Malignant Female Reproductive System NeoplasmPROOFNCT06089083
PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery
An observational study of Malignant Female Reproductive System Neoplasm and Gynecologic Cancer, run by University of California, San Francisco at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Female Reproductive System Neoplasm, Gynecologic Cancer, Gynecologic Neoplasm
- What is being tested?
- Physical function assessment and Self-reported Assessments and Questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Oct 2023to 30 Nov 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing evaluation for a newly diagnosed gynecologic malignancy
Who may be able to join
- 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
Who cannot join
- Contraindication to any study-related procedure or assessment
- Does not speak a language for which the consent form and study materials are available
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Alexi Wright, MD, MPH, 617-632-2334, Alexi_Wright@dfci.harvard.edu
Alexi Wright, MD MPH
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Janet Titzler, 415-353-9600, Janet.Titzler@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Assess the risk factors associated with frailty in newly diagnosed gynecologic cancer participants.
SECONDARY OBJECTIVES:
- 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.
- Being tested
- Physical function assessment, Self-reported Assessments and Questionnaires, Surgery (Standard of Care, Non-Interventional)
- Keywords
- Frailty, Risk Factors
- Medical subject headings
- Genital Neoplasms, Female, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical function assessmentOther
Physical assessments of frailty will be conducted in person.
Self-reported Assessments and QuestionnairesOther
Also called 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)Procedure or surgery
Also called Surgical Procedure
Surgical data will be reviewed via medical record
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physical function assessment; Other: Self-reported Assessments and Questionnaires; Procedure: Surgery (Standard of Care, Non-Interventional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who are categorized as frail
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.
Measured: At time of enrollment, 1 day
Demographic risk factors associated with those who screen positive for frailty
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.
Measured: At time of enrollment, 1 day
Oncologic risk factors associated with those who screen positive for frailty
Risk factors determined to be oncologic in nature will be assessed and analyzed for differences between participants categorized as frail versus non-frail.
Measured: At time of enrollment, 1 day
Secondary outcomes (8)
Mean number of healthy days at home
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.
Measured: Up to 10 years
Mean length of hospital stay
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.
Measured: Up to 10 years
Percentage of participants readmitted to hospital
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.
Measured: Up to 10 years
Percentage of participants with reported surgical complications
Participants with documented peri-operative complications following standard of care surgery for gynecological cancer will be summarized and used as a covariate in analysis.
Measured: Up to 10 years
Mean time to initiation of standard of care chemotherapy
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.
Measured: Up to 10 years
Median Progression Free Survival (PFS)
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.
Measured: Up to 10 years
Median Overall Survival (OS)
Overall survival as defined by days from date of diagnosis to date of death, or study completion whichever occurs first.
Measured: Up to 10 years
Mean number of treatment delays
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.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start18 Oct 2023
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Conquer Cancer Foundation, American Society of Clinical Oncology, National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Stephanie Cham, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089083
- Sponsor's protocol ID
- 23407
- Other IDs
- NCI-2023-07434, R03AG088902, K12HD001262
- Acronym
- PROOF
- Status last verified
- Jan 2026
- First submitted
- 12 Oct 2023
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06089083
- Acronym / sponsor ID
- PROOF / 23407
- Keywords
- Frailty, Risk Factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Conquer Cancer Foundation, American Society of Clinical Oncology, National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2033 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- Assess the risk factors associated with frailty in newly diagnosed gynecologic cancer participants.
SECONDARY OBJECTIVES:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed gynecologic cancer | – | Other: Physical function assessment, Other: Self-reported Assessments and Questionnaires, Procedure: Surgery (Standard of Care, Non-Interventional)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing evaluation for a newly diagnosed gynecologic malignancy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindication to any study-related procedure or assessment
- Does not speak a language for which the consent form and study materials are available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical function assessmentPhysical assessments of frailty will be conducted in person. | Other | Newly diagnosed gynecologic cancer |
| Self-reported Assessments and QuestionnairesAlso: QuestionnairesQuality of life questionnaires and self-reported measures will be provided to complete during the course of the study | Other | Newly diagnosed gynecologic cancer |
| Surgery (Standard of Care, Non-Interventional)Also: Surgical ProcedureSurgical data will be reviewed via medical record | Procedure or surgery | Newly diagnosed gynecologic cancer |
Primary outcome
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.
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.
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.
8 secondary outcomes
Mean number of healthy days at home
Time frame: Up to 10 years
Mean length of hospital stay
Time frame: Up to 10 years
Percentage of participants readmitted to hospital
Time frame: Up to 10 years
Percentage of participants with reported surgical complications
Time frame: Up to 10 years
Mean time to initiation of standard of care chemotherapy
Time frame: Up to 10 years
Median Progression Free Survival (PFS)
Time frame: Up to 10 years
Median Overall Survival (OS)
Time frame: Up to 10 years
Mean number of treatment delays
Time frame: Up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Cham, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Female Reproductive System Neoplasm and Gynecologic Cancer, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet Titzler (415-353-9600, janet.titzler@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who are categorized as frail (time frame: At time of enrollment, 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.