Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients
Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients Undergoing Surgery and Chemotherapy
Population Health Research Institute
280 participants
Jun 15, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Age must be 55 years or older at registration
- Must meet any one of the following criteria:
- Have stage II-IV ovarian or endometrial cancer, undergoing cytoreductive surgery via laparotomy, with or without neoadjuvant chemotherapy (NACT)
- Have any stage endometrial, uterine or cervical cancer planned for laparotomy where laparoscopy is deemed unfeasible/high-risk due to comorbidities
- Are undergoing laparotomy for pelvic mass, highly suspicious for malignancy; or
- Are undergoing laparotomy for gynecologic malignancy recurrence.
Exclusion Criteria6
- Unable to provide informed consent
- Require urgent surgery within 24 hours of first consultation to the Gynecological Oncology team
- Are undergoing neoadjuvant radiation therapy
- Have a previously documented history of dementia
- Have cognitive, language, vision, or hearing impairment that impacts ability to understand the directions for the completion of the study instruments
- Are participating in a clinical trial investigating a new systemic therapy
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Interventions
A way to summarize the overall level of fitness or frailty of an older adult after they had been evaluated by an experienced clinician
Defined by the presence of three from the following five clinical features: weakness, slow walking speed, unintentional weight loss, exhaustion, and low physical activity
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05738252