Cognition and Patients With Lung Cancer
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: Self-questionnaire, Cognitive tests, Assessment of the impact of social vulnerability on patient complaints.
- Кому может быть актуально
- Состояния в реестре: Localized, Operable Non-small Cell Lung Cancer. Базовые параметры: 18 лет — 74 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
- Франция
- 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
Observation of Cognitive Complaints in Patients With Localized, Operable Non-small Cell Lung Cancer
Обзор
Cognitive complaints in patients treated for cancer can impact their quality of life. Studies show that these cognitive complaints may have multifactorial origins and appear at different stages of the care pathway. In a population of patients treated for confirmed localized non-small cell lung cancer (NSCLC), this study aims to detect and monitor the onset of cognitive complaints over time. The timing of the complaints during the treatment, the cognitive functions affected (memory, attention, concentration…), as well as the perceived intensity of the discomfort, will be examined. The study also explores the influence of co-factors such as mood, fatigue, socio-cultural status, and level of social vulnerability on these cognitive complaints.
Подробное описание
Chemofog" is the term used to describe cognitive difficulties associated with cancer treatments, such as chemotherapy, radiotherapy, and surgery.
These difficulties may include problems with memory, executive functions, attention, orientation, verbal comprehension, and information processing speed, and can occur during and after treatment.
Although generally mild to moderate, they can limit patients' ability to return to work and manage daily tasks. These cognitive difficulties are often associated with mood changes and increased fatigue.
They significantly impair functional independence and quality of life for cancer patients.
A baseline assessment of cognitive function prior to treatment is essential. Various factors-such as age, medical or psychiatric history, social vulnerability, or other neurological and psychological risk factors-may preexist the cancer diagnosis.
Subsequently, the impact of the disease itself, the treatments, changes in socio-professional status, and increased or induced socioeconomic hardship, as well as psychological upheaval (such as receiving the diagnosis, anxiety, or family disruptions), may all lead to cognitive disturbances.
These disturbances, referred to as Cancer-Related Cognitive Impairment (CRCI), affect the quality of life of cancer survivors.
According to one study, 26% of lung cancer survivors present with CRCI.
Biological and genetic factors such as cellular senescence, inflammatory processes, and DNA damage are thought to play a role in the development of CRCI.
Current research seeks to identify relevant biomarkers of cognitive decline, such as cytokine levels, to better understand its mechanisms and improve its management.
Various risk factors for CRCI have been identified: advanced age, lower baseline cognitive functioning, and lack of physical activity.
Cognitive complaints have been recognized for more than 20 years and may affect up to 75% of cancer patients, regardless of cancer type.
Yet too few patients are informed of the existence of CRCI, even though awareness of these issues can directly impact their abilities-particularly in the professional sphere.
A French-language framework and international guidelines have been developed to help standardize cognitive assessment.
Nevertheless, the absence of methodological consensus on the selection of variables (biomarkers, cognitive tests, adjustment factors), measurements, analysis of results, and timing of evaluations leads to these difficulties being underdiagnosed.
Thus, further studies are needed to investigate this subject and ultimately implement appropriate management strategies.
Based on the recommendations of the Association Francophone des Soins Oncologiques de Support (AFSOS), which emphasize the importance of raising clinicians' awareness of the "chemofog/CRCI" issue-both to better define cognitive complaints and to propose appropriate management-our study aims to examine cognitive complaints in individuals diagnosed with confirmed, operable, localized non-small cell lung cancer (NSCLC).
Вмешательства
- Другое Self-questionnaire
FACT-Cog, HADS, FA12, EPICES, socio-professional and socio-demographic questionnaire - Другое Cognitive tests
Hopkins Verbal Learning Test (HVLT). Trail Making Test (TMT). Verbal fluency test. Digit memory WAIS-IV. - Другое Assessment of the impact of social vulnerability on patient complaints
EPICES at month 12
Первичные конечные точки
- To examine the onset, intensity and duration of the PCI (Perceived Cognitive Impairment) score [Срок оценки: 12 months]
Вторичные конечные точки (8)
- Determine whether there is a clinical and/or social phenotype associated with cognitive complaint. [Срок оценки: 12 months]
- Determine whether there is a clinical and/or social phenotype associated with mood [Срок оценки: 12 months]
- Determine whether there is a clinical and/or social phenotype associated with fatigue [Срок оценки: 12 months]
- Assessment of the impact of perioperative surgical and medical treatments on cognitive complaint [Срок оценки: 12 months]
- Assessment of the impact of perioperative surgical and medical treatments on mood. [Срок оценки: 12 months]
- Assessment of the impact of perioperative surgical and medical treatments on fatigue. [Срок оценки: 12 months]
- Objective assessment via cognitive tests of the impact of cancer, treatments and co-factors on patients' cognition [Срок оценки: 12 months]
- Assessment of the impact of social vulnerability on patient complaints [Срок оценки: 12 months]
Критерии участия
Критерии включения
- Adult patient aged 18 to 74 years
- Suspected or confirmed localized and operable non-small cell lung cancer (NSCLC)
- Surgical treatment with or without perioperative systemic medical therapy
- Ability to independently complete self-questionnaires via the Cleanweb platform
- Patients with access to a phone, tablet, or computer at home to complete the electronic self-questionnaires.
Критерии исключения
- Known pre-existing cognitive disorders
- Presence on the day of inclusion of one or more factors causing mental confusion: electrolyte imbalances, renal failure, hepatic failure, infections, bladder distension, fecal impaction
- Known psychiatric or neurological diseases (e.g., multiple sclerosis, Parkinson's disease, dementia, stroke, traumatic brain injury with loss of consciousness)
- Current use of neuroleptic treatments
- History of cancer treatment within the past 10 years
- Fibromyalgia
- Individuals who cannot read French or are not French-speaking
- Patients who have never attended school
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Франция · 1 центр
- Hôpital Cochin - Service de pneumologie — Paris
Идентификаторы
NCT: NCT07160751 · APHP250754