About this trial
This prospective cohort study will evaluate functional decline, health-related quality of life, and long-term oncological outcomes in adults aged 65 years and older undergoing curative-intent resective surgery for gastrointestinal cancer at Hospital Universitario Mayor-Méderi in Bogotá, Colombia.
The primary objectives are to identify prognostic factors associated with functional decline and clinically meaningful deterioration in health-related quality of life at 12 months after surgery. Functional decline will be assessed using the Katz Index of Independence in Activities of Daily Living, and quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Long-term oncological outcomes will include overall survival, time to recurrence, and disease-free survival, with estimates reported at 1, 3, and 5 years after surgery.
Participants will undergo standardized preoperative assessment of demographic, oncological, functional, frailty, nutritional, cognitive, psychological, and sarcopenia-related factors. Multivariable prognostic models will be developed to evaluate their association with the primary outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Mortality
Loss to follow-up
Not taken to surgery
Emergency surgery
Trial population
Patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent in the Hospital Universitario Mayor - Méderi, Bogotá, Colombia.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Functional decline based on the Katz Index of Independence in Activities of Daily Living
Functional decline will be defined as a decrease of at least 1 point from the preoperative baseline score on the Katz Index of Independence in Activities of Daily Living at 12 months after surgery. The Katz Index ranges from 0 to 6, with higher scores indicating greater independence in basic activities of daily living.
Clinically meaningful deterioration in global health status/quality of life assessed with the EORTC QLQ-C30
Clinically meaningful deterioration in health-related quality of life will be defined as a decrease of at least 10 points from the preoperative baseline score on the Global Health Status/Quality of Life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, version 3.0, at 12 months after surgery. This scale ranges from 0 to 100, with higher scores indicating better global health status and quality of life.
Secondary outcomes
Overall survival
Overall survival will be defined as the time from surgery to death from any cause. Participants who are alive at the end of follow-up will be censored at the date of their last known follow-up. Survival estimates will be reported at 1, 3, and 5 years after surgery.
Time to recurrence
Time to recurrence will be defined as the time from surgery to the first documented recurrence of the index gastrointestinal malignancy. Death without prior documented recurrence will be considered a competing event. Estimates will be reported at 1, 3, and 5 years after surgery.
Disease-free survival
Disease-free survival will be defined as the time from surgery to the first documented recurrence of the index gastrointestinal malignancy or death from any cause, whichever occurs first. Disease-free survival estimates will be reported at 1, 3, and 5 years after surgery.
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