PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery (PROOF)

PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer; Malignant Female Reproductive System Neoplasm; Gynecologic Neoplasm
• Intervention / Treatment: Other: Physical function assessment; Other: Self-reported Assessments and Questionnaires; Procedure: Surgery (Standard of Care, Non-Interventional)

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Janet Titzler; Phone Number: 415-353-9600; Email: Janet.Titzler@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Phone Number: 877-827-3222; Email: cancertrials@ucsf.edu
      • Principal Investigator: Stephanie Cham, MD
      • Contact: Janet Titzler; Phone Number: 415-353-9600; Email: Janet.Titzler@ucsf.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
      • Contact: Alexi Wright, MD, MPH; Phone Number: 617-632-2334; Email: Alexi_Wright@dfci.harvard.edu
      • Principal Investigator: Alexi Wright, MD MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women undergoing evaluation for a newly diagnosed gynecologic malignancy

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Contraindication to any study-related procedure or assessment
• Does not speak a language for which the consent form and study materials are available

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Newly diagnosed gynecologic cancer; Participants will undergo physical function assessments, complete surveys, and medical records every 3 months +/- 4 weeks prior to standard of care surgery (outside of this protocol). After surgery subjects will be followed for at least 3 months +/- 4 weeks for up to one year after diagnosis. Medical record reviews will occur periodically to examine for long-term follow up oncologic outcomes of progression free survival, overall survival, and chemotherapy delays for up to 10 years after enrollment.

Other: Physical function assessment; Physical assessments of frailty will be conducted in person.; Other: Self-reported Assessments and Questionnaires; Quality of life questionnaires and self-reported measures will be provided to complete during the course of the study; Other Names: Questionnaires; Procedure: Surgery (Standard of Care, Non-Interventional); Surgical data will be reviewed via medical record; Other Names: Surgical Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	At time of enrollment, 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	Up to 10 years

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute on Aging (NIA); American Society of Clinical Oncology; Conquer Cancer Foundation
• Investigators: Principal Investigator: Stephanie Cham, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2033

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Risk Factors; Frailty
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Pathological Conditions, Signs and Symptoms; Frailty; Genital Neoplasms, Female; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Standard of Care; Surveys and Questionnaires; Surgical Procedures, Operative
• Other Study ID Numbers: 23407; NCI-2023-07434 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP)); R03AG088902 (U.S. NIH Grant/Contract); K12HD001262 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No