Frailty in Patients With Gastrointestinal Cancer Who Are Undergoing Major Surgery
A Descriptive and Comparative Analysis of Frailty in Rural Versus Urban Cancer Patients Undergoing Major Surgical Oncologic Procedures
1 other identifier
observational
100
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2023
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2023
CompletedFirst Posted
Study publicly available on registry
January 23, 2023
CompletedStudy Start
First participant enrolled
March 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
April 29, 2026
April 1, 2026
3.4 years
January 12, 2023
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Adverse outcomes after major surgery
30 days post-operative
Study Arms (1)
Major surgery for gastrointestinal cancer
Patients with gastrointestinal cancer who are scheduled for major surgery
Interventions
Frailty survey using the Clinical Risk Analysis Index (RAI-C).
Eligibility Criteria
Participants with gastrointestinal cancer who are referred for elective major surgery
You may qualify if:
- 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
You may not qualify if:
- under 18 years
- pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Guthrie Medical Group
East Corning, New York, 14830, United States
Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebekah Macfie, MD
The Guthrie Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2023
First Posted
January 23, 2023
Study Start
March 13, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04