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

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Gynecologic Neoplasm; Malignant Female Reproductive System Neoplasm; Gynecologic Cancer

Treatments: Other: Physical function assessment; Other: Self-reported Assessments and Questionnaires; Procedure: Surgery (Standard of Care, Non-Interventional)

Study type: Observational

Funder types: Other

Identifiers

NCT06089083

23407

NCI-2023-07434 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

225 participants in 1 patient group

Newly diagnosed gynecologic cancer

Description:

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.

Treatment:

Procedure: Surgery (Standard of Care, Non-Interventional)

Other: Self-reported Assessments and Questionnaires

Other: Physical function assessment