Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients (FARGO)

Population Health Research Institute (PHRI)

Status: Enrolling

Conditions: Oncology; Gynecologic Cancer; Frailty

Treatments: Diagnostic Test: Frailty Phenotype; Diagnostic Test: Clinical Frailty Scale

Study type: Observational

Funder types: Other

Identifiers

NCT05738252

v1.0_20211130

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: Female

Ages: 55 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

280 participants in 4 patient groups

Group A

Description:

We expect that some of the eligible patients (Group A) will undergo surgery without NACT. Group A will undergo only one preoperative study visit (baseline) within 45 days prior to their surgery. Group A will complete the study assessments and follow-ups. Some patients of Group A will undergo adjuvant chemotherapy after surgery; this will not affect their study timeline.

Treatment:

Diagnostic Test: Clinical Frailty Scale

Diagnostic Test: Frailty Phenotype

Group B

Description:

Patients undergoing NACT before their surgery (group B) will have a first baseline study assessment within 45 days prior to their first chemotherapy treatment; in this group, a second preoperative study visit will be repeated after chemotherapy is considered terminated at least 18 days post-chemotherapy cycle and within 45 days prior to surgery. Group B will complete the study assessments and follow-ups. Some patients of Group B will undergo adjuvant chemotherapy after surgery; this will not affect their study timeline.

Treatment:

Diagnostic Test: Clinical Frailty Scale

Diagnostic Test: Frailty Phenotype

Group C

Description:

Post-chemotherapy, a small proportion of patients will not be deemed eligible for surgery by the treating physician (group C). Group C will be included in the evaluation of chemotherapy-related outcomes, and will also be asked to complete a follow-up visit 6 months from the date of registration

Treatment:

Diagnostic Test: Clinical Frailty Scale

Diagnostic Test: Frailty Phenotype

Group D

Description:

An even smaller proportion of patients will initially be deemed eligible, recruited, and will complete the baseline assessment; however, they will eventually not undergo neither surgery nor chemotherapy. For Group D, a follow-up visit at 6 months from the baseline visit will be completed.

Treatment:

Diagnostic Test: Clinical Frailty Scale

Diagnostic Test: Frailty Phenotype