Predictive Factors for Functional and Quality of Life Decline in Patients >65 Years With a Gastrointestinal Tract Cancer Diagnosis Taken to Curative Resectable Surgery

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

About this trial

Introduction: Human life expectancy has increased significantly, leading to a transformation in the global demographic structure. Cancer is considerably more common among older adults compared to younger populations, as age is one of the main risk factors for its development. In fact, most solid tumors are considered age-related diseases. For this reason, the incidence of cancer among older individuals is expected to continue rising. Oncological care for this population group is particularly complex and represents a significant challenge, as comorbidities and the social aspects of aging create clinical scenarios that differ greatly from those seen in younger patients.

Objective: To identify the predictive factors of functional decline and quality of life at 12 months of follow-up, as well as oncological outcomes at 5 years of follow-up, in patients aged 65 years and older with gastrointestinal cancer who undergo curative-intent resective surgery at Hospital Universitario Mayor - Méderi, Bogotá, Colombia.

Methodology: Longitudinal and analytical observational study of prospective prognostic cohort type.

Expected Results: Predictive model of functional decline and quality of life, as well as oncological outcomes, in patients with gastrointestinal cancer undergoing curative-intent surgical procedures.

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

327 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

Predictive factors associated with functional and quality of life decline at 12 months

Factors associated with functional and quality of life decline at 12 months follow-up

Time frame
12 months
2

Predictive factors associated with oncological outcomes

Predictive factors associated with oncological outcomes

Time frame
5 years

Secondary outcomes

1

Population characterization

To describe demographical, clinical, paraclinical, presurgical functional and of quality of life, and surgical outcomes in patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent

Time frame
5 years
2

Surgical and functional outcomes

To describe postoperative surgical (mortality and complicactions) and functional and of quality of life outcomes at 1, 6, and 12 months followup in patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent

Time frame
1 year
3

Oncological outcomes

To describe oncological outcomes (overall survival, disease-free period, disease-specific survival) in patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent at 1, 3 and 5 years follow-up

Time frame
5 years
4

Comparison

To compare demographical, clinical, surgical, functional and of quality of life, and surgical outcomes in patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent that had functional and quality of life decline versus those that did not at 1, 6 and 12 months follow-up

Time frame
1 year

Other outcomes

Sponsors and contacts

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