Actively Recruiting
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study
Led by University of California, San Francisco · Updated on 2026-01-26
500
Participants Needed
2
Research Sites
313 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
C
Conquer Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how frailty, a condition that makes people more vulnerable to health stressors, affects outcomes and quality of life in adults newly diagnosed with gynecologic cancer. The study aims to assess risk factors linked to frailty and compare quality of life, surgical, and cancer-related outcomes between patients who are frail and those who are not. This observational study involves participants from gynecologic oncology services at two institutions. Participants will take part in physical function assessments and complete quality of life surveys before their standard surgery for cancer. After surgery, they will be followed for at least three months and up to one year to monitor recovery and quality of life. Additionally, medical records will be reviewed periodically for up to 10 years to assess long-term cancer outcomes, including survival and treatment delays. During the study, participants will undergo regular physical and self-reported evaluations every three months, along with medical record reviews. Researchers will measure frailty at enrollment and track outcomes such as length of hospital stay, readmissions, surgical complications, and chemotherapy timing. Long-term follow-up will assess progression-free and overall survival, as well as treatment delays. The total participation time may extend to 10 years for some assessments.
CONDITIONS
Brief Title
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Contraindication to any study-related procedure or assessment
- Does not speak a language for which the consent form and study materials are available
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at the time of diagnosis
Duration - Up to 1 month before surgery
Participants undergo physical function assessments and complete questionnaires to assess frailty and quality of life prior to surgery.
Visits every 3 months ± 4 weeks prior to surgery
Duration - Surgery day plus immediate post-operative period
Participants undergo standard of care surgery for gynecologic cancer, which is non-interventional within this study.
Medical record review of surgical data
Duration - At least 3 months post-surgery
Participants are followed for at least 3 months after surgery with physical assessments and quality of life surveys to monitor recovery.
Follow-up visits every 3 months ± 4 weeks for up to one year after diagnosis
Duration - Up to 10 years after enrollment
Participants' medical records are reviewed periodically for oncologic outcomes such as progression-free survival, overall survival, and chemotherapy delays.
Periodic medical record reviews
Trial Site Locations
Total: 2 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
J
Janet Titzler
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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