Predictive Factors Associated With Functional Decline and Quality of Life Decline at 12 Months Follow-up and 5 Year Oncological Follow-up in Patients >65 Yares With a Gastrointestinal Tract Cancer Diagnosis Taken to Resectable Surgery With a Curative Intent in Hospital Universitario Mayor-Méderi, Bogotá, Colombia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- Predictive factors associated with functional and quality of life decline at 12 months
研究概览
简要总结
Introduction: Human life expectancy has increased significantly, leading to a transformation in the global demographic structure. Cancer is considerably more common among older adults compared to younger populations, as age is one of the main risk factors for its development. In fact, most solid tumors are considered age-related diseases. For this reason, the incidence of cancer among older individuals is expected to continue rising. Oncological care for this population group is particularly complex and represents a significant challenge, as comorbidities and the social aspects of aging create clinical scenarios that differ greatly from those seen in younger patients.
Objective: To identify the predictive factors of functional decline and quality of life at 12 months of follow-up, as well as oncological outcomes at 5 years of follow-up, in patients aged 65 years and older with gastrointestinal cancer who undergo curative-intent resective surgery at Hospital Universitario Mayor - Méderi, Bogotá, Colombia.
Methodology: Longitudinal and analytical observational study of prospective prognostic cohort type.
Expected Results: Predictive model of functional decline and quality of life, as well as oncological outcomes, in patients with gastrointestinal cancer undergoing curative-intent surgical procedures.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastrointestinal cancer tract diagnosis (oesophagus, stomach, duodenum, pancreas, liver, biliary tract, small bowel, appendix, colon and rectum)
- •Have resectable disease by surgery
- •Taken to surgery by curative intent
- •Willingness to participate and enrollment by informed consent
- •Attended in the Mederi Hospital Networn
排除标准
- •Mortality
- •Loss to follow-up
- •Not taken to surgery
- •Emergency surgery
- •Taken to surgery as an oncological relapse or due to complications previous to an index procedure
- •Endoscopical treatment
- •Second primary tumor without a minimum 5 year disease free period from the primary one
- •Basal functionality 0/6 by Katz score.
研究组 & 干预措施
Patients aged over 65 years with a gastrointestinal tract cancer diagnosis
Patients aged over 65 years with a gastrointestinal tract cancer diagnosis that are taken to surgery with a curative intent.
结局指标
主要结局
Predictive factors associated with functional and quality of life decline at 12 months
时间窗: 12 months
Factors associated with functional and quality of life decline at 12 months follow-up
Predictive factors associated with oncological outcomes
时间窗: 5 years
Predictive factors associated with oncological outcomes
次要结局
- Population characterization(5 years)
- Surgical and functional outcomes(1 year)
- Oncological outcomes(5 years)
- Comparison(1 year)
- Qualitative evaluation(1 year)
- Oncological evaluation(5 years)
- Subgroup analysis(1 year)
- Internal validation(1 year)
研究者
Camilo Ramirez Giraldo
Principal Investigator
Hospital Universitario Mayor Méderi