Cancer and Aging Research Group (CARG) Chemotherapy Toxicity Risk Scores in Older Adults With Cancer in China
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: Chemotherapy.
- Кому может быть актуально
- Состояния в реестре: Cancer, Cancer-related Problem/Condition. Базовые параметры: от 70 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Correlation of the Cancer and Aging Research Group (CARG) Chemotherapy Toxicity Risk Scores and Unplanned Hospitalizations in Older Cancer Patients--A Multi-center Prospective Cohort Study
Обзор
The goal of this observational study is to learn about the impact of chemotherapy-related toxicity on older cancer patients in China. The main question it aims to answer is: Does the Cancer and Aging Research Group (CARG) chemotherapy toxicity risk score predict chemotherapy-related toxicity in Chinese cancer patients over age 70? Participants over age 70 on systemic chemotherapy will answer questions listed in the CARG chemotherapy toxicity risk tool.
Подробное описание
Study Background:
There's a high burden of cancer in the geriatric population. Because of factors such as declining organ function, older adults with cancer generally have lower tolerability of chemotherapy than younger patients. In cancer patients aged ≥ 70 years, chemotherapy-related toxic effects were associated with reduced quality of life and/or decreased physical functioning or death after 1 year. Identifying of older patients at high risk of experiencing chemotherapy-related adverse events is one of the key components for developing new prevention and intervention strategies to improve treatment outcomes in older adults with cancer. The CARG toxicity score prediction model and calculator established by the Cancer and Aging Research Group (CARG) in 2011 is widely used in many countries and regions around the world and are recommended by several international guidelines. However, data from older adults with cancer in China are scarce. Prospective studies exploring the correlation between the CARG chemotherapy risk score and unplanned hospitalizations are limited.
Study Objectives:
* To assess the predictive value of the CARG chemotherapy toxicity risk score in older adults with cancer in China * To explore the correlation between the CARG scores and the unplanned hospitalizations
Study Method:
This is a multi-center prospective cohort study to collect data from cancer patients aged ≥ 70 years from Renji Hospital and Henan Cancer Hospital. Patients will complete the CARG chemotherapy toxicity risk score questionnaires upon initiating a new chemotherapy regimen. The demographics, tumor characteristics (type of cancer and stage), clinical characteristics (e.g. ECOG performance status, NRS-2002 score, and comorbidities), and cancer treatment (e.g. chemotherapy regimen, line of treatment, combined targeted and/or immunotherapy) will be documented for the baseline evaluation. Toxicity, unplanned hospitalization events, and completion of chemotherapy treatment will be assessed for each visit.
Вмешательства
- Препарат Chemotherapy
Admission to the hospital for a new chemotherapy regimen (initial or change)
Первичные конечные точки
- Number of Participants with Grade 3-5 Chemotherapy-Related Adverse Events as Assessed by CTCAE v4.0 [Срок оценки: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy]
- Number of Participants with Unplanned Hospitalization Events [Срок оценки: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy]
Вторичные конечные точки (5)
- Number of Participants with Treatment Discontinuation Events [Срок оценки: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy]
- Number of Participants with Dose Reduction Events [Срок оценки: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy]
- Number of Participants with Dose Delay Events [Срок оценки: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy]
- Number of Participants with Dose Missing Events [Срок оценки: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy]
- Number of Participants with Events of Reduction in Relative Dose Intensity (RDI) [Срок оценки: Each planned admission/unplanned hospitalization until 1 month after completion of chemotherapy or 6 months after the start of chemotherapy]
Критерии участия
Критерии включения
- Age≥ 70 years old
- Confirmed diagnosis of solid tumor (any stage)
- ECOG-PS score 0-2 points
- Admission to the hospital for a new chemotherapy regimen (initial or change)
- Patients need to have the ability to read and write, or communicate in Chinese
- The patient must have the ability to give informed consent.
Критерии исключения
- Patients who are on immunotherapy and/or targeted therapy only
- Patients with hematologic malignancy
- Patients with severe infections (sepsis, severe respiratory tract infections, severe urinary tract infections, severe abdominal infections, etc.).
- Patients with severe heart, liver, and kidney dysfunction or failure
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 · 2 центра
- Henan Cancer Hospital — Чжэнчжоу
- Renji Hospital — Шанхай
Идентификаторы
NCT: NCT06717178 · LY2024-267-B