G8 Screening Tool Validation in Older Adults With Cancer in Portugal

NCT07487298 | Not Yet Recruiting

• 1 other identifier: G8-PT-ULSB
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Frailty; Aged

Keywords

G8 screening tool; geriatric screening; oncogeriatrics; frailty; comprehensive geriatric assessment; CGA; older adults with cancer; geriatric oncology; frailty screening; G8 validation

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline (single assessment at study inclusion)

Secondary Outcomes (3)

• Prevalence of Frailty Based on Comprehensive Geriatric Assessment

  At baseline (single assessment at study inclusion)

• Agreement Between G8 Screening Tool and Comprehensive Geriatric Assessment

  At baseline (single assessment at study inclusion)

• Discriminative Ability of the G8 Screening Tool (ROC Curve Analysis)

  At baseline (single assessment at study inclusion)

Study Arms (1)

Older Adults With Cancer

Patients aged ≥70 years with a diagnosis of cancer undergoing geriatric assessment, including G8 screening and comprehensive geriatric assessment.

Other: G8 Screening Tool; Other: Comprehensive Geriatric Assessment

Interventions

G8 Screening Tool OTHER

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.

Older Adults With Cancer

Comprehensive Geriatric Assessment OTHER

A multidimensional diagnostic process used to evaluate frailty across multiple domains including functional, cognitive, nutritional, and social status.

Older Adults With Cancer

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults (≥70 years) with solid malignancies referred for multidisciplinary geriatric oncology evaluation and considered for systemic anticancer treatment.

You may qualify if:

• 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;
• Ability to understand and respond to assessment tools (G8 and comprehensive geriatric assessment), with or without caregiver assistance;
• Provision of written informed consent by the patient or legal representative.

You may not qualify if:

• 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);
• Refusal to participate or inability to provide informed consent.

Sponsors & Collaborators

• Hospital de Braga: lead

Study Sites (1)

Hospital de Braga (Unidade Local de Saúde de Braga)

Braga, Braga District, 4710-243, Portugal

Location

MeSH Terms

Conditions

Neoplasms; Frailty

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Catarina M Ferreira, MD

CONTACT

+351961139172; ana.c.ferreira@ulsb.min-saude.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

PT (1)