Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients

Official title

Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients Undergoing Surgery and Chemotherapy

Overview

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.

Interventions

• Diagnostic test 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
• Diagnostic test 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

Primary outcome measures

• All-cause death or new disability at 6 months [Time frame: 6 months]

Secondary outcome measures (12)

• All cause death [Time frame: 28 days and 1 year]
• Oncologic Outcomes: Progression Free Survival (PFS) [Time frame: at 6 and 12 months]
• Oncologic Outcomes: Cancer-specific death [Time frame: at 6 and 12 months]
• New Disability [Time frame: 28 days, 6 months and 1 year after surgery]
• Major vascular complications [Time frame: at 28 days, 6 months, and 1 year after surgery]
• Infection, and infection with sepsis [Time frame: at 28 days, 6 months, and 1 year after surgery]
• In-hospital delirium [Time frame: During the index hospital admission for surgery up to the first 3 days after surgery or before discharge from hospital]
• Bleeding Independently Associated with Mortality after noncardiac Surgery [Time frame: 28 days after surgery]
• Acute congestive heart failure [Time frame: 28 days after surgery, 6 months and 1 year after surgery]
• Unplanned admission to ICU [Time frame: during index hospitalization for surgery]
• New clinically important atrial fibrillation [Time frame: 28 days after surgery, 6 months and 1 year after surgery]
• Length of stay [Time frame: during index hospitalization for surgery]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Canada · 4 centers

• Juravinksi Hospital — Hamilton
• Credit Valley Hospital — Mississauga
• Sunnybrook — Toronto
• University Health Network — Toronto

Publications

• Nguyen JMV, Vicus D, Hogen L, Zigras T, Pare G, Chong M, Benitez YR, Devereaux PJ, Ofori S, Borges FK, Di Sante E, Miletic D, Panus O, Vincent J, Ramasundarahettige C, Nene S, Patel A, Marcucci M. Frailty Assessment for Risk prediction in Gynecologic Oncology patients undergoing surgery and chemotherapy (FARGO) study protocol: Rationale and design of a multi-centre prospective cohort study. PLoS O PMID 40720507

Identifiers

NCT: NCT05738252 · v1.0_20211130

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗