PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery

(PROOF Trial)

Recruiting at 1 trial location

Overseen By Nathalie Halley

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Francisco

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

225 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Stephanie Cham, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Inclusion Criteria

You are being assessed for a newly detected gynecological cancer.

You are 18 years of age or older.

You or your legal guardian/representative must possess the capacity to comprehend a written informed consent document and be willing to sign it.

Treatment Details

Participant Groups

Group I: Newly diagnosed gynecologic cancer Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

American Society of Clinical Oncology

Collaborator

Trials

40

Recruited

148,000+

Conquer Cancer Foundation

Collaborator

Trials

22

Recruited

4,000+