Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients Undergoing Surgery and Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 4
- 主要终点
- All-cause death or new disability at 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 110 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
All-cause death or new disability at 6 months
时间窗: 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: 1. For individuals with a disability score of \<25% at baseline, new disability is defined as a disability score ≥25% at follow-up; 2. 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).
次要结局
- In-hospital delirium(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(28 days after surgery)
- Length of stay(during index hospitalization for surgery)
- Oncologic Outcomes: Cancer-specific death(at 6 and 12 months)
- New Disability(28 days, 6 months and 1 year after surgery)
- Major vascular complications(at 28 days, 6 months, and 1 year after surgery)
- Infection, and infection with sepsis(at 28 days, 6 months, and 1 year after surgery)
- New clinically important atrial fibrillation(28 days after surgery, 6 months and 1 year after surgery)
- Chemotherapy-related outcomes(Before Surgery, 6-months post-surgery)
- All cause death(28 days and 1 year)
- Oncologic Outcomes: Progression Free Survival (PFS)(at 6 and 12 months)
- Chemotherapy-related outcomes: total dose received(Before Surgery, 6-months post-surgery)
- Chemotherapy-related outcomes: time to completion of all chemotherapy cycles(Before Surgery, 6-months post-surgery)
- Acute congestive heart failure(28 days after surgery, 6 months and 1 year after surgery)
- Unplanned admission to ICU(during index hospitalization for surgery)
- Chemotherapy-related outcomes: Change in health-related function or well-being(Before Surgery, 6-months post-surgery)
- Chemotherapy-related outcomes: patient's decisional regret(Before Surgery, 6-months post-surgery)