Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05738252
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2023-01-31
Brief Title:
Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients
Sponsor:
Population Health Research Institute
Organization:
Population Health Research Institute
Study Overview
Official Title:
Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients Undergoing Surgery and Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-06
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:
FARGO
Brief Summary:
FARGO is a prospective cohort study that aims to determine the performance of preoperative frailty assessment based on the Frailty Phenotype FP compared to a perioperative cardiovascular risk assessment based on the combination of preoperative Revised Cardiac Risk Index RCRI age and occurrence of myocardial injury after noncardiac surgery MINS in predicting the composite of all-cause death or new disability at 6 months after surgery in patients aged 55 or older Patients will have confirmed or suspected gynecologic cancer undergoing cytoreductive or high-risk surgery with or without chemotherapy
Detailed Description:
Little is known about how to best predict postoperative outcomes recovery from complications and chemotherapy tolerance in an increasingly older and medically complex GO population Measuring frailty may represent a comprehensive tool for risk prediction The study 1 will help fill the current gap in knowledge 2 will translate into clinical practice changes both locally and when replicated in a larger multi-centre study elsewhere in Canada and worldwide and 3 will inform future studies on shared decision-making strategies and interventions
By evaluating the role of frailty as a static or dynamic predictor of patient important outcomes and by considering the complexity of these patients and also of their treatment trajectories the study has the potential to fill those gaps and influence how care is delivered By involving stakeholders in the evaluation of feasibility and acceptability of frailty assessment this will inform a change in care that is sustainable innovative and patient-centred
There have been substantial knowledge advancements about perioperative risk factors and the long-term impact of postoperative complications however oncology patients and patient-reported outcomes have been insufficiently studied There is increased literature on frailty assessment in noncardiac surgery however studies that included GO patients are few and of low-quality The study will overcome the limitations of the current knowledge and practice and will potentially change healthcare delivery
By evaluating the role of frailty as a static or dynamic predictor of patient important outcomes and by considering the complexity of these patients and also of their treatment trajectories the study has the potential to fill those gaps and influence how care is delivered By involving stakeholders in the evaluation of feasibility and acceptability of frailty assessment this will inform a change in care that is sustainable innovative and patient-centred
There have been substantial knowledge advancements about perioperative risk factors and the long-term impact of postoperative complications however oncology patients and patient-reported outcomes have been insufficiently studied There is increased literature on frailty assessment in noncardiac surgery however studies that included GO patients are few and of low-quality The study will overcome the limitations of the current knowledge and practice and will potentially change healthcare delivery
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