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

NCT06761534 | Enrolling By Invitation DMC

• 1 other identifier: EK2023004
• Study Type: observational
• Target: 678
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an observational research.

1. 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. 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. 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. 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. 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. 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. 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. 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.

Conditions

Geriatric Assessment; Geriatric Patients; Patients With Cancer; Assessment Tool

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  (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

  Baseline

Secondary Outcomes (2)

• Accuracy

  Baseline

• Specificity

  Baseline

Other Outcomes (3)

• ORR

  From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or the end of study, whichever came first, assessed up to 12 months.

• PFS

  From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or death or the end of study, whichever came first, assessed up to 12 months.

• AE

  From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or death or the end of study, whichever came first, assessed up to 12 months.

Study Arms (1)

Elderly cancer patients

Elderly cancer patients were assessed with the screening tool and G8. If the patient's screening result is positive (frailty risk population), continue with the CGA.

Other: Screening of comprehensive geriatic assessment.; Other: the G8 assessment; Other: Comprehensive Geriatric Assessment (CGA)

Interventions

Screening of comprehensive geriatic assessment. OTHER

The participants are screened before anti-tumor therapy with a comprehensive assessment screening tool developed for elderly cancer patients, which is more suitable for individualized decision-making in anti-tumor treatment.

Elderly cancer patients

the G8 assessment OTHER

The G8 is a rapid geriatric screening test that takes only a few minutes to complete. It is used as a calibration standard to validate the novel screening tool in this study.

Elderly cancer patients

Comprehensive Geriatric Assessment (CGA) OTHER

The participants screened as a high frailty risk will undergo CGA to determine the most appropriate treatment plan.

Elderly cancer patients

Eligibility Criteria

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

Study Population

Among all participants, 316 were used to develop the screening tool, 10 for the pre-testing, and 132 for the reliability and validity testing of the screening scale. After the scale was completed, the remaining 220 patients were used for the external validation of the tool. Finally, all patients evaluated using the screening tool were grouped according to different screening results, and the treatment effects and risks among the groups were compared.

You may qualify if:

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

You may not qualify if:

• Unable to understand the content of the research
• Unable to cooperate with CGA and screening assessments

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Interventions

Geriatric Assessment

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 7, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

CN (1)