Cancer Abdomen, Elderly (People Aged 65 or More), Functional Autonomy Level, Quality of Life, Sarcopenia in Elderly
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Hospital Universitario Mayor Méderi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Attended in the Mederi Hospital Networn
Exclusion criteria
* Mortality * Loss to follow-up * Not taken to surgery * Emergency surgery * Taken to surgery as an oncological relapse or due to complications previous to an index procedure * Endoscopical treatment * Second primary tumor without a minimum 5 year disease free period from the primary one * Basal functionality 0/6 by Katz score.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive factors associated with functional and quality of life decline at 12 months | 12 months | Factors associated with functional and quality of life decline at 12 months follow-up |
| Predictive factors associated with oncological outcomes | 5 years | Predictive factors associated with oncological outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Population characterization | 5 years | 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 |
| Surgical and functional outcomes | 1 year | 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 |
| Oncological outcomes | 5 years | 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 |
| Comparison | 1 year | 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 |
| Qualitative evaluation | 1 year | To evaluate predictive demographical, clinical, paraclinical factorsfor functional and of quality of life, and surgical for in patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent at 1, 6 and 12 months follow-up |
| Oncological evaluation | 5 years | To evaluate predictive demographical, clinical, paraclinical, presurgical, functional and of quality of life, and surgical factors for overall survival, disease-free period and disease-free 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 |
| Subgroup analysis | 1 year | To explore functional and quality of life decline at 1, 6 and 12 months follow-up by subgroups according to decade groups. |
| Internal validation | 1 year | To perform an internal validation of a predictive model for functional and quality of life decline at 12 months follow-up in patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent |
Countries
Colombia
Contacts
CONTACTCamilo Ramírez-Giraldo, Surgeon
Outcome results
None listed