Development and Verification of a Screening Tool for Comprehensive Geriatric Assessment of Elderly Tumor Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Screening of comprehensive geriatic assessment., the G8 assessment, Comprehensive Geriatric Assessment (CGA).
- Who it may be relevant to
- Registry conditions: Geriatric Assessment, Geriatric Patients, Patients With Cancer, Assessment Tool. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Screening of comprehensive geriatic assessment.
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. - Other the G8 assessment
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. - Other Comprehensive Geriatric Assessment (CGA)
The participants screened as a high frailty risk will undergo CGA to determine the most appropriate treatment plan.
Primary outcome measures
- Sensitivity [Time frame: Baseline]
Secondary outcome measures (2)
- Accuracy [Time frame: Baseline]
- Specificity [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Unable to understand the content of the research
- Unable to cooperate with CGA and screening assessments
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Sichuan Cancer Hospital — Chengdu
Identifiers
NCT: NCT06761534 · EK2023004