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Набор по приглашению NCT06761534

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

Наблюдательное Geriatric Assessment Geriatric Patients Patients With Cancer Assessment Tool

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Screening of comprehensive geriatic assessment., the G8 assessment, Comprehensive Geriatric Assessment (CGA).
Кому может быть актуально
Состояния в реестре: Geriatric Assessment, Geriatric Patients, Patients With Cancer, Assessment Tool. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Вмешательства

  • Другое 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.
  • Другое 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.
  • Другое Comprehensive Geriatric Assessment (CGA)
    The participants screened as a high frailty risk will undergo CGA to determine the most appropriate treatment plan.

Первичные конечные точки

  • Sensitivity [Срок оценки: Baseline]
Вторичные конечные точки (2)
  • Accuracy [Срок оценки: Baseline]
  • Specificity [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Sichuan Cancer Hospital — Чэнду

Идентификаторы

NCT: NCT06761534 · EK2023004

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗