PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study
University of California, San Francisco
Summary
This study seeks to understand how frailty, a term that describes people who are more vulnerable stressors such as a new medical problem, affects the outcomes and quality of life in adult patients with gynecologic cancer.
Description
PRIMARY OBJECTIVE: I. Assess the risk factors associated with frailty in newly diagnosed gynecologic cancer participants. SECONDARY OBJECTIVES: I. Compare primary quality of life endpoint of "healthy days at home" between non-frail and frail participants (primary quality of life endpoint). II. Compare other perioperative, oncologic, and quality of life outcomes between non-frail and frail participants. OUTLINE: This is an observational study. All new patients being evaluated for a new diagnosis of gynecologic cancer by the University of California, San Francisco (UCSF) Gynecologic Oncolo…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Age 18 years or greater * Undergoing evaluation for a newly diagnosed gynecologic malignancy * Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it Exclusion Criteria: * Contraindication to any study-related procedure or assessment * Does not speak a language for which the consent form and study materials are available
Interventions
- OtherPhysical function assessment
Physical assessments of frailty will be conducted in person.
- OtherSelf-reported Assessments and Questionnaires
Quality of life questionnaires and self-reported measures will be provided to complete during the course of the study
- ProcedureSurgery (Standard of Care, Non-Interventional)
Surgical data will be reviewed via medical record
Locations (2)
- University of California, San FranciscoSan Francisco, California
- Dana Farber Cancer InstituteBoston, Massachusetts