Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06089083

PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Malignant Female Reproductive System Neoplasm Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Frailty Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gynecologic Cancer Gynecologic Neoplasm Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Francisco, San Francisco, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Questionnaires

Surgery (Standard of Care, Non-Interventional)

Procedure

Surgical data will be reviewed via medical record

Other names: Surgical Procedure

Primary outcomes

  1. Proportion of participants who are categorized as frail

    Time frame: At time of enrollment, 1 day

    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.

  2. Demographic risk factors associated with those who screen positive for frailty

    Time frame: At time of enrollment, 1 day

    Demographic risk factors obtained from medical record review (i.e. sex, age, race, ethnicity, cancer type, cancer histology, cancer stage, comorbidities, etc.) will be assessed and analyzed for differences between participants categorized as frail versus non-frail.

  3. Oncologic risk factors associated with those who screen positive for frailty

    Time frame: At time of enrollment, 1 day

    Risk factors determined to be oncologic in nature will be assessed and analyzed for differences between participants categorized as frail versus non-frail.

Secondary outcomes

  1. Mean number of healthy days at home

    Time frame: Up to 10 years

    The number of healthy days at home is defined as healthy days at home is defined as: 365 days minus (1) mortality days, (2) total number of days spent in inpatient, observation, skilled nursing facilities (SNF), rehabilitation, long-term hospital settings, emergency department and will be summarized and used as covariate in analysis.

  2. Mean length of hospital stay

    Time frame: Up to 10 years

    The number of days participants stay in the hospital following standard of care surgery for gynecological cancer will be summarized and used as covariate in analysis.

  3. Percentage of participants readmitted to hospital

    Time frame: Up to 10 years

    Participants with documented re-admission to a hospital following standard of care surgery for gynecological cancer will be summarized and used as a covariate in analysis.

  4. Percentage of participants with reported surgical complications

    Time frame: Up to 10 years

    Participants with documented peri-operative complications following standard of care surgery for gynecological cancer will be summarized and used as a covariate in analysis.

  5. Mean time to initiation of standard of care chemotherapy

    Time frame: Up to 10 years

    The median number of days following standard of care surgery for gynecological cancer to first standard of care chemotherapy initiation will be summarized and used as a covariate in analysis.

  6. Median Progression Free Survival (PFS)

    Time frame: Up to 10 years

    Progression free survival is defined as the time from date of diagnosis to date of radiographic progression, and/or doubling of cancer antigen 125 (CA-125) from baseline.

  7. Median Overall Survival (OS)

    Time frame: Up to 10 years

    Overall survival as defined by days from date of diagnosis to date of death, or study completion whichever occurs first.

  8. Mean number of treatment delays

    Time frame: Up to 10 years

    Chemotherapy delays is defined by the number of chemotherapy infusions that are delayed due for medical purposes and the total number of days infusions are delayed for will be summarized and used as a covariate in analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Janet Titzler

CONTACT

[email protected]

415-353-9600

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • American Society of Clinical Oncology
  • Conquer Cancer Foundation
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Aging (NIA)

Registry information

Official study title

PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study

Acronym: PROOF

Important dates

Study start
2023
Primary completion
2027
Study completion
2033
First posted
Oct 18, 2023
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.