PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Contraindication to any study-related procedure or assessment
Does not speak a language for which the consent form and study materials are available
Trial population
Women undergoing evaluation for a newly diagnosed gynecologic malignancy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Physical function assessment
Other interventionPhysical assessments of frailty will be conducted in person.
Self-reported Assessments and Questionnaires
Other interventionQuality of life questionnaires and self-reported measures will be provided to complete during the course of the study
Surgery (Standard of Care, Non-Interventional)
Procedure/SurgerySurgical data will be reviewed via medical record
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Newly diagnosed gynecologic cancer3 interventions
Trial outcomes
Primary outcomes
1
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 day2
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 day3
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 daySecondary outcomes
1
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 years2
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.
Time frame
Up to 10 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
Conquer Cancer Foundation
Collaborator
American Society of Clinical Oncology
Collaborator
National Institute on Aging (NIA)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov