To hear about similar clinical trials, please enter your email below
Trial Title:
Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients
NCT ID:
NCT05738252
Condition:
Gynecologic Cancer
Frailty
Oncology
Conditions: Official terms:
Neoplasms
Frailty
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Clinical Frailty Scale
Description:
A way to summarize the overall level of fitness or frailty of an older adult after they
had been evaluated by an experienced clinician
Arm group label:
Group A
Arm group label:
Group B
Arm group label:
Group C
Other name:
CFS
Intervention type:
Diagnostic Test
Intervention name:
Frailty Phenotype
Description:
Defined by the presence of three from the following five clinical features: weakness,
slow walking speed, unintentional weight loss, exhaustion, and low physical activity
Arm group label:
Group A
Arm group label:
Group B
Arm group label:
Group C
Other name:
FP
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.
Criteria for eligibility:
Study pop:
FARGO will recruit patients aged 55 or older, with confirmed or suspected gynecologic
cancer, undergoing cytoreductive or high-risk surgery with or without chemotherapy.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
55 Years
Maximum age:
110 Years
Locations:
Facility:
Name:
Juravinksi Hospital
Address:
City:
Hamilton
Zip:
L8V 1C3
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Julie My Van Nguyen, MD
Phone:
905-521-2100
Email:
nguyenjmv@HHSC.CA
Facility:
Name:
Credit Valley Hospital
Address:
City:
Mississauga
Zip:
L5M 2N1
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Tiffany Zigras, MD
Facility:
Name:
Sunnybrook
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Danielle Vicus, MD
Facility:
Name:
University Health Network
Address:
City:
Toronto
Zip:
M5G 2Z5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Liat Hogen, MD
Phone:
416-946-4501
Phone ext:
5065
Email:
Liat.Hogen@uhn.ca
Start date:
June 15, 2023
Completion date:
October 2025
Lead sponsor:
Agency:
Population Health Research Institute
Agency class:
Other
Source:
Population Health Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05738252
