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NCT06089083Recruiting

PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery

University of California, San Francisco

Start Date

10/18/2023

Completion Date

11/30/2033

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

OTHER

Physical function assessment

OTHER

Self-reported Assessments and Questionnaires

PROCEDURE

Surgery (Standard of Care, Non-Interventional)

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Conditions

Malignant Female Reproductive System NeoplasmGynecologic CancerGynecologic Neoplasm

Locations

University of California, San Francisco

San Francisco, California 94143

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States