Меню
Набор скоро начнётся NCT06890091

Study of the Association Between Fatigue Experienced by Patients and the Specific Side Effects of CART Cells, During the First Month After Administration for Non-Hodgkin's Lymphoma

— Наблюдательное Fatigue Symptom Lymphoma Non-Hodgkin Chimeric Antigen Receptor T-cell Therapy Adverse Events

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: Fatigue assessment.
Кому может быть актуально
Состояния в реестре: Fatigue Symptom, Lymphoma Non-Hodgkin, Chimeric Antigen Receptor T-cell Therapy, Adverse Events. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
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

Etude de l'Association Entre la Fatigue Ressentie Par Les Patients et Les Effets Secondaires spécifiques Des CART Cells, au Cours du Premier Mois après l'Administration Pour un Lymphome Non Hodgkinien

Обзор

The incidence of cancer in 2023 is estimated at 433136 cases, according to INCa. Haemopathies account for 12% of these new cases of cancer cases of cancer, and around two-thirds are lymphoid haemopathies, in particular lymphomas. There are many treatments available for lymphoma. However, the arrival in France in 2018 of immunotherapy treatments such as CAR-T Cells have changed the paradigm of treatment options for certain non-Hodgkin's lymphomas. In these treatments can have both short-term and long-term adverse effects and long-term adverse effects. During hospitalisation for the administration of CAR-T Cells, acute side effects include CRS and ICANS. There is also another complication very specific to this treatment that has been observed in patients: cytopenias. This is despite the fact that one of the symptoms frequently mentioned and felt by patients during the first month after month after treatment is fatigue. Despite numerous studies on the prevalence of fatigue, healthcare professionals often underestimate this symptom. Nurses, and in particular the advanced practice nurse have a crucial role to play in assessing fatigue. The EORTC scale QLQ-FA12 is a multidimensional scale which assesses the physical emotional and cognitive dimensions of fatigue. The theory of symptom management, which was developed in 1994 by the California College of Nursing in San Francisco, is a relevant framework for understanding fatigue in patients. This theory places the patient's experience at the centre of care. This holistic approach provides a detailed framework for understanding this symptom. "According to the theoretical model, measuring the symptom is an important step and characterising it is an essential element in better targeting the actions to be taken". Although CAR-T Cell therapy is innovative and allows long-term remissions, it is important to evaluate and understand how patients live with this treatment. To our knowledge, few studies have been carried out on quality of life, particularly regarding fatigue, following the first month of CAR-T Cell administration. The research question we will address in this study is: "Is there an association between the side effects of CAR-T Cell treatment and the state of fatigue in patients receiving this treatment for non-Hodgkin's lymphoma during the first month?"

Вмешательства

  • Другое Fatigue assessment
    Fatigue score measured by the EORTC QLQ-FA 12 fatigue self-assessment scale

Первичные конечные точки

  • Fatigue score [Срок оценки: At day 30]
Вторичные конечные точки (12)
  • Fatigue score [Срок оценки: At inclusion]
  • Fatigue score [Срок оценки: At day 2]
  • Fatigue score [Срок оценки: At day 10]
  • Fatigue score [Срок оценки: At day 21]
  • Physical Fatigue subscore [Срок оценки: At inclusion]
  • Physical Fatigue subscore [Срок оценки: At day 2]
  • Physical Fatigue subscore [Срок оценки: At day 10]
  • Physical Fatigue subscore [Срок оценки: At day 21]
  • Physical Fatigue subscore [Срок оценки: At day 30]
  • Cognitive Fatigue subscore [Срок оценки: At inclusion]
  • Cognitive Fatigue subscore [Срок оценки: At 2 days]
  • Cognitive Fatigue subscore [Срок оценки: At 10 days]

Критерии участия

Критерии включения

  • Adult (age> 18year old)
  • Person hospitalised for treatment with CAR-T Cells for non-Hodgkin's lymphoma.
  • Person able to understand and read the French language.

Критерии исключения

  • Patient under legal protection
  • Opposition to research

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06890091 · APHP241779

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗