Clinical trial · Observational
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study
NCT06089083CI-TRIAL-00101659PROOFrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Gynecologic Neoplasm | Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical function assessment | Other | — | UNRESOLVED |
| Self-reported Assessments and Questionnaires | Other | — | UNRESOLVED |
| Surgery (Standard of Care, Non-Interventional) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Other: Physical function assessment
- Other: Self-reported Assessments and Questionnaires
- Procedure: Surgery (Standard of Care, Non-Interventional)
Primary outcomes (3)
- measure
- Proportion of participants who are categorized as frail
- timeFrame
- At time of enrollment, 1 day
- description
- The Fried frailty phenotype (FP) assesses physical frailty through five criteria: unintentional weight loss; weakness or poor handgrip strength; self-reported exhaustion; slow walking speed; and low physical activity. Participants who receive a score of \>3 will be categorized as 'frail'. Participants who receive a score \<=3 will be categorized as Non-frail at time of enrollment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.