Clinical trial NCT06089083: PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery
Official title: PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Female Reproductive System Neoplasm
Gynecologic Cancer
Gynecologic Neoplasm
Keywords: Frailty
Risk Factors
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Conquer Cancer Foundation
name: American Society of Clinical Oncology
First posted: 2023-10-18
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing evaluation for a newly diagnosed gynecologic malignancy

Brief 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.

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

Primary outcomes:
measure: Proportion of participants who are categorized as frail
timeFrame: At time of enrollment, 1 day
measure: Demographic risk factors associated with those who screen positive for frailty
timeFrame: At time of enrollment, 1 day
measure: Oncologic risk factors associated with those who screen positive for frailty
timeFrame: At time of enrollment, 1 day
Secondary outcomes:
measure: Mean number of healthy days at home
timeFrame: Up to 10 years
measure: Mean length of hospital stay
timeFrame: Up to 10 years
measure: Percentage of participants readmitted to hospital
timeFrame: Up to 10 years
measure: Percentage of participants with reported surgical complications
timeFrame: Up to 10 years
measure: Mean time to initiation of standard of care chemotherapy
timeFrame: Up to 10 years
measure: Median Progression Free Survival (PFS)
timeFrame: Up to 10 years
measure: Median Overall Survival (OS)
timeFrame: Up to 10 years
measure: Mean number of treatment delays
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: University of California, San Francisco
name: Stephanie Cham, MD
role: PRINCIPAL_INVESTIGATOR
References: