PROmOting Gynecologic Cancer Patients With Frailty to Achieve Functional Recovery - PROOF Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Proportion of participants who are categorized as frail
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Contraindication to any study-related procedure or assessment
- •Does not speak a language for which the consent form and study materials are available
研究组 & 干预措施
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.
干预措施: Physical function assessment (Other)
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.
干预措施: Self-reported Assessments and Questionnaires (Other)
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.
干预措施: Surgery (Standard of Care, Non-Interventional) (Procedure)
结局指标
主要结局
Proportion of participants who are categorized as frail
时间窗: 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.
Oncologic risk factors associated with those who screen positive for frailty
时间窗: 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.
Demographic risk factors associated with those who screen positive for frailty
时间窗: 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.
次要结局
- Mean number of healthy days at home(Up to 10 years)
- Mean length of hospital stay(Up to 10 years)
- Median Progression Free Survival (PFS)(Up to 10 years)
- Percentage of participants readmitted to hospital(Up to 10 years)
- Percentage of participants with reported surgical complications(Up to 10 years)
- Median Overall Survival (OS)(Up to 10 years)
- Mean time to initiation of standard of care chemotherapy(Up to 10 years)
- Mean number of treatment delays(Up to 10 years)