Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients

Frailty Clinical Trial

— FARGO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738252
• Other study ID #: v1.0_20211130
• Status: Recruiting
• Start date: June 15, 2023
• Est. completion date: October 2025

Study information

• Verified date: February 2024
• Source: Population Health Research Institute
• Contact: Julie My Van Nguyen, MD
• Phone: 905-521-2100
• Email: nguyenjmv[@]HHSC.CA
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: October 2025
• Est. primary completion date: May 2025
• Gender: Female
• Age group: 55 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Gynecologic Cancer
• Neoplasms
• Oncology

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Juravinksi Hospital	Hamilton	Ontario
Canada	Credit Valley Hospital	Mississauga	Ontario
Canada	Sunnybrook	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death or new disability at 6 months	Disability status is determined using the 12-item World Health Organization Disability Assessment Schedule (WHODAS 2.0). New disability at any time point is based according to the following criteria that account for baseline disability scores: For individuals with a disability score of <25% at baseline, new disability is defined as a disability score =25% at follow-up; For individuals with a disability score =25%, new disability is defined an increase in disability score of =8%.; Vascular death is defined as any death with a vascular cause and includes those deaths following a myocardial infarction, cardiac arrest, stroke, cardiac revascularization procedure (i.e., percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery), pulmonary embolus, hemorrhage, or deaths due to an unknown cause. Non-vascular death is defined as any death due to a clearly documented non-vascular cause (e.g. trauma, infection, malignancy).	6 months
Secondary	All cause death	Death is defined as all cause mortality.	28 days and 1 year
Secondary	Progression-free survival	defined as the time from treatment initiation to tumor progression or recurrence or death from any cause, or to the date of censoring at the last time the subject was known to be alive	up to 1 year after surgery
Secondary	New Disability	New disability will be assessed utilizing the 12-item WHODAS 2.0 assessment, and will be defined as a disability score =25% at follow-up, or a score increase of =8% for those already disabled at baseline.	28 days, 6 months, and 1 year after surgery
Secondary	Major vascular complications	defined as a composite of vascular death, and non-fatal myocardial infarction (or myocardial injury for the 28-day time point), stroke, symptomatic proximal venous thromboembolism, and cardiac arrest	at 28 days, 6 months, and 1 year after surgery
Secondary	Infection, and infection with sepsis	Infection is defined as a pathologic process caused by the invasion of normally sterile tissue or fluid or body cavity by pathogenic or potentially pathogenic organisms.; The Third International Consensus Definitions Task Force defines sepsis as a "life-threatening organ dysfunction due to a dysregulated host response to infection." Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria, sepsis will require a quick Sequential Organ Failure Assessment (qSOFA) Score =2 points due to infection. The qSOFA includes the following items and scoring system: Altered mental status (1 point); systolic blood pressure of 100 mm Hg or less (1 point), and; respiratory rate of 22 breaths/min or more (1 point).	at 28 days, 6 months, and 1 year after surgery
Secondary	In-hospital delirium	Delirium during the first 3 days after surgery or before discharge from the hospital, based on Confusion Assessment Method (CAM). According to CAM, patients are diagnosed with delirium if they meet the first 2 criteria (acute onset with fluctuating course, AND attention deficit), and at least one of the second 2 criteria (disorganized thinking OR altered level of consciousness). Participants will be screened for postoperative delirium while in hospital, twice daily, during the first 3 days after surgery or until discharge (if before 3 days), by research personnel, using the 3D-CAM, or the CAM-ICU any time the participants are in the PACU or in ICU	First 3 days post-surgery
Secondary	Cancer-specific death	death directly attributable to the primary gynecological cancer or directly related to its treatment, in the absence of other causes of death	up to 1 year after surgery
Secondary	Bleeding Independently Associated with Mortality after noncardiac Surgery	BIMS is a bleeding meeting any of the following 3 criteria: Leading to a postoperative hemoglobin <70 g/L; Requiring transfusion of one or more units of red blood cells; Judged to be the immediate cause of death	28 days after surgery
Secondary	acute congestive heart failure	The definition of congestive heart failure requires at least one of the following clinical signs (i.e. any of the following signs: elevated jugular venous pressure, respiratory rales/crackles, crepitations, or presence of S3) and at least one of the following: Radiographic findings (i.e., vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema) OR; Heart failure treatment implemented with diuretics with documented clinical improvement.	28 days after surgery
Secondary	Unplanned admission to ICU	admission to the ICU that was not planned	during index hospitalization for surgery
Secondary	new clinically important atrial fibrillation	The definition of new clinically important atrial fibrillation requires the documentation of atrial fibrillation or atrial flutter of any duration on an ECG or rhythm strip, which results in angina congestive heart failure, symptomatic hypotension, or requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion.	28 days after surgery
Secondary	Length of stay	time spent in hospital immediately after surgery	during index hospitalization for surgery
Secondary	Total chemotherapy dose received	defined as Relative Dose Intensity (RDI), as calculated as the percentage of the standard dose that was administered, using the formula below: Carboplatin RDI (%) = total dose administered / total standard dose *100; Paclitaxel RDI (%) = total dose administered / total standard dose *100	Before Surgery, 6-months post-surgery
Secondary	Time to completion of all chemotherapy cycles	Expressed as number of days	Before Surgery, 6-months post-surgery
Secondary	Patient's decisional regret	defined as "distress or remorse after a (health care) decision," assessed using the Decisional Regret scale, a validated a 5-item scale	Before Surgery, 6-months post-surgery
Secondary	Change in health-related function or well-being	defined as the difference in WHODAS 2.0 score after chemotherapy compared to before chemotherapy	Before Surgery, 6-months post-surgery