Frailty in Patients With Gastrointestinal Cancer Who Are Undergoing Major Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Frailty survey.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Descriptive and Comparative Analysis of Frailty in Rural Versus Urban Cancer Patients Undergoing Major Surgical Oncologic Procedures
Overview
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
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.
Interventions
- Other Frailty survey
Frailty survey using the Clinical Risk Analysis Index (RAI-C).
Primary outcome measures
- Percent of patients considered frail assessed by Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher [Time frame: pre-operative]
Secondary outcome measures (1)
- Adverse outcomes after major surgery [Time frame: 30 days post-operative]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Guthrie Medical Group — East Corning
- Robert Packer Hospital — Sayre
Identifiers
NCT: NCT05694338 · 2212-74