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Recruiting NCT06089083

PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery

— Observational Malignant Female Reproductive System Neoplasm Gynecologic Cancer Gynecologic Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical function assessment, Self-reported Assessments and Questionnaires, Surgery (Standard of Care, Non-Interventional).
Who it may be relevant to
Registry conditions: Malignant Female Reproductive System Neoplasm, Gynecologic Cancer, Gynecologic Neoplasm. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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
  • Procedure Surgery (Standard of Care, Non-Interventional)
    Surgical data will be reviewed via medical record

Primary outcome measures

  • Proportion of participants who are categorized as frail [Time frame: At time of enrollment, 1 day]
  • Demographic risk factors associated with those who screen positive for frailty [Time frame: At time of enrollment, 1 day]
  • Oncologic risk factors associated with those who screen positive for frailty [Time frame: At time of enrollment, 1 day]
Secondary outcome measures (8)
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • University of California, San Francisco — San Francisco
  • Dana Farber Cancer Institute — Boston

Identifiers

NCT: NCT06089083 · 23407 · NCI-2023-07434 · R03AG088902 · K12HD001262

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗