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RecruitingObservational

PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study

NCT ID: NCT06089083Sponsor: University of California, San FranciscoLast updated: 2026-01-26

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.

Detailed 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 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.

Arms & 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

Outcome measures

Primary

  • Proportion of participants who are categorized as frail

    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.

    Time frame: At time of enrollment, 1 day

  • Demographic risk factors associated with those who screen positive for frailty

    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.

    Time frame: At time of enrollment, 1 day

  • Oncologic risk factors associated with those who screen positive for frailty

    Risk factors determined to be oncologic in nature will be assessed and analyzed for differences between participants categorized as frail versus non-frail.

    Time frame: At time of enrollment, 1 day

Secondary

  • Mean number of healthy days at home

    Time frame: Up to 10 years

  • Mean length of hospital stay

    Time frame: Up to 10 years

  • Percentage of participants readmitted to hospital

    Time frame: Up to 10 years

  • Percentage of participants with reported surgical complications

    Time frame: Up to 10 years

  • Mean time to initiation of standard of care chemotherapy

    Time frame: Up to 10 years

  • Median Progression Free Survival (PFS)

    Time frame: Up to 10 years

  • Median Overall Survival (OS)

    Time frame: Up to 10 years

  • Mean number of treatment delays

    Time frame: Up to 10 years

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy 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

Study locations (2)

University of California, San Francisco

San Francisco, California, 94143

Recruiting
Janet Titzler · Contact
Stephanie Cham, MD · Principal Investigator

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Alexi Wright, MD, MPH · Contact
Alexi Wright, MD MPH · Principal Investigator
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery | Cancerify