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Not Yet RecruitingNCT07487298

G8 Screening Tool Validation in Older Adults With Cancer in Portugal

Prospective Validation of the G8 Geriatric Screening Tool in Older Adults With Cancer in Portugal (G8-PT Study)

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
Hospital de Braga · Academic / Other
Sex
All
Age
70 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERG8 Screening ToolThe 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.
OTHERComprehensive Geriatric AssessmentA multidimensional diagnostic process used to evaluate frailty across multiple domains including functional, cognitive, nutritional, and social status.

Timeline

Start date
2026-03-20
Primary completion
2027-06-30
Completion
2027-12-15
First posted
2026-03-23
Last updated
2026-03-23

Locations

1 site across 1 country: Portugal

Source: ClinicalTrials.gov record NCT07487298. Inclusion in this directory is not an endorsement.