About this trial
The G8 screening tool is widely recommended for the identification of frailty in older adults with cancer. However, prospective validation data in the Portuguese population are currently lacking.
This prospective observational study aims to evaluate the diagnostic performance of the G8 screening tool compared with a Comprehensive Geriatric Assessment (CGA) in older adults with cancer. Patients aged ≥70 years with solid tumors will be assessed using both the G8 screening tool and a multidimensional CGA. Frailty will be defined as impairment in at least one CGA domain. The performance of the G8 will be evaluated in terms of sensitivity, specificity, and area under the receiver operating characteristic curve.
This study aims to provide the first prospective validation of the G8 screening tool in Portuguese older adults with cancer and to support its implementation in clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥70 years;
Histologically confirmed solid malignancy, regardless of tumor site or stage;
Referral to a multidisciplinary geriatric oncology consultation;
Consideration for or planned systemic anticancer treatment;
Disqualifiers
Age <70 years;
Diagnosis of hematological malignancy (e.g., leukemia, lymphoma, multiple myeloma);
Severe cognitive impairment precluding completion of assessment tools without available caregiver support;
Clinical instability or acute condition preventing data collection (e.g., hospitalization for acute complication);
Trial population
Older adults (≥70 years) with solid malignancies referred for multidisciplinary geriatric oncology evaluation and considered for systemic anticancer treatment.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
G8 Screening Tool
Other interventionThe G8 is a screening tool used to identify frailty in older patients with cancer and to select those who may benefit from a comprehensive geriatric assessment.
Comprehensive Geriatric Assessment
Other interventionA multidimensional diagnostic process used to evaluate frailty across multiple domains including functional, cognitive, nutritional, and social status.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic Accuracy of the G8 Screening Tool for Detecting Frailty
The diagnostic performance of the G8 screening tool will be evaluated against comprehensive geriatric assessment (CGA) as the reference standard. Measures will include sensitivity, specificity, positive predictive value, and negative predictive value for identifying frailty.
Secondary outcomes
Prevalence of Frailty Based on Comprehensive Geriatric Assessment
The prevalence of frailty will be determined based on comprehensive geriatric assessment (CGA), defined as the presence of at least one impaired domain according to predefined criteria.
Agreement Between G8 Screening Tool and Comprehensive Geriatric Assessment
The level of agreement between the G8 screening tool and comprehensive geriatric assessment (CGA) will be evaluated using appropriate statistical measures, including concordance statistics.
Discriminative Ability of the G8 Screening Tool (ROC Curve Analysis)
The discriminative performance of the G8 screening tool for identifying frailty will be assessed using receiver operating characteristic (ROC) curve analysis, including calculation of the area under the curve (AUC) and identification of optimal cut-off values.
Sponsors and contacts
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