A Descriptive and Comparative Analysis of Frailty in Rural Versus Urban Cancer Patients Undergoing Major Surgical Oncologic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Percent of patients considered frail assessed by Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher
研究概览
简要总结
This research is for patients who have gastrointestinal cancer and have a planned major surgery. The purpose of this research is to identify cancer patients who may be at risk for frailty. Frailty is common in older adults and may include symptoms of weight loss, weakness, fatigue, low activity, slow walking and other illnesses. Frailty may increase the risk of problems after major surgery. The study will involve a survey, a blood sample, and a review of medical records.
详细描述
The goals of the study are to:
- Describe the rate of frailty in surgical cancer patients
- Assess if frailty correlates with problems (adverse outcomes) after major surgery
Participants taking part will be asked to complete a survey to assess frailty before surgery. The frailty survey is referred to as the Clinical Risk Analysis Index (RAI-C).
Participants will have about 10 ml (2 teaspoons) of blood drawn before surgery. Blood tests will include complete blood count (CBC), vitamin A, creatinine, C-Reactive Protein (CRP), DHEA, albumin, and prealbumin.
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
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •histologically proven gastrointestinal malignancy
- •referral for elective major surgical procedures at including operations for upper and lower gastrointestinal malignancies and hepato-pancreato-biliary
- •referral for neoadjuvant treatment followed by any of the above major surgical procedures
排除标准
- •under 18 years
- •pregnant women
研究组 & 干预措施
Major surgery for gastrointestinal cancer
Patients with gastrointestinal cancer who are scheduled for major surgery
干预措施: Frailty survey (Other)
结局指标
主要结局
Percent of patients considered frail assessed by Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher
时间窗: pre-operative
Assess Clinical Risk Analysis Index (RAI-C) Scores in rural patients referred for major abdominal surgeries. Survey values will be added to yield a final RAI-C score between 0 and 81. Percent of patients considered frail will be defined as Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher
次要结局
- Adverse outcomes after major surgery(30 days post-operative)