NCT06089083 · University of California, San Francisco
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery
(PROOF)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Physical function assessment
Physical assessments of frailty will be conducted in person.
OTHER
Self-reported Assessments and Questionnaires
Quality of life questionnaires and self-reported measures will be provided to complete during the course of the study
PROCEDURE
Surgery (Standard of Care, Non-Interventional)
Surgical data will be reviewed via medical record
Primary outcome measures
Proportion of participants who are categorized as frail
Time frame: At time of enrollment, 1 day
The Fried frailty phenotype (FP) assesses physical frailty through five criteria: unintentional weight loss; weakness or poor handgrip strength; self-reported exhaustion; slow walking speed; and low physical activity. Participants who receive a score of \>3 will be categorized as 'frail'. Participants who receive a score \<=3 will be categorized as Non-frail at time of enrollment.
Demographic risk factors associated with those who screen positive for frailty
Time frame: At time of enrollment, 1 day
Demographic risk factors obtained from medical record review (i.e. sex, age, race, ethnicity, cancer type, cancer histology, cancer stage, comorbidities, etc.) will be assessed and analyzed for differences between participants categorized as frail versus non-frail.
Oncologic risk factors associated with those who screen positive for frailty
Time frame: At time of enrollment, 1 day
Risk factors determined to be oncologic in nature will be assessed and analyzed for differences between participants categorized as frail versus non-frail.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Francisco, California
- Boston, Massachusetts
Collaborators
Conquer Cancer Foundation, American Society of Clinical Oncology, National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 26, 2026 · Source of record for eligibility and locations