The purpose of this study is to evaluate changes in the electronic Frailty Index (eFI) score following 3-4 cycles of neoadjuvant chemotherapy (NACT) in participants with advanced ovarian and endometrial cancer.
Ability to understand and willingness to sign an IRB-approved informed consent.
Age > 55 years at the time of enrollment.
Newly diagnosed suspected ovarian/primary peritoneal/fallopian tube carcinoma of any histological subtype, FIGO Stage II-IV, per enrolling investigator, or newly diagnosed suspected endometrial carcinoma of any histologic subtype, FIGO Stage II-IV, per enrolling investigator.
Planned for 3 or 4 cycles of NACT, with interval cytoreductive surgery planned thereafter.
History of brain metastases.
History of poorly controlled psychiatric conditions, defined as hospitalization within the prior 3 months for psychiatric disorders, traumatic brain injury, cerebrovascular event, or dementia, per the enrolling investigator.
Use of anti-amyloid agents, cholinesterase inhibitors, or Memantine for Alzheimers/cognitive impairment, at the time of enrollment.
Vision impairment that would impede completion of study assessments, per enrolling investigator.
Patients 55 or older seen in clinic with either ovarian/primary peritoneal/fallopian tube carcinoma or endometrial carcinoma who are planned for NACT
Cohort
Prospective
data collection
Other interventionPROs, historical and longitudinal data collection and eFI calculation
Change in electronic frailty index (eFI)
eFI is an automated electronic medical record-based tool based on a deficit accumulation model of frailty that uses a combination of clinical encounters, diagnosis codes, laboratory workups, and Medicare annual wellness visit data as markers of frailty status.
Change in proportion of participants in the fit/pre-frail (eFI score ≤ 0.21) versus frail category (eFi score > 0.21)
eFI scores are categorized into fit/pre-frail and frail category using the cut of point 0.21
Prevalence of cognitive dysfunction
A MoCA score of 25 or less is used to define cognitive dysfunction
Prevalence of patient-reported cognitive dysfunction
A FACT-Cog PCI score of less than 54 is used to define cognitive dysfunction
Changes in cognitive function as measured by MoCA
Changes in cognitive function are calculated based on changes in MoCA before and after NACT
Length of hospital stay
Length of hospital stay
Surgical complication
Surgical complication is coded as 0 if no complications occurred, and 1 if any of the complications listed in the NSQIP surgical complication list were present (https://cdn-links.lww.com/permalink/aa/d/aa\_2020\_05\_21\_freundlich\_aa-d-19-02104r1\_sdc1.pdf).
Discharge disposition home vs. rehabilitation facility
A binary variable indicating discharge disposition: home (0) vs. rehabilitation facility (1).
Screening rate
Screening rate is defined as the proportion of individuals who are potentially eligible, per EMR review, and are willing to be enrolled, out of the total number of participants approached for screening.
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Wake Forest University Health Sciences
Lead sponsor
Atrium Health Wake Forest Baptist
Collaborator
