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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06089083
Other study ID # 23407
Secondary ID NCI-2023-07434
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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