PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery

a study on Female Reproductive System Neoplasm Gynecologic Cancer Gynecologic Neoplasm Neoplasms Genital Neoplasms Frailty

Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Stephanie Cham, MD (ucsf)
Headshot of Stephanie Cham
Stephanie Cham

Description

Summary

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.

Official Title

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

Details

PRIMARY OBJECTIVE:

  1. Assess the risk factors associated with frailty in newly diagnosed gynecologic cancer participants.

SECONDARY OBJECTIVES:

  1. 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.

Keywords

Malignant Female Reproductive System Neoplasm, Gynecologic Cancer, Gynecologic Neoplasm, Frailty, Risk Factors, Neoplasms, Female Genital Neoplasms, Physical function assessment, Newly diagnosed gynecologic cancer

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join if...

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

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Dana Farber Cancer Institute not yet accepting patients
    Boston Massachusetts 02215 United States

Lead Scientist at University of California Health

  • Stephanie Cham, MD (ucsf)
    Dr. Stephanie Cham’s primary research focus is to reduce disparities and improve perioperative care for gynecologic cancer patients, particularly in vulnerable populations, through innovative healthcare services outcomes research and the development of novel and scalable interventions including those leveraging new care delivery approaches and technology.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06089083
Study Type
Observational
Participants
Expecting 225 study participants
Last Updated