Hospital de Braga (Unidade Local de Saúde de Braga)
Braga, Braga District, 4710-243, Portugal
NCT Number: NCT07487298
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.
Trial opening soon.
Get Notified70 year and older
All sexes
Observational
Braga, Braga District, 4710-243, Portugal
Older adults represent a growing proportion of the oncology population and are characterized by significant heterogeneity in functional status, comorbidities, and physiological reserve. These factors may influence treatment tolerance, toxicity, and clinical outcomes.
International guidelines from European Society for Medical Oncology (ESMO), American Society of Clinical Oncology (ASCO), and International Society of Geriatric Oncology (SIOG) recommend the use of geriatric assessment to guide treatment decisions in older adults with cancer. The Comprehensive Geriatric Assessment (CGA) is considered the reference standard for evaluating multiple health domains, including functional status, cognition, nutrition, psychological state, social support, and comorbidities. However, its routine implementation is limited by time and resource constraints.
The G8 screening tool is a rapid geriatric screening instrument developed specifically for older patients with cancer. It consists of eight items derived mainly from the Mini Nutritional Assessment, along with additional clinical parameters such as age, mobility, polypharmacy, and self-perceived health status. A score ≤14 is generally considered indicative of frailty and the need for further assessment.
Although the G8 has been validated in several international settings, prospective validation data in the Portuguese population are lacking.
This prospective observational study aims to evaluate the diagnostic accuracy of the G8 screening tool compared with a multidimensional CGA in older adults with cancer in Portugal. Frailty will be defined as impairment in at least one CGA domain.
To our knowledge, this study represents the first prospective validation of the G8 screening tool in Portuguese older adults with cancer. The results of this study may support the implementation of geriatric screening strategies and improve clinical decision-making in oncogeriatric care in Portugal.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The 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.
A multidimensional diagnostic process used to evaluate frailty across multiple domains including functional, cognitive, nutritional, and social status.
Time frame: At baseline (single assessment at study inclusion)
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.
Time frame: At baseline (single assessment at study inclusion)
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.
Time frame: At baseline (single assessment at study inclusion)
The level of agreement between the G8 screening tool and comprehensive geriatric assessment (CGA) will be evaluated using appropriate statistical measures, including concordance statistics.
Time frame: At baseline (single assessment at study inclusion)
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.
Contact information is provided by the study sponsor or research team.
Hospital de Braga
Other
Prospective Validation of the G8 Geriatric Screening Tool in Older Adults With Cancer in Portugal (G8-PT Study)
Acronym: G8-PT
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