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This study is an observational research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy | (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 | Baseline |
| Specificity |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | the sum percentage of participants with CR and PR assessed by RECIST v1.1 criteria every 8-12 weeks. | 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 |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital | Chengdu | Sichuan | 610000 | China |
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|
| 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. |
|
| Comprehensive Geriatric Assessment (CGA) | Other | The participants screened as a high frailty risk will undergo CGA to determine the most appropriate treatment plan. |
|
(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)
| Baseline |
Systemic Progression-Free Survival assessed by the investigators using RECIST V1.1. |
| 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 | Number and percentage of patents with treatment-related adverse events assessed by CTCAE v5.0. | 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. |
| ID | Term |
|---|---|
| D015577 | Geriatric Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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