PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study
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
Study locations (2)
University of California, San Francisco
San Francisco, California, 94143
Dana Farber Cancer Institute
Boston, Massachusetts, 02215