PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery
NCT ID: NCT06089083
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
225 participants
OBSERVATIONAL
2023-10-18
2033-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Newly diagnosed gynecologic cancer
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.
Physical function assessment
Physical assessments of frailty will be conducted in person.
Self-reported Assessments and Questionnaires
Quality of life questionnaires and self-reported measures will be provided to complete during the course of the study
Surgery (Standard of Care, Non-Interventional)
Surgical data will be reviewed via medical record
Interventions
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Physical function assessment
Physical assessments of frailty will be conducted in person.
Self-reported Assessments and Questionnaires
Quality of life questionnaires and self-reported measures will be provided to complete during the course of the study
Surgery (Standard of Care, Non-Interventional)
Surgical data will be reviewed via medical record
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Does not speak a language for which the consent form and study materials are available
18 Years
FEMALE
No
Sponsors
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Conquer Cancer Foundation
OTHER
American Society of Clinical Oncology
OTHER
National Institute on Aging (NIA)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Stephanie Cham, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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