Promoting gynecologic cancer patients with frailty to achieve functional recovery cohort study (PROOF Cohort Study)

Project summary and abstract
Approximately 80% of patients with ovarian cancer and 30% of patients with uterine cancer are
diagnosed with advanced disease. In the absence of effective screening, many patients present with severe
functional decline from symptomatic burden from chronic malnutrition due to obstructed bowels,
hypoalbuminemia with ascites, and muscle wasting due to fatigue and physical inactivity. The average age of
diagnosis is 62 years old, however patients present with accelerated physiologic aging because of these
catabolic diseases. Furthermore, as the population continues to age the number of older adults with these
gynecologic cancers will significantly grow. Options for symptomatic relief and potential prolonged survival
require intensive treatment including months of poorly tolerated chemotherapy and morbid abdominal surgery.
The choice of treatment and timing is predominantly age-based and dependent upon subjective assessments
by surgeons, and the balance of over- and under-treatment of prolonging survival against the harms of
aggressive surgery and chemotherapy may be better achieved through objective frailty assessments.
Furthermore, older adults report that quality of life and functional independence are as important as traditional
oncologic measures, yet few researchers have examined these essential patient-centered outcomes.
The purpose of this study is to 1) objectively assess physical frailty in this patient population and
quantify the associations with perioperative (90-day healthy days at home after surgery) and oncologic adverse
events (relative dose intensity of chemotherapy) and 2) characterize and identify predictors of functional
recovery and quality of life at 3 and 6 months after presentation. To accomplish these aims, we will utilize an
existing research infrastructure of a prospective multi-center cohort (“Promoting gynecologic cancer patients
with frailty to achieve functional recovery cohort” aka “PROOF cohort” NCT06089083). We will perform
repeated functional and quality of life assessments in patients 50 years and older after presentation of
advanced ovarian or uterine cancer on 100 patients.
This is an innovative prospective study with longitudinal physical frailty and quality of life measures,
including functional recovery, that are not currently available in existing datasets. This proposed project
focuses on an understudied group who are particularly vunlerable as the majority of these women are older
adults with significant symptom burden. The overall goal is to create a rapid, novel physical frailty tool specific
to this paient population that will improve the ability of our field to assess the risks of over- vs under-treatment
and make objective treatment decisions in the use of surgery and chemotherapy that align with outcomes
important to older adults. The GEMSSTAR award is crucial to continuing the important work we have laid the
foundation for and will support the PI in becoming a leader bringing the field of aging research to gynecologic
oncology to improve patient centered outcomes in older adults.

Grant Number: 1R03AG088902-01
NIH Institute/Center: NIH
Principal Investigator: Stephanie Cham