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Description of Neurocognitive and Psychiatric Disorders Linked to Targeted Therapies in ALK/ROS1-Positive Lung Cancer and Their Impact on Quality of Life: Developing a Collaborative Patient-Researcher Care and Research Pathway
Led by Hospices Civils de Lyon · Updated on 2025-12-30
20
Participants Needed
2
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying neurocognitive and psychiatric disorders linked to targeted cancer therapies used for metastatic lung cancer with ALK/ROS1 fusion. These therapies, which inhibit specific proteins, have improved survival but may cause cognitive and mood problems more severe than those seen with chemotherapy. The study aims to describe these disorders through detailed assessments and understand their impact on patients' quality of life using a collaborative approach involving patients, researchers, and clinicians. Participants who have ALK/ROS1-positive lung cancer treated with anti-ITK-ALK/ROS1 therapies and report cognitive or psychiatric complaints undergo thorough evaluations. These assessments take place over one or two days, including neuropsychiatric and neurocognitive testing by specialists, and psychosocial evaluations either in person or remotely using questionnaires about daily life and social relationships. Data collected will be analyzed both qualitatively and quantitatively to capture the full patient experience. During the study, participants will have detailed visits involving psychiatrists, neuropsychologists, neurologists, and social psychologists. Assessments include clinical evaluations, standardized quality of life questionnaires, and interviews to explore the effects of treatment-related complaints on daily living. The main outcome is the characterization of neurocognitive and neuropsychiatric symptoms linked to the targeted therapies. Participation continues from enrollment through the completion of these evaluations, helping to better understand and support affected patients.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 neurocognitive and/or neuropsychiatric disorders related to the treatment
You will not qualify if you...
- History of neurocognitive and/or neuropsychiatric disorders prior to starting anti-ITK-ALK/ROS1 therapy, excluding those linked to cancer treatments
- Uncontrolled brain metastases or carcinomatous meningitis requiring corticosteroids
- Insufficient French proficiency to complete assessments
- Severe, progressive, or unstable medical conditions affecting evaluations (e.g., uncontrolled epilepsy, acute psychiatric disorders, visual hallucinations, acute infection)
- Use of toxic substances that may affect cognitive testing
- Deafness or blindness impairing participation
- Refusal or inability to provide consent to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 days
Participants undergo neuropsychiatric, neurocognitive, and psychosocial assessments conducted by a psychiatrist, neuropsychologist, neurologist, and social psychologists, which may be completed over two consecutive days or separate visits depending on participant preference.
1 or 2 visits (in-person and/or remote)
Trial Site Locations
Total: 2 locations
1
Day care Hospital, Pierre Wertheimer Hospital, Civil Hospitals of Lyon
Bron, France, 69500
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2
Pneumology service, Louis Pradel Hospital, Civil Hospitals of Lyon
Bron, France, 69500
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Research Team
M
Michael DURUISSEAUX, Professor
V
Virginie DESESTRET, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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