Trials / Recruiting
RecruitingNCT06089083
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Physical function assessment | Physical assessments of frailty will be conducted in person. |
| OTHER | Self-reported Assessments and Questionnaires | Quality of life questionnaires and self-reported measures will be provided to complete during the course of the study |
| PROCEDURE | Surgery (Standard of Care, Non-Interventional) | Surgical data will be reviewed via medical record |
Timeline
- Start date
- 2023-10-18
- Primary completion
- 2027-11-30
- Completion
- 2033-11-30
- First posted
- 2023-10-18
- Last updated
- 2026-01-26
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06089083. Inclusion in this directory is not an endorsement.