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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
Physical assessments of frailty will be conducted in person.
Quality of life questionnaires and self-reported measures will be provided to complete during the course of the study
Surgical data will be reviewed via medical record
University of California, San Francisco
San Francisco, California, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGProportion 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
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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 10 years