Clinical trial NCT05738252: Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients
Official title: Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients Undergoing Surgery and Chemotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gynecologic Cancer
Frailty
Oncology
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 280
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: FARGO will recruit patients aged 55 or older, with confirmed or suspected gynecologic cancer, undergoing cytoreductive or high-risk surgery with or without chemotherapy.

Brief 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.

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.

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

Primary outcomes:
measure: All-cause death or new disability at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: All cause death
timeFrame: 28 days and 1 year
measure: Oncologic Outcomes: Progression Free Survival (PFS)
timeFrame: at 6 and 12 months
measure: Oncologic Outcomes: Cancer-specific death
timeFrame: at 6 and 12 months
measure: New Disability
timeFrame: 28 days, 6 months and 1 year after surgery
measure: Major vascular complications
timeFrame: at 28 days, 6 months, and 1 year after surgery
measure: Infection, and infection with sepsis
timeFrame: at 28 days, 6 months, and 1 year after surgery
measure: In-hospital delirium
timeFrame: During the index hospital admission for surgery up to the first 3 days after surgery or before discharge from hospital
measure: Bleeding Independently Associated with Mortality after noncardiac Surgery
timeFrame: 28 days after surgery
measure: Acute congestive heart failure
timeFrame: 28 days after surgery, 6 months and 1 year after surgery
measure: Unplanned admission to ICU
timeFrame: during index hospitalization for surgery
measure: New clinically important atrial fibrillation
timeFrame: 28 days after surgery, 6 months and 1 year after surgery
measure: Length of stay
timeFrame: during index hospitalization for surgery
measure: Chemotherapy-related outcomes: total dose received
timeFrame: Before Surgery, 6-months post-surgery
measure: Chemotherapy-related outcomes: time to completion of all chemotherapy cycles
timeFrame: Before Surgery, 6-months post-surgery
measure: Chemotherapy-related outcomes: patient's decisional regret
timeFrame: Before Surgery, 6-months post-surgery
measure: Chemotherapy-related outcomes: Change in health-related function or well-being
timeFrame: Before Surgery, 6-months post-surgery
measure: Chemotherapy-related outcomes
timeFrame: Before Surgery, 6-months post-surgery
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinksi Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Maura Marcucci, MD
role: PRINCIPAL_INVESTIGATOR
References: