- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03846999
Comorbidities and Health Care Services Utilisation Among Long-term Breast Cancer Survivors (SURBCAN)
Обзор исследования
Статус
Условия
Подробное описание
The general objective of this study is to analyze the pattern of comorbidities and utilization of primary care officers and specialized attention of long-term breast cancer survivors and to compare it with women without history of cancer. Long-term breast cancer survivors are those women who survived for at least five years since de primary breast cancer diagnosis.The use of health care services for long-term breast cancer survivors presents new challenges for health systems in terms of defining the role of each health professional and each level of care in contact with these women during their follow-up.
The SURBCAN Project is an observational study that includes a retrospective cohort of women from five Spanish areas. The study is based on Real World Data from clinical history and tumor registration. Women with a diagnosis of breast cancer and a survival period of ≥ 5 years were identified, as well as those women without a cancer diagnosis and matched by age and area with breast cancer survivors (1:2). N= 21639 women (7241 cases /13,398 controls). Sociodemographic and clinical variables were included. The use of primary care and hospital attention and the presence of comorbidities were assessed during the follow-up period (2012-2016). The basal cohort, the comorbidities and the use of health services were described. Factors associated with use were analyzed through multi-level logistic regression models.
Expected results: Nowadays there are no results of cohort analysis that focus specifically in long-term breast cancer survivors. The SURBCAN study will provide evidence regarding comorbidity patterns and follow-up characteristics. The results will guide the elaboration of new recommendations and the decision making by stakeholders concerned to breast cancer survivor's follow-up.
This project combines the experience from experts groups in health services assessment, and analysis of comorbidities and chronic diseases, belonging to the REDISSEC network.
Тип исследования
Регистрация (Действительный)
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- >18 years old
- Women diagnosed with an incident breast cancer during the period from 01/01/2000 until 31/12/2006 who survived for at least 5 years.
- Women who visited at least once the primary health services during follow-up period (01/01/2012 to 31/12/2016).
Exclusion Criteria:
- Unknown diagnostic year
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
---|
Long-term breast cancer survivors
Analyze comorbidities and patterns of use of health services. Describe the specific use of health services in primary care vs. specialized care. Analyze comorbidities and patterns of use of health services by tumor characteristics. |
Women without history of cancer
Analyze comorbidities and patterns of use of health services.
Describe the specific use of health services in primary care vs. specialized care.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Frequency of comorbidities
Временное ограничение: 5 years of survival
|
Number of comorbidities of each woman at five-year survival from breast cancer.
Assessed through ICD10.
|
5 years of survival
|
Frequency of visits to healthcare services
Временное ограничение: 5 years of survival
|
Number of visits to primary care attention or specialised attention done by each women at five-year survival from breast cancer.
|
5 years of survival
|
Main health provider visited
Временное ограничение: 5 years of survival
|
Leading provider of health services (GP, oncologist, community nurse, oncology nurse, physiotherapist...) of each women at five-year survival from breast cancer.
|
5 years of survival
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Frequency of visits to primary care attention
Временное ограничение: at 5 years of survival
|
Number of visits to primary care attention done by each women at five-year survival from breast cancer.
|
at 5 years of survival
|
Frequency of visits to specialized care attention
Временное ограничение: at 5 years of survival
|
Number of visits to specialised attention done by each women at five-year survival from breast cancer.
|
at 5 years of survival
|
Annual mammogram frequency
Временное ограничение: 1 year
|
Assessment of the percentage of women who have a mammogram every year.
|
1 year
|
Соавторы и исследователи
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- SURBCAN Project
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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