Description of Neurocognitive and Psychiatric Disorders Associated With Targeted Therapies Used in the Treatment of Lung Cancers With ALK/ROS1 Fusion and Their Impact on Patients' Quality of Life: Construction of an Experimental Patient-researcher Collaborative Care and Research Pathway

Обзор

Targeted cancer therapies have a higher therapeutic index than chemotherapy and are prescribed to tens of thousands of patients in France each year. These treatments modify often ubiquitous signaling pathways involved in neuronal synaptic plasticity, the cellular substrate of cognitive and psychiatric functions. Neurocognitive and psychiatric disorders associated with targeted therapies are poorly described and therefore still poorly understood, although they appear to be clinically more severe than chemobrain (neurocognitive disorders related to chemotherapy). The case of patients with metastatic lung cancer with ALK/ROS1 fusion is emblematic. These cancers are treated very effectively with oral targeted therapies inhibiting the tyrosine kinase activity of ALK or ROS1 proteins (ITK-ALK/ROS1), with survival that can exceed 10 years. However, neurocognitive and psychiatric disorders associated with anti-ITK-ALK/ROS1 are reported in 7 to 60% of patients, with a prevalence of about 10% with anti-ITK-ALK/ROS1 brigatinib or alectinib and up to 53% with lorlatinib in industrial therapeutic trials. These disorders appear to be particularly frequent and severe with lorlatinib, including cognitive disorders - especially memory - mood disorders such as anxiety, depression and emotional lability, and psychotic disorders. Current therapeutic trials and care pathways are not designed to take into account these side effects related to anti-ITK-ALK/ROS1. Their incidence is therefore probably underestimated. The DRACONIS project aims to: (1) describe the complaints +/- neurocognitive and neuropsychiatric disorders associated with anti-ITK-ALK/ROS1 through a rigorous neuropsychological and psychiatric evaluation (i.e. patient phenotyping) and (2) understand the experience of complaints +/- neurocognitive and neuropsychiatric disorders associated with anti-ITK-ALK/ROS1 and their consequences on patients' quality of life in a comprehensive approach. The DRACONIS project is part of a multidisciplinary and collaborative approach through the establishment of a partnership between researchers, clinicians and representatives of the anti-ITK-ALK/ROS1 France Cancer du Poumon patient association. The project is notably monitored by a joint scientific committee composed of researchers, clinicians, patients and patient caregivers.

Вмешательства

• Другое Assessments of neuropsychiatric, neurocognitive and psychosocial alterations
  Assessments will be conducted over two consecutive days or on a separate visit, depending on participant preferences and logistical constraints. The first day will focus on the evaluation of neuropsychiatric and neurocognitive alterations. A comprehensive assessment involving various tools will be carried out by a psychiatrist, a neuropsychologist, and a neurologist. The second day, which may take place on-site or remotely (by telephone or secure videoconference), will be dedicated to psychosoci

Первичные конечные точки

• Neurocognitive and neuropsychiatric characterization of patients on anti-ITK-ALK/ROS1 targeted therapy who reported treatment-releated neurocognitive and/or neuropsychiatric complaints or disorders [Срок оценки: From enrollmenet day 1 visite to the end of the participation, day 2.]

Критерии участия

Критерии включения

• Adult patients aged 18 years or older, fluent in French
• Currently treated with anti-ITK-ALK/ROS1 for ALK/ROS1-positive lung cancer
• Identified by the prescribing physician as having complaints with or without associated neurocognitive and/or neuropsychiatric disorders related to the treatment.

Критерии исключения

• History of neurocognitive and/or neuropsychiatric disorders prior to initiation of anti-ITK-ALK/ROS1 targeted therapy, excluding disorders associated with anti-ITK-ALK/ROS1 or other systemic anticancer treatments
• Patients with uncontrolled brain metastases or carcinomatous meningitis (requiring symptomatic treatment with corticosteroids progressive or symptomatic)
• Patients who do not have sufficient proficiency in French to complete questionnaires and/or participate in semi-structured interviews
• Severe, progressive or unstable medical conditions that may interfere with the evaluation variables (uncontrolled epilepsy, acute psychiatric or psychotic disorders, visual hallucinations, acute infection).
• Consumption of toxic substances that may affect cognitive performance
• Deafness or blindness that may compromise participant evaluation or participation in tasks and scales
• Patients who refuse to participate in the study or are unable to express thein non-opposition to participating in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 2 центра

• Day care Hospital, Pierre Wertheimer Hospital, Civil Hospitals of Lyon — Bron
• Pneumology service, Louis Pradel Hospital, Civil Hospitals of Lyon — Bron

Идентификаторы

NCT: NCT06781905 · 69HCL24_0158 · 2024-A02274-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗