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
NCT ID: NCT06781905
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2025-01-16
2027-05-09
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with ALK/ROS1-positive lung cancer treated with anti-ITK-ALK/ROS1 reporting neurocognitive
Patients presenting a cognitive and/or neuropsychiatric complaint (i.e. patients reporting a subjective loss of their cognitive abilities and/or the appearance of neuropsychiatric symptoms) and/or patients identified by a carer or relative as presenting cognitive impairment and/or neuropsychiatric symptoms.
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 psychosocial assessments by a team of social psychologists using a comprehensive qualitative and quantitative approach to quality of life: daily life management, social relationships, and self-image and self-esteem. The collected data will be subjected to a reflexive thematic analysis. The qualitative exploration of quality of life will be complemented by a quantitative assessment using a standardized tool (EORTC QLQ LC13 and C30).
Interventions
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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 psychosocial assessments by a team of social psychologists using a comprehensive qualitative and quantitative approach to quality of life: daily life management, social relationships, and self-image and self-esteem. The collected data will be subjected to a reflexive thematic analysis. The qualitative exploration of quality of life will be complemented by a quantitative assessment using a standardized tool (EORTC QLQ LC13 and C30).
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Day care Hospital, Pierre Wertheimer Hospital, Civil Hospitals of Lyon
Bron, , France
Pneumology service, Louis Pradel Hospital, Civil Hospitals of Lyon
Bron, , France
Countries
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Central Contacts
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Facility Contacts
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Virginie DESESTRET, Professor
Role: primary
Michale DURUISSEAUX, Professor
Role: primary
Other Identifiers
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2024-A02274-43
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL24_0158
Identifier Type: -
Identifier Source: org_study_id