Assessing frailty to predict outcomes in older gynecologic cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: nguyenjmv@HHSC.CA
• Phone: 905-521-2100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.