PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery

Gynecologic Cancer Clinical Trial

— PROOF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06089083
• Other study ID #: 23407
• Secondary ID: NCI-2023-07434
• Status: Recruiting
• Start date: October 18, 2023
• Est. completion date: November 30, 2033

Study information

• Verified date: October 2023
• Source: University of California, San Francisco
• Contact: Nathalie Halley
• Phone: (415) 353-7957
• Email: Nathalie.Halley2[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: November 30, 2033
• Est. primary completion date: November 30, 2033
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Genital Neoplasms, Female
• Gynecologic Cancer
• Gynecologic Neoplasm
• Malignant Female Reproductive System Neoplasm
• Neoplasms

Intervention

Other:
• 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

Procedure:
• Surgery (Standard of Care, Non-Interventional)
Surgical data will be reviewed via medical record

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	American Society of Clinical Oncology, Conquer Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At time of enrollment, 1 day
Primary	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.	At time of enrollment, 1 day
Primary	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.	At time of enrollment, 1 day
Secondary	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.	Up to 10 years
Secondary	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.	Up to 10 years
Secondary	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.	Up to 10 years
Secondary	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.	Up to 10 years
Secondary	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.	Up to 10 years
Secondary	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.	Up to 10 years
Secondary	Median Overall Survival (OS)	Overall survival as defined by days from date of diagnosis to date of death, or study completion whichever occurs first.	Up to 10 years
Secondary	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.	Up to 10 years