Development and Verification of a Screening Tool for Comprehensive Geriatric Assessment of Elderly Tumor Patients

• Conditions: Geriatric Assessment; Geriatric Patients; Patients With Cancer; Assessment Tool

• Registration Number: NCT06761534
• Lead Sponsor: Sichuan Cancer Hospital and Research Institute

Brief Summary

This study is an observational research.

1. The study first conducted an electronic questionnaire survey among clinicians working in general and specialized hospitals at various levels nationwide to understand the implementation status and influencing factors of comprehensive geriatric assessment (CGA) for elderly cancer patients in China.

2. Based on the survey results, an interview outline was developed, and semi-structured interviews were conducted with professional doctors experienced in the diagnosis and treatment of elderly cancer patients to further explore the comprehensive factors influencing the implementation of CGA for this population.

3. According to the feedback from the semi-structured interviews, the survey results, and literature reports, the assessment dimensions required for the CGA screening tool were selected. An expert consultation survey questionnaire was designed around these dimensions, and the most suitable assessment items under each dimension were determined using the Delphi expert consultation method.

4. The G8 scale was used to assess elderly cancer patients. Items were selected based on their performance to form the screening tool. By setting thresholds and allocating weights for each item, CGA Screening Tool 1.0 was developed.

5. Pre-testing and modification of the screening tool were conducted. Investigators used the initially formed screening tool to conduct one-on-one patient testing. Feedback on the tool's clarity, relevance, clinical applicability (localization), and feasibility was obtained through consultation with a clinical expert panel to improve and refine its content and management process. This led to the revision and formation of CGA Screening Tool 2.0.

6. The reliability and validity of the CGA screening tool were verified using classical measurement theory to ensure the stability, reliability, and effectiveness of the scale tool in practical applications.

7. Patients were assessed using both CGA and the screening tool. External validation of Screening Tool 2.0 was performed using CGA as the gold standard to further evaluate the sensitivity, specificity, and accuracy of the screening tool.

8. Patients who participated in the assessment during the study were followed up to compare the correlation between different assessment results and patient completion of anti-tumor treatment, treatment efficacy, and the risk of related adverse reactions. The impact of the CGA screening tool on the implementation of CGA and its predictive ability for anti-tumor treatment were explored. Study data were obtained from the electronic medical record database and hospital information system of Sichuan Cancer Hospital, including clinicopathological features such as gender, age, clinical stage at diagnosis, and information related to anti-tumor treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-28
• Study First Submitted QC: 2025-01-05
• Study First Posted: 2025-01-07
• Study Start: 2025-02-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-12-15
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 678

Inclusion Criteria

1. Age ≥ 65 years old
2. There are clear pathological data to diagnose malignant tumors, and follow-up anti-tumor therapy is determined in this institution
3. Have a certain enthusiasm for this study, and voluntarily participate in this study

Exclusion Criteria

1. Unable to understand the content of the research
2. Unable to cooperate with CGA and screening assessments

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity	Baseline	(Truly frail elderly patients assessed by the novel screening tool and G8) / (Truly frail risk patients + elderly patients with negative results from novel screening tool but actually at risk of frailty after G8 assessment

Secondary Outcome Measures

Name	Time	Method
Accuracy	Baseline	(The number of elderly patients truly at risk of frailty assessed by the novel screening tool and G8 + the number of elderly patients truly without frailty risk) / Total number of elderly patients in the study
Specificity	Baseline	(True elderly patients without frailty risk assessed by the novel screening tool and G8) / (True patients without frailty risk + elderly patients with positive results from novel screening tool but actually without frailty risk after G8 screening)

Trial Locations

Locations (1)

Sichuan Cancer Hospital; 🇨🇳 Chengdu, Sichuan, China