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PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study
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.
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 Oncology service and the Dana-Farber Cancer Institute will be recruited in both the outpatient or inpatient setting. Study participants will be enrolled at the time of diagnosis and followed for up to one year after undergoing surgery for cancer.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
University of California, San Francisco
San Francisco, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Start Date
October 18, 2023
Primary Completion Date
November 30, 2027
Completion Date
November 30, 2033
Last Updated
January 26, 2026
500
ESTIMATED participants
Physical function assessment
OTHER
Self-reported Assessments and Questionnaires
OTHER
Surgery (Standard of Care, Non-Interventional)
PROCEDURE
Lead Sponsor
University of California, San Francisco
Collaborators
NCT06126276
NCT07215624
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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