Functional Decline and Quality of Life After Gastrointestinal Cancer Surgery in Older Adults

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorHospital Universitario Mayor Méderi

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

590 Participants
are grouped into 1 trial group
Group A: Patients aged over 65 years with a gastrointestinal tract cancer diagnosis

Trial outcomes

Primary outcomes

1

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.

Time frame
From preoperative baseline to 12 months after surgery
2

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.

Time frame
From preoperative baseline to 12 months after surgery

Secondary outcomes

1

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 frame
From surgery through 5 years of follow-up
2

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.

Time frame
From surgery through 5 years of follow-up
3

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.

Time frame
From surgery through 5 years of follow-up

Other outcomes

Sponsors and contacts

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