Assessing frailty to predict outcomes in older gynecologic cancer patients

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

This study is testing if checking for frailty before surgery can better predict recovery and complications for older women with gynecologic cancer compared to standard heart health checks.

Quick facts

• Study type: Observational
• Enrollment: 280 (estimated)
• Ages: 55 Years to 110 Years
• Sex: Female
• Sponsor: Population Health Research Institute (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 4 sites (Hamilton, Ontario and 3 other locations)
• Trial ID: NCT05738252 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of preoperative frailty assessments using the Frailty Phenotype compared to traditional cardiovascular risk assessments in predicting postoperative outcomes for patients aged 55 and older with gynecologic cancer. By focusing on patients undergoing high-risk surgeries, the study seeks to fill knowledge gaps regarding postoperative recovery and complications. The findings could lead to improved clinical practices and inform future decision-making strategies in gynecologic oncology care.

Who should consider this trial

Good fit: Ideal candidates are patients aged 55 or older with confirmed or suspected gynecologic cancer who are scheduled for cytoreductive surgery.

Not a fit: Patients requiring urgent surgery, those with cognitive impairments, or those undergoing neoadjuvant radiation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the prediction of postoperative outcomes, leading to better tailored care for older gynecologic cancer patients.

How similar studies have performed: While there is growing literature on frailty assessments in noncardiac surgery, studies specifically involving gynecologic oncology patients are limited and of low quality, making this approach relatively novel.

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

Where this trial is running

Hamilton, Ontario and 3 other locations

• Juravinksi Hospital — Hamilton, Ontario, Canada (RECRUITING)
• Credit Valley Hospital — Mississauga, Ontario, Canada (RECRUITING)
• Sunnybrook — Toronto, Ontario, Canada (RECRUITING)
• University Health Network — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Maura Marcucci, MD — Population Health Research Institute
• Study coordinator: Julie My Van Nguyen, MD

Conditions: Gynecologic Cancer, Frailty, Oncology