Clinical Frailty Scale: A way to summarize the overall level of fitness or frailty of an older adult after they had been evaluated by an experienced clinician
Frailty Phenotype: Defined by the presence of three from the following five clinical features: weakness, slow walking speed, unintentional weight loss, exhaustion, and low physical activity
Study 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
Sex
FEMALE
Min age
55 Years
Max age
110 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age must be 55 years or older at registration
2. Must meet any one of the following criteria:
1. Have stage II-IV ovarian or endometrial cancer, undergoing cytoreductive surgery via laparotomy, with or without neoadjuvant chemotherapy (NACT)
2. Have any stage endometrial, uterine or cervical cancer planned for laparotomy where laparoscopy is deemed unfeasible/high-risk due to comorbidities
3. Are undergoing laparotomy for pelvic mass, highly suspicious for malignancy; or
4. Are undergoing laparotomy for gynecologic malignancy recurrence.
Exclusion Criteria:
1. Unable to provide informed consent
2. Require urgent surgery within 24 hours of first consultation to the Gynecological Oncology team
3. Are undergoing neoadjuvant radiation therapy
4. Have a previously documented history of dementia
5. Have cognitive, language, vision, or hearing impairment that impacts ability to understand the directions for the completion of the study instruments
6. Are participating in a clinical trial investigating a new systemic therapy
Primary outcome measure(s)
All-cause death or new disability at 6 months — 6 months Disability status is determined using the 12-item World Health Organization Disability Assessment Schedule (WHODAS 2.0). New disability at any time point is based according to the following criteria that account for baseline disability scores:
1. For individuals with a disability score of \<25% at baseline, new disability is defined as a disability score ≥25% at follow-up;
2. For individuals with a disability score ≥25%, new disability is defined an increase in disability score of ≥8%.
Vascular death is defined as any death with a vascular cause and includes those deaths following a myocardial infarction, cardiac arrest, stroke, cardiac revascularization procedure (i.e., percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\] surgery), pulmonary embolus, hemorrhage, or deaths due to an unknown cause. Non-vascular death is defined as any death due to a clearly documented non-vascular cause (e.g. trauma, infection, malignancy).
Trial sites (4)
Facility
City
Region
Status
Juravinksi Hospital
Hamilton
Ontario
Recruiting
Credit Valley Hospital
Mississauga
Ontario
Recruiting
Sunnybrook
Toronto
Ontario
Recruiting
University Health Network
Toronto
Ontario
Recruiting
More Population Health Research Institute trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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