Frailty in Patients With Gastrointestinal Cancer Who Are Undergoing Major Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Descriptive and Comparative Analysis of Frailty in Rural Versus Urban Cancer Patients Undergoing Major Surgical Oncologic Procedures

Conditions
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Gastrointestinal Cancer

Intervention / Treatment
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* Other: Frailty survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: under 18 years pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Major surgery for gastrointestinal cancer<br>Patients with gastrointestinal cancer who are scheduled for major surgery | Other: Frailty survey<br>* Frailty survey using the Clinical Risk Analysis Index (RAI-C).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients considered frail assessed by Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher | 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 | pre-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse outcomes after major surgery | Assess adverse outcomes postoperatively and if their is a correlation with the frailty score | 30 days post-operative |