Observation of Cognitive Complaints in Patients With Localized, Operable Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To examine the onset, intensity and duration of the PCI (Perceived Cognitive Impairment) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
To examine the onset, intensity and duration of the PCI (Perceived Cognitive Impairment) score
时间窗: 12 months
Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) self-report questionnaire : min =0, max=132
次要结局
- Determine whether there is a clinical and/or social phenotype associated with cognitive complaint.(12 months)
- Determine whether there is a clinical and/or social phenotype associated with mood(12 months)
- Determine whether there is a clinical and/or social phenotype associated with fatigue(12 months)
- Assessment of the impact of perioperative surgical and medical treatments on cognitive complaint(12 months)
- Assessment of the impact of perioperative surgical and medical treatments on mood.(12 months)
- Assessment of the impact of perioperative surgical and medical treatments on fatigue.(12 months)
- Objective assessment via cognitive tests of the impact of cancer, treatments and co-factors on patients' cognition(12 months)
- Assessment of the impact of social vulnerability on patient complaints(12 months)