
II Compare other perioperative oncologic and quality of life outcomes between non-frail and frail participants
OUTLINE This is an observational study
All new patients being evaluated for a new diagnosis of gynecologic cancer by the University of California San Francisco UCSF Gynecologic Oncology service and the Dana-Farber Cancer Institute will be recruited in both the outpatient or inpatient setting Study participants will be enrolled at the time of diagnosis and followed for up to one year after undergoing surgery for cancer
I Assess the risk factors associated with frailty in newly diagnosed gynecologic cancer participants
SECONDARY OBJECTIVES
I Compare primary quality of life endpoint of healthy days at home between non-frail and frail participants primary quality of life endpoint
II Compare other perioperative oncologic and quality of life outcomes between non-frail and frail participants
OUTLINE This is an observational study
All new patients being evaluated for a new diagnosis of gynecologic cancer by the University of California San Francisco UCSF Gynecologic Oncology service and the Dana-Farber Cancer Institute will be recruited in both the outpatient or inpatient setting Study participants will be enrolled at the time of diagnosis and followed for up to one year after undergoing surgery for cancer
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-07434 | REGISTRY | NCI Clinical Trials Reporting Program CTRP | None |