Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients

NCT ID: NCT05738252

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 280 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2025-10-31

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.

Conditions

Gynecologic Cancer; Frailty; Oncology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

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.

Clinical Frailty Scale

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

Defined by the presence of three from the following five clinical features: weakness, slow walking speed, unintentional weight loss, exhaustion, and low physical activity

Group B

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.

Clinical Frailty Scale

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

Defined by the presence of three from the following five clinical features: weakness, slow walking speed, unintentional weight loss, exhaustion, and low physical activity

Group C

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

Clinical Frailty Scale

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

Defined by the presence of three from the following five clinical features: weakness, slow walking speed, unintentional weight loss, exhaustion, and low physical activity

Group D

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.

Clinical Frailty Scale

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

Defined by the presence of three from the following five clinical features: weakness, slow walking speed, unintentional weight loss, exhaustion, and low physical activity

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

CFS; FP

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maura Marcucci, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

Juravinksi Hospital

Hamilton, Ontario, Canada

Site Status: RECRUITING

Credit Valley Hospital

Mississauga, Ontario, Canada

Site Status: RECRUITING

Sunnybrook

Toronto, Ontario, Canada

Site Status: RECRUITING

University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Julie My Van Nguyen, MD

Role: CONTACT

nguyenjmv@HHSC.CA

905-521-2100

Emily Di Sante, MA

Role: CONTACT

emily.disante@phri.ca

905-521-2100

Facility Contacts

Julie My Van Nguyen, MD

Role: primary

nguyenjmv@HHSC.CA

905-521-2100

Tiffany Zigras, MD

Role: primary

Danielle Vicus, MD

Role: primary

Liat Hogen, MD

Role: primary

Liat.Hogen@uhn.ca

416-946-4501 ext. 5065

References

Nguyen JMV, Vicus D, Hogen L, Zigras T, Pare G, Chong M, Benitez YR, Devereaux PJ, Ofori S, Borges FK, Di Sante E, Miletic D, Panus O, Vincent J, Ramasundarahettige C, Nene S, Patel A, Marcucci M. Frailty Assessment for Risk prediction in Gynecologic Oncology patients undergoing surgery and chemotherapy (FARGO) study protocol: Rationale and design of a multi-centre prospective cohort study. PLoS One. 2025 Jul 28;20(7):e0325651. doi: 10.1371/journal.pone.0325651. eCollection 2025.

Reference Type: DERIVED

PMID: 40720507 (View on PubMed)

Other Identifiers

v1.0_20211130

Identifier Type: -

Identifier Source: org_study_id