Integrating Geriatric 8 (G8) Screening and Cancer and Age Research Group (CARG) Toxicity Assessment Score Into Routine Care for Older Adults With Cancer
Integrating Geriatric 8 (G8) Screening and Cancer and Age Research Group (CARG) Toxicity Assessment Score Into Routine Oncology Care for Older Adults With Cancer
This study evaluates whether using specialized geriatric screening and toxicity prediction tools can help oncologists personalize chemotherapy dosing and reduce severe side effects in older adults with solid cancers.
Older adults with cancer have diverse levels of physical resilience and functional reserve that standard oncologic performance scores often miss. Consequently, uniform standard chemotherapy dosing can lead to severe, life-threatening toxicities, unplanned hospitalizations, or early treatment discontinuation.
In this prospective-retrospective comparative study, patients aged 65 years and older who are starting chemotherapy are prospectively evaluated using the Geriatric 8 (G8) screening tool. Patients identified as vulnerable (G8 score ≤ 14) undergo a Comprehensive Geriatric Assessment (CGA) across functional, nutritional, cognitive, and psychological domains. In addition, all prospective participants are evaluated using the Cancer and Age Research Group (CARG) toxicity tool to calculate their risk of severe side effects. Chemotherapy doses are risk-adapted based on CARG scores:
- Low Risk: Standard chemotherapy dose
- Intermediate Risk: 20% dose reduction
- High Risk: 50% dose reduction
Participants are followed every 3 months for 1 year to evaluate treatment tolerance, adherence, tumor response, and survival. These outcomes will be compared against a historical retrospective cohort of older patients with solid tumors who received standard-dose chemotherapy without G8 screening or CARG toxicity risk stratification.
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Older adult patients (aged 65 years and older) with confirmed solid malignancies who are scheduled to initiate chemotherapy at the Clinical Oncology Department, Assiut University Hospitals, Faculty of Medicine. The population comprises prospectively presenting patients undergoing oncogeriatric screening and risk-adapted chemotherapy, alongside a historical control cohort of comparable older patients previously treated at the same center.
Описание
Inclusion Criteria:
- Age 65 years or older
- Confirmed diagnosis of any solid malignancy
- Scheduled to initiate cytotoxic chemotherapy
Exclusion Criteria:
- Hematological malignancies (e.g., leukemia, lymphoma)
- Treatment plans consisting exclusively of non-chemotherapy modalities (e.g., endocrine therapy, immunotherapy monotherapy, or radiotherapy alone)
- Incomplete or missing medical records (applicable to the retrospective historical control cohort)
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: OTHER
Когорты и вмешательства
Группа / когорта |
|---|
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Prospective G8/CARG-Guided Cohort
Older adult patients (aged ≥ 65 years) with solid malignancies prospectively evaluated prior to chemotherapy using the Geriatric 8 (G8) screening tool (scores ≤ 14 trigger a Comprehensive Geriatric Assessment) and the Cancer and Age Research Group (CARG) toxicity calculator. Chemotherapy dosing is risk-adapted: standard dose for low risk (CARG 0-5), a 20% dose reduction for intermediate risk (CARG 6-9), and a 50% dose reduction for high risk (CARG ≥ 10). Patients undergo periodic clinical, geriatric, and radiological evaluations every 3 months for 1 year. |
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Retrospective Historical Control Cohort
A historical control cohort of older adult cancer patients (aged ≥ 65 years) with comparable solid malignancies treated with standard-dose chemotherapy prior to the institutional implementation of routine G8 screening and CARG toxicity risk assessment. Treatment-related toxicities, treatment completion, tumor response, and survival outcomes are collected retrospectively from medical records. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage of Participants With Grade 3 to 5 Chemotherapy-Related Toxicities
Временное ограничение: Up to 12 months
|
Percentage of participants who experience at least one severe, life-threatening, or fatal (Grade 3, 4, or 5) adverse event related to chemotherapy. Toxicities are evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) criteria. |
Up to 12 months
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- G8 and CARG Toxicity in Cancer
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