PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Female Reproductive System Neoplasm, Gynecologic Cancer, Gynecologic Neoplasm

Intervention / Treatment
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* Other: Physical function assessment
* Other: Self-reported Assessments and Questionnaires
* Procedure: Surgery (Standard of Care, Non-Interventional)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly diagnosed gynecologic cancer<br>Participants will undergo physical function assessments, complete surveys, and medical records every 3 months +/- 4 weeks prior to standard of care surgery (outside of this protocol). After surgery subjects will be followed for at least 3 months +/- 4 weeks for up to one year after diagnosis. Medical record reviews will occur periodically to examine for long-term follow up oncologic outcomes of progression free survival, overall survival, and chemotherapy delays for up to 10 years after enrollment. | Other: Physical function assessment<br>* Physical assessments of frailty will be conducted in person.<br>Other: Self-reported Assessments and Questionnaires<br>* Quality of life questionnaires and self-reported measures will be provided to complete during the course of the study<br>* Other names: Questionnaires;Procedure: Surgery (Standard of Care, Non-Interventional)<br>* Surgical data will be reviewed via medical record<br>* Other names: Surgical Procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | At time of enrollment, 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of healthy days at home | The number of healthy days at home is defined as healthy days at home is defined as: 365 days minus (1) mortality days, (2) total number of days spent in inpatient, observation, skilled nursing facilities (SNF), rehabilitation, long-term hospital settings, emergency department and will be summarized and used as covariate in analysis. | Up to 10 years | 
| Mean length of hospital stay | The number of days participants stay in the hospital following standard of care surgery for gynecological cancer will be summarized and used as covariate in analysis. | Up to 10 years | 
| Percentage of participants readmitted to hospital | Participants with documented re-admission to a hospital following standard of care surgery for gynecological cancer will be summarized and used as a covariate in analysis. | Up to 10 years | 
| Percentage of participants with reported surgical complications | Participants with documented peri-operative complications following standard of care surgery for gynecological cancer will be summarized and used as a covariate in analysis. | Up to 10 years | 
| Mean time to initiation of standard of care chemotherapy | The median number of days following standard of care surgery for gynecological cancer to first standard of care chemotherapy initiation will be summarized and used as a covariate in analysis. | Up to 10 years | 
| Median Progression Free Survival (PFS) | Progression free survival is defined as the time from date of diagnosis to date of radiographic progression, and/or doubling of cancer antigen 125 (CA-125) from baseline. | Up to 10 years | 
| Median Overall Survival (OS) | Overall survival as defined by days from date of diagnosis to date of death, or study completion whichever occurs first. | Up to 10 years | 
| Mean number of treatment delays | Chemotherapy delays is defined by the number of chemotherapy infusions that are delayed due for medical purposes and the total number of days infusions are delayed for will be summarized and used as a covariate in analysis. | Up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Risk Factors