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Trial Title:
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery
NCT ID:
NCT06089083
Condition:
Malignant Female Reproductive System Neoplasm
Gynecologic Cancer
Gynecologic Neoplasm
Conditions: Official terms:
Neoplasms
Genital Neoplasms, Female
Frailty
Conditions: Keywords:
Frailty
Risk Factors
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Physical function assessment
Description:
Physical assessments of frailty will be conducted in person.
Arm group label:
Newly diagnosed gynecologic cancer
Intervention type:
Other
Intervention name:
Self-reported Assessments and Questionnaires
Description:
Quality of life questionnaires and self-reported measures will be provided to complete
during the course of the study
Arm group label:
Newly diagnosed gynecologic cancer
Other name:
Questionnaires
Intervention type:
Procedure
Intervention name:
Surgery (Standard of Care, Non-Interventional)
Description:
Surgical data will be reviewed via medical record
Arm group label:
Newly diagnosed gynecologic cancer
Other name:
Surgical Procedure
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.
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.
Criteria for eligibility:
Study pop:
Women undergoing evaluation for a newly diagnosed gynecologic malignancy
Sampling method:
Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nathalie Halley
Phone:
415-353-7957
Email:
Nathalie.Halley2@ucsf.edu
Contact backup:
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Stephanie Cham, MD
Email:
Principal Investigator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Alexi Wright, MD, MPH
Phone:
617-632-2334
Email:
Alexi_Wright@dfci.harvard.edu
Investigator:
Last name:
Alexi Wright, MD MPH
Email:
Principal Investigator
Start date:
October 18, 2023
Completion date:
November 30, 2033
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
Conquer Cancer Foundation
Agency class:
Other
Collaborator:
Agency:
American Society of Clinical Oncology
Agency class:
Other
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06089083
