Understanding Frailty in Gynecologic Cancer Patients

This study, called PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery, is looking at how frailty affects women with newly diagnosed gynecologic cancer. Frailty describes people who are more vulnerable to stress, like a new medical problem. Researchers want to understand the risk factors for frailty and how it impacts your quality of life and recovery after surgery. You would complete questionnaires and have physical assessments. The study will also review your medical records, including surgical information. The goal is to compare outcomes between frail and non-frail patients to improve care. This is an observational study, meaning you won't receive new treatments, but researchers will gather information about your health journey.

Study design
This is an observational study planning to enroll 500 women aged 18 or older with newly diagnosed gynecologic cancer.
What's involved
You would undergo physical assessments and complete self-reported questionnaires. Your medical records, including surgical data, would also be reviewed.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to one year after undergoing surgery for cancer.

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NCT06089083

PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery

Recruiting
Not specifiedAges 18+Observational
University of California, San Francisco
~500 participants
Updated 2026-01-26 on ClinicalTrials.gov
What's tested:Physical function assessmentSelf-reported Assessments and QuestionnairesSurgery (Standard of Care, Non-Interventional)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants who are categorized as frail
Measured over At time of enrollment, 1 day
+2 more outcomes measured
Malignant Female Reproductive System Neoplasm
Gynecologic Cancer
Gynecologic Neoplasm
2 sites across 2 states
California1
Massachusetts1
  • Stephanie Cham, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Contraindication to any study-related procedure or assessment
Does not speak a language for which the consent form and study materials are available
  • Proportion of participants who are categorized as frailAt 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 frailtyAt 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 frailtyAt 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.