PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06089083
Status
Recruiting
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Conditions

  • Gynecologic Cancer
  • Gynecologic Neoplasm
  • Malignant Female Reproductive System Neoplasm

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Physical function assessment — OTHER
    Physical assessments of frailty will be conducted in person.
  • Self-reported Assessments and Questionnaires — OTHER
    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) — PROCEDURE
    Surgical data will be reviewed via medical record

Study Details

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.

Key Dates

Start date
Oct 18, 2023
Status verified
Jan 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2033

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Proportion of participants who are categorized as frail [ Time Frame: At time of enrollment, 1 day ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Janet Titzler
[email protected]
415-353-9600
[email protected]
877-827-3222
Stephanie Cham, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Alexi Wright, MD, MPH
[email protected]
617-632-2334
Alexi Wright, MD MPH (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, San Francisco· San Francisco, CADana Farber Cancer Institute· Boston, MA

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