Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients

Launched by POPULATION HEALTH RESEARCH INSTITUTE · Feb 10, 2023

Keywords

ClinConnect Summary

The FARGO trial is a study looking at how well different assessments predict health outcomes for older women with gynecologic cancer before they undergo surgery. Specifically, it compares two ways to evaluate a patient's health: one based on frailty, which is a measure of how vulnerable a person might be due to age or health issues, and another based on heart health risks. The goal is to see which method better predicts whether patients will experience death or new disabilities within six months after their surgery.

To be eligible for this study, participants need to be 55 years or older and have specific types of gynecologic cancer, such as certain stages of ovarian or endometrial cancer, and be scheduled for surgery. Important to know is that participants will be asked to provide information about their health and may undergo some assessments, but they will also receive support and guidance throughout the study. This research aims to improve care for older women facing surgery for cancer by identifying those who may need additional help during their recovery.

Gender

FEMALE

Eligibility criteria

• 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