Understanding frailty in gynecologic cancer patients to improve recovery
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study
This study looks at how frailty affects recovery and quality of life in adults newly diagnosed with gynecologic cancer to see what factors might contribute to being frail.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT06089083 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of frailty on the outcomes and quality of life in adult patients newly diagnosed with gynecologic cancer. The primary objective is to identify risk factors associated with frailty in these patients. Secondary objectives include comparing the quality of life, specifically 'healthy days at home,' between frail and non-frail participants, as well as evaluating other perioperative and oncologic outcomes. Participants will be recruited at the time of diagnosis and followed for up to one year post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing evaluation for a newly diagnosed gynecologic malignancy.
Not a fit: Patients who are unable to provide informed consent or have contraindications to study-related procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery strategies for frail gynecologic cancer patients, enhancing their quality of life.
How similar studies have performed: Other studies have explored frailty in cancer patients, indicating potential for meaningful insights, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California and 1 other locations
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie Cham, MD — University of California, San Francisco
- Study coordinator: Janet Titzler
- Email: janet.titzler@ucsf.edu
- Phone: 415-353-9600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.