Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age55-110
SponsorPopulation Health Research Institute
About this trial
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 criteria
Qualifiers
Age must be 55 years or older at registration
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Clinical Frailty Scale
- Frailty Phenotype
Treatment groups
280 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov